Burch Colposuspension and Tension-Free Vaginal Tape in the Management of Stress Urinary Incontinence in Women

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1 European Urology European Urology ) 469±473 Colposuspension and Tension-Free Vaginal Tape in the Management of Stress Urinary Incontinence in Women A. Liapis *, P. Bakas, G. Creatsas 2nd Department of Obstetrics and Gynecology, Aretaieio Hospital, University of Athens, Greece Accepted 22 January 2002 Abstract Objective: Objective of the study was to compare the ef cacy and the complications of tension-free vaginal tape ) and colposuspension in the treatment of female genuine stress incontinence GSI). Methods: In this controlled, prospective, randomized study, participated 35 patients who underwent colposuspension and 36 patients that underwent procedure. Patients with prolapse more than rst degree, previous surgical treatment of stress urinary incontinence SUI) and detrusor instability were excluded from the study. Results: The operative time for was signi cantly shorter compared to BC. The severity and duration of postoperative pain for was signi cantly less compared to BC. The necessary time for return to normal activity was 10 days for and 21 days for BC. The cure rate after 24 months of follow-up was as follows: : 84% and BC: 86%, while the improvement was 7% for and 6% for BC. Conclusions: and colposuspension are equally effective in the management of female GSI at two years follow-up. procedure requires much less operative time, has much shorter hospitalization time, with signi cantly less postoperative pain and faster return to normal daily activities than colposuspension. # 2002 Elsevier Science B.V. All rights reserved. Keywords: colposuspension; Stress incontinence; 1. Introduction Stress urinary incontinence SUI) is a signi cant problem affecting 20% of women over 45 years old [1,2] with signi cant nancial and psychological consequences for the patients. Many surgical procedures have been proposed for treatment of SUI but none of them has been proven completely successful. colposuspension has been widely used because of its very good results in the short and long term [3,4]. The procedure continues to be the preferred choice of treatment by most authors for the management of genuine stress incontinence GSI) in women without intrinsic sphincter insuf ciency. A new procedure has been developed for the management of women with GSI and is called tension-free vaginal tape ). Many authors have demonstrated the effectiveness * Corresponding author. Present address: N. Paritsi 9A, N. Psychiko, P.C.: Athens, Greece. Tel.: ; Fax: address: eurotas@ath.forthnet.gr A. Liapis). and the easiness with which procedure is performed [5,6]. Purpose of this study was to compare the effectiveness, postoperative complications, need for analgesia and time to return to work between colposuspension and procedure. 2. Material and methods This is a controlled, prospective, randomized and blind study on behalf of the surgeon and was performed in the Urodynamic Unit of the 2nd Department of Obstetrics and Gynecology of the University of Athens, Aretaieion Hospital. Thirty ve patients with GSI underwent colposuspension, while 36 patients underwent procedure. All patients underwent clinical and urodynamic evaluation uro ow, lling and voiding cystometry, urethral pro lometry) at initial visit and at 24 months follow-up. Patient selection criteria for participation in the study included stage I anterior wall prolapse or less according to the International continence society classi cation, no previous operation for urinary incontinence, absence of urge incontinence and competent intrinsic urethral sphincter. When selection of the patients according to the mentioned criteria was completed, the patients were placed in the waiting list for operation of the out /02/$ ± see front matter # 2002 Elsevier Science B.V. All rights reserved. PII: S )

2 470 A. Liapis et al. / European Urology ) 469±473 Table 1 Patients characteristics patients department. They were asked to come to the hospital for operation when their turn was coming up by the staff of the outpatients department which is independent from the staff of Urogynecology Unit. colposuspension or TV procedure were performed on an alternate fashion, so that the surgeon did not affect the decision about the operation to be performed. All patients signed an informed consent and approval of the hospital ethical committee was obtained. All patients were operated by two surgeons belonging to the senior staff of the department and they performed both procedures. Preoperative patients characteristics are provided in Table 1. The parameters we assessed to compare colposuspension with procedure included the duration of the operation, the duration of hospitalization, the time to return to normal activity, the duration and severity of postoperative pain, the intraoperative and postoperative complications and the ef cacy of the operation. Postoperative pain was assessed with the use of three parameters including the type of the used analgesic [7], the duration of analgesia use, and the self-assessment of pain in a scale with four degrees 0Ðno pain, 1Ðmild pain, 2Ðmoderate pain, 3Ðsevere pain) [7]. Time to return to normal activity was de ned as interval of time between operation and return to daily normal activities. Telephone contact with the patients was necessary to assess the time to return to normal activity. The outcome of both operations was assessed objectively. Objective assessment included 1 h pad test, while objective cure was considered a pad weight difference <1 g, and improvement a reduction of urine loss to less than 50% of urine loss they experienced before the operation and it was based on the ndings of 1 h pad test. Both procedures were performed under epidural anesthesia. The power of the study regarding the ef cacy of the two methods is 76.91%, while regarding the operative time, the hospital stay time and the return to normal activity time is 99.97%. Statistical analysis was performed with the use of Student's t-test and w 2 -test and P < 0:05 was considered statistically signi cant. 3. Operative technique colposuspension Age mean) ±64) ±62) Parity mean) Body mass index mean) colposuspension colposuspension was performed through a low transverse abdominal incision, approximately 2 cm above the symphysis pubis. After careful dissection, access to space of Retzius was obtained and the left index nger covered with a sterile glove was introduced in to the vagina, elevating the anterior vaginal wall. Two or three Ethibond no. 1 non-absorbable sutures were applied on both sides of the urethra in the paravaginal fascia, on a symmetrical way and then the sutures were anchored in to the iliopectineal ligaments, ipsilaterally. The second or the third suture was placed at the level of the bladder neck to restore its intra-abdominal position. A Stamey suprapubic catheter was placed in the bladder for 3±5 days and it was removed when the urine residual was less than 100 ml with a voided urine volume greater than 200 ml. Also, a negative pressure draining system was placed in the space of Retzius and it was removed the rst or second postoperative day procedure procedure was performed in lithotomy position. A number 20 double or three way foley catheter was introduced in to urethra for bladder emptying and a 2 cm longitudinal incision was performed in the anterior vaginal wall, starting 1 cm distal to external urethral ori ce. After careful dissection with scissors of vaginal mucosa from the pubocervical fascia, two small incisions 1 cm wide are performed 2 cm laterally to the midline and 1 cm above the sympysis pubis in the lower abdominal wall for passage of the needle-driver. Subsequently, the specially designed driver is passed through the foley catheter in to the bladder and is pushed to lie over the left thigh and the device attached to its driver is passed through the incision in the vaginal mucosa form the left side and laterally to the urethra in to the space of Retzius and the device comes out through the ipsilateral incision in the skin. The same is performed on the other side. At this stage, a cystoscopy is performed to exclude perforation of the bladder, followed by lling of the bladder with normal saline up to the maximum cystometric capacity. We adjust the tape by placing a pair of scissors in the loop of tape in the vagina and pulling gradually the ends of tape from the abdomen, while we ask from the patient to cough a few times. When urine leakage is prevented at a speci c position of tape, we stop the procedure taking care to leave the tape not tight below the urethra. We remove the needles and suture the incisions in the skin and the vaginal mucosa. We replace the number 20 foley catheter with a number 16 foley catheter which is left in place until next morning when the residual of urine in the bladder is checked [8]. 4. Results The results of the study are shown in Tables 2±6. The duration of operation for procedure was signi cantly less compared to colposuspension P < 0:01) and the range for procedure was 16±25 min while for colposuspension was 46± 70 min. The preoperative and postoperative results of uro owmetry are presented in Table 4. Short duration

3 A. Liapis et al. / European Urology ) 469± Table 2 The relation between the severity of pain postoperatively, the type of the analgesic used and the type of the operation colposuspension Antalgic character Antalgic class %) 7 20%) >0.05 Antalgic class 2± %) ± <0.001 Subjective feeling Not at all or mild pain 8 22%) %) <0.001 Rather or very painful 27 78%) ± <0.001 Table 3 Operative and postoperative data concerning colposuspension and colposuspension Operative time 58 min 20 min <0.05 Hospital stay mean) days days <0.05 Return to normal activity mean) 21 days 10 days <0.05 Table 4 Results of uro owmetry preoperatively and at 24 months follow-up for colposuspension and procedure Peak ow rate ml/s) Preoperative At 24 months FLU colposuspension NS procedure NS FLU: follow-up, NS: not statistically signi cant P < 0:05). analgesics that were used postoperatively included paracetamol, proparacetamole class 1), ni umic acid class 2), nalfu ne class 3), pethidine i.m. class 4). The percentage of patients that required only 1 day analgesics class 1 or required analgesia only the day of the operation for method was signi cantly less than that of patients operated with colposuspension P < 0:01). All patients who underwent did not require any analgesia during the rst postoperative day, while 27% of patients with colposuspension did require analgesia in the rst postoperative day. The hospital stay of patients with procedure mean 2:1 1:1) was signi cantly less than that of patients Table 6 Results of colposuspension and procedure with colposuspension mean 5:7 2:2). Return to normal activity was signi cantly less for group compared to colposuspension group and this difference was statistically signi cant P < 0:01) Table 3). Lntraoperative complications for included four cases of bladder perforation, while we had no signi cant intraoperative complications with colposuspension. Postoperative complications for group included ve patients with development of infection of the lower urinary tract LUTI), six patients with development of detrusor instability and two cases with development of sensory urgency. In the colposuspension group we had two cases with hematoma at the incision site with conservative management, three cases with urinary retention that were treated with suprabic catheteresation for 14±21 days. Also we had ve patients with development of detrusor instability, two patients with LUTI, one case with sensory urgency and four cases that complained of pain at the incision site up to 6 months postoperatively Table 5). The cure rate for procedure at 24 months followup was 84% and the improvement was 7%, while for colposuspension the cure rate was 86% and the improvement was 6%. There was not any statistically signi cant difference between the two groups. 5. Discussion colposuspension %) %) Cure rate >0.05 Improvement 6 7 >0.05 colposuspension has been used for long time for the management of GSI in women with very good results in the short term and long term and can be compared favorably with other operative techniques for the management of GSI. procedure has been introduced since 1995 [9] and during the last few years signi cant discussion has been developed about this Table 5 Complications of colposuspension and procedure Bladder perforation LUTI DI SU Hematoma Urinary retention Pain at incision site colposuspension ± procedure ± ± ± LUTI: lower urinary tract infection, DI: detrusor instability, SU: sensory urgency.

