Total urethra suspension strap for treating stress urinary incontinence and bladder bulging

Abstract

The invention relates to a total urethra suspension strap for treating stress urinary incontinence and bladder bulging. The total urethra suspension strap comprises a left strap piece, a right strap piece, a urethra far-end supporting piece and a bladder neck supporting piece. The left sling piece and the right sling piece are respectively provided with a suspension line; the urethra far-end supporting piece and the bladder neck supporting piece are respectively provided with a positioning flattening line. The device has the advantages that the mesh is placed in the gap between the bladder and the vagina to restore the support of the bladder and the urethra, a rear pelvic cavity is reconstructed to strengthen the support effect of the levator ani muscle and the perineum body, and based on a urine control mechanism, the mechanical balance of the pelvic cavity is restored by restoring the hammock structure and reconstructing levator ani muscle fissure holes and the perineum body; meanwhile, the operation modes of SUI, bladder prolapse, uterine prolapse and rectum bulge are achieved, good results are obtained in the aspects of complications, effective rate, patient satisfaction and the like, and the method can be used as a novel standardized treatment method for treating bladder prolapse and stress urinary incontinence and has wide application prospects in clinical popularization.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and specifically, to a total urethral suspension sling for treating stress urinary incontinence complicated with cystocele. Background Art

[0002] Female pelvic floor dysfunction (PFD) is a group of diseases caused by various etiologies, resulting in weak pelvic floor support, and further leading to displacement of pelvic organs and their functional abnormalities. Pelvic floor dysfunctional diseases include urinary incontinence, fecal incontinence, pelvic organ prolapse, urination and defecation disorders, and female sexual dysfunction. Among them, the most common ones are stress urinary incontinence and pelvic organ prolapse. Pelvic organ prolapse and stress urinary incontinence are very common in middle-aged and elderly patients. Studies have shown that the incidence of urinary incontinence in women over 60 years old is 37.7%, and the incidence of pelvic organ prolapse is close to 50%.

[0003] The prevalence of symptomatic SUI varies with the anatomical location of prolapse, and has the strongest correlation with anterior pelvic prolapse (cystocele). Relevant literature reports that among patients with urinary incontinence, 46.3% have cystocele and / or disappearance of the urethrovesical fold. Among patients with cystocele, 58% of the patients have combined UI, and most of them are SUI. Therefore, SUI and POP (bladder prolapse) may actually belong to different manifestation stages or forms of the same disease. In the more than two decades since the "integral theory" was proposed, midurethral sling (MUS) has been largely regarded as the "gold standard" for treating SUI.

[0004] Currently, the main method for treating stress urinary incontinence is transvaginal tension-free midurethral sling (including different surgical procedures such as TVT, TVT-O, TOT, etc.). Although good results have been achieved, MUS still has some problems, mainly including: for patients with SUI complicated with mild to moderate anterior vaginal wall prolapse, MUS cannot solve their prolapse problem, and a considerable part of their prolapse is symptomatic. If an anti-prolapse operation is performed, the SUI symptoms cannot be effectively relieved; due to the small force-bearing area of the sling, patients with a large urethral mobility before surgery may have difficulty urinating after surgery, and the average probability is 5.53%; and some need surgical removal to relieve the difficulty of urination. The reason for this dilemma is that in previous studies, we often regarded the two diseases as completely independent, and lacked an overall perspective to explain this problem.

[0005] Secondly, transvaginal tension-free mid-urethral sling procedures (including different procedures such as TVT, TVT-O, TOT, etc.) have the problem that if the sling is placed too loosely, it cannot achieve the effect of improving symptoms, while if it is placed too tightly, it is prone to postoperative dysuria, and it cannot solve the problem of cystocele in patients. For cystocele, especially moderate to severe cystocele, the current treatment methods include autologous tissue repair and pelvic floor mesh implantation (TVM). The puncture points for the mesh placement method are all external and inferior, emphasizing puncturing the sacrospinous ligament, and the mesh is required to be placed between the cervix and the bladder neck, which results in the emergence of new stress urinary incontinence in some patients after surgery, or no improvement in the original stress urinary incontinence. Currently, there is no good solution for stress urinary incontinence complicated with cystocele.

[0006] In summary, there is an urgent need for a biomechanical reconstruction method based on the mechanism of urinary control to treat stress urinary incontinence complicated with cystocele, and a total urethral suspension sling with good curative effect. There is currently no report on such a total urethral suspension sling. Summary of the Invention

[0007] The object of the present invention is to provide a total urethral suspension sling for treating stress urinary incontinence complicated with cystocele by a biomechanical reconstruction method based on the mechanism of urinary control and achieving good curative effect.

[0008] To achieve the above object, the technical solution adopted by the present invention is:

[0009] A total urethral suspension sling for treating stress urinary incontinence complicated with cystocele, the total urethral suspension sling includes a left sling piece, a right sling piece, a distal urethral support piece, and a bladder neck support piece; the left sling piece, the right sling piece, the distal urethral support piece, and the bladder neck support piece are integrally formed; the total urethral suspension sling as a whole has an inverted T-shaped structure; the left sling piece and the right sling piece are respectively provided with suspension lines; the distal urethral support piece and the bladder neck support piece are both provided with positioning flattening lines;

[0010] The left sling piece and the right sling piece are located at a position 0.5 cm outside the middle of the bilateral pubic bones in the use state; the bladder neck support piece is located 0.5 cm above the bladder neck in the use state;

[0011] The contour of the distal urethral support piece is arc-shaped; the contours of the left sling piece and the right sling piece are straight-shaped, and the total urethral suspension sling is formed by cutting.

[0012] As a preferred technical solution, the suspension line is in the structural form of a double-strand line.

[0013] As a preferred technical solution, the total urethral suspension sling is configured with 3-0 absorbable barbed sutures for submucosal embedding suture of the anterior vaginal wall.

[0014] As a preferred technical solution, the total urethral suspension sling is further configured with 2-0 fishbone sutures for suturing and reinforcing the levator ani muscle.

[0015] As a preferred technical solution, the width of the left sling piece and the right sling piece is 1.5 cm - 2.0 cm.

[0016] As a preferred technical solution, the length of the distal urethral support piece is 2 - 3 cm; the width of the distal urethral support piece is 3 - 4 cm.

[0017] As a preferred technical solution, after the total urethral suspension sling is implanted, it is fully flattened by the traction of the positioning flattening lines of the distal urethral support piece and the bladder neck support piece, and covers the area between the distal urethra and the bladder neck.

[0018] As a preferred technical solution, the total urethral suspension sling is configured with 2-0 absorbable sutures for fixing the four corners of the sling.

[0019] As a preferred technical solution, the total urethral suspension sling is configured with a Foley catheter and a palpation balloon for determining the position of the bladder neck.

[0020] To achieve the above second object, the solution adopted by the present invention is:

[0021] A total urethral suspension sling using any one of the above embodiments, and the application of the total urethral suspension sling in the treatment of stress urinary incontinence combined with cystocele.

[0022] The advantages of the present invention are as follows:

[0023] 1. The total urethral suspension sling for treating stress urinary incontinence combined with cystocele of the present invention places a mesh in the vesicovaginal space to restore the support of the bladder and urethra, and reconstructs the posterior pelvis to strengthen the support of the levator ani muscle and perineal body. Based on the urinary control mechanism, by restoring the hammock structure, reconstructing the levator ani hiatus and perineal body, the mechanical balance of the pelvis is restored. At the same time, it is a surgical method to solve SUI, cystocele, uterine prolapse and rectocele, and good results have been achieved in terms of complications, efficiency, patient satisfaction, etc. It can be used as a new standardized treatment method for treating cystocele combined with stress urinary incontinence and has broad application prospects in clinical promotion.

[0024] 2. The total urethral suspension sling includes a left sling piece and a right sling piece, and the width of the left sling piece and the right sling piece is 1.5 cm - 2.0 cm, which is wider than the traditional sling, ensuring a larger force-bearing surface of the sling on the descending pubic ramus, preventing the sling from moving, and thus reducing the recurrence rate.

[0025] 3. The full urethral suspension sling is provided with a distal urethral support piece, which can support the distal part of the urethra. Compared with the mid-urethral suspension, due to the extension of the urethral support surface, the incidence of postoperative dysuria is reduced.

[0026] 4. The full urethral suspension sling is provided with a bladder neck support piece, emphasizing that the stress point of the sling is located at the descending ramus of the pubis, and the main support point is located at the bladder neck, suspending the bladder neck to restore its normal position. Compared with the traditional anterior pelvic mesh, since a supporting force is given to the mid-urethra, the functional urethral length is extended, the incidence of postoperative urinary incontinence is reduced, and the possibility of re-placing the mid-urethral sling is decreased, reducing the medical cost.

[0027] 5. The full urethral suspension sling is integrally in an inverted T-shaped structure; it is designed specifically for the pathogenesis of stress urinary incontinence and cystocele, facilitating the support around the bladder neck, the support of the anterior vaginal wall, and the suspension of the arcus tendineus fasciae pelvis, forming an external pressure to increase the urethral closure pressure.

[0028] 6. The left sling piece and the right sling piece are respectively provided with suspension threads; the distal urethral support piece and the bladder neck support piece are both provided with positioning flattening threads. The effects of this design are: on the one hand, it is convenient for suspension. Especially the suspension threads of the left sling piece and the right sling piece are implanted through the obturator foramen. Tighten the suspension threads outside the skin on both sides until the left and right sling pieces are pulled out of the skin, cut the left and right sling pieces close to the skin, which can establish a suspension effect on the arcus tendineus fasciae pelvis, making the functional length of the female urethra longer, thus playing a good role in urine control; on the other hand, the preset middle positioning flattening threads ensure the correct placement and flattening of the sling mesh during the operation, effectively improving the cure rate and reducing the incidence of complications.

[0029] 7. The full urethral suspension sling is equipped with 3-0 absorbable barbed sutures for submucosal embedding and suturing of the anterior vaginal wall. The effects of this design are: reducing sling exposure and improving the improvement rate of postoperative urinary incontinence; at the same time, making the sling integrated with the anterior vaginal wall suture, realizing the support of the anterior vaginal wall and increasing the urethral closure pressure.

[0030] 8. The full urethral suspension sling is also equipped with 2-0 fishbone sutures for suturing and strengthening the levator ani muscle. The effects of this design are: facilitating the establishment of a supporting effect on the levator ani muscle and the perineal body, increasing the urethral closure pressure, making the functional length of the female urethra longer, thus playing a good role in urine control. Brief Description of the Drawings

[0031] Attached Figure 1 is a schematic diagram of the normal female pelvic floor anatomical structure.

[0032] Attached Figure 2 is a schematic plan view of the full urethral suspension sling for the treatment of stress urinary incontinence combined with cystocele of the present invention.

[0033] Attached Figure 3 is Figure 2 the corresponding physical schematic diagram.

[0034] Attached Figure 4 is the schematic diagram of the relative positions of the bladder and PCL in patients with stress urinary incontinence.

[0035] Attached Figure 5 is the schematic diagram of the relative positions of the bladder and PCL after mid-urethral suspension.

[0036] Attached Figure 6 is the schematic diagram of the relative positions of the bladder and PCL after total urethral suspension.

[0037] Attached Figure 7 is the schematic diagram of the operation method of the total urethral suspension sling of the present invention. Detailed implementation manners

[0038] The present invention will be further described below in conjunction with the embodiments and with reference to the accompanying drawings.

[0039] The reference numerals and components involved in the accompanying drawings are as follows:

[0040] 1. Left sling piece 2. Right sling piece

[0041] 3. Distal urethral support piece 4. Bladder neck support piece

[0042] 5. Suspension line 6. Positioning flattening line [[ID=4D]]

[0043] To make the objectives, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are some but not all of the embodiments of the present invention. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without creative efforts shall fall within the protection scope of the present invention.

[0044] For the convenience of understanding the embodiments of the present invention, the following will further explain with specific embodiments in conjunction with the accompanying drawings. The embodiments do not constitute a limitation to the embodiments of the present invention.

[0045] In the description of the embodiments of the present invention, it should be noted that the orientation or positional relationship indicated by terms such as "one side" and "the other side" is based on the orientation or positional relationship shown in the drawings. It is only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and thus should not be construed as a limitation to the present invention. In addition, unless otherwise clearly specified and defined, the terms "installed", "connected", and "connected" should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be directly connected or indirectly connected through an intermediate medium, and it can be the communication inside two elements. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0046] Embodiment 1

[0047] To facilitate the understanding of the technical solution of the present application, this embodiment provides Figure 1 , Figure 1 which is a schematic diagram of the normal female pelvic floor anatomical structure. PS: Pubic symphysis B: Bladder U: Urethra UT: Uterus CX: Cervix V: Vagina PB: Perineal body LAM: Levator ani muscle R: Rectum S: Sacrum C: Coccyx.

[0048] Please refer to Figure 2 , Figure 2 which is a schematic plan view of the total urethral suspension sling for treating stress urinary incontinence combined with cystocele of the present invention. The total urethral suspension sling for treating stress urinary incontinence combined with cystocele; the total urethral suspension sling includes a left sling piece 1, a right sling piece 2, a distal urethral support piece 3, and a bladder neck support piece 4; the left sling piece 1, the right sling piece 2, the distal urethral support piece 3, and the bladder neck support piece 4 are integrally formed; the total urethral suspension sling as a whole has an inverted T-shaped structure; the left sling piece 1 and the right sling piece 2 are respectively provided with suspension lines 5; the distal urethral support piece 3 and the bladder neck support piece 4 are both provided with positioning flattening lines 6.

[0049] The suspension line 5 is in the structural form of a double-strand line.

[0050] The total urethral suspension sling is configured with 3-0 absorbable barbed sutures for submucosal embedding suture of the anterior vaginal wall.

[0051] The total urethral suspension sling is also configured with 2-0 fishbone sutures for suturing and strengthening the levator ani muscle.

[0052] The left sling piece 1 and the right sling piece 2 are located at a position 0.5 cm outside the middle of the bilateral pubic bones in the use state; the bladder neck support piece 4 is located 0.5 cm above the bladder neck in the use state.

[0053] The width of the left sling piece 1 and the right sling piece 2 is 1.5 cm - 2.0 cm. As a preference, the width of the left sling piece 1 and the right sling piece 2 is 2 cm. The length of the distal urethral support piece is 2 - 3 cm; the width of the distal urethral support piece is 3 - 4 cm; the contour of the distal urethral support piece 3 is arc-shaped; the contours of the left sling piece 1 and the right sling piece 2 are straight-shaped.

[0054] Please refer to Figure 3 , Figure 3 is Figure 2 the corresponding physical schematic diagram. The full urethral suspension sling is cut. It is cut from an ultra-light macroporous non-absorbable mesh ([[]] Chivasso, Italy).

[0055] It should be noted for this embodiment that:

[0056] For a better understanding of the technical solution of the present invention, the applicant made the following schematic diagrams of models. Figure 4 It is a schematic diagram of the relative positions of the bladder and the PCL of a patient with stress urinary incontinence; Figure 5 It is a schematic diagram of the relative positions of the bladder and the PCL after mid-urethral suspension; Figure 6 It is a schematic diagram of the relative positions of the bladder and the PCL after full urethral suspension. PS: Pubic symphysis; B: Bladder U: Urethra SC: Sacrococcyx PCL: Pubococcygeal line.

[0057] Under normal circumstances, the bladder base is close to horizontal and the bladder neck is closed. The bladder neck is located at the lower 1 / 3 junction of the pubic symphysis and is usually higher than the pubococcygeal line, that is, the PCL (the line connecting the lower edge of the pubic symphysis and the tip of the coccyx). The posterior bladder-urethral angle formed by the axis of the proximal urethra and the horizontal tangent of the bladder base is normally between 90° - 110°. When the bladder neck is closed at a right angle, the closing performance of the proximal urethra is the strongest and the resistance is the greatest. When the supporting structure of the bladder neck orifice is weak, the bladder neck cannot be closed tightly, the mobility of the bladder neck increases, the bladder neck orifice moves downward, and the posterior bladder-urethral angle often increases or even disappears, resulting in weakened urine control ability and easy occurrence of urinary incontinence when the abdominal pressure increases. When performing cystourethrography on SUI patients, it is found that most patients have a funnel-shaped bladder neck, the bladder neck orifice moves downward, lower than the PCL, and the posterior bladder-urethral angle increases or even disappears.

[0058] When the bladder neck position is not restored during mid-urethral suspension (see Figure 5 ), through full urethral suspension combined with posterior pelvic reconstruction (see Figure 6 ), the position of the bladder neck is lifted by using the suspension sling, and the support of the levator ani muscle and the perineal body on the bladder neck and urethra is strengthened, so that the bladder neck returns to the normal position.

[0059] The described total urethral suspension sling includes a left sling piece 1 and a right sling piece 2, and the widths of the left sling piece 1 and the right sling piece 2 are 1.5 cm - 2.0 cm, which are wider than traditional slings. This ensures that the sling has a larger stress-bearing surface on the descending ramus of the pubis, preventing the sling from moving, thereby reducing the recurrence rate.

[0060] The described total urethral suspension sling is provided with a distal urethral support piece 3, which can support the distal part of the urethra. Compared with the mid-urethral suspension, due to the extension of the urethral support surface, the incidence of postoperative dysuria is reduced.

[0061] The described total urethral suspension sling is provided with a bladder neck support piece 4, emphasizing that the stress point of the sling is located on the descending ramus of the pubis, and the main support point is located at the bladder neck. The bladder neck is suspended to restore its normal position. Compared with traditional anterior pelvic mesh, since a supporting force is given to the mid-urethra, the functional urethra length is extended, the incidence of postoperative urinary incontinence is reduced, and the possibility of re-placing the mid-urethral sling is reduced, thus reducing medical costs.

[0062] The described total urethral suspension sling is in an inverted T-shaped structure as a whole; it is specifically designed for the pathogenesis of stress urinary incontinence and cystocele, facilitating the support around the bladder neck, the support of the anterior vaginal wall, and the suspension of the arcus tendineus fasciae pelvis, forming an external pressure to increase the urethral closure pressure.

[0063] The left sling piece 1 and the right sling piece 2 are respectively provided with suspension threads 5; the distal urethral support piece 3 and the bladder neck support piece 4 are both provided with positioning flattening threads 6. The effects of this design are as follows: on the one hand, it is convenient for suspension. In particular, the suspension threads 5 of the left sling piece 1 and the right sling piece 2 are implanted through the obturator foramen. The suspension threads 5 outside the skin on both sides are tightened until the right sling pieces 2 are pulled out of the skin, and the right sling pieces 2 are cut close to the skin, which can establish a suspension effect on the arcus tendineus fasciae pelvis, making the functional length of the female urethra longer, thereby playing a good role in urine control; on the other hand, the preset intermediate positioning flattening threads 6 ensure the correct placement and flattening of the sling during the operation, effectively improving the cure rate and reducing the incidence of complications.

[0064] The described suspension thread 5 is in the structural form of a double-strand thread. The effects of this design are: increasing the mechanical properties, while facilitating the pulling of the introducer and facilitating the implantation of the sling.

[0065] The described total urethral suspension sling is configured with a 3-0 absorbable barbed thread for submucosal embedding suture of the anterior vaginal wall. The effects of this design are: reducing sling exposure and improving the improvement rate of postoperative urinary incontinence; at the same time, making the sling integrated with the anterior vaginal wall suture, realizing the support of the anterior vaginal wall and increasing the urethral closure pressure.

[0066] The described full urethral suspension sling is also configured with 2-0 fishbone sutures for reinforcing the levator ani muscle. The effect of this design is as follows: It is convenient to establish a supporting effect on the levator ani muscle and the perineal body, increase the urethral closure pressure, make the functional length of the female urethra longer, and thus play a good role in urine control (it has been anatomically proven that the pubourethral ligament does not exist. The contraction of the levator ani muscle may be the main reason. The levator ani muscle consists of three muscles, and some fibers of the pubovisceral muscle penetrate around the urethra and vagina, and together with the hammock formed by the pelvic fascia and the anterior vaginal wall, they support the urethra. In addition, as reported by Christian Wallner et al., during the contraction process, the levator ani muscle does not simply lift upward, but contracts upward and ventrally. This movement mode causes strong pressure on the vagina and urethra from the back and both sides, helping to close the vagina and urethra, and thus assisting in urine control. This contraction mechanism of the levator ani muscle also plays an important role in maintaining the normal position of pelvic organs. Under normal circumstances, the type I fibers of the levator ani muscle are in a continuous contraction state, maintaining the closure of the urogenital hiatus just like the anal sphincter maintains the closure of the anus. When the levator ani hiatus expands due to certain reasons or the contraction force of the levator ani muscle significantly weakens, this closure effect cannot be maintained, resulting in POP similar to hernia. In the pelvic cavity, it is the levator ani muscle with greater contraction force that truly supports and maintains the normal position of various organs in the pelvic cavity, rather than various ligament connective tissues formed by the peritoneal reflection. The main function of these connective tissues is to maintain the morphology of organs above the levator ani plane, such as the anteversion and anteflexion of the uterus and the normal position of the urethra. Without the support of the levator ani muscle and the function of closing the urogenital hiatus, the ligaments and connective tissues will inevitably stretch and deform and lose their functions).

[0067] The described left sling piece 1 and right sling piece 2 are located at a position 0.5 cm outside the middle of the bilateral pubic bones in the use state; the described bladder neck support piece 4 is located 0.5 cm above the bladder neck in the use state. The effect of this design is as follows: Compared with other puncture paths, the puncture point is shifted inward and closely adheres to the descending ramus of the pubis, reducing the possibility of puncturing the adductor muscles and effectively reducing the probability of postoperative pain in the inner thigh; at the same time, it emphasizes that the stress point of the sling action is located on the descending ramus of the pubis, and the main support point is located at the bladder neck, suspending the bladder neck to restore its normal position. The upper end of the sling is located 0.5 cm above the bladder neck, and the lower end is located at the distal end of the urethra, covering the entire length of the urethra.

[0068] The contour of the described distal urethral support piece 3 is arc-shaped; the contours of the described left sling piece 1 and right sling piece 2 are straight-shaped. The effect of this design is as follows: It is a targeted design and is in line with the human physiological structure.

[0069] The surgical method of the full urethral suspension sling for treating stress urinary incontinence complicated with cystocele of the present invention is as follows:

[0070] After the anesthesia took effect, the patient was placed in the lithotomy position. After routine disinfection and draping, a Foley catheter was indwelled. The labia minora on both sides were retracted with silk threads to obtain a good surgical field. The anus was covered with a drape to prevent contamination of the incision.

[0071] 1. Separation of the anterior vaginal wall space

[0072] To reduce bleeding and better separate the tissue space, 60 - 100 ml of 0.25 - 0.5:1000 epinephrine saline was used for hydrodissection in the vaginal and vesicourethral spaces. A 3 - 4 cm midline incision was made in the vaginal mucosa between the lower urethral fold and 0.5 cm above the bladder neck, ensuring that the entire layer of the vaginal mucosa was incised to guarantee the blood supply of the vaginal wall. The position of the bladder neck was determined by palpating the balloon by pulling the Foley catheter. Then, the anterior vaginal space was continuously dissected using a combination of blunt and sharp dissection, and both ends were dissected to the posterior side of the descending ramus of the pubis to create space for the placement of the sling later.

[0073] 2. Placement and fixation of the sling

[0074] The mid - outer 0.5 cm of the middle segment of the bilateral descending rami of the pubis was selected as the puncture point (using bony landmarks instead of skin landmarks), and a skin incision of about 5 mm was made with a small round knife. Under the guidance of the index finger, the puncture guide was passed through the fascia lata of the thigh, the obturator membrane, and the bilateral pelvic fascia, and the silk thread used to guide the upper arm of the sling was passed through the puncture guide, and then the puncture guide was withdrawn, thus placing one arm of the sling (referring to the TOT placement method), and the other arm was placed in the same way. Under the traction of the upper and lower guiding lines of the sling, the sling was fully flattened, and it could be found that the sling covered between the distal urethra and the bladder neck. The four corners of the sling were fixed with 2 - 0 absorbable sutures. To reduce sling exposure and improve the postoperative improvement rate of urinary incontinence, 3 - 0 absorbable barbed sutures were used for submucosal embedding suture of the anterior vaginal wall, making a double - layer fold of the mucosa as close as possible to the tendinous arch of the pelvic fascia, and then the vaginal mucosa incision was closed. The guiding lines suspended outside the skin on both sides were tightened until the sling was pulled out of the skin, and the sling was cut close to the skin.

[0075] 3. Reconstruction of the posterior compartment (levator hiatus and perineal body)

[0076] Similarly, to reduce bleeding and better separate tissue spaces, 40 - 60 ml of 0.25 - 0.5:1000 adrenaline - saline solution was used for hydro - dissection in the rectovaginal space. 20 - 40 ml was injected into the perineal body to make the perineal body swollen and white. A "diamond - shaped" incision was made between the lateral margin of the hymen and the plane of the cervix. The widest part of the "diamond" was at the plane of the levator hiatus so that the formed vagina could accommodate two fingers. For elderly women / those without sexual needs, it could be appropriately narrowed. After fully exposing the field of view, the rectovaginal space was bluntly dissected until above the bilateral levator ani muscles, reaching the Douglas space. 2 - 0 fish - bone suture was used to suture the levator plate horizontally from behind the levator ani muscle (below the cervix) to form a ridge on the posterior vaginal wall below the cervix and reconstruct the posterior fornix depression. The levator ani muscle was sutured in a imbricate pattern to reinforce it and narrow the levator hiatus above the perineal body. The vaginal mucosa was sutured to the levator ani muscle plane with 2 - 0 absorbable suture.

[0077] Continue to suture the perineal membrane with 2 - 0 fish - bone suture and use horizontal mattress suture for the damaged external anal sphincter ( Figure 2 ), to thicken and lengthen the perineal body. The vaginal incision was closed with 2 - 0 absorbable suture. Iodophor gauze was packed in the vagina for hemostasis by compression.

[0078] Please refer to Figure 7 [[ID=?]], Figure 7 which is a schematic diagram of the operation method of the total urethral suspension sling of the present invention. The operation method of the total urethral suspension sling includes the following steps:

[0079] A Inject adrenaline - saline solution between the anterior vaginal wall and the vesicourethral space to reduce bleeding during subsequent dissection and better separate tissues

[0080] B Dissect the space between the vagina and the vesicourethra to reserve enough space for the placement of the sling

[0081] C Select the position 0.5 cm outside the middle of the bilateral pubic bones as the puncture point and use the method of touching bony landmarks to locate the puncture point

[0082] D Place the sling into the above - mentioned space under the guidance of the puncture guide

[0083] E Spread the sling under the traction of the upper and lower positioning flattening lines and fix the four corners of the sling so that the sling is spread between the bladder neck and the distal urethra, and close the vaginal incision after embedding

[0084] F Inject adrenaline - saline solution into the space between the posterior vaginal wall and the rectum for hydro - dissection

[0085] G Make a diamond - shaped cut on the posterior vaginal wall, and the widest part of the cut is approximately at the plane of the levator hiatus

[0086] H Dissect the Douglas space upward on both sides to expose the bilateral levator ani muscles It should be noted that there is an unclear symbol "? " in the original text at line ID = 10, which is retained as it is in the translation.

[0087] I Use 2-0 fishbone sutures to horizontally suture both sides of the levator ani muscle above the perineal body to reduce the area of the levator ani hiatus and reconstruct the posterior vaginal fornix.

[0088] J Use 2-0 absorbable sutures to close the posterior vaginal wall incision above the perineal body.

[0089] K Horizontally suture the external anal sphincter and the perineal body to thicken and lengthen the perineal body.

[0090] L Close the posterior vaginal wall incision.

[0091] Study cases

[0092] Using the suspension sling of this embodiment, perioperative complications were mainly recorded, as well as the postoperative recovery of patients, including postoperative POP staging, POP symptom score sheet, urinary incontinence improvement score sheet, and overall patient satisfaction.

[0093] 1 Clinical data

[0094] 219 patients received surgical treatment during this period, among which 207 women had complete clinical and follow-up data, thus constituting the study group. The median age was 50 (45 - 57) years old, and the median body mass index was 23.44 (21.78 - 25.39) kg / m2. All patients had experienced childbirth, and the proportion of vaginal deliveries reached 97.6% (202 / 207). Most patients were in the perimenopausal period, and 54.6% (113 / 207) of the patients had menopause. The proportion of patients with a history of previous hysterectomy or anti-POP / SUI surgery was relatively small, accounting for 5.3% (11 / 207). See Table 1.

[0095] Table 1 - Baseline data of 207 patients

[0096]

[0097] IQR = Interquartile range; BMI = Body mass index; POP = Pelvic organ prolapse; SUI = Stress urinary incontinence.

[0098] 2. Statistical analysis

[0099] IBM-spss v.27 software was used for statistical analysis on Windows (IBM Corporation, Armonk, New York, USA). The Shapiro-wilk test was used to test the normality of continuous variables. For continuous variables that were statistically analyzed and conformed to a normal distribution, they were described by the mean and standard deviation (SD), and the paired t-test was used to compare the differences in measured values before and after surgery; for non-normal distributions, they were reported as the median and interquartile range, and the signed rank sum test was used to compare the differences in measured values before and after surgery; categorical variables were described by proportions, and the chi-square test or Fisher's exact probability method was used to compare the proportions. P < 0.05 was considered statistically significant.

[0100] 3. Perioperative outcomes

[0101] The perioperative outcomes are shown in Table 2.

[0102] Table 2 – Perioperative information and complications

[0103]

[0104] As can be seen from Table 2 above, the median operation time was 80 (75 - 85) minutes, and the median estimated blood loss was 35 (25 - 50) ml. There were 6 cases (2.9%) of intraoperative complications: 2 cases of bladder injury, 3 cases of perforation of the lateral vaginal wall during puncture, and 1 case of rectal injury. During the operation, it was irrigated with iodophor solution and then buried and sutured, an anal tube was indwelled, the patient fasted for 7 days after the operation, parenteral nutrition support was given, and antibiotics were used to prevent infection. Then the patient was discharged smoothly. All cases completed sling implantation and posterior pelvic repair (without stopping any operation). In the early stage, the urinary catheter was removed 1 - 2 days after the operation. Acute urinary retention occurred in 4 patients, and the urinary catheter was indwelled again for 3 days and then removed, and all recovered normal urination. In the later stage, the urinary catheter was indwelled for 3 - 4 days, and none of the patients had dysuria, which was considered related to perineal edema after the operation. One patient had a pelvic hematoma detected by B - ultrasound examination due to lower abdominal discomfort 7 days after the operation, and the hematoma was absorbed after 1 month of conservative treatment.

[0105] The median follow - up time was 15 (9 - 20) months. The POP classification and symptom improvement after the operation are shown in Table 3.

[0106] Table 3 - Subjective recovery and anatomic reduction of patients before and after the operation

[0107]

[0108]

[0109] a For data with a normal distribution, paired t - test was used; b For data with a non - normal distribution, Wilcoxon signed - rank test was used;; c Chi - square test; d Fisher's exact test; SD = standard deviation. APC = anterior pelvic. MPC = middle pelvic. PPC = posterior pelvic.

[0110] As shown in Table 3, the median follow-up time was 15 (9 - 20) months. The postoperative POP classification and symptom improvement are shown in Table 3. The total score of the PFDI-20 before surgery was 46.17 ± 11.84, and after surgery it was 13.12 ± 10.13, with an average difference of 33.04 (31.16 - 34.93, 95% CI), p < 0.001, indicating a statistically significant difference. For the International Consultation on Incontinence Questionnaire-Short Form (ICI-Q-SF), the median before surgery was 10.00 (9.00 - 12.00), and after surgery it was 1.00 (0 - 2.00), with a z value of 12.47, p < 0.001, showing a statistically significant difference. Among the Patient Global Impression of Improvement (PGI-I) scores, 188 cases (90.8%) of patients felt "much improved / very much improved" compared with before surgery.

[0111] Table 4 - Postoperative improvement

[0112]

[0113] As shown in Table 4, when using the full urethral suspension sling in this embodiment, the cure rate of SUI was 83.1% (172 / 207), and 90.8% (188 / 207) of the patients had significant improvement.

[0114] Table 5 - Postoperative complications

[0115]

[0116] As shown in Table 5, when the SUI symptoms improved, the urge symptoms also improved. Among them, 10 cases were new-onset UUI after surgery, with a proportion of 4.8%. After bladder training and oral solifenacin, the symptoms were relieved, and no severe urge incontinence occurred; this was slightly lower than the previously reported UUI incidence of 8.35% after MUS surgery.

[0117] The vaginal sling exposure rate was 7.7% (16 / 207). For 3 cases with a small exposure area, after applying estrogen ointment and reexamination, the recovery was good. For 9 cases, the sling was removed under general anesthesia, among which 3 cases had recurrence of urinary incontinence after removal, 1 case had mild urinary incontinence after removal, and 5 cases had good recovery. For 4 cases, the sling was removed under local anesthesia in the outpatient clinic, and after estrogen-assisted treatment after removal, all had good recovery;

[0118] 2 cases (0.9%) of patients had recurrence of urinary incontinence within 1 month after surgery, which was defined as surgical failure.

[0119] Stress urinary incontinence recurred in 14 patients (6.8%), and 1 patient underwent a second operation due to recurrence combined with cystocele; 4 patients had stage II anterior pelvic prolapse after surgery, 2 of whom had SUI symptoms, and 1 patient improved after undergoing a second operation; 3 patients had cervix elongation mainly manifested as prolapse symptoms (defined as C≥0, point D≥-4, estimated cervix length≥5 cm), and 1 of them underwent conization of the cervix due to severe subjective symptoms, and the urinary control of all 3 patients was good; Cervix elongation is easily misdiagnosed as uterine prolapse because their clinical manifestations are very similar. Currently, the cause of cervix elongation is unknown. It is speculated that it may be due to mechanical traction after prolapse reduction, leading to regrowth of the cervix;

[0120] The incidence of postoperative dysuria was 1.4% (3 / 207), lower than the previously reported 5.53%; and none of them required excision of the sling to relieve the obstruction. The patients with dysuria all had a characteristic, that is, dysuria in the squatting position, while the dysuria was relieved when the buttocks were elevated or sitting, presumably because the sling was placed at a lower position, below the bladder neck, and the bladder descended and the urethra was folded during squatting, resulting in obstructive symptoms.

[0121] Two patients reported discomfort in the lower abdomen, and the symptoms gradually disappeared after observation; one patient had pain in the inner side of the right thigh after surgery, did not require painkillers, and the pain disappeared after 3 months; there was no occurrence of dyspareunia.

[0122] In summary, as described in this study: 207 patients were retrospectively analyzed. The median follow-up time was 15 months (range 4–28). There were 6 intraoperative complications (2.7%), including 2 cases of bladder perforation, 3 cases of lateral vaginal wall perforation, and 1 case of rectal injury. There were 4 cases of acute urinary retention, 1 case of pelvic hematoma, and 2 cases of surgical failure after surgery. The main postoperative complications included 16 cases of mesh exposure (7.7%), 14 cases of recurrence of stress urinary incontinence (6.8%), 10 cases of new-onset urge urinary incontinence after surgery (4.8%), 4 cases of cystocele, 2 of whom had SUI symptoms, and 1 patient improved after undergoing a second operation; 3 cases of cervix elongation, and 1 of them underwent conization of the cervix; 3 cases had mild symptoms of dysuria, 2 patients reported discomfort in the lower abdomen, 1 patient had pain in the inner side of the right thigh after surgery, and there was no occurrence of dyspareunia. The postoperative POP grading was significantly improved compared with that before surgery, P<0.001, and PFDI-20 and ICI-Q-SF were significantly improved, P<0.001. The cure rate of SUI was 83.1% (172 / 207), and the overall improvement rate of GPI-I was 90.8% (188 / 207).

[0123] The total urethral suspension sling for treating stress urinary incontinence combined with cystocele in the present invention places a sling in the vesicovaginal space to restore the support of the bladder and urethra, reconstructs the posterior pelvis to strengthen the supporting effect of the levator ani muscle and perineal body. Based on the urinary control mechanism, by restoring the hammock structure, reconstructing the levator ani hiatus and perineal body, the mechanical balance of the pelvis is restored. At the same time, it is a surgical method to solve SUI, cystocele, uterine prolapse and rectocele, and good results have been achieved in terms of complications, efficiency, patient satisfaction, etc. It can be used as a new standardized treatment method for treating cystocele combined with stress urinary incontinence and has broad application prospects in clinical promotion.

[0124] The above are only the preferred embodiments of the present invention. It should be noted that for those of ordinary skill in the art of this technology, without departing from the principle of the present invention, several improvements and supplements can still be made, and these improvements and supplements should also be regarded as the protection scope of the present invention.

Claims

1. A total urethral suspension sling for treating stress urinary incontinence combined with cystocele, characterized in that, The described total urethral suspension sling includes a left sling piece, a right sling piece, a distal urethral support piece, and a bladder neck support piece; the left sling piece, the right sling piece, the distal urethral support piece, and the bladder neck support piece are integrally formed; the total urethral suspension sling is in an inverted T-shaped structure as a whole; the left sling piece and the right sling piece are respectively provided with suspension lines; the distal urethral support piece and the bladder neck support piece are both provided with positioning and flattening lines. The left sling piece and the right sling piece are located at a position 0.5 cm outside the middle of the bilateral pubic bones in the use state; the bladder neck support piece is located 0.5 cm above the bladder neck in the use state. The contour of the distal urethral support piece is arc-shaped; the contours of the left sling piece and the right sling piece are straight-shaped, and the total urethral suspension sling is cut.

2. The full urethral suspension sling according to claim 1, characterized in that, The suspension line is in the structural form of a double-strand line.

3. The total urethral suspension sling according to claim 1, characterized in that, The total urethral suspension sling is configured with a 3-0 absorbable barbed suture for submucosal embedding suture of the anterior vaginal wall.

4. The total urethral suspension sling according to claim 3, characterized in that The total urethral suspension sling is also configured with a 2-0 fishbone suture for suturing and strengthening the levator ani muscle.

5. The full urethral suspension sling according to claim 1, characterized in that, The widths of the left sling piece and the right sling piece are 1.5 cm - 2.0 cm.

6. The total urethral suspension sling according to claim 5, characterized in that, The length of the distal urethral support piece is 2 - 3 cm; the width of the distal urethral support piece is 3 - 4 cm.

7. The full urethral suspension sling according to claim 1, wherein After the total urethral suspension sling is implanted, under the traction of the positioning and flattening lines of the distal urethral support piece and the bladder neck support piece, the total urethral suspension sling is fully flattened and covers between the distal urethra and the bladder neck.

8. The total urethral suspension sling according to claim 4, characterized in that, The total urethral suspension sling is configured with 2-0 absorbable sutures for fixing the four corners of the sling.

9. The total urethral suspension sling according to claim 1, characterized in that, The total urethral suspension sling is configured with a Foley catheter for determining the position of the bladder neck.

10. A full urethral suspension sling using any one of claims 1-9, characterized in that, The application of the total urethral suspension sling in the treatment of stress urinary incontinence combined with cystocele.

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