Comparison of bone-anchored male sling and collagen implant for the treatment of male incontinence

Transcription

1 Blackwell Publishing AsiaMelbourne, AustraliaIJUInternational Journal of Urology Blackwell Publishing Asia Pty Ltd??? Original ArticleComparison of male sling and collagen implant R Onur and A Singla International Journal of Urology (2006) 13, Original Article Comparison of bone-anchored male sling and collagen implant for the treatment of male incontinence RAHMI ONUR 1 AND AJAY SINGLA 2 1 Department of Urology, Firat University, Faculty of Medicine, Elazig, Turkey and 2 Department of Urology, Wayne State University School of Medicine, Detroit, MI, USA Aim: To compare the effectiveness of transurethral collagen injection and perineal bone-anchored male sling for the treatment of male stress urinary incontinence (SUI). Methods: Seventy-one men with SUI underwent either transurethral collagen injections (n = 34) or perineal bone-anchored male sling (n = 37) between June 1999 and October Most of the patients in each group had radical retropubic prostatectomy and/ or external beam radiation therapy (EBRT) in relation to the cause of incontinence. There was one patient in both groups who only had EBRT for the cause. The mean duration of incontinence were 4.2 and 4.4 years, respectively. injections were carried out transurethrally either under regional or general anesthesia until co-aptation of mucosa was observed. The male sling was placed under spinal anesthesia with a bone drill using either absorbable or synthetic materials. Retrospectively, all patients were assessed for continence status and procedure-related morbidity, if present. The outcome of both procedures was also compared with the degree of incontinence. Results: Ten (30%) patients in the collagen group showed either significant improvement or were cured following injections. Preoperatively, the mean pad use in collagen group was 4.5 (SD 2.8) per day, whereas it was 2.2 (SD 1.1) after the injection(s). injection failed in 24 (70%) of the patients. Patients who received the male sling had a mean preoperative pad use of 3.7 (SD 1.5) and postoperatively, the number decreased to 1.6 (SD 1.2). Most of the patients in this group were either totally dry or significantly improved (n: 28, 76%). There was a statistically significant difference between two groups in respect to success rate (P < 0.05). Analysis of treatment outcome with the degree of incontinence revealed that the male sling is most effective in patients with minimal-to-moderate incontinence. Conclusions: Our results suggest that the male sling, a minimally invasive procedure, is more effective than collagen implant in the treatment of mild-to-moderate SUI in men. Key words collagen, comparison, incontinence, male sling. Introduction Stress urinary incontinence (SUI) caused by intrinsic sphincter deficiency (ISD) in men is a well-recognized complication of treatment for benign or malignant prostate diseases. Although the reported incidence of postprostatectomy incontinence differs depending on the procedure carried out, definition of incontinence, how data were collected, improved understanding of the neuroanatomy of male incontinence and subsequent surgical innovations have led to substantial decrease in the incidence of this complication. 1 Nevertheless, it affects 5 12% of patients who underwent radical prostatectomy. 2,3 Current management of male SUI include transurethral injection of bulking agents, artificial urinary sphincter (AUS) and Correspondence: Rahmi Onur MD, Department of Urology, Firat Tip Merkezi 23200, Elazig, Turkey. rahmionur@yahoo.com Received 7 November 2005; accepted 24 February recently described sling procedures including bulbourethral and bone-anchored perineal male sling. 4 7 Although AUS has the highest success rate in the treatment of SUI in men, it was reported that in 36% of patients, at least one revision was necessary because of infection, erosion or mechanical problems. 8 Furthermore, the non-physiological and rather cumbersome nature of this device obviates the necessity for other treatment options. Transurethral collagen injection is another alternative in the treatment of male SUI. 4,5,9 However, success rate related to this procedure ranges from 8 to 20%, have relatively been low and short-lasting More recently, perineal bone-anchored sling has been introduced for treatment of post-prostatectomy incontinence and early results suggest that the male sling appears to be safe and efficacious. 7,11,12 In a retrospective analysis, a direct head-to-head comparison of collagen and AUS showed that AUS had significantly higher continence rates compared with collagen injection. 13 However, to date a similar comparison of male sling and collagen implant has not been carried out. To our knowledge, we present the first report comparing the efficacy of two modalities.

