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

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

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).

Study Overview

• Status: Completed
• Conditions: Female Stress Incontinence
• Intervention / Treatment: Procedure: sub-urethral tape (TVT-O); Other: stand standard mid-urethral sling (TVT-O)

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".

• Study Type: Interventional
• Enrollment (Actual): 137
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Aberdeenshire
    • Aberdeen, Aberdeenshire, United Kingdom, AB25 2ZD
      • (Grampian) Aberdeen Royal Infermary

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single-incision Mini-slings (SIMS- Ajust); AjustTM has polypropylene fixing anchors (one is fixed and the other adjustable) which are anchored onto the obturator membrane. The pulley like system enables adjustment of the tension once the arms have been anchored. Once in place, the anchors rest at right angles to insertion which is claimed to reduce the chances of anchor dislodgment	Procedure: sub-urethral tape (TVT-O); Tension free vaginal tape vs. single incision sub-urethral tension free vaginal tape
Other: standared med urethral sling (SMUS); standard med urethral sling (SMUS)TVT-O, was done as originally described by Deleval et al.	Other: stand standard mid-urethral sling (TVT-O)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
• 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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
• Patient-reported Success rates	Patient-reported Success rates o Assessed by PGI-I "Very Much Improved/ Much Improved."	1 year

Collaborators and Investigators

• Sponsor: University of Aberdeen
• Collaborators: Aberdeen Royal Infirmary
• Investigators: Principal Investigator: Mohamed Abdel-Fattah, MRCOG, University of Aberdeen

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Actual): October 1, 2010
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: October 27, 2010
• First Submitted That Met QC Criteria: October 27, 2010
• First Posted (Estimate): October 29, 2010

Study Record Updates

• Last Update Posted (Estimate): January 24, 2013
• Last Update Submitted That Met QC Criteria: January 23, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: urodynamic urinary incontinence, sub-urethral tape
• Additional Relevant MeSH Terms: Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Urinary Incontinence; Urinary Incontinence, Stress
• Other Study ID Numbers: SI-TOT