Quality of Life Impact of Using Tension-free Vaginal Tape for Stress Urinary Incontinence

Original Article Quality of Life Impact of Using Tension-free Vaginal Tape for Stress Urinary Incontinence Shi-Wei Huang, Hong-Jeng Yu, Wai-Yan Wong, Jun Chen Department of Urology, National Taiwan University Hospital, Taipei, Taiwan, R.O.C. OBJECTIVES: To assess the efficacy, safety and quality of life impact of the tension-free vaginal tape (TVT) procedure in the treatment of female stress urinary incontinence. MATERIALS AND METHODS: From November 1999 through May 2001, 32 TVT procedures performed by a single surgeon in the Department of Urology were prospectively analyzed. Preoperative work-up included a questionnaire regarding urinary symptoms and quality of life (QOL) assessment, a 1-hour pad test, voiding cystourethrography (VCUG), and urodynamic studies. The questionnaire, pad test, and uroflowmetry were repeated 6 months after the operation. RESULTS: The mean age of these women was 58.2 (range, 32 to 78) years, and the mean parity was 3.6 (range, 0 to 7); the mean operation time was 31.2±16.2 (range, 15-75) minutes. Bladder perforations occurred in 2 patients and were treated uneventfully with prolonged indwelling catheterization for 7 days; 87% of the women voided satisfactory immediately after catheter removal. The success rate (cure or improvement) was 93%. There was no significant change in urinary flow (maximal flow rate 21.8±6.9 ml/s preoperatively vs. 18.6±7.6 ml/s postoperatively, p>0.05) or percentage residual urine volume (8.7%±5.6% preoperatively vs. 10.3%±6.7% postoperatively, p>0.05).the QOL score improved from 4.9±1.6 to 1.7±1.3 (p<0.01).in addition to urinary incontinence, urinary frequency, nocturia, and urgency were also significantly improved by the operation. CONCLUSIONS: The TVT procedure is a promising technique that in this short-term analysis, appears to be safe and effective, producing substantial improvement in patients quality of life. Follow-up studies are warranted to evaluate the long-term outcome of this procedure. (JTUA 13:151-6, 2002) Key words: stress urinary incontinence, tension-free vaginal tape, quality of life assessment. INTRODUCTION Female stress urinary incontinence (SUI) is a common disorder in women. The prevalence rate ranges from 8% to 34% [1]. The etiology of SUI is not fully understood, but trauma to the pelvic floor during childbirth is suggested as a major risk factor [2], whereas body mass index, ages and parity were also declared to be positively associated factors [3]. During the past few decades, many operative procedures have been developed to treat female SUI [4]. Among these procedures, Tension-free vaginal tape (TVT), first introduced by Ulmsten et al. [5] in 1996, has been claimed to be a minimally invasive procedure with satisfactory results. Recent reports indicate a cure rate of 85% to 90% by objective and subjective assessments, and successful outcomes were sustained for up to 3 years [6,7]. The ultimate goal of surgical intervention in patients with SUI is to cure the urinary incontinence without perturbation of normal micturition and consequently to improve the quality of life (QOL). The TVT procedure has been introduced to Taiwanese urologists in recent years, and a paucity of data regarding treatment outcomes has been reported by urologists. Therefore, we conducted a prospective study to evaluate treatment outcomes of the TVT procedure in treating Taiwanese patients with SUI. The main variables analyzed were the success rate, patient satisfaction, and the QOL score. MATERIALS AND METHODS From November 1999 to May 2001, TVT procedures performed on 32 female patients with SUI by the same senior surgeon (H.J.Y) in the Department of Received: July 16, 2002 Revised: Aug. 26, 2002 Accepted: Oct. 31, 2002 Address reprint requests and correspondence to: Hong-Jeng Yu, MD Department of Urology, National Taiwan University Hospital, No. 7 Chang-Shan S. Rd., Taipei, Taiwan 100, R.O.C. 台 灣 泌 尿 醫 誌 第 十 三 卷 第 四 期 (91 年 12 月 ) 151

TVT for Stress Urinary Incontinence Urology were prospectively analyzed. Preoperative assessment included urogynecological history, a physical examination, a questionnaire regarding urinary symptoms and a QOL assessment, a 1-hour pad test, urodynamic studies, and voiding cystourethrography (VCUG). The urodynamic studies included cystometry (including valsalva leak point pressure, VLPP), urethral pressure profilometry (including stress UPP), uroflowmetry, and a pressure flow study. The questionnaire, pad test, and uroflowmetry with residual urine measurement were repeated 6 months after the operation. The questionnaire was administered by the same well-trained medical assistant, and residual urine was measured by catheterization after uroflowmetry. The grades of SUI were classified by combining Blaivas and Olsson's and McGuire's classifications [8,9]. Type 1 and type 2 SUI were defined as the bladder neck descending during the valsalva maneuver under VCUG and a valsalva leak point pressure (VLPP) of greater than 60 cmh 2 O under 250 ml of bladder volume, respectively, while type 3 SUI was diagnosed when the bladder neck and urethra remained open at rest in the absence of detrusor contraction under VCUG with severe symptoms or a VLPP of less than 60 cmh 2 O. The TVT procedure was performed as described by Ulmsten et al. [5] under spinal or epidural anesthesia. The tape was placed at the level of the midurethra. An indwelling urethral catheter was routinely left in place for 48 hours, and a patient was discharged immediately after the catheter was removed. Questionnaire. The questionnaire was composed of 2 parts; the first part was comprised of the presence of storage and voiding symptoms, and the degree of bother produced by any of these symptoms. Storage symptoms included frequency, urgency, and nocturia. Voiding symptoms included residual urine sensation, a small-caliber stream, intermittency, and straining to urinate These questions were scored according to the responses: not at all (0), slightly bothersome (1), moderately bothersome (2), and greatly bothersome (3) [10]. The second part was a global assessment of the impact of urinary leakage on the quality of life (QOL). Patients were asked: If you were to spend the rest of your life with your urinary leakage just the way it is now, how would you feel about that? The answers to this question ranged from delighted (0) to terrible (6). The questionnaire is given in the Appendix. Outcome analysis. The outcome of surgical treatment was categorized as cured, improved, and failed according to subjective and objective means. Objective cure was defined as a 1-hour pad test of less than 1 g. Objective improvement was defined as a pad test of between 1 to 5 g and a greater than 50% reduction in the pad test when compared to that performed before the operation. Failure was defined as a pad test of greater than 5 g. Subjective cure was defined as no urine loss Appendix. The questionnaire on the quality of life before and after incontinence operations used in our study (modified from items in the short forms of the Incontinence Impact Questionnaire and the Urogenital Distress Inventory) Are you satisfied with the operation? Very satisfied, satisfied, some what satisfied, dissatisfied, very dissatisfied. If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that? delighted (0); pleased (1); mostly satisfied (2); mixed about equally satisfied and dissatisfied (3); mostly dissatisfied (5); unhappy (6); terrible (7) 1. If your friends have stress urinary incontinence, would you recommend that they receive the operation? 2. If you could choose again, would you receive the operation again? 3. Has urine leakage affected your sexual life? 0, no activity; 1, not bothered; 2, mildly bothered; 3, moderately bothered; 4, severely bothered 4. Do you experience, and if so, how much are you bothered by the following symptoms: 0, no symptoms; 1, mildly bothered; 2, moderately bothered; 3 severely bothered Frequent urination (more Residual urine sensation than every 2 hours) Urgency with or without Straining to urinate urge incontinence Nocturia (more than 2 Small caliber of stream times a night) Leakage related to activity, coughing, or sneezing 152 Small amounts of leakage (drops) Pain or discomfort in the lower abdominal or genital area JTUA Vol.13 No.4, Dec. 2002

SW Huang, HJ Yu, WY Wong, et al during exercise; improvement was defined as <50% leakage episodes compared to before the operation; and failure was defined as >50% leakage episodes compared to before the operation [11]. Statistical analysis. The variables compared before and after the operation were analyzed using paired t-test for normally distributed variables and the Wilcoxon paired sign rank test for non-normally distributed variables. Results were significant at a p value <0.05. RESULTS The mean age of the 32 patients was 58.2 (range, 32 to 78) years and mean parity was 3.6 (range, 0 to 7). Seven women had received pelvic or transvaginal surgery, and 5 had received anti-incontinence surgery previously. The mean operation time was 31.2±16.2 (range, 15-75) minutes; the mean hospital stay was 4.2 (range, 3-7)days; and the Foley catheter was left in place for a mean of 2.8 (range, 2-7) days. The detrusor pressure at Qmax was 25.3±9.2 cmh 2 O, and the maximal urethral closure pressure (MUCP) was 63.5±28.4 cmh 2 O preoperatively. Nine patients were classified into type 3 SUI, and 23 patients were classified into type 1 or 2 SUI. Bladder perforation occurred in 2 patients who had previously undergone anti-incontinence surgery due to inadvertent insertion of the applicator and were treated uneventfully with an indwelling catheter for 7 days. Both cases were among the earliest 10 patients. No patient had significant intraoperative bleeding that required a blood transfusion. Twenty-eight patients could void immediately and smoothly after Foley catheter removal, and 4 patients complained of voiding difficulty but needed no catheterization. Thirty patients reported being cured or subjectively improved, while 29 patients reported being cured or objectively improved. Among the 3 patients for which the procedure objectively failed, 2 patients were type 3, and 1 patient was type 2 SUI. The success rate was about 78% in type 3 SUI (ISD) patients and 96% among type 1 or 2 (BN hypermobility) patients. Thirty patients (93%) were satisfied with the operation. Twenty-nine patients would choose the operation again despite other choices; 31 patients would recommend the procedure to their friends with SUI. The maximal flow rate was 21.8±6.9 ml/s preoperatively and 18.6±7.6 ml/s postoperatively without a significant change (p=0.62). The percentage of residual urine volume changed from 8.7%±5.6% preoperatively to 10.3%±6.7% postoperatively (p=0.58). Urine leakage observed on the pad test was significantly reduced from a mean of 38.4±28.6 (range, 7.6-138.5) g before the operation to 2.1±1.9 (range, 0-9.3) g after the operation. The QOL score improved from 4.9±1.6 preoperatively to 1.7±1.3 postoperatively (p<0.05) (Table 1). Of the urinary symptoms analyzed, a significant improvement in the symptom scores of urinary frequency, urgency, and nocturia was observed (Table 1). Thirteen of the 18 women reported an unsatisfactory sexual life caused by urinary incontinence before. Among these 18 women with active sexual lives, 11 of the 18 women declared that the operation improved their sexual life, while 1 woman complained of dyspareunia and foreign body sensation during sexual intercourse after the procedure. Twenty four patients had urgency with or without urge incontinence preoperatively, and the symptoms disappeared or were improved in 19 patients after the operation. However, 4 among the 32 patients had worsened urgency symptoms postoperatively. All symptoms of urgency, frequency, and nocturia improved significantly (Table 1) (p<0.05). Nine patients complained of worsening of their voiding symptoms after the operation. The maximal flow rate in these 9 patients decreased from 20.8 ± 8.9 ml/s preoperatively to 15.7±8.6 ml/s postoperatively (p<0.05). The percentage of residual urine volume changed from 9.0%±6.4% preoperatively to 11.4%±7.4% postoperatively (p=0.08). Residual urine sensation, intermittency, a small-caliber stream, and straining to urinate scores showed no changes after the operation in any patients. DISCUSSION In the past few decades, many surgical procedures have been introduced to treat female SUI based on different concepts of the pathophysiology. The TVT is Table 1. Change in urinary symptom scores before and after TVT Urinary symptoms Preoperative Postoperative p value Frequent urination 1.90 ± 094 b 0.61 ± 0.80 < 0.01 Urgency 1.66 ± 1.19 0.66 ± 0.65 < 0.01 Nocturia 1.65 ± 1.18 0.75 ± 0.72 < 0.01 Residual urine sensation 0.65 ± 1.13 0.95 ± 1.05 0.35 Small caliber of stream 0.61 ± 1.2 0.80 ± 0.92 0.54 Intermittency 0.62 ± 1.19 0.81 ± 0.98 0.43 Straining to urinate 0.31 ± 0.80 0.50 ± 0.68 0.36 Pain or discomfort in the lower abdominal or genital area 0.38 ± 0.96 0.15 ± 0.38 0.62 QOL score 4.9 ± 1.6 1.7 ± 1.3 < 0.01 a Symptom scores: 0, no symptoms; 1, mildly bothersome; 2, moderately bothersome 3, severely bothersome. b Values represent the mean±standard deviation; QOL, quality of life. 台 灣 泌 尿 醫 誌 第 十 三 卷 第 四 期 (91 年 12 月 ) 153

TVT for Stress Urinary Incontinence innovative in its placement of urethral support without elevation of the bladder neck and just placing the tape loosely around the midurethra to enforce the pubourethral ligament. It is based on the theory that tension in the pubourethral ligament is essential for a correct interplay between the muscles and the vaginal hammock [12]. Many clinical investigations have demonstrated the safety and efficacy of TVT in treating female patients with SUI. The reported cure rate is around 85%-90% with minimal side effects, while the failure rate usually ranges from 5% to 10% [5-7]. This suggests that the procedure is highly reproducible and well standardized, which no doubt, accounts for its rapid and widespread diffusion. In our study, the subjective cured and improved rate of 93% and low complication rate (7%) were comparable with these of other reports. The TVT was initially recommended as a primary operation for patients with genuine stress incontinence due to hypermobility of the urethra. However, it now has expanded indications to more-complicated cases like type 3 SUI (ISD) or recurrent SUI patients with encouraging results (86%-91% success rates) [13,14]. The objective success rate in our patients was 96% among type 1 or 2 SUI but dropped to 78% in type 3 SUI patients. Bladder perforation is the most common complication. The prevalence rate of bladder perforation was reported to be about 6%-10%, and the complication necessitates repositioning of the trocar with prolonged catheterization [15,16]. The perforation most commonly occurs on the left side when the procedure is performed by right-handed surgeons, so the perforation might be a consequence of learning a new procedure [15]. Haab et al. [16] reported up to a 30% bladder perforation rate in patients with a history of anti-incontinence procedures versus 2.1% in patients who had had no previous surgery (p<0.05), implying that patient selection is also an important factor. In our patients, the 2 bladder perforations occurred in the earliest 10 patients, and both cases had previously undergone anti-incontinence surgery. There was no further complications in these 2 patients, and both of them are now able to void well with satisfactory results. More attention must be paid to patients who have previously received anti-incontinence surgery, and the perforations must be noticed during the operation. The goal of anti-incontinence surgery is not only to restore the continence mechanism but also to ensure a better QOL. In this study, we used a questionnaire modified from items in the short forms of the Incontinence Impact Questionnaire and the Urogenital Distress Inventory [10] to evaluate the impact of TVT procedures on patient satisfaction, QOL, and lower urinary symptoms. The storage symptoms (urgency, nocturia, and frequency) were all improved after the operation in our patients. A prospective study reported de novo urgency in 3 of 120 patients (2.5%) who underwent the TVT procedure [15]. In the same study, 26 subjects had mixed symptoms preoperatively which were resolved in 15. The reason for this low incidence is not clear. It is 154 likely that placing the tape around the mid-urethra instead of the proximal bladder neck, which imposed a less-irritating effect on the bladder neck to the bladder base region, may have partly contributed to this. Despite the fact that the TVT produces no tension on the urethra, immediate postoperative voiding problems were noted in 6% to 17% of patients [5,11], and there were also reported cases with urinary obstruction, which required subsequent urethrolysis [17]. None of our patients required self-catheterization after the operation. Nevertheless, 9 patients stated that they had to exert some strength to completely empty their bladder after the operation. The maximal flow rate with percent residual urine significantly changed after the operation in these 9 patients, among which only 3 patients were moderately to severely bothered by it, while most patients were able to tolerate the discomfort. It is tempting to speculate that in these patients, excessive tension might have been exerted on the urethra by the tape. This problem raises the greatest issue expressed by surgeons during anti-incontinence surgery, i.e, how to apply a perfect equilibrium force on the urethra to meet the requirement of satisfactory urinary continence and emptying. Three patients experienced a failed procedure, but the reasons for failure are not fully known. It was speculated that the tape might not have been adequately placed or that these patients might have had more-severe intrinsic deficiency since 2 of them had type 3 SUI. There are several limitations inherent in our study. First, since this is only an initial report, both the continence rate and scores related to the degree of bother might change with time. Therefore, a longer follow-up period is warranted to justify the long-term efficacy of TVT in treating our patients with SUI. Second, the success rate seemed worse in the ISD patients, but due to the limited number of patients in this study, we can draw no conclusion about the success of TVT in type 3 SUI patients compared to type 1 or type 2 SUI patients. In this regard, more cases have been recruited and a detailed investigation is ongoing. CONCLUSIONS In this short-term study, the TVT procedure appears to be a simple, safe, and effective technique for correction of female SUI, given the high success rate and the significant improvement in patients QOL and storage symptoms with minimal complications. Follow-up studies are warranted to evaluate the long-term outcome of this procedure. REFERENCES 1. Herzog AR, Fultz NH. Prevalence and incidence of urinary incontinence in community-dwelling populations. J Am Geriatr Soc 1990;38:273-81. 2. Handa VL, Harris TA, Ostergard DR. Protecting the pelvic floor: Obstetric management to prevent incontinence and pelvic organ prolapse. Obstet Gynecol 1996;88:470-8. 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SW Huang, HJ Yu, WY Wong, et al 3. Jan P, Pal WH, Hakan R. Obstetric risk factors for stress urinary incontinence: a population-based study. Obstet Gynecol 2000;96:440-5. 4. Leach GE, Dmochowski RR, Appell RA, et al. American Urological Association: Stress Urinary Incontinence Clinical Guidelines Panel summary report on surgical management of female stress urinary incontinence. J Urol 1997;158:875-80. 5. Ulmsten U, Henriksson L, Johnson P, et al. An ambulatory surgical procedure under local anesthesia for treatment of female urinary incontinence. Int Urogynecol J 1996;7:81-6. 6. Ulmsten U, Johnson P, Rezapour M. A three-year follow up of tension-free vaginal tape for surgical treatment of female stress urinary incontinence. Br J Obst Gyn 1999;106:345-50. 7. Olsson L, Kroon U. A three-year postoperative evaluation of tension-free vaginal tape. Gynecol Obstet Inv 1999;48(4):267-9. 8. Blaivas JG, Ollson CA. Stress incontinence: classification and surgical approach. J Urol 1998;139: 727-31. 9. McGuire EJ, Ritzpatrick CC, Wan J. Clinical assessment of urethral sphincter function. J Urol 1993; 150(5):1452-4. 10. Shumaker SA, Wyman JF, Uebersax JS, McClish D, Fantl JA. Health-related quality of life measures for women with urinary incontinence: The Incontinence Impact Questionnaire and the Urogenital Distress Inventory. Qual Life Res 1994;3:291-306. 11. Wang AC, Lo TS. Tension-free vaginal tape: a minimally invasive solution to stress urinary incontinence in women. J Reprod Med 1998;43:429-34. 12. Petros P, Ulmsten U. An integral theory on female urinary incontinence. Experimental and clinical considerations. Acta Obstet Gynecol Scand 1990;69: 153-6. 13. Rezapour M, Ulmsten U. Tension-Free Vaginal tape (TVT) in women with recurrent stress urinary incontinence-a long-term follow up. Int Urogynecol J 2001;(suppl 2):S9-11. 14. Rezapour M, Falconer C, Ulmsten U. Tension-free vaginal tape (TVT) in stress urinary incontinence women with intrinsic sphincter deficiency (ISD)-a long-term follow up. Int Urogynecol J 2001;(suppl 2):S12-4. 15. Soulie M, Delbert-Julhes F, Cuvillier X, et al. Cure of female urinary incontinence with prolene band (TVT): preliminary results of a prospective multicenter study. Prog Urol (France) 2000;10:622-8. 16. Haab F, Sananes S, Amarenco G, et al. Results of tension-free vaginal tape procedure for the treatment of type 2 stress urinary incontinence at a minimum follow up of 1 year. J Urol 2001;165:159-62. 17. Choe JM. Tension-free vaginal tape: Is it truly tension-free? J Urol 2001;166(3):1003. 台 灣 泌 尿 醫 誌 第 十 三 卷 第 四 期 (91 年 12 月 ) 155