Feasibility of Comparing Two Surgical Treatment of Female Urodynamic Stress — SITOT  

Female Stress Incontinence Clinical Trial

Official title: Feasibility of Comparing Two Surgical Treatment of Female Urodynamic Stress Incontinence (SITOT)

Status Completed

Clinical Trial Summary

Aim: The study aim to assess the feasibly a large prospective multi-centre randomised study for comparing the relatively new "Single incision sub-urethral tapes" with the standard surgical treatment of female urodynamic stress incontinence (USI).

Clinical Trial Description

Single incision tension-free sub-urethral vaginal tapes procedures8 have been recently described in an attempt to avoid the blind passage of the trochars through the groin & the adductor muscles and consequently reducing the incidence & severity of postoperative leg pain. The obvious advantages would be shorter hospital stay, early recovery, early resumption of day to day activities & earlier return to work. A number of small prospective audits and case-series have been presented in international conferences reporting on the safety & outcomes for these procedures. However all these studies were for preliminary reports for proof of concept and therefore the studies populations were 15-70 women with short term follow-up of 2-3 month9-11.These studies have shown low perioperative complication rates: bladder injury 0-1%, vaginal erosion 1-3% & one study showing 1.3% pain at 6 weeks follow-up. The patient reported success rates were 77-93% at 2-3 month follow-up9-12.

Objectives:

1. Establish the feasibility of the "Single incision sub-urethral tapes" to be done under local anaesthesia.

2. The feasibility of randomisation to the standard surgical treatment TVT-O / TVT.

3. To compare the surgical approach in this relatively new procedure against the standard procedures as regard: Peri-operative complication rates, Postoperative pain, Time to discharge from the hospital,

4. To compare the outcomes as regard: Patient-reported cure rates, Patient satisfaction, Impact on Quality of life (QoL) and sexual function at 3 month & 1 -year follow-up. The objective cure rates will be assessed at 3 month follow-up.

Design:

A pilot prospective randomised study within participating urogynaecology units of the "Scottish Pelvic Floor Network". ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Female Stress Incontinence
• Urinary Incontinence, Stress

• NCT number: NCT01230450
• Study type: Interventional
• Source: University of Aberdeen
• Status: Completed
• Phase: Phase 1
• Start date: November 2009
• Completion date: October 2011