Clinical trial NCT01230450: Feasibility of Comparing Two Surgical Treatment of Female Urodynamic Stress
Official title: Feasibility of Comparing Two Surgical Treatment of Female Urodynamic Stress Incontinence (SITOT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Female Stress Incontinence
Keywords: urodynamic urinary incontinence, sub-urethral tape
Lead sponsor: University of Aberdeen
Sponsor class: OTHER
Collaborators: name: Aberdeen Royal Infirmary
First posted: 2010-10-29
Enrollment: 137
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

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".

Eligibility criteria: 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

Primary outcomes:
measure: • Feasibility of the single incision sub-urethral tape to be done under local anaesthesia
timeFrame: 1 year
Secondary outcomes:
measure: • Patient-reported Success rates
timeFrame: 1 year
Other outcomes:
Locations:
city: Aberdeen
country: United Kingdom
facility: (Grampian) Aberdeen Royal Infermary
state: Aberdeenshire
Study officials:
affiliation: University of Aberdeen
name: Mohamed Abdel-Fattah, MRCOG
role: PRINCIPAL_INVESTIGATOR
References: