Randomized trial of porcine dermal sling (Pelvicol implant) vs. tension-free vaginal tape (TVT) in the surgical treatment of stress incontinence: a questionnaire-based study.

The objective of this study was to compare porcine dermal sling (Pelvicol implant, Bard) with tension-free vaginal tape (TVT) in the surgical treatment of stress incontinence. One hundred and forty-two women with genuine stress incontinence (GSI) were randomly assigned to either Pelvicol implant pubovaginal sling (n=74) or TVT (n=68). They were followed up at a minimum of 6 months (range 6-24 months), with a median follow-up of 12 months. The majority (n=109) of procedures were carried out in a day surgery unit. The median operation time was 35 minutes (range 15-60) in the TVT group and 30 minutes (range 20-80) in the Pelvicol implant group; 81% of the TVT group and 77% of the Pelvicol implant group were able to void urine within 24 hours, and had insignificant residual bladder volumes. The prevalence of postoperative symptomatic voiding dysfunction was 3.4% after TVT and 1.4% after Pelvicol implant. Nine percent of the TVT group developed de novo urge incontinence and 6% of the Pelvicol implant group had de novo urge incontinence 6 months after the procedure. Postoperative evaluation was done at the outpatient department, and a postal questionnaire was also completed to determine subjective continence status. The patient-determined cure rate was 85% in the TVT group and 89% in the Pelvicol implant group. The Pelvicol implant sling had a comparable patient- determined success rate with TVT and should be considered in the surgical treatment of women with genuine stress incontinence.     

The tension-free vaginal tape procedure for female urinary incontinence without preoperative urodynamic evaluation

BACKGROUND: We evaluated the short-term outcomes of the tension-free vaginal tape (TVT) technique for female urinary incontinence, when the diagnosis was based on incontinence symptoms and pelvic examination including cough stress test or transperineal ultrasonography or both, but without preoperative urodynamic verification. STUDY DESIGN: Tension-free vaginal tape was performed on 191 patients under local (82%) or spinal (18%) anesthesia. One hundred twenty-seven women (66%) had stress urinary incontinence and 64 (34%) had mixed incontinence. Fifty-eight percent had undergone previous surgery; 21% for incontinence. Thirty-four women underwent concomitant surgery. The age range was from 32 to 84 years (mean 60) and parity from 0 to 8 (mean 2). Seventy-four (39%) had concomitant chronic illnesses. The diagnosis of incontinence was based on specific questionnaires and physical examinations. Urogynecological ultrasonography was performed on patients with mixed incontinence. The mean followup was 17 months. RESULTS: The mean operative time was 27 min (16 to 63), the mean hospital stay was 2 days (1 to 10). Intraoperative complications were: bladder perforation in five patients (2.6%), hematoma in five patients (2.6%), heavy bleeding (400 mL) in one patient, and persistent retention in four patients (2.2%). Altogether, 164 of 187 patients (87.7%) were completely cured, and 23 patients experienced no improvement. Six patients (4.8%) developed de novo urge incontinence, 60% had less urge incontinence. The cure rates were: 97% among stress urinary incontinence patients versus 69% among mixed incontinence patients (p = 0.001); TVT alone, 88% versus in combination with other surgery 85% (p = 0.576); TVT under local anesthesia, 88% versus under spinal anesthesia 88%; TVT with recurrent incontinence, 85% versus primary incontinence 89% (p = 0.583); and in patients with concomitant illnesses, 82% versus healthy 91% (p = 0.076). CONCLUSIONS: Tension-free vaginal tape can be used to treat patients with primary or recurrent stress or mixed incontinence with or without concomitant surgery under local or spinal anesthesia. But the success rate is considerably lower in patients in whom TVT is performed for mixed incontinence.     

Randomized trial of porcine dermal sling (Pelvicol<Superscript>™</Superscript> implant) vs. Tension-free Vaginal Tape (TVT) in the Surgical treatment of stress incontinence: a questionnaire-based study

 The objective of this study was to compare porcine dermal sling (Pelvicol^™ implant, Bard) with tension-free vaginal tape (TVT) in the surgical treatment of stress incontinence. One hundred and forty-two women with genuine stress incontinence (GSI) were randomly assigned to either Pelvicol^™ implant pubovaginal sling (n=74) or TVT (n=68). They were followed up at a minimum of 6 months (range 6–24 months), with a median follow-up of 12 months. The majority (n=109) of procedures were carried out in a day surgery unit. The median operation time was 35 minutes (range 15–60) in the TVT group and 30 minutes (range 20–80) in the Pelvicol^™ implant group; 81% of the TVT group and 77% of the Pelvicol^™ implant group were able to void urine within 24 hours, and had insignificant residual bladder volumes. The prevalence of postoperative symptomatic voiding dysfunction was 3.4% after TVT and 1.4% after Pelvicol^™ implant. Nine percent of the TVT group developed de novo urge incontinence and 6% of the Pelvicol^™ implant group had de novo urge incontinence 6 months after the procedure. Postoperative evaluation was done at the outpatient department, and a postal questionnaire was also completed to determine subjective continence status. The patient-determined cure rate was 85% in the TVT group and 89% in the Pelvicol^™ implant group. The Pelvicol^™ implant sling had a comparable patient- determined success rate with TVT and should be considered in the surgical treatment of women with genuine stress incontinence. Received: 15 January 2002 / Accepted: 1 July 2002     

Sequential assessment of urodynamic findings before and after tension-free vaginal tape (TVT) operation for female genuine stress incontinence

OBJECTIVES: To sequentially compare the urodynamic findings in patients with genuine stress incontinence (GSI) before and after tension-free vaginal tape (TVT) operation. PATIENTS AND METHODS: Between January 2001 and January 2002, 24 consecutive patients with GSI who completed multi-channel urodynamic study and 20-minute pad test before operation and at 3, 6, and 12 months after operation were enrolled. The sequential urodynamic findings of each case were compared and analyzed. RESULTS: The mean age of the 24 patients was 60.6+/-10.7 years with the parity of 3.5+/-1.4. No statistical differences in voiding and storage functions before and after TVT operation were noted. In contrast, significant changes of stress urethral pressure profile (sUPP) including maximal urethral pressure, maximal urethral closure pressure, functional urethral length, urethral closure area and continence area were observed at 6 and 12 months postoperatively ( p<0.03 ). The median pad weight test decreased from 72g (range 10-220) to 0g 3 months after operation and remained unchanged at 6 and 12 months postoperatively. CONCLUSIONS: This prospective study demonstrates that TVT operation, if done properly, does not significantly impair voiding and storage functions. The significantly increased sUPP parameters may contribute, at least in part, to the high cure rate of TVT operation.     

Tension-Free Vaginal Tape (TVT) in Stress Incontinent Women with Intrinsic Sphincter Deficiency (ISD) - A Long-Term Follow-up

In a prospective long-term study 49 women with stress incontinence and ISD (intrinsic sphincter deficiency) were followed for a mean of 4 years (range 3-5) after TVT operation. Preoperatively all patients underwent urodynamic investigations, quality of life evaluation, a 24-hour pad test and a gynecologic examination to properly verify the incontinence symptoms. The same protocol was used for postoperative evaluation. The mean age of the women was 66 years (- 11) and mean parity 2 (range 0-4). A standard TVT operation was performed under local anesthesia. At the postoperative evaluations 36 patients (74%) were completely cured of their incontinence problems. In addition, 6 women (12%) were significantly improved. In 7 patients (14%) no improvement was found. The majority of these not cured patients were >70 years of age and had urethral resting pressure of <10 cmH₂O. Few intra- and postoperative complications occurred. It is concluded that TVT can be used for surgical treatment of patients with ISD and stress incontinence. However, older patients (>70 years) with a very low resting urethral pressure and an immobile urethra seem to constitute a risk group where TVT surgery is less successful.     

Treatment for unsuccessful tension-free vaginal tape operation by shortening pre-implanted tape

PURPOSE: We studied the efficacy of shortening the pre-implanted suburethral tape in patients with recurrent urodynamic stress incontinence after a TVT operation. MATERIALS AND METHODS: A total of 14 women, including 6 with ISD, were treated for recurrent urodynamic stress incontinence after the initial TVT operation by performing the shortening procedure under local anesthesia. Urodynamics, a 1-hour pad test, introital ultrasonography of the urethra and a cotton swab test were done before the procedure and 1 year postoperatively. RESULTS: All 14 patients completed the shortening procedure. Mean patient age was 47.2 years (range 43 to 66). Mean time between initial TVT and the shortening procedure was 4 months (range 3 to 14). Ten patients (71.4%) were objectively cured and treatment failed in 4 (2 with ISD and 2 with a fixed urethra). Mean operative time was 17 minutes (range 10 to 25). No intraoperative surgical complications were observed. The 1-hour pad test showed a decrease from a median of 9.0 gm to 1.0. Median postoperative hospital stay was 1 day (range 1 to 4). Spontaneous voiding with adequate post-void residual urine was noted in all patients before discharge home. CONCLUSIONS: Shortening a pre-implanted TVT tape for the treatment of recurrent urodynamic stress incontinence is a safe, effective and minimally invasive option requiring only a short hospital stay. However, ISD and an immobile urethra seem to be risk factors for failure. Long-term followup is needed to determine if this surgery achieves long-lasting results.     

Assessment of TVT efficacy in the management of patients with genuine stress incontinence with the use of epidural vs intravenous anesthesia

Our aim was to validate the use of intravenous anesthesia as an alternative to epidural anesthesia for the placement of tension-free vaginal tape (TVT) in patients with urodynamic stress incontinence. Eighty-six patients participated in this prospective study. Forty-five patients were operated with intravenous anesthesia and 41 patients with epidural anesthesia. All patients had a full history taken and a complete gynecological examination performed at initial visit. Preoperative and postoperative urodynamic investigations included filling and voiding cystometry, urethral profilometry, uroflow, and cough stress test. Genuine stress incontinence diagnosis was based on the findings of urodynamic investigations. Patients with prolapse more than first degree or detrusor instability were excluded from the study. The objective success rate for patients operated with intravenous anesthesia was 86.6%, whereas for patients operated with epidural anesthesia was 88% at 12 months of follow-up. We had no cases of postoperative bleeding or hematoma development. Postoperative urinary tract infection developed in three cases (3 of 74). Application of TVT procedure with intravenous anesthesia provides comparable results with the use of epidural anesthesia and could be a very good alternative.     

Burch colposuspension and tension-free vaginal tape in the management of stress urinary incontinence in women

OBJECTIVE: Objective of the study was to compare the efficacy and the complications of tension-free vaginal tape (TVT) and Burch colposuspension in the treatment of female genuine stress incontinence (GSI). METHODS: In this controlled, prospective, randomized study, participated 35 patients who underwent Burch colposuspension and 36 patients that underwent TVT procedure. Patients with prolapse more than first degree, previous surgical treatment of stress urinary incontinence (SUI) and detrusor instability were excluded from the study. RESULTS: The operative time for TVT was significantly shorter compared to BC. The severity and duration of postoperative pain for TVT was significantly less compared to BC. The necessary time for return to normal activity was 10 days for TVT and 21 days for BC. The cure rate after 24 months of follow-up was as follows: TVT: 84% and BC: 86%, while the improvement was 7% for TVT and 6% for BC. CONCLUSIONS: TVT and Burch colposuspension are equally effective in the management of female GSI at two years follow-up. TVT procedure requires much less operative time, has much shorter hospitalization time, with significantly less postoperative pain and faster return to normal daily activities than Burch colposuspension.     

Eleven years prospective follow-up of the tension-free vaginal tape procedure for treatment of stress urinary incontinence

The aim of this study was to evaluate the long-term effectiveness and safety of the tension-free vaginal tape (TVT) procedure. In a Nordic three-center prospective observational cohort study, 90 women with primary stress incontinence had a TVT operation performed in local anesthesia. Assessment included a 24-h pad test, a stress test, physical examination, and a visual analog scale for assessing the degree of bother. Patient's global impression of cure was obtained, and condition specific quality of life questionnaires were used. Seventy-seven percent of the initial cohort of 90 women and 89% of those alive and capable of cooperating were assessed 11.5 years after the TVT operation. Ninety percent of the women had both a negative stress test and a negative pad test being objectively cured. Subjective cure by patients global impression was found in 77%, 20% being improved and only 3% regarded the operation as a failure. No late-onset adverse effects of the operation were found, and no case of tape erosion was seen. The TVT procedure is safe and effective for more than 10 years.     

Sexual function after using tension-free vaginal tape for the surgical treatment of genuine stress incontinence

OBJECTIVE: To determine whether the use of the tension-free vaginal polypropylene tape (TVT) procedure for the treatment of genuine stress incontinence (GSI) affects sexual activity. PATIENTS AND METHODS: Sixty-seven women treated by insertion of a TVT between September 1998 and March 2001 for GSI were sent questionnaires 6-36 months after surgery to determine any urinary symptoms, sexual activity, patient satisfaction and the use of hormone-replacement therapy. RESULTS: The questionnaire was returned by 57 patients (87%); 43 (76%) reported being sexually active and 14 (25%) were not. Of the former, 31 (72%) reported no change in sexual function after surgery and only two reported an improvement; six (14%) reported that sexual function was worse and four did not reply to the questions. The patients reporting that sexual function was worse cited loss of libido as the main reason. No patients complained of dyspareunia. CONCLUSIONS: There was no significant change in sexual function or activity after the TVT procedure and patients can thus be reassured that this operation will not affect their sex life.     

Autologous fascial sling vs polypropylene tape at short-term followup: a prospective randomized study

PURPOSE: The incidence of urinary incontinence in women of childbearing age is about 30%. Around half have stress incontinence. Many treatment modalities have been elucidated to treat stress incontinence, and among the most popular are rectus fascia sling and tension-free vaginal tape (TVT). The introduction of TVT to the urological armamentarium put a multiplicity of synthetic materials into use in the correction of stress urinary incontinence. A comparison of the impact of these 2 commonly used techniques is needed. MATERIALS AND METHODS: A total of 53 female patients older than 21 years (mean age 45.09) were randomized, using closed envelopes, to undergo TVT or rectus fascia sling. Randomization was performed after patients received spinal anesthesia. One surgeon performed the 2 types of treatment. Associated grade 2 cystocele was simultaneously corrected. Patients with bladder or urethral pathology, as well as those with cystocele greater than grade 2, were excluded from analysis. RESULTS: All 53 patients completed 6 months of followup and all had stress urinary incontinence. There were 15 patients who underwent sling surgery and 17 who underwent TVT who had concomitant grade 1 or 2 cystocele. No statistically significant difference was found between the 2 groups at baseline. Cure was accomplished in 23 of 25 (92%) with sling and in 26 of 28 (92.9%) with TVT at first followup visit (1 week). There were 7 patients who needed at least 1 extra week of catheterization in the sling group and 3 in the TVT group. No significant difference was detected in terms of post-void residual urine, symptom score, and filling and voiding parameters. At 6 months 1 patient had de novo detrusor overactivity and 7 had wound pain. Compared to those with TVT, 2 cases of sling were considered treatment failures, none had de novo overactivity and 2 had wound pain. None of the patients had symptoms suggestive of urethral erosion. CONCLUSIONS: Rectus fascia sling and TVT seem to be equally effective regarding primary outcome measure (ie cure of stress incontinence). Symptom score related to incontinence surgery as well as simultaneous correction of cystocele are comparable in the 2 groups. Fascial sling is a longer treatment process yet it is more economical. Longer followup is vital before rigorous conclusions can be drawn.     

Randomized comparison of the suprapubic arc sling procedure vs tension-free vaginal taping for stress incontinent women

The purpose of this study was to compare the surgical outcome and attendant complications of the suprapubic arc (SPARC) sling and tension-free vaginal tape (TVT) procedures. Sixty-two women with genuine stress incontinence (GSI) alone or combined with pelvic prolapse less than International Continence Society (ICS) stage II were randomly allocated to either SPARC or TVT groups. A routine suprapubic ultrasonography was performed for all patients 1 day after the anti-incontinence operation. A comparison of the peri- and postoperative results comprising surgical outcomes and complications revealed no significant differences between the two groups. Although the difference in the rates of bladder injury was not statistically significant (SPARC 12.9 vs TVT 0.0%, p = 0.112), it was clinically significant. Routine suprapubic ultrasonography revealed eight subjects had retropubic hematomas greater than 5 cm. The cure rate for SPARC was not significantly different from TVT (80.7 vs 87.1%, p = 0.706). We concluded that the SPARC sling and TVT procedures proved to be equally effective. Subsequent suprapubic ultrasonography, in particular for the symptomatic patients, was found to be of clinical merit.     

An Assessment of the Early Surgical Outcome and Urodynamic Effects of the Tension-free Vaginal Tape (TVT)

Fifty-two women underwent a tension-free vaginal tape (TVT) procedure for genuine stress incontinence (GSI). Preoperative assessment included a detailed medical history, pelvic examination, a 1-hour pad test with a comfortably full bladder, and urinary culture. Thirteen of the 52 women were excluded for various reasons. Both before and 12–24 months postoperatively all patients had a full urodynamic investigation using microtip transducer catheters. The study subjects were instructed to maintain a 1-week baseline urinary diary 1 week before the operation, and postoperative urodynamic assessment as well. The period of follow-up ranged from 12 to 24 months (median 19 months). Another 1-hour pad test with a comfortably full bladder and urinary culture were carried out thereafter. Comparisons of the 39 women pre- and postoperatively found a significantly improved 1-hour pad test (34.9 ± 34.7 vs 8.3 ± 24.0, P<0.001). Analyzing the urodynamic effects of surgery revealed no significant postoperative changes except for the maximal urethral closure pressure (MUCP) at rest. An objective assessment using a pad test revealed the success rate (cure plus improved) to be 90% (35/39) and the failure rate 10% (4/39). TVT can thus be considered a safe and effective procedure for GSI in women. Moreover, the urodynamic effects of surgery were not found to be critical to success.     

Tension-Free Vaginal Tape (TVT) in Women with Recurrent Stress Urinary Incontinence - A Long-term Follow up

In a prospective long-term follow-up study we evaluated the results of TVT surgery in 34 women with recurrent stress urinary incontinence in whom previous traditional surgical procedures had failed. The women were followed for a mean of 4 years (range 3-5) after TVT surgery. The mean age was 58.9 - 10 years and the mean parity 2 (0-4). Pre- and postoperative evaluation was performed according to a protocol which included gynecologic examination, urodynamic investigations, quality of life evaluation and 24-hour pad test. According to the protocol 28 patients (82%) were cured, 3 (9%) were significantly improved, and the operation failed in 3 cases (9%). There were no significant intra- or postoperative complications. All patients were operated on under local anesthesia with a short hospitalization and had no long-term postoperative voiding problems.     

Tension free vaginal tape: is the intra-operative cough test necessary?

The tension-free vaginal tape (TVT) procedure is recognised as an effective treatment for genuine stress incontinence. It was first described using local anaesthesia, with an intra-operative cough test helping to correctly position the tape. Many patients prefer general anaesthesia and often, patients with genuine stress incontinence do not leak when supine. This aim of this study was to compare the outcome in TVTs performed under general anaesthesia with those performed under spinal anaesthesia. Retrospective analysis of 105 patients, all of whom had urodynamically proven genuine stress incontinence and underwent TVT procedure, was performed: 52 under spinal anaesthesia and 53 under general anaesthesia. The primary and secondary outcome measures were the success or failure of the procedure and the complication rate, respectively. There was no significant difference in outcome or complication rate between the two groups. The type of anaesthetic used does not influence the outcome and we question the necessity of an intra-operative cough test. Editorial Comment: Many surgeons in the USA perform the tension-free vaginal tape (TVT) either alone or with other pelvic reconstructive procedures under general anesthesia. The cough stress test as originally recommended under regional or local anesthesia is performed with the patient in the recumbent position, theoretically lessening its validity and reliability at predicting success. This small retrospective study demonstrates equal efficacy in short-term follow-up when TVT sling tensioning is performed by surgeon judgment as with other pubovaginal slings, or by using the cough stress test when feasible under spinal anesthesia. It is hoped that future studies with larger number of patients and longer follow-up will confirm this.     

Tension-free vaginal tape sling for recurrent stress incontinence after transobturator tape sling failure

The transobturator tape (TOT) sling is a new minimally invasive technique to treat stress urinary incontinence (SUI). Short-term follow-up studies show high success rates; however, as with any surgical treatment of SUI, failures are known to occur. The treatment of recurrent or persistent stress urinary incontinence after a TOT sling is therefore a new dilemma as well. In this paper, we describe the successful use of a retropubic tension-free vaginal tape (TVT) sling in five patients after failed TOT sling. We present case series of five patients who had TOT slings placed for stress incontinence that failed and subsequently had TVT slings placed for persistent SUI. The TVT slings were placed under local/regional anesthesia without removal of the TOT sling. Retrospective chart review of office and hospital charts was completed, and both objective and subjective data were collected. Five patients had TVT slings placed 6–30 weeks after early failure of TOT slings that were placed for stress urinary incontinence. Postoperatively, all patients with urodynamic testing showed evidence of intrinsic sphincter deficiency; however, all maintained urethral mobility of 30°. All five patients had successful treatment of their incontinence with the retropubic tension-free sling procedure with a mean follow-up of 17 months. Recurrent or persistent stress urinary incontinence after TOT sling may be treated with TVT sling without removal of the TOT sling. Further studies with larger numbers and longer-term follow-up is warranted.     

Quality of life after tension-free vaginal tape surgery for female stress incontinence

OBJECTIVE: To undertake a long-term follow-up evaluation of the quality of life (QOL) of women who had undergone a tension-free vaginal tape (TVT) procedure. MATERIAL AND METHODS: During the period 1995-2001, 970 women with urinary stress incontinence underwent TVT surgery at the Department of Obstetrics and Gynecology, Falun Hospital. A questionnaire was mailed on average 5.7 years after the TVT procedure. Two incontinence-specific QOL instruments--the Incontinence Impact Questionnaire-7 (IIQ-7) and the Urogenital Distress Inventory-6 (UDI-6)--were administered. An additional questionnaire included general questions and questions about chronic diseases that may be associated with urinary incontinence. RESULTS: The mean age at surgery was 58.7 years (range 29-89 years). Of 913 eligible women, 768 (78.9%) responded. Mean IIQ-7 and IDU-6 scores as estimated by the women improved dramatically at follow-up as compared to preoperative values: from 43.7 to 11.5 for the IIQ-7 and from 54.2 to 24.0 for the UDI-6 on a scale from 0 to 100 (p = 0.0001 for both). There were few differences in mean QOL scores even 8 years after TVT surgery, compared to those determined a shorter time after the operation. Women with diabetes, chronic constipation, chronic bronchitis and preoperative recurrent urinary infections had a relative improvement in QOL of the same magnitude as that of the remaining study population. Advanced age was negatively associated with an improvement in QOL scores. CONCLUSIONS: Improvements in measures of QOL after TVT surgery are dramatic and persist for years. Women with concomitant diseases that may be associated with urinary incontinence can be assured that there is a good chance of success with TVT surgery.     

One-year follow-up of tension-free vaginal tape (TVT) and trans-obturator suburethral tape from inside to outside (TVT-O) for surgical treatment of female stress urinary incontinence: a prospective randomised trial

OBJECTIVES: To compare tension-free vaginal tape (TVT) and trans-obturator suburethral tape from inside to outside (TVT-O) for surgical treatment of stress urinary incontinence (SUI) for complications (primary end point) and success rate (secondary end point). METHODS: Seventy-two consecutive patients, with a mean age of 53.2 yr (range: 38-69 yr) and affected by SUI, were included in this randomised controlled trial. After preoperative assessment, patients were randomly allocated to the TVT or TVT-O procedure. Operative time, perioperative complications, and hospital stay were prospectively recorded. Cure of SUI was defined as no leakage of urine during the stress test at urodynamic testing at the 12-mo evaluation. The Wilcoxon signed rank sum test, Mann-Whitney U test, McNemar test, and Fisher exact test were used to verify statistical significance, set at p<0.05. RESULTS: All patients were evaluable at the 12-mo follow-up. The characteristics of patients were well balanced between groups after randomisation. The mean operative time was significantly shorter in the TVT-O group. Perioperative complications were significantly more common after the retropubic approach (5% and 27% in TVT-O and TVT groups, respectively, p<0.04). The groups did not differ significantly in intraoperative blood loss, hospital stays, and time to return to normal activities. Sixty-five patients (90%) were successfully treated for SUI 12 mo after the operation (89% and 91% for TVT-O and TVT groups, respectively). CONCLUSIONS: Both techniques appear to be equally effective in the surgical treatment of SUI. However, TVT-O had a shorter operative time and lower overall perioperative complication rate.     

Concomitant vaginal surgery did not affect outcome of the tension-free vaginal tape operation during a prospective 3-year followup study

PURPOSE: We compare outcomes when vaginal surgery and a tension-free vaginal tape (TVT) operation were done concomitantly and when only a TVT operation was done in patients with stress or mixed urinary incontinence. MATERIALS AND METHODS: Outcomes in 75 consecutive patients who underwent a TVT operation concomitantly with vaginal surgery (group 1) were compared with outcomes in 75 who underwent only a TVT operation (group 2) between August 1998 and June 2000. Group 2 patients were matched for age and incontinence type with group 1 patients. All study subjects had a followup visit to the study hospital 2 months after the operation. Questionnaire based assessments were done 2 and 3 years after the operation. RESULTS: Ten group 1 (13%) and 6 group 2 (8%) patients had a lower urinary tract infection. Other infections occurred after operation in 10 group 1 (13%) and 1 group 2 (1.3%) patients. Four cases (5.3%) of intraoperative bladder perforation occurred in group 1. A total of 15 group 1 (20%) and 7 group 2 (9.3%) patients were treated for transient urinary retention. Two months after the operation 93% of group 1 and 97% of group 2 were free of stress urinary incontinence. The corresponding percents 2 years after operation were 88% and 93%, and at 3 years they were 87% and 92%, respectively. CONCLUSIONS: Complications and transient urinary retention occurred more often after TVT operations and concomitant vaginal surgery than after the TVT operation alone. There were no statistically significant differences in regard to the cure of stress urinary incontinence and incidence of urge symptoms during the 3-year followup.     

A multicenter study of tension-free vaginal tape (TVT) for surgical treatment of stress urinary incontinence

The aim of the study was to evaluate the safety and efficacy of TVT (tension-free vaginal tape) for the surgical treatment of stress urinary incontinence. The design was a prospective open multicenter study including six centers, each operating an approximately 20 patients. In total 131 patients suffering from genuine stress incontinence were included. They were followed for at least 1 year using a specific protocol for objective and subjective evaluation of the outcome. All patients underwent the operation under local anesthesia. Mean operation time was 28 minutes (range 19–41 minutes); 119 (91%) of the patients were cured according to the protocol and another 9 (7%) were significantly improved. There were 3 (2%) failures. The majority of the patients (about 90%) were operated upon on a day-care basis, which implied that they were released from the hospital within 24 hours, with no postoperative catheterization. No defect healing and no tape rejection occurred. Three patients needed an indwelling catheter for 3 days. In 1 patient catheterization was necessary for more than 10 days. Two uncomplicated hematomas and one uncomplicated bladder perforation occurred. Based on the results, we conclude that TVT is a safe and effective ambulatory procedure for surgical treatment of genuine stress urinary incontinence.Editorial Comment: This is the first prospective study of a relatively new and minimally invasive surgical procedure for stress urinary incontinence. The authors are to be complimented on the fact that they went out into the community hospitals in their area to see if their results could be reproduced by the average practicing gynecologist. Also, it is good to see that the investigators used a validated quality of life assessment to provide very important follow-up information on the improvement in the patient's quality of life, as this should be the basic tenet of all therapies for urinary incontinence. However, many questions remain regarding the diagnostic criteria they used in selecting their patients, as well as the degree of testing performed postoperatively. Further study is needed to confirm the results found here with a very new and interesting technique in the surgical treatment of stress incontinence.