NCT01230450

Feasibility of Comparing Two Surgical Treatment of Female Urodynamic Stress

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 137 (actual)
• Sponsor: University of Aberdeen · Academic / Other
• Sex: Female
• Age: 20 Years
• Healthy volunteers: Not accepted

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).

Detailed 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".

Conditions

• Female Stress Incontinence

Interventions

Type	Name	Description
PROCEDURE	sub-urethral tape (TVT-O)	Tension free vaginal tape vs. single incision sub-urethral tension free vaginal tape
OTHER	stand standard mid-urethral sling (TVT-O)

Timeline

• Start date: 2009-11-01
• Primary completion: 2010-10-01
• Completion: 2011-10-01
• First posted: 2010-10-29
• Last updated: 2013-01-24

Locations

1 site across 1 country: United Kingdom