4 472 A. Liapis et al. / European Urology ) 469±473 method [10,11]. Signi cant attention has been given in the selection criteria for the patients participating in the study, so that the two groups could be comparable. Patients with anterior vaginal wall prolapse more than stage I were excluded from the study so that the participating patients underwent only procedure or colposuspension. Patients with previous operation for urinary incontinence or detrusor instability were excluded because these factors could affect the results of the operations. We had no statistically signi cant difference in the preoperative patients characteristics. The required mean operative time for procedure was 20 min and was signi cantly less than the time required for colposuspension 58 min). The operative time depends on the presence or not of previous operation, especially for colposuspension, the development of intaoperative complications and the experience of the surgeon. The reduced operative time is advantageous for the patient by reducing the risks associated with anesthesia and for the health system by reducing the operative cost. Undoubtedly, procedure is much less painful for the patient compared to colposuspension and in our study none of the patients with procedure required any analgesia even in the rst postoperative day. The required hospitalization for procedure was 2:1 1:1 and for colposuspension was 5:7 2:2, while it has been reported a mean hospitalization time of 3 days for procedure [12] and 4±6 days for colposuspension [13]. Also, it has been reported a return to normal activity of 11 weeks for colposuspension [14]. In our study, there is a signi cant difference between the two methods with 10 days required for return to normal activity for and 4 weeks for colposuspension. We found no signi cant difference in relation to intraoperative and immediate postoperative complications between the two methods with the exception of bladder perforation which is much more frequent in the group and depends on the presence of previous operations in the space of Retzious and the expertise of the surgeon [5,9]. Also, it has been reported a transient neuropathy of the ischial nerve in patients who underwent colposuspension. Complications from the incisional wound appeared to be less in the group although not statistically signi cant. Patients with urinary retention after colpsuspension were discharged home with a suprapubic catheter in place and appropriate instructions. We did not found statistically signi cant difference in the preoperative and postoperative mean peak ow rate for these procedures and these could be attributed to the fact that the incidence of late voiding dysfunction after procedure is very small and is reported about 3% [15] and consequently a very large number of patients is required to detect a small difference. Out ow obstruction lasting for more than a week has been reported to have an incidence of 2.8% after procedure and patients can be managed with transvaginal release of tape on an out-patients basis [16]. In the present study, we used two comparable group of patients allocated randomly to either colposuspension or procedure. A cure rate of 86% for colposuspension and 84% for procedure at 24 months follow-up gives comparable results. procedure requires much shorter operating time, provides a much shorter duration of hospitalization and a faster return to normal activity compared to colposuspension. Our present practice has been changed in favor of procedure with parallel reduction in the performance of colposuspension. We do perform colposuspension in patients with stress incontinence and signi cant cystocele which is extended laterally, because this patients require paravaginal repair for reconstruction of pelvic fascia in addition to the operation for the urinary incontinence. procedure gradually gains wider acceptance but the long term results of the procedure at 5 and 10 years should be assessed. References [1] Health Survey Questionnaire. Market and opinion research international. 95 Southwalk Street, London SE1 OHX [2] Thomas TM, Plymat KR, Blannin J, Meade TW. The prevalence of urinary stress incontinence. BMJ 1980;281:1243±5. [3] Druin J, Tessier J, Bertrand PE, Schick E. colposuspansion: Long term results and review of published report. Urology 1999;54: 808±14. [4] Alcalay M, Monga A, Stanton S. colposuspansion: A 10±20 years follow-up. 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