2 1208 R Onur and A Singla Table 1 Comparison of patient characteristics in collagen and male sling groups (n: 34) (n: 37) Mean age (range) 67 (51 78) 69 (50 81) Duration of incontinence (years) Cause RRP (%) 27 (79%) 30 (81%) RRP + EBRT (%) 6 (18%) 6 (16%) EBRT (%) 1 (3%) 1 (3%) Valsalva leak point pressure 62 cm H 2 O 66 cm H 2 O Median follow-up (months) 15 18* *P < EBRT, external beam radiation therapy; RRP, radical retropubic prostatectomy. Methods Seventy-one men who had undergone either transurethral collagen injections (n = 34) or perineal bone-anchored male sling (n = 37) for SUI comprising two consecutive groups of patients between June 1999 and October 2003 were included into the study. International Review Boards approval was obtained for the study data. Because the male sling was not available before 2001 in our institution, patients referred before this date, received collagen injections. Patients who received collagen were selected retrospectively before male sling procedure. However, after the introduction of the male sling, patients were offered to undergo either collagen injection or sling. Patients who received collagen injection(s) previously and not treated, had the chance to cross-over from collagen to male sling. All patients were assessed with a detailed history, physical examination, urinalysis, urodynamic study and cystourethroscopy, if necessary. Most of the patients in each group had radical retropubic prostatectomy (RRP) and/or external beam radiation therapy (EBRT) for the cause of the incontinence. There was one patient in both groups who received EBRT as the cause of intrinsic sphincter deficiency. The cause of incontinence was summarized in Table 1. Patients in collagen group were incontinent for a mean time of 4.2 years (SD: 3, range: 1 10), whereas time of duration of incontinence in the male sling group was 4.4 years (SD: 3, range: 1 10). Patient characteristics, cause of ISD and daily pad usage (pad per day: PPD) were noted in all patients. Incontinence was classified as mild (1 2 PPD), moderate (3 4 PPD) and severe (>5 PPD). All patients were tested for Valsalva leak point pressure (VLPP), adequate bladder capacity and presence of uninhibited contractions. Patients with untreated urinary tract infections, neurogenic bladder, unmanaged detrusor instability and experiencing urge incontinence more predominantly than stress incontinence or known hypersensitivity to bovine collagen were excluded from the study. For patients undergoing collagen injection, an intradermal test injection was done 1 month before the procedure to rule out any immunologic reactivity. All injections were given transurethrally under either regional or general anesthesia and the collagen was implanted submucosally at the 3-, 6- and 9-o clock positions until co-aptation of mucosa was observed. In some cases, injection was repeated if the seal effect was unsatisfactory. The bladder was emptied by a 12F straight catheter. All patients were checked for postvoid residual (PVR) urine after voiding and patients were discharged home on the same day of injection. In patients with unsatisfactory results, another injection was considered after 6 8 weeks. The male sling was placed under spinal anesthesia while patients were in the lithotomy position as described previously. 7 Three titanium bone screws with preloaded number one polypropylene suture (InVance-In bone drill, American Medical Systems, MN, USA) were placed into the inner aspect of the pubic rami on each side. A 4 cm 7 cm, absorbable graft (dermis, fascia lata or small intestinal submucosa) were used in seven patients, whereas siliconecoated prolene mesh (InVance-In bone drill) or composite graft (dermis and mesh cut in a trapezoid shape with the dermis placed facing the urethra) were used in the other 30 patients. Sling tension was adjusted by the cough test in all patients under spinal anesthesia as described in our previous report. 7 Because we used the cough test to adjust the tension of the sling, we preferred spinal anesthesia. However, in collagen injection, co-aptation was the rule so type of anesthesia did not affect the procedure. A Foley catheter was left in place for 1 day and patients were asked to void the day after the procedure. Patients with high PVR urine were managed by clean intermittent catheterization (CIC). Postoperatively, all patients were assessed for continence status and procedure related morbidity, if present. The condition of SUI was cured when patients reported no leakage and used no pads after the procedure, improved (postoperative PPD use decreased >50% before surgery and maximum 1 2 PPD) and failed (improvement in PPD use was less than 50% before surgery or equal or greater than 3 PPD). For statistical evaluation, the procedure was classified to be successful in patients who were dry or improved. Statistical analysis between the groups was calculated using Student s t-test and Fischer s exact χ 2 test. Results Clinical data for patients in each group are summarized in Table 1. For the collagen patients, the mean number of injections was 2.1 (range: 1 5) with a mean of 8.8 ml (range: 2 34) collagen injected. Twelve (35%) patients in collagen group received one injection and another 12 (35%) received two injections. Ten (30%) patients recieved three or more injections. Preoperatively, mean pad use in collagen group was 4.5 (SD 2.8) per day, whereas it was 2.2 (SD 1.1) after the injection(s) with a median follow-up of 15 months (range: 5 31 months). Of the patients, five (15%) were completely cured and five (15%) showed significant improvement before surgery (>50% improvement). injection failed in 24 (70%) of the patients. Patients who received perineal bone-anchored male sling had a mean preoperative pad use of 3.7 (SD 1.5) and at a median follow-up of 18 months (range: 6 25 months),

3 Comparison of male sling and collagen implant 1209 mean number of PPD decreased to 1.6 (SD 1.2). Similarly, most of the patients in this group were either completely cured (n: 15, 41%) or significantly improved (n: 13, 35%). Overall, male sling was successful in 76% of the patients, whereas it failed in 24% of the patients. There was a statistically significant difference between two groups (P < 0.05) (Fig. 1). Patients who received absorbable biomaterial as a sling failed in our series, whereas polypropylene mesh either alone or in combination with an absorbable material were successful as sling materials except in two patients. When patients were assessed with the severity of incontinence (Table 2), none of the patients with mild incontinence failed in the male sling group, whereas four patients with mild incontinence in the collagen group failed to improve. Success of collagen implant in patients with moderate incontinence was low, but the Number of patients Cured/improved P < Failed P < 0.05 Fig. 1 Outcome of collagen injections and perineal boneanchored male sling in patients with stress incontinence. Statistically significant difference was noted between the two groups (P < 0.05) male sling was successful in 22 out of 27 patients in this group. Statistically significant difference was observed between two groups (χ 2 : , P < 0.05). One-half of the patients with severe incontinence who underwent male sling were either improved or cured. In the collagen group, 80% of patients with severe incontinence failed (Table 2). One patient developed urinary retention and required CIC temporarily in the collagen group. In patients who underwent the male sling, two (5%) had high PVR urine early in the postoperative period and required temporary catheterization and CIC. No de novo urgency or urge incontinence was observed in the collagen group, whereas one patient who received male sling developed de novo urgency after the procedure. Post-operatively, four (11%) patients in the sling group had mild buttock pain which resolved by analgesics within 2 weeks. Only one (3%) patient had prolonged pain (for 3 months) but no sign or symptoms of any osseous complication was observed. Discussion A better understanding of pelvic neuroanatomy has led to the development of different surgical alternatives in the treatment of male SUI. Traditionally, collagen implant is well tolerated and has low complication rates, has been recommended for mild-to-moderate incontinence in male SUI. 1,3,14 It has been reported that best results can be obtained in patients with mild degrees of incontinence and with a preoperative VLPP greater than 60 cmh 2 O. Similarly, eliminating poor prognostic factors such as postoperative radiation therapy, adjuvant cryotherapy and bladder neck incisions might improve the outcome of collagen injection. 10 Aboseif et al. reported treatment results in 88 patients with collagen injection. A total of 48% of patients in their series were dry and 22% showed significant improvement. 15 In another study, collagen injection revealed dry/improved rate of 58% in patients with post-radical prostatectomy at a mean follow-up of 10.4 months. 16 However, clinical results regarding the efficacy of collagen injection are not consistent. Griebling et al. treated 25 men with incontinence after RRP and transurethral resection of prostate and obtained minimal improvement and significant improvement in eight (32%) and two (8%) patients, respectively. 17 Our results were consistent with the latter studies and only 30% of the patients were cured or had significant improvement. Perineal bone-anchored male sling procedure is one of the recent alternatives introduced for the management of Table 2 Distribution of treatment outcomes according to the severity of incontinence Severity of incontinence (n: 34) (n: 37) Cured/improved Failed Cured/improved Failed Mild (%) 6 (60%) 4 (40%) 3 (100%) Moderate (%) 1 (11%) 8 (89%) 22 (81%) 5 (19%)* Severe (%) 3 (20%) 12 (80%) 3 (43%) 4 (57%) *χ 2 : , P < 0.05.

