Feasibility of Comparing Two Surgical Treatment of Female Urodynamic Stress Incontinence (SITOT)
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- University of Aberdeen
- Enrollment
- 137
- Locations
- 2
- Primary Endpoint
- • Feasibility of the single incision sub-urethral tape to be done under local anaesthesia
Study Overview
Brief 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:
- Establish the feasibility of the "Single incision sub-urethral tapes" to be done under local anaesthesia.
- The feasibility of randomisation to the standard surgical treatment TVT-O / TVT.
- 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,
- 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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Outcomes
Primary Outcomes
• Feasibility of the single incision sub-urethral tape to be done under local anaesthesia
Time Frame: 1 year
* 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
Secondary Outcomes
- • Patient-reported Success rates(1 year)