Efficacy of the InVance TM Male Sling in Men with Stress Urinary Incontinence

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1 european urology 51 (2007) available at journal homepage: Reconstructive Urology Efficacy of the InVance TM Male Sling in Men with Stress Urinary Incontinence Hakim Fassi-Fehri *, Lionel Badet, Arnaud Cherass, François-Joseph Murat, Marc Colombel, Xavier Martin, Albert Gelet Department of Urology and Transplantation, Edouard Herriot Hospital, Lyon, France Article info Article history: Accepted August 22, 2006 Published online ahead of print on September 7, 2006 Keywords: Stress urinary incontinence InVance TM bulbourethral sling Prostate surgery Radiotherapy Abstract Objectives: To evaluate the efficacy and safety of the InVance TM bulbourethral sling in male stress urinary incontinence. Materials and methods: Between June 2003 and April 2005, the InVance TM bulbourethral sling was implanted into 50 patients with urinary incontinence after prostate surgery in 49 cases and pelvic trauma in 1 case. The patients were monitored and evaluated in a prospective manner (continence, tolerance, and satisfaction). The treatment was considered to be successful if the patient stopped wearing any kind of continence pad (patient cured) or only one pad per day (patient improved), with no de novo urinary disorders and without significant postvoid residual urine. Patient satisfaction with the procedure was assessed. Results: After a median follow-up of 6 mo, 50% of patients were dry, 26% had improved, and 24% suffered treatment failure. The success rates for the patients with severe incontinence and those who had undergone radiation therapy were 50% and 25%, respectively. All patients who were dry or had improved were satisfied and presented no obstructive or irritative de novo urinary disorders. The overall success rate for the 51 procedures conducted was 74.5%. Six cases of transitory acute urine retention and six cases of persistent perineal pain were reported. Explantation was necessary because of suppuration of the sling in three patients and of a de novo irritative urinary disorder in one patient. No cases of pubic osteitis or urethral erosion were reported. Conclusions: The InVance TM bulbourethral sling procedure makes it possible to treat stress urinary incontinence after prostate surgery with satisfactory and lasting short-term results. Severe incontinence and a past history of pelvic radiation therapy seem to be factors contributing to the failure of this procedure. # 2006 European Association of Urology. Published by Elsevier B.V. All rights reserved. * Corresponding author. Service d Urologie et de la Transplantation, Hôpital Edouard Herriot, Place d Arsonval, Pavillon V, Lyon, France. Tel ; Fax: address: hakim.fassi-fehri@chu-lyon.fr (H. Fassi-Fehri) /$ see back matter # 2006 European Association of Urology. Published by Elsevier B.V. All rights reserved. doi: /j.eururo

2 european urology 51 (2007) Introduction Male stress urinary incontinence is the result of de novo sphincter insufficiency and is a potential complication of prostate surgery. It is particularly common after radical prostatectomy, but can also occur after surgical adenomectomy or endoscopic resection of the prostate. Regardless of the severity of the incontinence observed in the postoperative period, the condition often improves during the subsequent period of months. In addition, recovery can be accelerated by means of bladder training/ sphincter reeducation. A minimum delay of 6 mo to 1 yr is needed before envisaging an active treatment for any incontinence resulting from surgery that the patient feels is a handicap. The artificial sphincter is currently preferred treatment in this patient group [1,2]. The technique involved has been largely standardized, but is complex and not without risk [3]. Although excellent results are obtained in terms of quality of life, there is still a degree of residual incontinence [4]. Currently, periurethral injections, whose action is often incomplete and transitory, tend to be used less frequently. New techniques such as periurethral balloons [5] and bulbourethral slings [6,7] have also been developed in recent years and have shown encouraging results. The concept of bulbourethral compression as a treatment for male stress urinary incontinence was first introduced by Berry [8] and developed by Kaufman [9]. The technique consisted of compressing the bulbar urethra by means of a silicone pad attached to the corpus cavernosum by several strips. The poor results obtained and a high level of complication resulted in abandonment of this procedure [10]. The success first of bladder neck suspension techniques using the vaginal approach [11,12] and then of urethral support by means of a synthetic sling in women [13] breathed new life into the concept of urethral compression in men as a means of treating stress urinary incontinence after prostate surgery. The first publications [14,15,22] reported encouraging results. From a technical point of view, two approaches were described. The first consisted of making a urethral support using one or more suspended slings with a retropubic approach and, the second, using a purely perineal approach, of performing bulbourethral