Urinary incontinence treatment device

Abstract

This device for urinary incontinence treatment comprises a sensor for detecting urination, a stimulation pad configured to apply a stimulus to a wearer, and a mechanical part. The mechanical part comprises: a stimulus generating unit that generates a signal causing the stimulation pad to apply a stimulus to a wearer; and a control unit for controlling the stimulus generating unit so as to generate the signal when the sensor detects urination. The stimulation pad comprises a first stimulation pad pair and a second stimulation pad pair. The stimulus generating unit supplies electrical signals with different frequencies ranging from 4,000 to 4,300 Hz to the respective stimulation pad pairs. The differences between the frequencies of the first stimulation pad pair and the frequencies of the second stimulation pad pair are set to fall within the range of 200-300 Hz and the range of 1-10 Hz. The position thereof is arranged such that the electrical signal applied by the first stimulation pad pair and the electrical signal applied by the second stimulation pad pair intersect within the body of the wearer and the interference waves reach the bladder.

Description

Technical Field

[0001] The present invention relates to a device for treating urinary incontinence.

Background Art

[0002] As a treatment method for urinary incontinence, electrostimulation therapy such as low-frequency therapy is known (see, for example, Patent Document 1). The low-frequency therapy performs low-frequency stimulation when not urinating and stimulates the afferent pathway in the spinal cord region to suppress the contraction of the urinary muscles and increase the volume of urine stored in the bladder (the amount of urine discharged at one time). As a treatment device for performing low-frequency stimulation, there are a type that performs low-frequency stimulation from the body surface and a type that is implanted into the body to directly stimulate the sacral nerves. In the type that performs low-frequency stimulation from the body surface, since the target to be stimulated is the bladder wall or the pelvic floor muscle group, the treatment effect is not stable and it cannot be said that it has been established as a treatment method. In addition, in the type implanted into the body, although it is effective in directly stimulating the nerves, there is a problem that placement by surgery is required and it is extremely invasive to the patient. The low-frequency stimulation by these treatment devices is usually performed about twice a day at fixed time intervals. However, since the timing of the low-frequency stimulation is when the bladder is stable and not incontinent, it has been difficult to obtain stability in the treatment effect.

Prior Art Documents

Patent Documents

[0003]

Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0004] Therefore, an object of the present invention is to provide a device for treating urinary incontinence that can be expected to have a stable treatment effect by effectively stimulating nerves that are deep in the body and located around the bladder, despite being minimally invasive.

Means for Solving the Problems

[0005] To achieve the aforementioned objective, the urinary incontinence treatment device of the present invention is A sensor for detecting urination, A stimulation pad configured to provide stimulation to the wearer, (i) A stimulation generating unit that generates a signal for the stimulation pad to stimulate the wearer, and (ii) A control unit that controls the stimulation generation unit to generate the signal when the sensor detects urination. It comprises a mechanical part equipped with, The aforementioned stimulation pad comprises a first pair of stimulation pads and a second pair of stimulation pads. The stimulation generating unit supplies electrical signals of different frequencies to the first stimulation pad pair and the second stimulation pad pair, The first pair of stimulating pads and the second pair of stimulating pads are electrode pads configured to provide electrical stimulation to the wearer when the electrical signal is supplied to them. The frequency of the electrical signal is within the range of 4,000Hz to 4,300Hz, and the difference between the frequency of the first stimulation pad pair and the frequency of the second stimulation pad pair is set to be within the range of 200Hz to 300Hz and 1Hz to 10Hz. The first pair of stimulating pads and the second pair of stimulating pads are positioned so that the electrical signals provided by the first pair of stimulating pads and the electrical signals provided by the second pair of stimulating pads intersect within the wearer's body and the interference waves reach the bladder.

[0006] In one embodiment of the urinary incontinence treatment device of the present invention, it is preferable that the sensor, the stimulation pad, and the mechanical part can be attached to a diaper.

[0007] In another embodiment of the urinary incontinence treatment device of the present invention, it is preferable that a diaper is further provided, the sensor and the stimulation pad are provided on the diaper, and the mechanical part is connected to the sensor and the stimulation pad.

[0008] In another embodiment of the urinary incontinence treatment device of the present invention, it is preferable that at least one of the sensor and the stimulation pad is formed in the diaper by patterning a conductive material.

[0009] Furthermore, other devices for treating urinary incontinence according to the present invention include: A diaper equipped with a sensor for detecting urination, and a urinary incontinence treatment device that can be connected to the diaper, A stimulation pad configured to provide stimulation to the wearer, (i) The stimulation pad is a stimulation generating unit that generates a signal to stimulate the wearer, (ii) A sensor element connection portion for connecting the sensor to the mechanical part, (iii) A control unit connected to the sensor element connection portion, which controls the stimulation generation unit to generate the signal when the sensor detects urination. It comprises a mechanical part equipped with, The aforementioned stimulation pad comprises a first pair of stimulation pads and a second pair of stimulation pads. The stimulation generating unit supplies electrical signals of different frequencies to the first stimulation pad pair and the second stimulation pad pair, The first pair of stimulating pads and the second pair of stimulating pads are electrode pads configured to provide electrical stimulation to the wearer when the electrical signal is supplied to them. The frequency of the electrical signal is within the range of 4,000Hz to 4,300Hz, and the difference between the frequency of the first stimulation pad pair and the frequency of the second stimulation pad pair is set to be within the range of 200Hz to 300Hz and 1Hz to 10Hz. The first pair of stimulating pads and the second pair of stimulating pads are positioned so that the electrical signals provided by the first pair of stimulating pads and the electrical signals provided by the second pair of stimulating pads intersect within the wearer's body and the interference waves reach the bladder.

[0010] In another embodiment of the urinary incontinence treatment device of the present invention, it is preferable that at least one of the sensor and the stimulation pad is formed in the diaper by patterning a conductive material.

[0011] Alternatively, another urinary incontinence treatment device of the present invention is: A diaper that can be connected to a diaper, comprising a sensor for detecting urination and a stimulation pad configured to stimulate the wearer, is a device for treating urinary incontinence. The stimulation pad is an electrode pad configured to deliver electrical stimulation to the wearer when an electrical signal is supplied, and comprises a first pair of stimulation pads and a second pair of stimulation pads. The first pair of stimulating pads and the second pair of stimulating pads are positioned such that when the diaper is worn, the electrical signals from the first pair of stimulating pads and the electrical signals from the second pair of stimulating pads intersect within the wearer's body and the interference waves reach the bladder. The aforementioned device for treating urinary incontinence is, (i) The stimulation pad is a stimulation generating unit that generates a signal to stimulate the wearer, (ii) A sensor element connection portion for connecting the sensor to the mechanical part, (iii) A control unit connected to the sensor element connection portion, which controls the stimulation generation unit to generate the signal when the sensor detects urination. Equipped with a mechanical section, The stimulation generating unit supplies electrical signals of different frequencies to the first stimulation pad pair and the second stimulation pad pair, The frequency of the electrical signal is within the range of 4,000Hz to 4,300Hz, and the difference between the frequency of the first stimulation pad pair and the frequency of the second stimulation pad pair is set to be within the range of 200Hz to 300Hz and 1Hz to 10Hz.

