Method of electrical stimulation of tissue structures in small pelvis in areas susceptible to functional influence of cavernous nerves in patients who have undergone laparoscopic radical prostatectomy

Abstract

FIELD: medicine.SUBSTANCE: invention relates to medicine, specifically to urology. It can be used for electrical stimulation of tissue structures in the small pelvis in areas susceptible to the functional influence of the cavernous nerves. The method is used in patients who have undergone laparoscopic radical prostatectomy. The electrodes are installed intraoperatively under combined laparoscopic and transrectal ultrasound guidance in the small pelvis area. To achieve this, after forming the urethrovesical anastomosis, a puncture is performed using a needle with a diameter of 1 mm in the functional zones of the cavernous nerves, through which the system’s electrodes are introduced stimulation. In this case, the distal contact group of electrodes is placed in the area of the rhabdosphincter via a perineal approach through the pararectal tissue, and subsequent groups are placed in the zones of предполагаемой physiological activity of the cavernous nerves and brought to the surgical site. Then the needle is removed, and the proximal part of the electrodes is brought out through the anterior abdominal wall and secured to the skin. After connecting the electrodes to the generator, electrical stimulation is performed in a mode with a frequency of 2 Hz, a pulse duration of 1 ms, and an amplitude of 15 mA. The criterion for the system’s functionality is considered to be the visually observed contraction of the pelvic muscles.EFFECT: method is accessible, provides effective electrical stimulation and compliance.1 cl, 1 ex

Description

[0001] The invention relates to medicine, in particular to urology, namely to the invasive treatment of clinically manifested urinary incontinence (UI) in patients after laparoscopic radical prostatectomy (LRP): with dripping urine leakage, both at rest and during physical activity, the inability to accumulate urine in the bladder, the need to use urological rehabilitation means (urological pads, urocondoms, diapers).

[0002] Surgical techniques performed as part of the LRP remain the primary treatment for patients with prostate cancer (PCa) in cases of localized and some locally advanced forms of the oncological process. NM following various LRP methods is a pathological condition that, according to various sources, affects between 0.8% and 87% of men who have undergone LRP for prostate cancer. It is worth noting that pathophysiologically, UTI after LRP is most often caused by mechanical damage and / or denervation of the striated urethral sphincter or the occurrence of detrusor hyperactivity, leading to imperative UTI (Stolzenburg JU Nerve sparing endoscopic extraperitoneal radical prostatectomy - effect of puboprostatic ligament preservation on early continence and positive margins / Stolzenburg JU, Liatsikos EN, Rabenalt R., Do M., Sakelaropoulos G., Horn LC, Truss MC / / Eur Urol. - 2006. - 49. - P. 103-112).In the modern medical community, despite extensive technical capabilities and in-depth knowledge of pelvic anatomy, there is great concern about the quality of rehabilitation of patients after LRP who are faced with the problem of incontinence, since this disease significantly affects the quality of life of patients (Chughtai B. Conservative treatment for postprostatectomy incontinence / Chughtai B., Lee R., Sandhu J. / / Rev Urol. - 2013. - 15. - P. 61-66). Psychological disorders that arise in patients due to postoperative incontinence significantly maladjust them. Incontinence after LRP usually begins to level out after 3 months.Currently, several risk factors have been identified that may influence the regulation of urinary continence in patients in the postoperative period: patient age (59 years and older); tumor stage; severity of urination disorders observed before surgery; parameters of radiation therapy preceding LRP; extent of previous prostate surgeries; concomitant diseases (diabetes mellitus, cardiovascular system) and, of course, surgical factors: surgical technique and method, surgeon's experience, etc. Other components that provoke urinary incontinence after LRP are also noted (excessive walking load, running, immoderate fluid intake, physical overexertion, etc.).

[0003] Non-invasive correction methods for urinary incontinence after LRP, used by urologists at both outpatient and inpatient stages of medical care, include: the stop test (its positive result is voluntary interruption of urination), reflecting a positive prognosis for the restoration of continence; behavioral therapy; pelvic floor muscle training; biofeedback method; electrical cutaneous stimulation; electromagnetic stimulation of the pelvic floor muscles and sacral zone; other technologies are also used.

[0004] A method of pelvic floor muscle stimulation using electrical stimulation and biofeedback is known, proposed in 2009 (Early Recovery of Urinary Continence after Radical Prostatectomy Using Early Pelvic Floor Electrical Stimulation and Biofeedback, G. Mariotti et al., The Journal of Urology, 2009, DOI: 10.1016 / j.juro.2008.11.104). In the treatment group, a course of treatment after prostatectomy was carried out 7 days after catheter removal in the amount of 12 sessions, 2 sessions per week. Each session included biofeedback for 15 minutes and 20 minutes of electrical stimulation of the pelvic floor muscles.

[0005] The disadvantages of this method include its combination nature, as the available data do not allow us to determine the contribution of electrical stimulation alone to the effect. The lack of a detailed description of the stimulation itself, as well as reports of the large-scale implementation of this technology, reflecting the rehabilitation capabilities of patients undergoing LRP, are currently found only in references in the practice of Russian urologists.

[0006] A method for stimulating the pelvic floor muscles by electrobalneotherapy is known (Method for stimulating the pelvic floor muscles by electrobalneotherapy: patent RU2727587, Russian Federation, application RU2020105298, declared 02 / 05 / 2020, published 07 / 22 / 2020), the procedure is carried out for women in a bath with fresh water with a volume of 200-220 liters, which has built-in plate electrodes for supplying electric current, the patient after a hygienic shower is immersed in a bath filled with fresh water at a temperature of 35-36 ° C, so that the impact zone - the pelvic area with the perineum - is completely covered with water, then a faradic current of 120 mA intensity with a frequency of 20 Hz is supplied to two electrodes located transversely in the wall of the bath in the projection area of ​​the patient's pelvis, the intensity of the current is gradually increased until a sensation of vibration and muscle contractions appears in the pelvic area, external and internal groups of thigh muscles, then over the course of 3-5 minutes the intensity of the current continues to be gradually increased,maintaining the sensation of muscle contractions, but not more than 240 mA, focusing on the subjective state of the patient - not allowing discomfort, the total duration of the procedure is 10-15 minutes, after its completion, the patient gets out of the bath, wipes herself with a towel and rests in a lying or reclining position for 20-25 minutes, the course is 10-12 procedures daily or 2 days in a row alternating one day of rest.

[0007] The disadvantages of this method include contraindications and risks typical of hydrotherapy, the lack of selective action, a long course with daily visits, as well as the stationary nature and resource-intensive nature of the proposed method (a special bath with built-in electrodes and a large volume of water).

[0008] The technical problem is the need to develop an effective method for electrical stimulation of pelvic tissue structures in areas subject to the functional influence of cavernous nerves in patients who have undergone laparoscopic radical prostatectomy, devoid of the above-mentioned disadvantages.

[0009] The technical result consists in increasing the efficiency and compliance of electrical stimulation of pelvic tissue structures in areas subject to the functional influence of cavernous nerves in patients who have undergone laparoscopic radical prostatectomy, devoid of the above-mentioned disadvantages.

[0010] The technical result is achieved in that in the method of electrical stimulation of the tissue structures of the pelvis in areas subject to the functional influence of the cavernous nerves in patients who have undergone laparoscopic radical prostatectomy, including the installation of electrodes in the pelvic area and the supply of electric current to them to stimulate muscle contraction, according to the invention, the installation of electrodes is carried out intraoperatively under combined control: laparoscopic and transrectal ultrasound, for which, after the formation of the urethrovesical anastomosis, a puncture is made with a needle with a diameter of 1 mm of the functional zones of the cavernous nerves, through which the electrodes of the stimulation system are inserted, while the distal contact group of electrodes is installed in the area of ​​​​the rhabdosphincter perineal access through the pararectal tissue, and the subsequent groups are in the zones of the expected physiological activity of the cavernous nerves and brought into the area of ​​​​the operation, after which the needle is removed,and the proximal part of the electrodes is brought out through the anterior abdominal wall and fixed to the skin, and electrical stimulation is carried out after connecting the electrodes to the generator in a mode with a frequency of 2 Hz, a pulse duration of 1 ms and an amplitude of 15 mA, while the criterion for the system's performance is considered to be a visually observable contraction of the pelvic muscles.

[0011] The proposed technique ensures effective electrical stimulation and compliance due to the intraoperative placement of electrodes.

[0012] The claimed method is carried out as follows.

[0013] Patients undergo standard laparoscopic radical prostatectomy (LRP) with unilateral or bilateral nerve sparing without pelvic lymphadenectomy. A mandatory step of the surgery is reconstruction of the pelvic anatomical structures. After creating the urethrovesical anastomosis and checking its tightness, transrectal ultrasound imaging of the pelvic organs and structures, particularly the pararectal tissue and vascular and nerve bundles, is performed.

[0014] Next, under ultrasound guidance, to prevent vascular damage and minimize trauma to surrounding tissue, a 1 mm diameter needle is used to puncture the functional areas of the cavernous nerves. Electrodes from the Boston Scientific Precision Spectra stimulation system are then inserted into the needle.

[0015] The distal contact group of electrodes is placed on the right and left sides of the rhabdosphincter area via a perineal approach through the pararectal tissue under ultrasound guidance of a transrectal probe and laparoscopic visual control. Subsequent groups are placed in the area of ​​suspected physiological activity of the cavernous nerves and also advanced to the surgical site. The next step is to remove the needle from the abdominal cavity. The electrodes, in turn, are not intracorporeally fixed in the area of ​​the base of the vascular-nerve bundles.

[0016] A puncture of the anterior abdominal wall is performed, followed by removal of the proximal portion of the electrodes. To prevent migration, the electrodes are secured to the skin on the anterior abdominal wall, significantly facilitating their subsequent removal.

[0017] The bladder is drained with a Ch20 Foley catheter, and a "signal" drain is inserted into the abdominal cavity in the vesicorectal space for 1 day. Electrical stimulation is performed after connecting the electrodes to the generator at a frequency of 2 Hz, 1 ms, and an amplitude of 15 mA. The system's performance is assessed by visually observed pelvic muscle contraction.

[0018] The claimed method is explained by an example.

[0019] Patient A, who underwent laparoscopic radical prostatectomy, was treated with electrical stimulation of the pelvic tissue structures in areas affected by the functional influence of the cavernous nerves.

[0020] The method involved placing electrodes in the pelvic region and applying an electric current to them to stimulate muscle contraction. The electrodes were inserted intraoperatively under combined laparoscopic and transrectal ultrasound guidance. After creating a urethrovesical anastomosis, a 1 mm diameter needle was used to puncture the functional zones of the cavernous nerves, through which the stimulation system electrodes were inserted. The distal contact group of electrodes was placed in the rhabdosphincter area via a perineal approach through the pararectal tissue, and subsequent groups were placed in areas of suspected physiological activity of the cavernous nerves. The needle was then removed, and the proximal portion of the electrodes was brought out through the anterior abdominal wall and fixed to the skin. Electrical stimulation was administered after connecting the electrodes to the generator at a frequency of 2 Hz, a pulse duration of 1 ms, and an amplitude of 15 mA.The criterion for the system's performance was considered to be the visually observable contraction of the pelvic muscles.

[0021] The result of electrode placement and electrical stimulation was assessed as good: the target effect was achieved, no complications were identified.

Claims

A method for electrical stimulation of pelvic tissue structures in areas subject to the functional influence of cavernous nerves in patients who have undergone laparoscopic radical prostatectomy, including the installation of electrodes in the pelvic area and the application of electric current to them to stimulate muscle contraction, characterized in that the installation of the electrodes is performed intraoperatively under combined control: laparoscopic and transrectal ultrasound, for which, after the formation of a urethrovesical anastomosis, a puncture is made with a needle with a diameter of 1 mm in the functional zones of the cavernous nerves, through which the electrodes of the stimulation system are inserted, while the distal contact group of electrodes is installed in the area of ​​the rhabdosphincter by perineal access through the pararectal tissue, and the subsequent groups are installed in the zones of the expected physiological activity of the cavernous nerves and brought into the area of ​​​​the operation, after which the needle is removed,and the proximal part of the electrodes is brought out through the anterior abdominal wall and fixed to the skin, and electrical stimulation is carried out after connecting the electrodes to the generator in a mode with a frequency of 2 Hz, a pulse duration of 1 ms and an amplitude of 15 mA, while the criterion for the system's performance is considered to be a visually observable contraction of the pelvic muscles.