compression by means of a sling attached to the pubic bone. The InVance TM bulbourethral sling is made of synthetic mesh and exerts pressure on the urethra, reducing the possibility of urinary leakage. We previously described our preliminary results using this procedure [16]. Hence, we report a series of 50 patients with stress urinary incontinence treated consecutively with the InVance TM bulbourethral sling with regards to short-term follow-up. 2. Patients and methods 2.1. Patients Between June 2003 and April 2005 the InVance TM sling was implanted into 50 patients with stress urinary incontinence. The incontinence was the result of prostate surgery in 49 patients (33 radical prostatectomies, 13 combined endoscopic prostate resection and focalized ultrasounds for cancer, and 4 endourethral prostate resections for benign prostatic hyperplasia) and sphincter insufficiency after pelvic trauma in 1 patient. Eight patients had a past history of radiotherapy. The incontinence was quantified arbitrarily by the number of pads used per day. It was considered to be mild (grade 1: one to 2 pads) in 10 cases, moderate (grade 2: three to four pads) in 30 cases, and severe (grade 3: three to 5 or more pads or use of a penile sheath) in 10 cases. A full preoperative workup was conducted including debimetry, postvoid residual (PVR) urine measurement, and vesicourethral fibroscopy; urodynamic evaluation was performed on 26 patients. All patients had previously undergone pelvic floor exercises. Twelve patients had been unsuccessfully treated with trans-sphincter macroplastic injections, and one patient had undergone an explantation of an AMS 800 artificial urinary sphincter because of urethral erosion Methods The procedure was performed with the patient in the dorsal lithotomy position, and with a 16 or 18 Charrière urinary catheter in place under general or spinal anaesthetic. Preventive antibiotic treatment by a loading dose of Cefacidal was administered. The surgical approach used was perineal, with a 5-cm vertical incision made between the scrotum and the anus. Once through the subcutaneous plane and after incision of the Colles fascia, the bulbocavernous muscle was exposed. The dissection was then made laterally in the direction of the right and left ischiopubic branches. The bony relief was uncovered by incising the periosteum from the pubic symphysis to be sure that the screws could be directly and solidly inserted into the bone. Care was taken not to damage the corpus cavernosum during the dissection. The first screw, attached to a Prolene no. 1 thread, was put in place by means of the InVance TM electric screwdriver at the upper end of the ischiopubic branch, 0.5 cm under the symphysis. A second screw was placed 4 cm lower, and the third between the first two; both had Prolene no. 1 threads attached to them. The rectangular sling used was made of multiperforated polyester coated with silicone and measured 7 cm long 4 cm wide. The polypropylene threads were cut at the end and passed through the mesh of the sling along the length of its right edge. The sling was then attached to the right ischiopubic branch by knotting the three threads, then tensed to a maximum towards the opposite ischiopubic branch. The lefthand threads were passed through the plate, taking the obliqueness of the ischiopubic branch into account, and then

3 500 Failure was generally observed immediately after removal of the urinary catheter and postoperatively in the first 6 mo. After this period, all the patients who were dry or who had improved remained stable, regardless of the length of the postoperative period (Fig. 1). One patient underwent a second procedure, giving an overall number of implants of 51. IPSS score and urodynamic results are summarized in Table 2. All patients who were dry or improved were satisfied with the outcome and did not present any obstructive or irritative de novo urinary disorder. This finding represented a global success rate of 74.5% for the 51 procedures conducted. The success rate in the patients with mild or moderate incontinence was, respectively, 90% and 76.6% versus 50% in the patients with severe incontinence (Fig. 2). In addition, the failure rate in the patients with a past history of radiotherapy was higher: 75% versus 16.3 % in the nonirradiated patients (Fig. 3). Most patients reported postoperative perineal pain, which diminished in the course of the first postoperative month. In six (12%) patients, perineal pain of an intensity of more than 3 on an analogue visual scale (AVS) persisted for more than 3 mo postoperatively and required analgesic management. In one (2%) patient, perineal pain of an intensity varying between 3 and 5 on an AVS was reported. Other morbidities reported included two cases of spontaneously resolving perineal haemaeuropean urology 51 (2007) Table 1 Continence at 1-, 3-, 6-, 12- and 18-mo evaluation Follow up visits 1 mo 3 mo 6 mo 12 mo 18 mo No. of patients (N) Dry or improved (n [%]) 42 (84) 26 (89.6) 16 (94.1) 14 (100) 6 (100) Failed (n [%]) 8 (16) 3 (10.4) 1 (5.9) 0 (0) 0 (0) knotted. In its final position, the sling compressed the urethra along a 4-cm length. A cough test was performed systematically in patients undergoing the procedure under spinal