[0012] In yet another embodiment of the urinary incontinence treatment device of the present invention, it is preferable that at least one of the sensor and the stimulation pad is formed on the diaper by patterning a conductive material.

[0013] In the present invention, it is preferable that the control unit includes a frequency adjustment unit and performs frequency setting according to the pathological condition.

[0014] Also, in the present invention, it is preferable that the control unit includes a time adjustment unit and performs stimulation application time setting according to the pathological condition.

[0015] Alternatively, in the present invention, it is preferable that the control unit includes a frequency adjustment unit and a time adjustment unit and performs frequency setting and stimulation application time setting according to the pathological condition.

Advantages of the Invention

[0016] According to the present invention, it is possible to provide a urinary incontinence treatment device that can effectively stimulate nerves deep in the body and localized around the bladder, thereby expecting a stable treatment effect, despite being minimally invasive.

Brief Description of the Drawings

[0017] [Figure 1] FIG. 1 is a diagram schematically showing a urinary incontinence treatment device according to a first embodiment of the present invention. [Figure 2] FIG. 2 is a block diagram showing an example of the configuration of the urinary incontinence treatment device of the present invention. [Figure 3] FIG. 3 is a diagram schematically showing an example of the arrangement of stimulation pads of the urinary incontinence treatment device of the present invention. [Figure 4] FIG. 4 is a diagram schematically showing a urinary incontinence treatment device according to a second embodiment of the present invention. [Figure 5] FIG. 5 is a diagram schematically showing a urinary incontinence treatment device according to a third embodiment of the present invention.

Modes for Carrying Out the Invention

[0018] The present invention will be described below with reference to examples of the urinary incontinence treatment device. However, the present invention is not limited to or restricted by the following examples. Note that the drawings referenced below are schematic representations, and the ratios of the dimensions of the objects depicted in the drawings may differ from the ratios of the dimensions of actual objects. The ratios of the dimensions of objects may also differ between drawings.

[0019] [First Embodiment] Figure 1 is a schematic diagram showing a urinary incontinence treatment device according to the first embodiment of the present invention. Figure 2 is a block diagram showing an example of the configuration of the urinary incontinence treatment device according to the present invention. The urinary incontinence treatment device 100 of this embodiment comprises a sensor 10, a stimulation pad 20, and a mechanical unit 30. The mechanical unit 30 comprises a stimulation generating unit 31 and a control unit 32. The sensor 10 detects urination. The sensor 10 is electrically connected to the control unit 32 which constitutes the mechanical unit 30. The stimulation pad 20 is configured to provide stimulation to the wearer. The stimulation pad 20 is electrically connected to the stimulation generating unit 31 which constitutes the mechanical unit 30. The control unit 32 and the stimulation generating unit 31 are electrically connected. The stimulation generating unit 31 generates a signal for the stimulation pad 20 to provide stimulation to the wearer. The control unit 32 controls the stimulation generating unit 31 to generate the signal when the sensor 10 detects urination.

[0020] The stimulation pad 20 comprises a first stimulation pad pair 21 and a second stimulation pad pair 22. The first stimulation pad pair 21 (21a, 21b) and the second stimulation pad pair 22 (22a, 22b) are electrode pads configured to deliver electrical stimulation to the wearer when an electrical signal is supplied to them.

[0021] The stimulation generating unit 31 supplies electrical signals of different frequencies to the first stimulation pad pair 21 and the second stimulation pad pair 22, respectively. The frequencies of the electrical signals supplied to the first stimulation pad pair 21 and the second stimulation pad pair 22 are within the range of 4,000 Hz to 4,300 Hz. Each stimulation pad is set such that, within the aforementioned frequency range, the difference between the frequency of the first stimulation pad pair and the frequency of the second stimulation pad pair is within the range of 200 Hz to 300 Hz and 1 Hz to 10 Hz.

[0022] The first pair of stimulating pads 21 and the second pair of stimulating pads 22 are positioned so that the electrical signals from the first pair of stimulating pads 21 and the electrical signals from the second pair of stimulating pads 22 intersect near the bladder inside the wearer's body. In the region where the electrical signals intersect, an interference wave is generated with a frequency equal to the difference (phase difference) between the frequency of the electrical signal from the first pair of stimulating pads 21 and the frequency of the electrical signal from the second pair of stimulating pads 22.

[0023] Here, we will explain the significance of setting the interference wave frequencies within the ranges of 200Hz to 300Hz and 1Hz to 10Hz.

[0024] The nerves of the bladder extend from the sacral spinal cord S2-4 to the bladder smooth muscle, bladder epithelium, and urethra. These nerve fibers are known to consist of myelinated Aδ fibers and unmyelinated C fibers. Myelinated nerves (myelinated Aδ fibers) are characterized by their fast nerve conduction velocity and transmit normal sensory information; in the bladder, they transmit normal urges to urinate. Unmyelinated nerves (unmyelinated C fibers) have a slower nerve conduction velocity compared to myelinated nerves and transmit pathological sensory information; in the bladder, they transmit pathological urges to urinate and pain.

[0025] When considering the mechanism of urinary incontinence, it is known that it occurs due to a complex combination of both the sensory nerves that sense the normal urge to urinate and the sensory nerves that sense the pathological urge to urinate. The inventors focused on a diagnostic method for investigating the cause of incontinence, utilizing the fact that the frequency that specifically stimulates the unmyelinated bladder sensory nerves (unmyelinated C fibers) is 5 Hz, and the frequency that specifically stimulates the myelinated bladder sensory nerves (myelinated Aδ fibers) is 250 Hz. They then solved the problem of unstable treatment effects by stimulating the nerve fibers localized around the bladder with nerve fiber-specific frequencies according to the pathological condition of each individual patient. Furthermore, the present invention's urinary incontinence treatment device aims to improve and stabilize the treatment effect by timing the low-frequency stimulation to coincide with the bladder's involuntary contraction (when the patient experiences incontinence).

[0026] Generally, the current used in low-frequency therapy devices has a low frequency of 1Hz to 1,200Hz, resulting in a tingling sensation. Also, low-frequency currents do not reach as deeply as high-frequency currents. Therefore, in the urinary incontinence treatment device 100 of the present invention, electrical signals of different frequencies in a relatively high frequency range of 4,000Hz to 4,300Hz are applied from two directions, the direction of the first stimulation pad pair 21 and the direction of the second stimulation pad pair 22, generating interference waves in the intersecting region of the two directions, thereby enabling effective delivery of low-frequency stimulation to the target area, which is deep within the body (nerve fibers localized around the bladder). With this device, surgical implantation is not required, making it minimally invasive and less burdensome for the patient, while still allowing the delivery of electrical stimulation of a specific frequency that is expected to have a therapeutic effect to deep within the body.

[0027] The aforementioned interference wave consists of a frequency that is the difference (phase difference) between two given frequencies. In this invention, the difference between the frequency of the electrical signal of the first stimulation pad pair and the frequency of the electrical signal of the second stimulation pad pair is set to be within the ranges of 200Hz to 300Hz and 1Hz to 10Hz, centered around 250Hz, which is the frequency that specifically stimulates the sensory nerves of the myelinated bladder (myelinated Aδ fibers), and 5Hz, which is the frequency that specifically stimulates the sensory nerves of the unmyelinated bladder (unmyelinated C fibers), respectively. Generally, the frequency that specifically stimulates nerve fibers depends on the diameter of the nerve fiber and varies from person to person. Furthermore, in myelinated nerves, there are individual differences in the length and spacing of the myelin sheath, and the frequency that specifically stimulates nerve fibers also depends on the length and spacing of the myelin sheath. Therefore, in this invention, these individual differences are taken into consideration, and the frequency of the interference wave is set to a frequency band with a width centered around 250Hz and 5Hz, respectively.

[0028] [Sensor] Sensor 10 is not particularly limited as long as it is a sensor capable of detecting urination. Sensor 10 can detect urination by detecting a wet state, but is not limited to this. The wet state can be detected by monitoring the electrical properties (physical properties) that change according to the wet state and detecting wetting by the change in electrical properties. Examples of such physical properties include resistance, conductance, impedance, and capacitance. A specific example of the structure of sensor 10 is a sensor element comprising a pair of conductors arranged spaced apart, and a detection circuit electrically connected to each of the conductors.

[0029] The sensor 10 can detect urination based on the difference in electrical properties between the presence and absence of urine (moisture) in the sensor's detection area (for example, the area between the pair of conductors). This difference in electrical properties is based on the fact that urine (moisture) is conductive.

[0030] For example, when detecting urination using electrical resistance, the electrical resistance is relatively high in a dry state where no urine (moisture) is present, and decreases when the environment becomes moist due to urination. When detecting urination using conductance, since conductance is the reciprocal of electrical resistance, the conductance is relatively low in a dry state where no urine (moisture) is present, and increases when the environment becomes moist due to urination.

[0031] In one aspect of the present invention, the sensor element is detachable and electrically connected to the sensor connection portion. The detachable sensor element may be provided in the diaper described later. In this case, the sensor element can be formed directly into the diaper using a conductive resin or the like by a printing method described later.

[0032] In the urinary incontinence treatment device 100, it is preferable that the sensor element of the sensor 10 is positioned on or near the urination area.

[0033] [Stimulation Pad] The stimulation pad 20 is an electrode pad configured to deliver electrical stimulation to the wearer when an electrical signal is supplied. The stimulation pad 20 can be configured similarly to electrode pads used in electrotherapy devices for performing known low-frequency therapy, etc., and as an example, an electrode pad in which the electrode element and the gel portion that is attached to the surface of the body are integrally molded can be cited. The gel portion is preferably made of a material that is adhesive and conductive (for example, a water-containing urethane gel or a water-containing acrylic gel). Alternatively, as described later, the thickness can be made thin by a printing method using a conductive resin or the like.

[0034] The stimulation pad is electrically connected to the mechanical unit 30 (described later) via, for example, a lead wire (cable), and is configured to receive electrical signals from the mechanical unit 30 and supply those signals to the body part to which it is attached. Alternatively, the stimulation pad can also be connected to the mechanical unit 30 wirelessly.

[0035] The stimulation pad 20 in this embodiment comprises a first stimulation pad pair 21 (21a, 21b) and a second stimulation pad pair 22 (22a, 22b). There may be three or more stimulation pad pairs. The first stimulation pad pair 21 and the second stimulation pad pair 22 generate an electrical signal of a predetermined frequency between the paired stimulation pads.

[0036] The first pair of stimulating pads 21 and the second pair of stimulating pads 22 are positioned so that the electrical signals from the first pair of stimulating pads 21 and the electrical signals from the second pair of stimulating pads 22 intersect within the wearer's body. Electrical signals of different frequencies are supplied to the wearer from different directions from each pair of stimulating pads, and by intersecting near the area where the nerve group that innervates the bladder is located, stimulation at a desired frequency can be applied to the said area.

[0037] Figure 3 is a schematic diagram illustrating an example of the arrangement of stimulation pads in the urinary incontinence treatment device of the present invention. In Figure 3, the relationship between the positions of the bladder P, rectum Q, and sacrum R and the positions of the stimulation pads is shown in a horizontal cross-sectional view of the body in the region near the sacrum. In the figure, the upper side is the ventral side of the body, and the lower side is the dorsal side of the body. The bladder P is located in the midline of the pelvic cavity, and the nerve group innervating the bladder P is concentrated on the dorsal side of the lower hemisphere of the bladder P. Therefore, it is preferable that the crossover region of the electrical signals of the paired stimulation pads be in the area shown by the diagonal lines in the figure near the midline. Specifically, examples of the arrangement of the stimulation pads include, at a height near the area directly above the sacrum, stimulation pad 21a constituting the first pair of stimulation pads 21 is on the ventral left side, stimulation pad 21b is on the dorsal right side, and stimulation pad 22a constituting the second pair of stimulation pads 22 is on the ventral right side, stimulation pad 22b is on the dorsal left side. The stimulation pads should be arranged such that the electrical signals from multiple pairs of stimulation pads intersect within the wearer's body and the interference waves reach the bladder; however, the arrangement is not limited to the above configuration.

