Feasibility of Comparing Two Surgical Treatment of Female Urodynamic Stress

Female Stress Incontinence Clinical Trial

— SITOT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01230450
• Other study ID #: SI-TOT
• Status: Completed
• Phase: Phase 1
• First received: October 27, 2010
• Last updated: January 23, 2013
• Start date: November 2009
• Est. completion date: October 2011

Study information

• Verified date: January 2013
• Source: University of Aberdeen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

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).

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".

Recruitment information / eligibility

• Status: Completed
• Enrollment: 137
• Est. completion date: October 2011
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• USI

• Mixed incontinence symptoms with predominantly bothering stress component (No DO on UDS).

• Primary Incontinence Surgery.

• BMI < 35

• Ability to understand the information leaflet and sign an informed consent form in English.

• All would have had failed or declined PFMT.

Exclusion Criteria:

• Mixed incontinence with pre-dominant OAB and/or Neurological conditions e.g. MS.

• Detrusor Overactivity on Urodynamics.

• Inability to understand English.

• Un-willing for randomisation.

• Concomitant surgery.

• Patient requiring postoperative hospital-stay for medical or social reasons

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

Intervention

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)

Locations

Country	Name	City	State
United Kingdom	(Grampian) Aberdeen Royal Infermary	Aberdeen	Aberdeenshire

Sponsors (2)

Lead Sponsor	Collaborator
University of Aberdeen	Aberdeen Royal Infirmary

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	• Feasibility of the single incision sub-urethral tape to be done under local anaesthesia	Feasibility of the single incision sub-urethral tape to be done under local anaesthesia?; Number of women approached and declining LA o Number of women in LA group converted to GA	1 year	Yes
Secondary	• Patient-reported Success rates	Patient-reported Success rates; o Assessed by PGI-I "Very Much Improved/ Much Improved."	1 year	Yes