Status:
COMPLETED
Feasibility of Comparing Two Surgical Treatment of Female Urodynamic Stress
Lead Sponsor:
University of Aberdeen
Collaborating Sponsors:
Aberdeen Royal Infirmary
Conditions:
Female Stress Incontinence
Eligibility:
FEMALE
20+ years
Phase:
PHASE1
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 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
137 Patients enrolled
Trial Details
Trial ID
NCT01230450
Start Date
November 1 2009
End Date
October 1 2011
Last Update
January 24 2013
Active Locations (1)
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1
(Grampian) Aberdeen Royal Infermary
Aberdeen, Aberdeenshire, United Kingdom, AB25 2ZD