[0038] When there are three pairs of stimulation pads (not shown), they can be configured as follows: The frequencies of the electrical signals supplied from each pair of stimulation pads are set as follows: for example, the first pair of stimulation pads is around 4,000 Hz, the second pair is around 4,250 Hz, and the third pair is around 4,005 Hz. The pads are then positioned so that the intersection points of the electrical signals supplied by the first pair of stimulation pads and the second pair, and the intersection points of the electrical signals supplied by the first pair and the third pair, are near the bladder inside the wearer's body. If it is desired to supply stimulation centered on a frequency of 250 Hz, which specifically stimulates the sensory nerves (myelinated Aδ fibers) of the myelinated bladder, electrical signals are supplied from the first pair of stimulation pads and the second pair of stimulation pads to generate an interference wave. Furthermore, if it is desired to apply stimulation centered on 5 Hz, which specifically stimulates the unmyelinated sensory nerves (unmyelinated C fibers) of the bladder, electrical signals are applied from the first pair of stimulation pads and the third pair of stimulation pads to generate an interference wave. In this way, it is also possible to obtain the desired frequency by pre-determining the frequency of the electrical signals applied from each pair of stimulation pads and selecting the combination of stimulation pad pairs instead of adjusting the frequency.

[0039] [Machinery Department] The mechanical unit 30 includes a stimulation generating unit 31 that generates a signal for the stimulation pad 20 to stimulate the wearer, and a control unit 32 configured to generate stimulation in the stimulation generating unit 31 in response to urination detected by the sensor 10. The main function of the mechanical unit 30 is to generate stimulation when urination is detected by the sensor 10, and to bring the stimulation pad 20 into a state where it can stimulate the wearer. The stimulation generating unit 31 and the control unit 32 can be implemented in hardware, for example, by logic circuits formed on an integrated circuit (IC chip). Alternatively, the stimulation generating unit 31 and the control unit 32 may be implemented in software. In this case, the mechanical unit 30 includes a CPU that executes program instructions, a memory for the CPU to load the program, and an auxiliary storage device that stores the program and various data, and the stimulation generating unit 31 and the control unit 32 are realized when the CPU executes the program.

[0040] In the urinary incontinence treatment device 100, it is preferable that the mechanical part 30 is positioned on the abdomen. The mechanical part 30 may also be positioned on the back, but when the device is worn while lying down, such as during sleep or hospitalization, it is preferable to position it on the abdomen as it reduces discomfort on the wearer's back and makes it easier to put on and take off.

[0041] Figure 1 shows a configuration in which the stimulation pad 20 and the mechanical unit 30 (stimulation generating unit 31) are connected by a cable, but the present invention is not limited to this. The stimulation pad 20 and the mechanical unit 30 only need to be electrically connected, and may be connected wirelessly, for example. It is also preferable to be able to switch between wireless and wired connections. When connected wirelessly, for example, when going to sleep, if the mechanical unit 30 is placed at the bedside and controlled, discomfort caused by the mechanical unit is eliminated, which is preferable from the viewpoint of achieving good sleep.

[0042] [Stimulation generating unit] The stimulation generation unit 31 is an electrical signal generation unit. Based on the control of the control unit 32, the electrical signal generation unit uses the power supply as a power source to generate electrical signals (AC voltage signals, AC current signals) of a predetermined frequency and supply them to the electrode elements of the stimulation pads 20 (first stimulation pad pair 21, second stimulation pad pair 22).

[0043] The frequency of the electrical signal is set appropriately within the range of 4,000 Hz to 4,300 Hz. In this case, the frequency of the electrical signal supplied to the first stimulation pad pair 21 (first frequency) and the frequency of the electrical signal supplied to the second stimulation pad pair 22 (second frequency) must be different frequencies, as described above. The frequency supplied to each stimulation pad pair is, for example, a preset frequency or a frequency input via a frequency input means that can be provided in the control unit 32 described later. In either case, the difference between the first frequency and the second frequency is set or input to be within the range of 200 Hz to 300 Hz and 1 Hz to 10 Hz. From the viewpoint of making the urinary incontinence treatment device 100 easy to use, it is preferable that the frequencies be preset.

[0044] The output current and output voltage can be set as appropriate within a range that does not impair the objective of the present invention. For example, the output current can be about 1 to 100 mA, preferably about 1 to 50 mA, and more preferably about 5 to 30 mA. The output voltage can be about 1 to 100 V, preferably about 2 to 80 V, and more preferably about 5 to 60 V. From the viewpoint of making the urinary incontinence treatment device 100 easy to use, it is preferable that the output current and output voltage are set in advance.

[0045] [Control Unit] The control unit 32 is electrically connected to the sensor 10 and the stimulation generation unit 31. In response to urination detected by the sensor 10, the control unit 32 generates a signal to the stimulation generation unit 31 for the stimulation pads 20 (first stimulation pad pair 21, second stimulation pad pair 22) to stimulate the wearer. Specifically, when the sensor 10 detects urination (wet state) above a predetermined threshold, the control unit 32 sends a control signal to the stimulation generation unit 31 for the stimulation generation unit 31 to generate an electrical signal for a predetermined time.

[0046] The time for generating the electrical signal can be set appropriately within a range that does not impair the objective of the present invention. For example, the time for generating the electrical signal can be about 10 seconds to 30 minutes, preferably about 5 to 20 minutes, and particularly preferably about 15 minutes. The time for generating the electrical signal is, for example, a preset time, or a time input via a time input means, which may be provided in the control unit 32 and will be described later. From the viewpoint of making the urinary incontinence treatment device 100 easy to use, it is preferable that the time for generating the electrical signal is preset.

[0047] The control unit 32 may also include the following means: A frequency input means for inputting the frequency of an electrical signal (allowing the frequency to be set according to each patient); A frequency adjustment unit that adjusts the frequency to the frequency input by the frequency input means; A time input means for inputting the duration for generating electrical signals (allowing the stimulation duration to be set according to each patient); A time adjustment unit that adjusts the stimulation application time to the time input by the time input means; A switch (forced generation switch) for sending a control signal to the electrical signal generation unit to forcibly generate an electrical signal, regardless of the detection by the aforementioned sensor; A switch (force stop switch) for forcibly stopping the transmission of a control signal for generating an electrical signal, regardless of the detection by the aforementioned sensor.

[0048] The frequency input means and the time input means may be for directly inputting values, or they may be like selection switches that allow selecting a value from a plurality of options. Alternatively, a selection switch may be provided that has a set pattern of multiple combinations of frequency and time depending on the pathological condition or type of treatment applied, and the frequency adjustment unit and the time adjustment unit may be controlled by a value according to the selected pattern. The patterns may be set in advance, or it is more preferable that new patterns can be stored and set. In the above, an example has been shown in which the control unit 32 is equipped with a frequency adjustment unit and a time adjustment unit to set the frequency and stimulation application time according to the pathological condition, but it is not limited to this. In the present invention, the control unit 32 may be equipped with only one of the frequency adjustment unit and the time adjustment unit, and the frequency setting or stimulation application time setting may be performed according to the pathological condition.

[0049] [Diapers] In a preferred embodiment of the present invention, the sensor 10, stimulation pad 20, and mechanical unit 30 can be attached to the diaper 40. Alternatively, they may be attached to underwear worn between the legs, such as incontinence pants, instead of the diaper 40. It is also preferable to provide the sensor 10 and stimulation pad 20, which can be attached to the diaper 40, on the diaper, and to electrically connect the mechanical unit 30 wirelessly or the like.

[0050] A "diaper" refers to an absorbent item worn between the legs of a person to absorb and retain liquids such as urine. Diapers are usually disposable.

[0051] The composition of diaper 40 is publicly known. Typically, it consists of an outer body that forms the front and back when worn, and an absorbent body that is held in a cross-linked state between the front and back bodies. When diaper 40 is worn, the absorbent body is located in the crotch area of ​​the wearer and absorbs and retains liquids such as urine excreted by the wearer. The absorbent body is made of an absorbent material such as a superabsorbent polymer.

[0052] Diaper 40 may be for children (including infants, toddlers, and school-aged children; especially for school-aged children (approximately 6 to 12 years old)) or for adults.

[0053] When diaper 40 is for children, the urinary incontinence treatment device of the present invention can be suitably used to treat pediatric patients with nocturnal enuresis. When using the urinary incontinence treatment device of the present invention, compared to conventional alarm therapy, there is no need for the mother or other person to wake the patient, and the burden on both the mother and the patient is greatly reduced.

[0054] When diaper 40 is for adults, the urinary incontinence treatment device of the present invention can be suitably used to treat patients with urinary incontinence (including daytime urinary incontinence), especially elderly patients. By performing treatment using the urinary incontinence treatment device of the present invention, the frequency of urinary incontinence is reduced, and patients can avoid wearing diapers or reduce the need to wear them. This can suppress the decline in motivation of patients, the progression of dementia, etc. Furthermore, the reduction in the frequency of urinary incontinence greatly reduces the burden on caregivers.

[0055] In the urinary incontinence treatment device of the present invention, it is preferable to further provide a waterproof member to protect the stimulation pad 20 from urination, depending on the mode of use. This prevents soiling of the stimulation pad 20 even if the back side of the diaper 40 becomes wet due to a large amount of urine or other reasons. The waterproof member can be formed in a sheet shape that covers the entire stimulation pads of each set, with the stimulation pads 21a and 22a provided on the ventral side as a pair, and the stimulation pads 21b and 22b provided on the dorsal side as a pair, and placed at two locations, front and back. However, it is not limited to this mode, and for example, the waterproof member may be placed at four locations so as to cover each of the stimulation pads 21a, 21b, 22a, and 22b that constitute the first pair of stimulation pads 21 and the second pair of stimulation pads 22.

[0056] [Second Embodiment] Figure 4 is a schematic diagram showing a urinary incontinence treatment device according to a second embodiment of the present invention. The urinary incontinence treatment device 200 of this embodiment is a urinary incontinence treatment device that can be connected to a diaper 40A equipped with a sensor 10A for detecting urination, and comprises a stimulation pad 20 and a mechanical unit 30A. An example of a diaper 40A equipped with a sensor 10A is the training pad that constitutes the "Piscol" nocturnal enuresis training system manufactured by Awajitec Co., Ltd. The urinary incontinence treatment device of the present invention can also be used in combination with such a diaper equipped with a sensor. By attaching the mechanical unit 30A (for reuse) to a disposable diaper 40A equipped with a sensor 10A, the daily use of the urinary incontinence treatment device of the present invention becomes easier. The sensor 10A can also be directly formed on the diaper using a conductive resin or the like by a printing method described later.

[0057] In the urinary incontinence treatment device 200, the mechanical unit 30A includes a stimulation generating unit 31 and a control unit 32, and further includes a sensor element connection portion 33 for connecting a sensor 10A to the mechanical unit 30A. The mechanical unit 30A is the same as the mechanical unit 30 in the first embodiment, except for the presence of the sensor element connection portion 33.

[0058] The sensor 10A of the diaper 40A is electrically connected to the control unit 32 that constitutes the mechanical unit 30A by connecting to the sensor element connection part 33 of the mechanical unit 30A. When the sensor 10A detects urination, the detection of urination is transmitted to the control unit 32 via the sensor element connection part 33. The control unit 32 and the stimulation generation unit 31 are electrically connected. The stimulation generation unit 31 generates a signal for the stimulation pad 20 to provide stimulation to the wearer. The control unit 32 then controls the stimulation generation unit 31 to generate the aforementioned signal when the sensor 10A detects urination.

[0059] The sensor 10A shown in Figure 4 comprises a pair of strip-shaped conductors, with one end of each conductor reaching the edge of the diaper 40A. The sensor 10A can detect urination due to the difference in electrical characteristics between the presence and absence of urine (moisture) in the region between these conductors. The sensor element connection portion 33 has a shape similar to a clip, allowing it to clamp one end of the conductor together with the diaper 40A. In this way, the sensor element connection portion 33 connects the sensor 10A to the mechanical unit 30A.

[0060] In Figure 4, as in the first embodiment, the stimulation pad 20 and the mechanical unit 30A (stimulation generating unit 31) are shown connected by a cable, but the embodiment is not limited to this. In this embodiment as well, the stimulation pad 20 and the mechanical unit 30A only need to be electrically connected, and may be connected wirelessly, for example.

[0061] [Third Embodiment] Figure 5 is a schematic diagram showing a urinary incontinence treatment device according to a third embodiment of the present invention. The urinary incontinence treatment device 300 of this embodiment is a urinary incontinence treatment device that can be connected to a diaper 40B equipped with a sensor 10B for detecting urination and a stimulation pad 20B, and comprises a mechanical unit 30B.

[0062] In the urinary incontinence treatment device 300, the mechanical unit 30B includes a stimulation generating unit 31 and a control unit 32, and further includes a sensor element connection portion 33 for connecting a sensor 10B to the mechanical unit 30B. The mechanical unit 30B is the same as the mechanical unit 30 in the first embodiment, except for the presence of the sensor element connection portion 33.

[0063] The sensor 10B of the diaper 40B is electrically connected to the control unit 32 that constitutes the mechanical unit 30B by connecting to the sensor element connection part 33 of the mechanical unit 30B. When the sensor 10B detects urination, the detection of urination is transmitted to the control unit 32 via the sensor element connection part 33. The control unit 32 and the stimulation generation unit 31 are electrically connected. The stimulation generation unit 31 generates a signal for the stimulation pad 20B to provide stimulation to the wearer. The control unit 32 then controls the stimulation generation unit 31 to generate the signal when the sensor 10B detects urination.

[0064] The sensor 10B shown in Figure 5 comprises a pair of strip-shaped conductors, with one end of each conductor reaching the edge of the diaper 40B. The sensor 10B can detect urination due to the difference in electrical characteristics between the presence and absence of urine (moisture) in the region between these conductors. The sensor element connection portion 33 has a clip-like shape, allowing it to clamp one end of the conductor together with the diaper 40B. In this way, the sensor element connection portion 33 connects the sensor 10B to the mechanical unit 30B.

[0065] In Figure 5, the stimulation pad 20B and the mechanical unit 30B are connected wirelessly, but as in Figures 1 and 4, they may also be connected by a cable or the like. In this embodiment, the daily use of the urinary incontinence treatment device of the present invention becomes simpler by attaching the mechanical unit 30B (which is reused) to a diaper 40B equipped with a disposable sensor 10B and stimulation pad 20B. The sensor 10B and stimulation pad 20B can also be directly formed into the diaper by patterning a conductive material such as a conductive resin to impart device functionality. Methods for patterning include printing, transfer, drawing, and plating. Forming the sensor and stimulation pad in this way makes it possible to lighten and thin these components. As a result, physical irritation during wear is eliminated, and discomfort is reduced. In addition, slippage due to weight is reduced, allowing for stable wear. Regarding the elimination of discomfort, it is particularly desirable that there is less discomfort during sleep, as this can lead to better sleep. Furthermore, cost reduction is expected due to the simplification of the manufacturing of the treatment device, and there is also the advantage of increased versatility.

[0066] (Example of use) There are two types of pathological conditions affecting bladder sensation. When the bladder is distended (when it is full of urine), the normal urge to urinate (distance stimulus) is responded to by myelinated nerves. Therefore, in cases where there is an abnormality in the nerves that control the normal urge to urinate, such as feeling the urge to urinate earlier than normal, stimuli in the range of 200Hz to 300Hz, centered around 250Hz, are effective. On the other hand, for pathological urges to urinate (noxious stimuli, stimuli that lead to pain) caused by diseases such as bacterial infections like cystitis, unmyelinated nerves respond, so stimuli in the range of 1Hz to 10Hz, centered around 5Hz, are effective.

[0067] Conventional low-frequency therapy required sessions lasting 20 minutes to an hour, but the urinary incontinence treatment device of the present invention enables "neuromodulation" by directly stimulating the target nerve, thus allowing for 200Hz to 300Hz treatment. For any frequency within the range of 1Hz to 10Hz, it is expected that therapeutic effects will be achieved in a short time (for example, from about 1 second to 5 minutes). Furthermore, since there is a high possibility of selectively treating the abnormal (need-to-treat) nerves, adverse effects on other healthy nerves in the surrounding area can be avoided. Some myelinated nerves respond around 2,000Hz. In this invention, since electrical signals with frequencies in the range of 4,000Hz to 4,300Hz are used, it is also preferable in that it does not affect the myelinated nerves that respond around 2,000Hz.

[0068] After urinary incontinence occurs, as soon as urination is detected by a sensor, the urinary incontinence treatment device of the present invention delivers an electrical stimulus to the patient (wearer) from the stimulation pad. The electrical stimulus may be around 250 Hz or around 5 Hz, depending on the pathological condition. If there are multiple causes or the cause is unknown, a 250 Hz stimulus may be delivered for a predetermined time (e.g., between 1 and 60 seconds), followed by a 5 Hz stimulus for a predetermined time (e.g., between 1 and 60 seconds). The 250 Hz frequency can be achieved, for example, by setting the frequency of the electrical signal of the first stimulation pad pair to 4,000 Hz and the frequency of the electrical signal of the second stimulation pad pair to 4,250 Hz, and by passing these two different wavelength electrical signals so that they cross within the body, a low-frequency 250 Hz stimulus generated by the phase difference can be delivered to the crossing point within the body. A frequency of 5 Hz can be achieved, for example, by setting the frequency of the electrical signal from the first stimulation pad pair to 4,000 Hz and the frequency of the electrical signal from the second stimulation pad pair to 4,005 Hz, and then passing these two electrical signals of different wavelengths so that they cross within the body. The resulting low-frequency 5 Hz stimulation can then be applied to the crossing point within the body due to the phase difference between them.

[0069] Urinary incontinence due to involuntary bladder contractions is caused by abnormal firing of sensory nerves in overactive bladder and neurogenic bladder. In the sensory nerve fibers of the bladder, Aδ fibers are nerves that respond to overstretching of the bladder wall, and C fibers are nerves that respond to noxious stimuli. Therefore, tailored treatment is possible by identifying the treatment frequency according to the patient's condition and the patient's specific cause of urinary incontinence. For example, even when treating patients for the same amount of time (e.g., 10 minutes) when urinary incontinence symptoms occur, more effective treatment can be achieved by applying different frequency stimuli in a time ratio according to the degree of the patient's condition. For example, patient A might receive 5Hz for 5 minutes and 250Hz for 5 minutes, while patient B might receive 5Hz for 2 minutes and 250Hz for 8 minutes.

[0070] The duration of stimulation at each frequency should be adjusted according to which nerves around the bladder need to be specifically stimulated, by adjusting the length of the stimulation time and the balance (ratio and stimulation pattern) of the stimulation times of the two types of frequencies. The stimulation time for each frequency can be controlled, for example, by providing a time input means such as a timer in the control unit 32, as described above.

[0071] The above example illustrates the application of stimulation using a combination of frequencies 250 Hz and 5 Hz. However, the frequency that specifically stimulates nerve fibers depends on the diameter of the nerve fiber, the length and spacing of the myelin sheath, and although it is around 250 Hz and 5 Hz, there are individual differences. Therefore, in treatment, it is more effective to measure the optimal frequency for each patient and then use the urinary incontinence treatment device of the present invention. In bladder sensation, the frequency that specifically acts on the nerves that require treatment by stimulation can be clarified by performing a nerve fiber selective sensory function test of the lower urinary tract using a peripheral nerve sensory threshold measurement device such as "Neurometer" (registered trademark) used in voiding function tests.