anaesthesia. The procedure ended with closure of the wound in two planes without drainage. The urinary catheter was removed on the first or second postoperative day. If there were no complications, the patient was able to leave hospital 24 h after removal of the urinary catheter, provided that urination without significant residue (<100 ml) had been restored. Follow-up controls were routinely scheduled at 1, 3, and 6 mo postoperatively and every 6 mo thereafter. The efficacy of the sling procedure was assessed in all patients by medical interview. The degree of urinary incontinence was quantified by the number of pads used per 24 day. De novo urinary disorders were sought during the interview and their intensity evaluated by means of the International Prostate Symptom Score (IPSS), debimetry, and measurement of PVR urine. Patient satisfaction was evaluated by means of a simple verbal scale. The treatment was defined as having been a success if the patient no longer used any form of protection (patient cured) or one protection per day (patient improved), without de novo urinary disorders and without significant PVR urine (<100 ml). In addition, the patient had to feel satisfied with the result. In all other situations, the treatment was considered to be a failure Statistical analysis The actuarial success rates were calculated with the use of the Kaplan-Meier method and compared with the use of the logrank test. 3. Results The mean age of the patients was 70 yr (48 81). Median follow-up was 6 mo (1 22) (Table 1). Twentyfive (50%) patients were dry, 13 (26%) patients had improved but still needed to wear one pad per day, and 12 (24%) patients had not obtained any improvement. Of the eight patients who had previously undergone radiotherapy, two (25%) were dry, and the other six (75%) were incontinent. Among the 22 patients with a minimal followup of 1 yr, 14 were considered as dry or improved (success rate = 63.6%). Among the 28 patients with follow-up of less than 1 yr, 24 patients were considered dry or improved (success rate = 85.7%). In our series, no patient has reached a 2-yr follow-up yet. Fig. 1 Kaplan-Meier curve of success rates (cured or improved) in 50 patients who underwent the InVance TM male sling procedure for urinary incontinence.

4 european urology 51 (2007) Table 2 Symptomatic and urodynamic outcome variables Follow up visits 1 mo 3 mo 6 mo 12 mo 18 mo Mean IPSS (range) Not available 8.6 (5 18) 9.1 (5 16) 8.8 (6 14) 8 (4 16) Mean Q max (range) 16 (9 32) 16.2 (10 47) 18.5 (9 56) 18.9 (9 45) 17 (10 37) Mean PVR (ml/s) (range) 55 (0 145) 38 (0 150) 42 (0 200) 28 (0 75) 24 (0 105) IPSS: International Prostate Symptom Score; Q max : maximum urinary flow rate; PVR: postvoid residual. the implantation of an artificial urinary sphincter was performed successfully 8 mo after the removal of an InVance TM sling because of infection. A third patient benefitted from the implantation of a second InVance TM sling 12 mo after the explantation of the first sling because of infection. 4. Discussion Fig. 2 Kaplan-Meier curve of success rates (cured or improved) after the InVance TM male sling procedure, according to the degree of preoperative incontinence. toma and acute urine retention on removal of the urinary catheter in six (12%) patients. This urine retention was transitory and in all cases resolved after 48 to 72 h of catheterization. No cases of chronic urine retention were recorded. An infection of the sling occurred within the first postoperative month in two patients and at 3 mo in one patient who was also receiving immunosuppressants. The infection required explantation of the sling in all cases. Exacerbation of irritative urinary symptoms occurred in one patient leading to removal of the prosthesis. No cases of pubic osteitis or urethral erosion have been reported to date. In one patient, the implantation of an artificial urinary sphincter was performed at the same time as explantation of the InVance TM because of irritative urinary symptoms. In another patient, Comiter [17] described a technique for the compression of the bulbar urethra using a polypropylene bulbourethral sling attached to the ischiopubic branches with four titanium screws. The originality of the compression exerted by the sling was that it was not circumferential and that it was not in direct contact with the urethra. The sling was applied against the preurethral fat with neither incision in the bulbocavernous muscle nor dissection of the urethra. This technique, using a purely perineal approach, made it possible to guarantee immediate continence as soon as the urinary catheter was removed, as well as spontaneous urination without manipulation. With an average follow-up of 12 mo, Comiter reported a success rate of 76%. The technique has since been applied by other teams with success rates varying between 55% and 76% [18 20]. To date, we have used this procedure on 49 patients with urinary incontinence after prostate surgery and 1 patient with urinary incontinence after pelvic trauma. With a global success rate of 74.5%, the results are comparable to those published Fig. 3 Kaplan-Meier curve of success rates (cured or improved) after the InVance TM male sling procedure, according to past history of radiotherapy.