4 1210 R Onur and A Singla male SUI. 4,7,11,12,18 The use of bone anchors provides a fixed urethral support and eliminates any abdominal incision. Minimal dissection leaving the bulbospongiosus muscle and periurethral tissue intact secures any nerve damage and helps to avoid direct contact of sling material to anterior urethral wall. Thus, only the ventral aspect of the urethra was compressed. Unlike the AUS that has a circumferential compression thereby predisposing to urethral atrophy or erosion, the male sling has no circumferential pressure on urethra which minimizes the risk of erosion. 11 Cespedes and Jacoby carried out perineal male sling using absorbable biomaterial to 58 patients. At 6 months postoperatively, 81% of their patients were completely dry or improved significantly and they suggested male sling for patients with moderate-to-severe post-prostatectomy incontinence. 18 In our earlier study, we showed that male sling using a non-absorbable material is more efficacious in mild-tomoderate SUI. 7 However, the type of material that should be used in the male sling and the ideal candidate have not been standardized yet. Comiter used polypropylene mesh as a sling in 21 patients. No urethral atrophy and/or erosion were reported after a mean follow-up of 1 year and the success rate was 90%. 11 In our series, we used both absorbable and non-absorbable/composite grafts and patients (n: 7) receiving absorbable biomaterials continued to experience incontinence. Exploration for placement of an artificial urinary sphincter in four out of seven patients showed no evidence of absorbable material within the surgical site. Because we had an early (3 6 month) failure in our patients who received absorbable biomaterials and observed no evidence of tissue on re-exploration of failed patients, we attribute the failure mainly to autolysis of the absorbable grafts. Overall success of the male sling was high compared with collagen implant. There was no significant difference between the two groups with respect to the number of patients, severity of incontinence and poor prognostic factors. Although the data of our current study showed the male sling to be a better choice in the treatment of male incontinence compared with collagen, our study had some limitations. We had a relatively short follow-up in both groups. However, in our previous report, we determined that patients who failed to improve or cure were noted during first 8 months. 7 Cespedes and Jacoby have similarly reported early failure (within 6 months) in 5% of their patients. 18 Thus, our 18 months follow-up was enough to reveal the short-term failure in male sling patients, if it happens in this timeframe. Follow-up was longer in the male sling group and this difference also contributed to the better role of male sling for treatment of male incontinence. Patients who underwent collagen injections did not have the expected clinical benefit in the early postoperative period thus, they did not want to continue further and repetitive injections which led to a shorter follow-up in the collagen injection group. Similarly, some of the patients accepted to receive other treatment modalities and lost the follow-up in the collagen group. Additionally, the retrospective nature of the current study and its inherent problems are the other limitations of this study. However, design of a comparative randomized study with collagen injection as one arm is a problem because many patients can require more than one injection. Thus, it is difficult to randomize patients in the two groups given the nature of the treatment. Because collagen injection was suggested to be effective when applied four to five times in a patient, 13 theoretically, we might have achieved better results if all patients had underwent four or five collagen injections. However, in the present study, most of the patients chose not to receive further injections after little or no improvement after one or two procedures. Recently, several investigators had a consensus for not proceeding further in patients who have not showed any symptomatic improvement despite receiving a second injection. 