[0072] Specifically, it is well known that in the following conditions, incontinence and frequent urination occur due to specific nerve fibers. Nocturnal enuresis in infants and young children is a volume-dependent incontinence caused by an overflow of urine volume, and it resolves naturally with age. The specific nerve fibers responsible for this are myelinated Aδ fibers, which transmit the normal urge to urinate, and their intrinsic frequency is 250 Hz, although there are individual differences as mentioned above. Urge urinary incontinence is caused by spinal cord injury or frontal lobe damage in the elderly, and intractable nocturnal enuresis is caused by underdeveloped spinal cord, etc. The specific nerve fibers responsible for these are unmyelinated C fibers, which transmit pathological urges to urinate and pain, and their intrinsic frequency is 5 Hz, although there are individual differences as mentioned above. Therefore, in the following examples, we investigated whether it is possible to treat these conditions by using low-frequency therapy at frequencies specific to these nerve fibers in experimental animals (mice). [Examples]

[0073] [Animal experimentation] Animal experiments were conducted using mice. Details of the experimental animals are as follows: Animal species: Mouse Sex: Female Number of animals used: 8 (4 mice with overactive bladder, 4 normal mice (control))

[0074] (Overactive bladder mice) Overactive bladder mice were selected as experimental animals to reproduce a pathological state of frequent urination. In overactive bladder mice, unmyelinated C fibers are primarily responsible for bladder sensation, while in normal mice, myelinated Aδ fibers are primarily responsible. Overactive bladder mice were prepared by injecting 1.5% H2O2 saline solution into the bladder of normal mice via a urethral catheter and draining it after 30 minutes.

[0075] (Electrode pad placement) In mice, low-frequency stimulation pads (electrode pads) were placed subcutaneously at four locations, as shown in Figure 3, under general anesthesia. The electrode pads were 8 mm in diameter, as specified for mice. Although this invention is characterized by being minimally invasive and requiring no surgical procedures, as it uses stimulation pads (electrode pads) that are designed to be in contact with or attached to the body surface, it is difficult to reproduce the state of being clothed in animal experiments. Therefore, the electrode pads were placed subcutaneously to ensure consistent conditions.

[0076] (Urinary incontinence treatment experiment (interferential low-frequency stimulation experiment)) The following experiments were conducted using established methods for animal experiments on urinary function. Under general anesthesia, a catheter was inserted into the bladder apex. Subsequently, while the mice were awake, saline solution (6 mL / hour) was injected through the catheter to accumulate urine in the bladder at a steady pace, and urination from the urethra was observed. During this time, the mice were fixed in a prone position.

[0077] The change in void volume before and after low-frequency (5Hz, 250Hz) stimulation (treatment) in awake mice with overactive bladder and normal mice was observed. For the 5Hz frequency, the electrical signal frequency of the first stimulation pad pair was set to 4,000Hz and the electrical signal frequency of the second stimulation pad pair to 4,005Hz, and the low-frequency 5Hz stimulation generated by the phase difference was applied to the crossover point in the body. For the 250Hz frequency, the electrical signal frequency of the first stimulation pad pair was set to 4,000Hz and the electrical signal frequency of the second stimulation pad pair to 4,250Hz, and the low-frequency 250Hz stimulation generated by the phase difference was applied to the crossover point in the body. The experiment was conducted for each stimulation frequency using two mice with overactive bladder and two normal mice, under awake conditions, as follows. (1) The amount of urine voided in one spurt before low-frequency stimulation was measured. (2) Low-frequency stimulation was applied for one minute at the moment of urination. This procedure was performed for three urinations. (3) The amount of urine urinated in one spurt after low-frequency stimulation was measured.

[0078] All urination observations were performed while the subjects were awake, and urination was observed visually by multiple people. The urine was collected in a urine collection tray, and the volume was measured using a measuring device. The results at a stimulation frequency of 5 Hz are shown in Table 1, and the results at a stimulation frequency of 250 Hz are shown in Table 2. "OAB" in the tables refers to overactive bladder (Over (Active Bladder) represents a mouse.

[0079] [Table 1]

[0080] [Table 2]

[0081] In mice with overactive bladder, stimulation at 5 Hz more than doubled the amount of urine voided per void, as shown in Table 1 (OAB1 and OAB2). Since mice with overactive bladder exhibit a pathological state of frequent urination, it was expected that treatment with 5 Hz stimulation, the intrinsic frequency for unmyelinated C fibers, would treat the condition, and the desired results were obtained. On the other hand, as shown in Table 2 (OAB1 and OAB2), no significant changes were observed with 250 Hz stimulation in mice with overactive bladder. Because these mice do not exhibit volume-dependent incontinence, stimulation at 250 Hz, the intrinsic frequency for myelinated Aδ fibers, did not produce a therapeutic effect.

[0082] On the other hand, in normal mice, as shown in Table 1 (Normal 1 and Normal 2), no significant changes were observed with 5Hz stimulation, but as shown in Table 2 (Normal 1 and Normal 2), the amount of urine voided per void more than doubled with 250Hz stimulation. Normal mice were used as a model for nocturnal enuresis caused by low urine volume per void, and the effect of increasing urine volume per void was obtained by applying 250Hz stimulation, which is the intrinsic frequency for myelinated Aδ fibers. Conversely, since these mice did not have pathological urges or pain to urinate, it can be seen that no therapeutic effect was obtained when 5Hz stimulation, which is the intrinsic frequency for unmyelinated C fibers, was applied.

[0083] From the above examples (animal experiments), it was confirmed that low-frequency stimulation at the moment of urination (incontinence) using a frequency specific to the nerve fibers of the disease state increased the amount of urine urinated in a single void. These examples demonstrate that more effective tailor-made treatment is possible by applying low-frequency stimulation at a patient-specific timing (during incontinence) and at a patient-specific frequency, according to each patient's disease state.

[0084] According to the present invention, since it uses stimulation pads (electrode pads) configured to be in contact with or attached to the body surface, it is possible to provide a urinary incontinence treatment device that is minimally invasive and does not require any surgical procedures, yet effectively stimulates nerves located deep within the body and localized around the bladder, thereby providing a stable therapeutic effect. The urinary incontinence treatment device of the present invention can be, for example, a diaper-type treatment device, and the patient can be treated simply by wearing the device. Therefore, it has the advantage of requiring little assistance from family members or caregivers, and the burden on caregivers is extremely low. Furthermore, the urinary incontinence treatment device of the present invention makes it possible to stimulate nerve fibers localized around the bladder with nerve fiber-specific frequencies according to the pathological condition, thereby realizing tailor-made treatment according to the patient's urinary incontinence pathology. [Explanation of Symbols]

[0085] 100, 200, 300 Urinary incontinence treatment device 10, 10A, 10B sensors 20, 20B Stimulation Pads 21. First stimulation pad pair (21a, 21b) 22. Second pair of stimulation pads (22a, 22b) 30, 30A, 30B mechanical part 31 Stimulus generation unit 32 Control Units 33 Sensor element connection points 40, 40A, 40B diapers P-bladder Q Rectum R Sacrum

Claims

1. A sensor for detecting urination, A stimulation pad configured to provide stimulation to the wearer, (i) A stimulation generating unit that generates a signal for the stimulation pad to stimulate the wearer, and (ii) A control unit that controls the stimulation generation unit to generate the signal when the sensor detects urination. It comprises a mechanical part equipped with, The aforementioned stimulation pad comprises a first pair of stimulation pads and a second pair of stimulation pads. The stimulation generating unit supplies electrical signals of different frequencies to the first stimulation pad pair and the second stimulation pad pair, The first pair of stimulating pads and the second pair of stimulating pads are electrode pads configured to provide electrical stimulation to the wearer when the electrical signal is supplied to them. The frequency of the electrical signal is within the range of 4,000 Hz to 4,300 Hz, and the difference between the frequency of the first stimulation pad pair and the frequency of the second stimulation pad pair is set to be within the range of 200 Hz to 300 Hz, centered on 250 Hz, which is the frequency that specifically stimulates myelinated Aδ fibers, and within the range of 1 Hz to 10 Hz, centered on 5 Hz, which is the frequency that specifically stimulates unmyelinated C fibers. The first pair of stimulating pads and the second pair of stimulating pads are positioned so that the electrical signals from the first pair of stimulating pads and the electrical signals from the second pair of stimulating pads intersect within the wearer's body and the interference waves reach the bladder. The control unit is equipped with a frequency adjustment section and is characterized by setting the frequency according to the pathological condition controlled by the myelinated Aδ fibers or the pathological condition controlled by the unmyelinated C fibers, in a device for treating urinary incontinence.

2. The device for treating urinary incontinence according to claim 1, wherein the sensor, the stimulation pad, and the mechanical part can be attached to a diaper.

3. We also have diapers, The device for treating urinary incontinence according to claim 1, wherein the sensor and the stimulation pad are provided in the diaper, and the mechanical part is connected to the sensor and the stimulation pad.

4. The device for treating urinary incontinence according to claim 3, wherein at least one of the sensor and the stimulation pad is formed in the diaper by patterning a conductive material.

5. A diaper equipped with a sensor for detecting urination, and a urinary incontinence treatment device that can be connected to the diaper, A stimulation pad configured to provide stimulation to the wearer, (i) A stimulation generating unit that generates a signal for the stimulation pad to stimulate the wearer, (ii) Sensor element connection portion for connecting the sensor, (iii) A control unit connected to the sensor element connection portion, which controls the stimulation generation unit to generate the signal when the sensor detects urination. It comprises a mechanical part equipped with, The aforementioned stimulation pad comprises a first pair of stimulation pads and a second pair of stimulation pads. The stimulation generating unit supplies electrical signals of different frequencies to the first stimulation pad pair and the second stimulation pad pair, The first pair of stimulating pads and the second pair of stimulating pads are electrode pads configured to provide electrical stimulation to the wearer when the electrical signal is supplied to them. The frequency of the electrical signal is within the range of 4,000 Hz to 4,300 Hz, and the difference between the frequency of the first stimulation pad pair and the frequency of the second stimulation pad pair is set to be within the range of 200 Hz to 300 Hz, centered on 250 Hz, which is the frequency that specifically stimulates myelinated Aδ fibers, and within the range of 1 Hz to 10 Hz, centered on 5 Hz, which is the frequency that specifically stimulates unmyelinated C fibers. The first pair of stimulating pads and the second pair of stimulating pads are positioned so that the electrical signals from the first pair of stimulating pads and the electrical signals from the second pair of stimulating pads intersect within the wearer's body and the interference waves reach the bladder. The control unit is equipped with a frequency adjustment section and is characterized by setting the frequency according to the pathological condition controlled by the myelinated Aδ fibers or the pathological condition controlled by the unmyelinated C fibers, in a device for treating urinary incontinence.

6. The device for treating urinary incontinence according to claim 5, wherein at least one of the sensor and the stimulation pad is formed in the diaper by patterning a conductive material.

7. A diaper that can be connected to a diaper, comprising a sensor for detecting urination and a stimulation pad configured to stimulate the wearer, is a device for treating urinary incontinence. The stimulation pad is an electrode pad configured to provide electrical stimulation to the wearer when an electrical signal is supplied, and comprises a first pair of stimulation pads and a second pair of stimulation pads. The first pair of stimulating pads and the second pair of stimulating pads are positioned such that when the diaper is worn, the electrical signals from the first pair of stimulating pads and the electrical signals from the second pair of stimulating pads intersect within the wearer's body and the interference waves reach the bladder. The aforementioned device for treating urinary incontinence is, (i) A stimulation generating unit that generates a signal for the stimulation pad to stimulate the wearer, (ii) Sensor element connection portion for connecting the sensor, (iii) A control unit connected to the sensor element connection portion, which controls the stimulation generation unit to generate the signal when the sensor detects urination. Equipped with a mechanical section, The stimulation generating unit supplies electrical signals of different frequencies to the first stimulation pad pair and the second stimulation pad pair, The frequency of the electrical signal is within the range of 4,000 Hz to 4,300 Hz, and the difference between the frequency of the first stimulation pad pair and the frequency of the second stimulation pad pair is set to be within the range of 200 Hz to 300 Hz, centered on 250 Hz, which is the frequency that specifically stimulates myelinated Aδ fibers, and within the range of 1 Hz to 10 Hz, centered on 5 Hz, which is the frequency that specifically stimulates unmyelinated C fibers. The control unit is equipped with a frequency adjustment section and is characterized by setting the frequency according to the pathological condition controlled by the myelinated Aδ fibers or the pathological condition controlled by the unmyelinated C fibers, in a device for treating urinary incontinence.

8. The device for treating urinary incontinence according to claim 7, wherein at least one of the sensor and the stimulation pad is formed in the diaper by patterning a conductive material.

9. The device for treating urinary incontinence according to any one of claims 1 to 8, wherein the control unit includes a time adjustment unit that sets the stimulation application time according to the pathological condition.

10. The device for treating urinary incontinence according to any one of claims 1 to 8, wherein the control unit comprises a frequency adjustment unit and a time adjustment unit, and performs frequency setting and stimulation application time setting according to the pathological condition.

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