5 502 european urology 51 (2007) recently [18,19]. In the current study, outcome was better in patients with mild or moderate incontinence (90% and 76.6%, respectively). Moreover, 50% of patients were dry. A careful selection of patients and maximum sling tension may explain this rate of dryness. The failures, most often in cases of severe incontinence (50%) or a past history of radiotherapy (75%), were observed in the immediate postoperative period on removal of the urinary catheter or within 1 to 3 mo. These results imply that the more severe the incontinence is, the less efficacious the treatment is. Overall, both high-grade incontinence and prior radiotherapy are bad prognostic criterions. These results follow a similar pattern as those achieved by Rajpurkar et al. [19] who reported success rates of 83% and 50% in cases of mild or severe incontinence, respectively, and by Castle et al. [18] with rates of 13% and 47% in irradiated and nonirradiated patients, respectively. To be fully effective, the sling must be tightened as much as possible to ensure sufficient occlusion of the bulbar urethra. Its very mode of action, however, probably renders it less effective than the artificial sphincter and may explain the failure rate in patients with severe incontinence. The higher failure rate in patients who had undergone radiotherapy may be due to increased periurethral fibrosis, thus making the compression less effective. No cases of erosion were recorded in the current series, but it cannot be ruled out that progressive atrophy of the preurethral tissues caused by the permanent compression exerted by the sling could reduce its efficacy and, in the long term, lead to poorer results [18]. Most authors perform a perioperative sphincterometry to adjust the sling using the retrograde leak point pressure (RLPP) [21]. The aim is to tighten the sling to obtain a pressure of between 50 and 70 cm H 2 O, corresponding to the pressure exerted on the urinary sphincter [17,21]. The aims of this adjustment are first to avoid the excessive compression of the perineal neurovascular structures, which are the source of pain [6], and second to reduce the risk of urethral atrophy [17]. It must nevertheless be noted that, despite the considerable tension exerted on the sling, the perineal pain observed in the current series in the postoperative period eased spontaneously in most cases within 1 3 mo, and only one patient continued to suffer from chronic sequelar perineal pain. The permanent action of the sling on the bulbar urethra raises the question of urinary tolerance. Through its obstructive nature, the InVance TM device is effectively liable, in theory, to provoke de novo urinary disorders. One patient did present with aggravated irritative urinary symptoms; he was also incontinent and classified as a failure. The intensity of the urinary symptoms were probably worsened by a past history of radiotherapy. Excluding this patient, no cases of de novo urinary disorders were observed, confirming the high level of urinary tolerance in implanted patients. The episode of urine retention that occurred in six patients on removal of the urinary catheter was, in all cases, transitory and resolved within h of catheterization. No patients presented with chronic urine retention. These observations corroborate those reported by others [17 19] and were consolidated by a postoperative urodynamic study that showed an increase in average RLPP without any de novo obstructive or irritative phenomena [23]. The synthetic nature of the device implanted implies a septic risk. In addition there is a potential risk of pubic osteitis, given the fact that the screws are attached to the bone. It is thus essential that all the necessary precautions be taken to avoid contamination of the operating site and the material implanted: sterile urine, perioperative antibiotic therapy, rigorous asepsis, and the shortest possible procedure. Infection rates previously reported are of the order of 2 7% [18,19,24] compared with 6% in this series; all of the latter occurred early after implantation and resolved after explantation of the sling and antibiotic therapy. With regards to pubic osteitis no cases were reported in the present study and, in general, the incidence is low. A 1.3% incidence was observed in a large series of 290 consecutive women who underwent bladder neck suspension using suprapubic bone anchors [25]. In two patients in whom the treatment failed, secondary treatment with an artificial sphincter implanted using the perineal approach was beneficial. The polyester sling with its silicone protection is easy to identify and explant because it is not colonized with fibrosis. The screws are left in place. In addition, the incision in the bulbocavernous muscle and dissection of the urethra are made easier by the absence of prior dissection of these tissues during the implantation of the sling. 5. Conclusions The InVance TM bulbourethral sling has been shown to be a simple and effective means of treating mild or moderate stress urinary incontinence in men after prostate surgery. It has the added advantage in men with limited manual dexterity or limited comprehension of spontaneous urination possible

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