Outcomes after anterior vaginal wall repair with mesh: a randomized, controlled trial with a 3 year follow-up.

OBJECTIVE: The objective of the study was to compare anterior colporrhaphy with and without a mesh. STUDY DESIGN: Two hundred two women with anterior prolapse were assigned to undergo colporrhaphy alone or reinforced with a tailored polypropylene mesh. Before and 2, 12, 24, and 36 months after surgery, the outcome was assessed by examination and standard questions. The primary endpoint was anatomic recurrence of anterior vaginal prolapse. Secondary outcomes were symptom resolution, reoperation, and mesh exposure. RESULTS: Recurrences of anterior vaginal prolapse were noted in 40 of the 97 (41%) in the colporrhaphy group and 14 of 105 (13%) in the mesh group (P < .0001). The number needed to treat was thus 4. The proportion of symptomatic patients, including those with dyspareunia, did not differ between the groups. The mesh erosion rate was 19%. CONCLUSION: At 3 year follow-up, anterior colporrhaphy with mesh reinforcement significantly reduced anatomic recurrences of anterior vaginal prolapse, but no difference in symptomatic recurrence were noted and the mesh erosion rate was high. The use of mesh was not associated with an increase in dyspareunia.

A randomized trial comparing tension-free vaginal tape with tension-free vaginal tape-obturator: 36-month results.

INTRODUCTION AND HYPOTHESIS: This is a randomized multicenter study comparing two mid-urethra tape procedures, the tension-free vaginal tape (TVT) with the tension-free vaginal tape-obturator (TVT-O) in terms of cure rate and complication rate. METHODS: Seven Finnish hospitals participated. Power calculations required 130 women in each group to detect a 10% difference in cure rate. A total of 267 underwent the allocated operation. Follow-up was scheduled at 2, 12, 36 and 60 months. A cough stress test was used as an objective outcome measure. Subjective outcome was assessed by five different condition-specific quality of life questionnaires. RESULTS: At 36 months of follow-up, 96% of the patients were evaluated. Objective cure rate was 94.6% in the TVT group and 89.5% in the TVT-O group (p = 0.131). Subjective cure rates were significant with no difference between the groups. CONCLUSION: The TVT and the TVT-O are equally effective in the treatment of stress urinary incontinence after 36-month follow-up with no difference in complication rates.

Retropubic compared with transobturator tape placement in treatment of urinary incontinence: a randomized controlled trial.

OBJECTIVE: To compare the intraoperative and immediate postoperative performance of the retropubic tension-free vaginal tape (TVT) procedure with that of the transobturator tension-free vaginal tape (TVT-O) procedure as primary treatment for female urinary stress incontinence. METHODS: Randomized multicenter comparative trial including four university hospitals and three central hospitals in Finland. Assessment preoperatively and 2 months postoperatively included a cough stress test and the following condition-specific quality of life questionnaires: the Urinary Incontinence Severity Score (UISS), the Detrusor Instability Score, the Incontinence Impact Questionnaire-Short Form, the Urogenital Distress Inventory-Short Form, and a visual analog scale (VAS). Operation time, theater time, hospital stay, intraoperative and immediate postoperative complications were recorded. RESULTS: Of the 273 originally randomized patients, 267 underwent the allocated operation, 136 in the TVT group and 131 in the TVT-O group. No significant differences in objective or subjective cure rates were detected. Patients in the TVT-O group had a significantly longer hospital stay, needed significantly more postoperative opiate analgesia and had significantly more complications than the patients in the TVT group. Patients in both groups had a significant postoperative improvement in quality of life, as indicated by the results of all the questionnaires used, with no difference between the groups. CONCLUSION: The TVT and the TVT-O procedures perform equally in terms of objective and subjective cure. The statistically significant higher complication rate in the TVT-O group is not regarded as clinically significant. CLINICAL TRIAL REGISTRATION: (www.ClinicalTrials.gov), NCT00379314 LEVEL OF EVIDENCE: I.

Low-weight polypropylene mesh for anterior vaginal wall prolapse: a randomized controlled trial.

OBJECTIVE: To compare anterior colporrhaphy with and without a tailored mesh. METHODS: Postmenopausal women with anterior vaginal prolapse to the hymen or beyond were randomly assigned to undergo traditional anterior colporrhaphy alone or reinforced with mesh. The low-weight monofilament polypropylene mesh was self-tailored, having four arms and being placed over the plicated fascia. Before and 2 and 12 months after surgery, participants were evaluated by physical examination, postvoidal residual urine measurement and standard questions covering prolapse-related symptoms. The primary outcome was recurrence of anterior vaginal prolapse at 12 months. Secondary outcomes included operative complications, symptom resolution, and postvoidal urine residual volume. RESULTS: Of the 202 women randomly assigned, 201 were operated on (97 without, 104 with mesh). Thirty-seven women (38.5%) in the no-mesh and seven (6.7%) in the mesh group experienced a recurrence of anterior wall prolapse (P<.001) at 12 months; as a result, the number needed to treat for benefit was four. The mean (standard deviation) postvoidal residual urine volume was lower in patients with mesh than in those undergoing the traditional operation: 25 (26) mL and 41 (57) mL (P=.01). Twenty-three women (23%) with mesh and 9 (10%) with no mesh reported stress urinary incontinence (P=.02). In 18 (17.3%), exposure of the mesh was noted, mainly asymptomatic. CONCLUSION: Anterior colporrhaphy, reinforced with, tailored mesh significantly reduced the rate of recurrence of anterior vaginal wall prolapse compared with the traditional operation, but was associated more often with stress urinary incontinence.

Five-year results of a randomized trial comparing retropubic and transobturator midurethral slings for stress incontinence.

BACKGROUND: Midurethral slings have become the most preferred surgical treatment for female urinary incontinence. OBJECTIVE: To compare the efficacy and safety of two midurethral sling procedures with a different technique of sling insertion 5 yr after intervention. DESIGN, SETTING, AND PARTICIPANTS: Multicenter randomized clinical trial conducted in seven public hospitals in Finland including primary cases of stress urinary incontinence. INTERVENTION: Surgical treatment with the retropubic tension-free vaginal tape (TVT) procedure or the transobturator tension-free vaginal tape (TVT-O) procedure. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Objective treatment success criteria were a negative stress test, a negative 24-h pad test, and no retreatment for stress incontinence. Patient satisfaction was assessed by condition-specific quality-of-life questionnaires. RESULTS AND LIMITATIONS: A total of 95% of the included women could be assessed according to the protocol 5 yr after surgery. The objective cure rate was 84.7% in the TVT group and 86.2% in the TVT-O group, with no statistical difference between the groups. Subjective treatment satisfaction was 94.2% in the TVT group and 91.7% in the TVT-O group, with no difference between groups. Complication rates were low, with no difference between groups. CONCLUSIONS: Both objective and subjective cure rates were >80% in both groups even when women lost to follow-up were included as failures. The complication rates were low, with no difference between the groups. No late-onset adverse effects of the tape material were seen. PATIENT SUMMARY: Female urinary stress incontinence can be treated surgically with minimally invasive midurethral sling procedures. Two main approaches of sling placement have been developed: the retropubic and the transobturatory. We compared both approaches and followed the patients for 5 yr. We found no difference in cure rate between the procedures, and patient satisfaction was high. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT00379314.

A randomized trial comparing TVT with TVT-O: 12-month results.

The aim of this randomized clinical trial was to compare the cure rate and the rate of complications of the tension-free vaginal tape (TVT) with those of the tension free vaginal tape obturator (TVT-O) procedure after one year of follow-up. The study was powered to show a ten per cent difference in cure rate and/or rate of complications. Of the initially treated 267 women 134 in the TVT group and 131 in the TVT-O group were evaluated. A cough stress test and a 24 h pad test were used as objective outcome measures. Subjective outcome was assessed by different condition-specific quality of life questionnaires and general health by the EQ-5D questionnaire. Objective cure rate was 95.5% in the TVT patients and 93.1% in TVT-O patients. Subjective cure rates showed significant improvement at one the year follow up in both groups. No significant differences in cure rates between groups were seen. The complication rate was equal in both groups.

Symptom resolution and sexual function after anterior vaginal wall repair with or without polypropylene mesh.

To evaluate whether symptom resolution and sexual function is better after reinforcement with polypropylene mesh than with traditional anterior repair. Ninety-seven patients were randomized to anterior colporrhaphy and 105 to an operation with mesh. Participants were evaluated up to 24 months by physical examination, standard questions, and questionnaire. The overall symptom rate did not differ between the groups, but a sensation of vaginal bulge was reported less frequently in the mesh group, the figures being 17 versus 5 (p = 0.003). The recurrence rate for the no-mesh group was 41% and for the mesh group 11% (p < 0.001). The dyspareunia score was statistically significantly lower in the mesh group (p = 0.015). The mesh exposure rate was 8%. Sensation of vaginal bulge was relieved more efficiently by the mesh technique without causing dyspareunia.