5,18,19 Similarly, Kageyama et al. reported that the volume of collagen injected does not necessarily correlate with the degree of clinical improvement. 20 Despite these limitations, we believe that the two treatment groups are representative of typical patients with post-prostatectomy incontinence and our results showed significant improvement in urinary incontinence following a male sling. This finding has led to a change in treatment policy at our institution and we currently offer male sling to patients with mild-tomoderate stress incontinence. There is an increasing body of evidence that boneanchored male sling can be effectively and safely used in the treatment of male incontinence. 7,11,18 In our experience, male sling offers significantly higher success rate over collagen implant in both mild-to-moderate and severe incontinent male patients. However, long-term results with larger prospective randomized studies will be needed to establish its efficacy over collagen injection. Acknowledgments We acknowledge the Scientific and Technical Research Council of Turkey (TUBITAK) for supporting Rahmi Onur, MD, in conducting his research. References 1 Faerber GJ, Richardson TD. Long-term results of transurethral collagen injection in men with intrinsic sphincter deficiency. J. Endourol. 1997; 11: Steiner MS, Morton RA, Walsh PC. Impact of anatomical radical prostatectomy on urinary incontinence. J. Urol. 1991; 145: Leandri P, Rossignol G, Gautier JR, Ramon J. Radical retropubic prostatectomy: morbidity and quality of life. Experience with 620 consecutive cases. J. Urol. 1992; 147: Franco N, Baum N. Suburethral sling for male urinary incontinence. Infect. Urol. 2001; 14: Smith DN, Appell RA, Rackley RR, Winters JC. injection therapy for post-prostatectomy incontinence. J. Urol. 1998; 160: Litwiller SE, Kim KB, Fone PD, White RW, Stone AR. Post-prostatectomy incontinence and the artificial urinary sphincter: long-term study of patient satisfaction and criteria for success. J. Urol. 1996; 156: Onur R, Rajpurkar A, Singla A. New perineal boneanchored male sling: lessons learned. Urology 2004; 64:

5 Comparison of male sling and collagen implant Clemens JQ, Schuster TG, Konnak JW, McGuire EJ, Faerber GJ. Revision rate after artificial urinary sphincter implantation for incontinence after radical prostatectomy: actuarial analysis. J. Urol. 2001; 166: Shortliffe LM, Freiha FS, Kessler R, Stamey TA, Constantinou CE. Treatment of urinary incontinence by the periurethral implantation of glutaraldehyde cross-linked collagen. J. Urol. 1989; 141: Sanchez-Ortiz RF, Broderick GA, Chaikin DC et al. injection therapy for post-radical retropubic prostatectomy incontinence: role of valsalva leak point pressure. J. Urol. 1997; 158: Comiter CV. The male sling for stress urinary incontinence: a prospective study. J. Urol. 2002; 167: Clemens JQ, Bushman W, Schaeffer AJ. Questionnaire based results of the bulbourethral sling procedure. J. Urol. 1999; 162: Kuznetsov DD, Kim HL, Patel RV, Steinberg GD, Bales G. Comparison of artificial urinary sphincter and collagen for the treatment of postprostatectomy incontinence. Urology 2000; 56: Cespedes RD. injection or artificial sphincter for postprostatectomy incontinence: collagen. Urology 2000; 55: Aboseif SR, O Connell HE, Usui A, McGuire EJ. injection for intrinsic sphincter deficiency in men. J. Urol. 1996; 155: Cummings JM, Boullier JA, Parra RO. Transurethral collagen injections in the therapy of post-radical prostatectomy incontinence. J. Urol. 1996; 155: Griebling TL, Kreder KJ, Williams RD. Transurethral collagen injection for treatment of postprostatectomy incontinence in men. Urology 1997; 49: Cespedes RD, Jacoby K. s for postprostatectomy incontinence. Tech. Urol. 2001; 7: Kylmala T, Tainio H, Raitanen M, Tammela TL. Treatment of postoperative male urinary incontinence using transurethral macroplastique injections. J. Endourol. 2003; 17: Kageyama S, Kawabe K, Suzuki K, Ushiyama T, Suzuki T, Aso Y. implantation for postprostatectomy incontinence: early experience with a transrectal ultrasonographically guided method. J. Urol. 1994; 152: