TransobturatorTape (Uratape W ): A New Minimally-Invasive ProceduretoTreatFemaleUrinaryIncontinence $

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1 European Urology European Urology 45 (2004) TransobturatorTape (Uratape W ): A New Minimally-Invasive ProceduretoTreatFemaleUrinaryIncontinence $ Emmanuel Delorme a,*, Stéphane Droupy b, Renaud de Tayrac c, Vincent Delmas d a Urology, 24, avenue Jean-Jaurès, Châlon sur Saône, France b Department of Urology, Kremlin-Bicêtre Hospital, Bicêtre, France c Department of Gynaecology, Béclère Hospital, Clamart, France d Department of Urology, Bichat Hospital, Paris, France Accepted 2 December 2003 Published online 13 December 2003 Abstract Objective: Assessment of one-year results of a new technique of transobturator suburethral tape in the treatment of female stress urinary incontinence. Methods: UraTape 1, a non-woven, non-elastic polypropylene tape with a 15 mm long central (suburethral) silicone-coated section was inserted via the transobturator route. The tape is inserted tension-free in a horizontal plane underneath the middle of the urethra between the two obturator foramens. The ends of the tape are tunnelled percutaneously with a tunneller. As the retropubic space is preserved intact, cystoscopy is not required. From May 2000 to February 2002, 150 patients with stress urinary incontinence without associated prolapse were operated and a minimum of 1 year follow-up was available for 32 patients (mean follow-up 17 months; range 13 29). The mean age was 64 years (range 50 81). All patients were assessed before surgery by clinical and urodynamic examination: 5 patients presented sphincter incompetence (maximum closure pressure <20 cmh 2 O); 5 patients presented with recurrent urinary incontinence after Burch procedure or TVT; 18 patients presented with mixed incontinence, six of them with detrusor instability confirmed by cystometry. The results were evaluated by two independent investigators (clinical examination, uroflowmetry, cough test). Voiding disorders suggesting bladder outflow obstruction were defined as the presence of the following two criteria: Q max < 15 ml/s, residual urine volume >20%. Results: 29/32 patients (90.6%) were cured and 3/32 (9.4%) were improved. Mean operating time was 15 minutes. No intra-operative complications were recorded. One patient had complete postoperative bladder retention which resolved after 4 weeks of self-catheterization. There were no problems with urethral erosion, residual pain or functional impairment related to the tape. 5/32 patients had voiding disorders suggesting bladder outflow obstruction. Two patients developed de novo urge incontinence. Conclusion: Uratape 1 transobturator tape is a simple and effective procedure with follow-up of one year for the treatment of female stress urinary incontinence confirmed after 1 year of follow-up. The transobturator approach avoids the risk of bladder, bowel or vascular injuries. Evaluation of the results after a longer follow-up period is needed to validate this technique. # 2003 Published by Elsevier B.V. Keywords: Stress urinary incontinence; Suburethral tape; Transobturator technique; Tension-free $ Co-published in Progrès en Urologie (see Progrès en Urologie, 2003;13:656 9). * Corresponding author. Tel. þ ; Fax: þ address: delormee_2000@yahoo.fr (E. Delorme). 1.Introduction Minimally-invasive procedures have recently been developed to treat female stress urinary incontinence [1,2]. All these procedures use a vertical, retropubic /$ see front matter # 2003 Published by Elsevier B.V. doi: /j.eururo

2 204 E. Delorme et al. / European Urology 45 (2004) route. This intrapelvic route exposes the patient to a number of complications (bladder perforation in particular), some of which can be serious (injuries to blood vessels or the gastrointestinal tract). Keeping the principle of a minimally-invasive procedure to reinforce the structures supporting the urethra, we wanted to find a procedure that would avoid these complications. In 2001, we described an original procedure [3], the transobturator way, and reported the results of a first series of patients in whom the tape designed for this route was implanted. Fig. 2. Crural puncture with the tunneler. 2.Materials and methods 2.1. Operative technique Specific equipment The procedure uses a special tape, Uratape 1 (Mentor-Porgès), made of non-woven, non-knitted, thermally-bonded polypropylene (TBP). The tape is divided into three sections: a central section 30 mm long and 10 mm wide, and two side pieces on either side of the central section, which taper off gradually towards the ends. The central section is coated with a thin layer of silicone over 15 mm of its length, on the surface of the tape that faces the urethra. There is a black line down the middle of the non-siliconised surface, on the vaginal side, to allow the tape to be positioned the right way round and along the midline. The other specific item of equipment is a tunneller, a speciallycurved needle with a blunt tip and an eye for the tape to be passed through Patient positioning The patient is put in the lithotomy position in hyperflexion, with her thighs bent back on the abdomen at an angle of Surgical technique A vertical midline vaginal incision is made in the middle third of the urethra passing through the whole thickness of the vaginal wall (Fig. 1). Starting at the incision, the vagina is released laterally on either side of the urethra with Mayo scissors over a width of approximately 15 mm. The dissection stops against the Fig. 1. Vaginal incision. ischiopubic ramus. The dissection must be in the deep tissue layer between the vesicovaginal fascia and the urethra, and not too superficially between the vesicovaginal fascia and the vaginal skin. The lateral margin of the ischiopubic ramus is identified between an index finger placed in the latero vaginal fornix and thumb placed in front of the obturator foramen. A puncture incision is made 15 mm lateral to the ischiopubic ramus on a horizontal line level with the preputium clitoridis. The tunneller is held in the same hand as the side on which the operator is working. The tunneller is held vertically with the handle downwards; it is then introduced through the skin incision and crosses the obturator membrane. As the membrane is crossed, a specific resistance is felt which is easily recognised (Fig. 2). The tunneller is then turned to a horizontal position, with the handle pointing medially. The tip of the tunneller is led medially towards the urethra, aiming above the urethral meatus and underneath the symphysis pubis. The safest method is to lead the tunneller round the ischiopubic ramus while remaining in contact with it. The aim of this procedure is to trace a perineal route with the instrument below the superior fascia of levator ani. A finger is placed in the incision to check that the tunneller is not piercing the vagina and is passing well above the latero vaginal fornix some way away from it. The index finger is introduced into the vaginal incision to fold the urethra upwards and protect it from the needle. The finger will then make contact with the tip of the tunneller laterally underneath the symphysis pubis. The tunneller is then guided by the finger into the vaginal incision. Once this procedure has been completed, it is prudent to check that the vagina and urethra have not been pierced by the tunneller. The end of the tape is introduced into the eye of the needle and then pulled through to place it in position. The texture of the tape allows the tape to be pulled hard without risk of breaking. The tape is inserted tension-free behind the urethra. The low elasticity of thermally-bonded polypropylene makes it possible to adjust the position of the tape very precisely. There are two important points to remember during this adjustment to reduce the risk of compressing the urethra, which causes voiding disorders: Leave a visible space between the tape and the urethra (a few millimetres). Avoid adjusting the tape with the patient in the Trendelenburg position, as the cervical and urethral region is at its highest in this position. It is therefore better to put the patient in horizontal position or even tilted to ensure that the urethra is at its lowest.

3 E. Delorme et al. / European Urology 45 (2004) The tape is positioned so that the silicon-coated surface is facing the urethra and the black line is facing the vagina. After any excess tape has been trimmed, the skin over the incision is moved away from the end of the tape and then sutured with a resorbable suture. The vaginal incision is closed with a few interrupted sutures using resorbable suture thread. The Foley catheter inserted during the procedure is removed on the first postoperative day and postvoid residual urine is measured by catheterization Patients This technique was used between May 2000 and February 2002, in 150 patients with stress urinary incontinence without associated prolapse and a minimum of 1 year follow-up was available in 32 patients, mean follow-up was 17 months (range13 29). The mean age was 64 years (range 50 81). Preoperative workup included clinical examination, urodynamic with cystomanometry, urethral profile, flowmetry and measurement of postvoid residual urine by catheterization. Five of these 32 patients had already undergone surgery for incontinence: 3 TVT procedures, 1 Burch and 1 multiple procedure. Five patients had undergone hysterectomy. Clinically, the type of incontinence was defined as pure urinary incontinence in 14 patients (43.7%), and mixed urinary incontinence in 18 patients (56.3%). In 6 patients, the preoperative urodynamic examination revealed bladder instability according to the ICS definition. Five of the 32 patients had sphincter insufficiency with urethral closure pressure <20 cmh 2 O(Table 1). One patient had preoperative flowmetry values of 14.9 ml/s (volume voided 333 ml). None of the 32 patients had postvoid residual urine. All 32 patients were operated on by the same surgeon (ED) using the transobturator technique. The technique could be used in all cases, with no surgical problems. Once the technique had been learnt, surgery lasted for less than 15 minutes. Cystoscopy was not used. There were no cases of haemorrhage or damage to the obturator nerves and vessels during passage of the needle along the transobturator route. The procedure was performed under spinal or general anaesthesia. Post-operative assessment consisted of clinical examination, flowmetry with measurement of postvoid residual urine by catheterization, and a cough test with a full bladder. Diagnosis of urethral obstruction was defined as maximum flow (Q max ) less than 15 ml/s and/or postvoid residual urine of more than 20% of the volume voided Analysis of results Patients were considered to be cured when they said they no longer wore any protection, had no stress leakage, and during a clinical examination had no leakage during a cough test with a full Table 1 Transobturator tape: results for stress urinary incontinence in relation to preoperative maximum urethral closure pressure (mean follow-up 17 months) Preoperative maximum urethral closure pressure N % Continent Improved <20 cmh 2 O(6 19) cmh 2 O >30 cmh 2 O bladder. Patients were considered to be improved when they judged themselves to be improved, and used less protection. The postoperative assessment visit was conducted onsite by an independent investigator (RdT). All the clinical records were assessed by two independent observers (SD and RdT). 3.Results Mean follow-up was 17 months (13 29). Stress urinary incontinence was completely cured in 29 patients, and partially cured in 3 patients. Results related to preoperative urethral closure pressure are shown in Table 1. Pre- and postoperative urgency is shown in Table 2. Five patients were found to have obstructive voiding disorders defined as Q max < 15 ml/s and/or postvoid residual urine >20% of volume voided. One of these 5 patients required self-catheterisation for 1 month, and still has obstructive symptoms. It should be noted that 4 of the 5 patients classed as having obstructive voiding disorders also had preoperative urethral closing pressure of 6 27 cmh 2 O. No vaginal or urethral erosion was reported. 4.Discussion De Lancey s theories on pelvic support for the bladder and urethra [4,5] help to explain the mechanism of action of urethral suspension in the treatment of stress urinary incontinence. The new minimally-invasive suspension techniques using a polypropylene tape satisfy the requirements for functional surgery. In the medium term, their results in the treatment of female stress urinary incontinence are satisfactory [6 8]. However, the long-term safety of this type of tape is not known, particularly in relation to changes in the synthetic material and changes in bladder and urethral behaviour caused by the tape, such as voiding disorders and bladder instability [6 10]. Among 150 cases operated with the transobturator approach, we have analysed one year minimal follow-up in 32 patients: transobturator tape gives the same results as retropubic tape in correcting stress urinary incontinence. Unlike the retropubic tapes, the purely perineal Table 2 Postoperative evolution of urgency Disappearance 4/18 Decrease 6/18 Same 7/18 Worsening 1/18 De novo urgency 2/14

4 206 E. Delorme et al. / European Urology 45 (2004) local location of the transobturator minimises the risk of trauma to internal organs (bladder perforation, damage to the intestine or to blood vessels and nerves) [6,8]. The position of the transobturator tape is similar to that of the natural hammock supporting the urethra [11] described by De Lancey [5]. Histological [12] and clinical [1,2,13] studies have shown that polypropylene is a synthetic material that is well tolerated by the body, with little exposure of the patient to infection and vaginal or urethral erosion. Unlike woven or knitted polypropylene, the solidity and lower elasticity of thermally-bonded polypropylene allows the tape to be positioned behind the urethra with great precision. Its solidity allows the tape to be moved right up to the last moment. Its elasticity of 5% is higher than that of collagen used for rehabilitation [12].Inany case, it is the elasticity of the collagen that determines the final elasticity of the assembly which will be lower than 5%, irrespective of the synthetic material used. The good tissue ingrowth with TBP was confirmed in a personal study by histological analysis of a fragment of tape explanted 4 months after insertion. The silicon-coated surface has a number of advantages. When covered with connective tissue, it is not colonised by fibroblasts, and a free layer remains at the interface between the silicone-coated part of the tape and the urethra. The silicone coating is used for a number of reasons: It reduces the risk of periurethral fibrosis, which is responsible for a number of failures (incontinence, severe voiding disorders, bladder instability). It prevents retraction, which has been reported with tapes which allow tissue ingrowth. Retraction reduces the supporting surface of the tape and may encourage certain complications, in particular, postoperative voiding disorders. It facilitates subsequent surgical treatment in the event of failure or recurrence of incontinence (insertion of artificial sphincter). In our series, we did not observe any cases of urethral or vaginal erosion. We studied a number of options for making the transobturator path: For this first series, we used a standard tunneller as described previously [3]. We now use a Helical 1 tunneller, the design of which was suggested by L. Boccon-Gibod. The design of this second generation tunneller is more ergonomic, which makes it possible to go around the ischiopubic ramus while remaining in contact with it, so making the surgical procedure easier (Fig. 3). We used an anatomic model to study the best direction for the route to be taken with the tunneller. The tunneller can be introduced either lateral to medial, as has been described previously, or medial to lateral (from the vagina to the obturator foramen). However, the medial to lateral route exposes the patient to risk of trauma to the pudendal nerve, or more particularly to the dorsal nerve of the clitoris, which is located behind and medial to the ischiopubic ramus. This risk is also present when retropubic needles are passed from top to bottom (when inserting retropubic tapes). Trauma to the pudendal nerve is expressed as dysaesthesia in the territory of the nerve. The complication is difficult to treat and results are inconsistent. 5.Conclusion Fig. 3. Tunneler. Its method of insertion and type of tape make Uratape 1 transobturator tape a novel solution. It allows minimally-invasive surgery to be used in stress urinary incontinence to restore the physiological and anatomical conditions of continence, as far as possible. The first operative and postoperative results after more than a year of follow-up show that this tape satisfies the aims we set ourselves. References [1] Ulmsten U, Petros P. Intravaginal slingplasty (IVS); an ambulatory surgical procedure for traitement of female urinary incontinence. Scand J Urol Nephrol 1995;29: [2] Villet R, Fitremann C, Salet-Lizee D, Collard D, Zafiropoulo N. Une nouvelle technique de traitement de l incontinence urinaire d effort: la bandelette sous-urétrale de problème sous anesthésie locale. Prog Urol 1998;8: [3] Delorme E. La bandelette transobturatrice: un procédé mini-invasif pour traiter l incontinence urinaire de la femme. Prog Urol 2001;11:

5 E. Delorme et al. / European Urology 45 (2004) [4] de Lancey JOL. Stress urinary incontinence: where are we now, where should we go. Am J Obstet Gynecol 1996;175: [5] de Lancey JOL, Richardson AC. Anatomy of genital support. Clinical Obstetrics and Gynaecology 1993;36: [6] Olsson I, Kroon U. A three-year postoperative evaluation of tension free vaginal tape. Gynecol Obstet Invest 1999;48: [7] Soulié M, Cuvillier X, Benaïssa A, Mouly P, Larroque JM, Bernstein J, et al. The tension-free transvaginal tape procedure in the treatment of female urinary stress incontinence: a French prospective multicentre study. Eur Urol 2001;39: [8] Peyrat L, Boutin JM, Bruyere F, Haillot O, Fakfak H, Lanson Y. Intestinal perforation as a complication of tension-free vaginal tape procedure for incontinence. Eur Urol 2001;39: [9] Tamussino K, Hanzal E, Kölle D, Ralph G, Riss P. The Austrian tension-free vaginal tape registry, Int Urogynecol J 2001;S28 9. [10] Zimmern PE. Le TVT vu d une autre rive. Prog Urol 2000;10: [11] Beco J, de Bisschop G, Dijkstra R, Nelissen G, Mouchel J. Perineology reaching equilibrium and preserving it? J Gynecol Obstet Biol Reprod 1999;28: [12] Falconer C, Sôderberg M, Blomgren B, Ulmsten U. Influence of different sling material on connective tissue metabolism in stress urinary incontinent women, Int Urogynecol J 2001;S [13] Margan PA, Ward KL, Johnson D, Smirni WE, Hilton P, Bibby J. Tension-free vaginal tape for primary genuine stress incontinence: a two-centre follow-up study. BJU Int 2000;86:39 42.