Female Stress Incontinence
Conditions
Keywords
urodynamic urinary incontinence, sub-urethral tape
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.
Interventions
PROCEDUREsub-urethral tape (TVT-O)
Tension free vaginal tape vs. single incision sub-urethral tension free vaginal tape
OTHERstand standard mid-urethral sling (TVT-O)
Sponsors
Aberdeen Royal Infirmary
University of Aberdeen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| • Feasibility of the single incision sub-urethral tape to be done under local anaesthesia | 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
| Measure | Time frame | Description |
|---|---|---|
| • Patient-reported Success rates | 1 year | Patient-reported Success rates o Assessed by PGI-I Very Much Improved/ Much Improved. |
Countries
United Kingdom
Outcome results
None listed