Evaluation of Prolene Mesh as a Transobturator Tape for Treatment of Female Stress Urinary Incontinence

ABSTRACT

INTRODUCTION: Slings are commonly used to treat female stress urinary incontinence (SUI). Various sling materials have been tried. The objective of this retrospective study was to determine the short-term efficacy, safety, and urodynamic effects of a suburethral sling made of polypropylene mesh and passed through the obturator foramen.

METHODS: The participants were 53 female patients with SUI; 16 (30%) had pure intrinsic sphincter deficiency (ISD) and 37 (70%) had mixed ISD and hypermobility. Preoperative evaluation consisted of history, voiding diary, examination, ascending cystography, urodynamic studies, and routine laboratory investigations. All patients were treated with a polypropylene mesh (Prolene; Ethicon Ltd, Bracknell, UK) suburethral sling. The Prolene mesh was cut into a tape measuring 30 x 1.5 cm and sterilized by autoclave. The mesh was placed at the midurethra and passed through the obturator foramen by Vicryl sutures, loaded on a curved needle that was specially designed to hold the suture. The needle was passed from the outside to the inside. The mesh was anchored to the subcutaneous tissue at the lateral edge of labia majora with Vicryl sutures. One month after surgery, patients had an interview, examination, urine analysis, and pelvic ultrasound to detect residual urine. Urodynamic evaluation was done 3 months postoperatively. Patients were then followed every 3 months through a voiding diary and examination. The mean follow-up period was 18 months.

RESULTS: All procedures were completed with no intraoperative complications, failures, or recurrences of SUI. At the 1-month follow-up, 3 patients (5%) had developed a small erosion of the anterior vaginal wall associated with lower abdominal pain, urgency, dysuria, and urinary tract infection. The patients were managed conservatively with antibiotics and local estrogen cream. At the 3-month follow-up, the erosion healed completely. Three patients (5%) complained of sensory urge incontinence both preoperatively and postoperatively. They were managed with anticholinergics.

CONCLUSION: Preliminary results showed that the suburethral transobturator Prolene mesh sling is a safe, efficient, reproducible, and low-cost technique for treatment of stress urinary incontinence. Complications exist but can be successfully managed.

KEYWORDS: Sling, Transobturator tape (TOT), Prolene, Stress urinary incontinence (SUI)

CORRESPONDENCE: Ahmed Abdelbary, MD, Department of Urology, Bani Swaif University, Bani Swaif, 11371, Egypt ().

CITATION: UroToday Int J. 2010 Feb;3(1). doi:10.3834/uij.1944-5784.2010.02.08

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INTRODUCTION

Slings have been used successfully to treat stress urinary incontinence (SUI) secondary to intrinsic sphincteric deficiency (ISD) and urethral hypermobility [1]. Currently, there are many variations in surgical technique, sling materials, and sling shape. The surgical options include: (1) vaginal wall slings; (2) pubovaginal slings that use autologous fascia, cadaveric fascia, or synthetic materials placed at the level of the bladder neck, with or without bone anchors; (3) tension-free vaginal tape (TVT) slings; and (4) transobturator tape (TOT) slings.

New sling materials have been pursued because of the morbidity and longer postoperative recovery time associated with harvesting autologous fascia [2]. The procedures described in the present study use surgical principles similar to that of the TOT sling. The author describes the placement of a polypropylene mesh under the midurethra using a specially designed curved needle to pull out the mesh. The purpose of this retrospective investigation was to determine the short-term efficacy, safety, and urodynamic effects of the suburethral sling made of polypropylene mesh.

METHODS

Participants

The participants were 53 female patients with SUI who were treated between February 2006 and July 2009. Of the 53 patients, 16 (30%) had pure ISD and 37 (70%) had mixed ISD and hypermobility. The mean patient age was 42.8 years (standard deviation [SD] = 6.45; range, 33-55 years). Two patients (4%) were postmenopausal; 51 patients (96%) were premenopausal. The mean number of deliveries was 4.5 (SD = 2.6; range, 2-11). The SUI was related to the last delivery in 23 patients (43%) and not related in 30 patients (57%). A cystocele was present in 22 patients (42%); a rectocele was present in 13 patients (25%).

Abdominal leak point pressure was obtained using a cough. The mean abdominal leak point pressure was 97 cm H20 (SD = 40; range, 40-175 cm H20).

Surgical Technique

The same procedure was used for all patients. A 1.5 x 30 cm polypropylene mesh (Prolene; Ethicon Ltd, Bracknell, UK) was prepared and 0 polyglactin (Vicryl 0) sutures were placed at each end of the mesh in a figure-8 fashion. The sling was soaked in a diluted povidone-iodine 10% solution (Betadine, Purdue Frederik Co, Stamford, CT, USA) to prevent infection. Absorbable sutures were used to fix the sling subcutaneously until adhesions could form and naturally hold it in place.

The patient was placed in a high, dorsal lithotomy position. The lower abdomen and genital area were prepared and draped in a sterile fashion. The labia were retracted laterally with stay sutures. A 16F Foley catheter was inserted through the urethra and the bladder was emptied. A weighted vaginal speculum was used for exposure. Submucosal saline injection (hydrodissection) aided in determination of the proper plane of dissection Figure 1.

An Allis clamp was used to grasp the anterior vaginal wall just proximal to the external urethral meatus. A 2 cm midline incision was made in the anterior vaginal wall, 1 cm distal to the bladder neck. Two additional Allis clamps were placed at the 2 edges of the incision to aid in the exposure Figure 2. The dissection was carried out laterally over the glistening periurethral fascia toward the ipsilateral inferior pubic ramus, until the bone was touched. A 1 cm skin incision was made at the level of the clitoris (on the site of insertion of the adductor longus muscle at the pubic tubercle). The needle was passed from the skin incision via the obturator foramen (outside-in) guided by a finger passed through the vaginal incision Figure 3.

The Vicryl suture was tied to the hole at the tip of the needle. The needle was pulled outside, bringing the mesh out of the skin incision Figure 4. The procedure was done bilaterally until the mesh was located at the proper place Figure 5 ; Figure 6. The mesh was fixed subcutaneously using Vicryl 3-0 suture, without creating any tension. The protruding part of the mesh was cut flush with the skin.

The anterior vaginal wall was closed by continuous Vicryl 3-0 suture. A vaginal pack was used.

Postoperative Care and Follow-up

The vaginal pack was removed 24 hours after the procedure. The patients were instructed to void every 3 hours. Their postvoid residual urine volume was recorded. The patients were discharged if they had no postvoid residual urine.

One month after surgery, patients had an interview, examination, urine analysis, and pelvic ultrasound to detect residual urine. Urodynamic evaluation was done 3 months postoperatively. Patients were then followed every 3 months through a voiding diary and examination. The mean follow-up period was 18 months.

RESULTS

The average intraoperative time was 15 minutes (range, 10-30 minutes). No intraoperative or major postoperative complications occurred. No patient needed additional surgery.

All of the patients were dry postoperatively, as assessed subjectively (no pads) and objectively through clinical examination and urodynamic evaluation. Three patients (5%) complained about sensory urge incontinence both preoperatively and postoperatively. They were managed with anticholinergics. At the 1-month follow up, three patients (5%) had developed a small erosion of the anterior vaginal wall associated with lower abdominal pain, urgency, dysuria, and urinary tract infection. They were managed conservatively by oral antibiotics and the application of local estrogen cream. At the 3-month follow-up, the erosion had healed completely. There were no postoperative changes in the presence of cystoceles or rectoceles in patients with these preoperative conditions.

DISCUSSION

Sling procedures have been used successfully for the treatment of stress urinary incontinence. New sling materials have been pursued because of the morbidity associated with the harvesting of autologous fascia. The present author reports a new surgical technique for the treatment of stress urinary incontinence, based on surgical principles similar to those of the ready-made TOT slings. The placement of a tightly woven polypropylene mesh under the midurethra is described. This mesh is fixed by absorbable sutures, does not require special disposable instruments for placement, and is inexpensive. In the author's initial experience, this technique proved to be effective and simple with minimal complications.

There are several obvious advantages to using synthetic materials for slings. The supply of artificial graft material is unlimited in quantity, consistent in quality, and can be fashioned in any size or shape. The use of synthetic materials obviates the need for harvesting tissue from a second operative site and minimizes dissection. When compared with absorbable biomaterials, synthetic materials are more uniform, consistent, and durable. In addition, artificial graft materials are sterile, biocompatible, noncarcinogenic, and free of biomaterials [3].

Artificial graft materials have some potential drawbacks. There are numerous reports of graft infection, erosion into the urethra, or extrusion into the vagina [4,5,6]. A postoperative infection in an artificial graft necessitates removal. Nevertheless, sling techniques have changed in several important ways. Slings are no longer used to pull the bladder neck into a high retropubic position with significant tension. Newer approaches position the sling at the midurethra. Adverse events can be minimized by proper patient selection, surgical technique, intraoperative handling of the material, and material choice [3].

The chemical and physical properties of the artificial materials determine how the sling is incorporated into the surrounding tissues and its susceptibility to infection, rejection, extrusion, or erosion. Theoretically, the degree of susceptibility to infection when using multifilament fibers is proportional to the small interstitial spaces between them. Tightly woven mesh or multifilament fibers may provide a safe harbor for small bacteria and may exclude macrophages and polymorphonuclear leukocytes. In comparison, in a loosely woven mesh of monofilament fibers, tissue ingrowth and neovascularization are relatively enhanced, and cellular access is not inhibited. In addition to the porosity of the mesh material affecting the degree of vascular ingrowth, there is an effect on the incorporation of the material into the surrounding tissue. Tissue bonding to the mesh is generally a beneficial process that strengthens and supports the repair; however, intensive scar formation may make sling removal more difficult if urethrolysis or sling removal becomes necessary. A tightly woven and large-diameter filament mesh will tend to exhibit increased stiffness or decreased pliability, which may contribute to migration, extrusion, or erosion [3].

In 2001, Delorme [7] introduced the transobturator approach for the surgical treatment of female SUI. Preliminary results from Delorme's initial study were confirmed by several series with 1-year follow-up. These studies reported complete resolution of SUI in 80-90% of the patients, improvement in 7-9%, and failure in 0-7% [8,9]. In the present study, the success rate (defined as no pads used by the patient) was 100%.

The risk of intraoperative bladder injury was previously reported as < 0.5% [9]. No intraoperative injuries were observed in the present study. Rates of postoperative voiding dysfunction or de novo urge symptoms were previously reported at 3.3% and 5%, respectively [9]. In the present study, 5% of the patients with preoperative urge symptoms continued to have these symptoms postoperatively. Vaginal erosion and urethral erosion were previously reported in 1.8% to 15% of patients [5,6]. Vaginal erosion was observed in 5% of the patients in the present study, and there was no urethral erosion.

CONCLUSIONS

Preliminary results from the present investigation showed that placement of a polypropylene mesh under the midurethra using the TOT technique provides a new, simple, quick, and inexpensive method to correct SUI.

Conflict of Interest: none declared

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