Status:
TERMINATED
Weighted Vaginal Cones Versus Biofeedback in the Treatment of Urodynamic Stress Incontinence: a Randomized Trial.
Lead Sponsor:
Queen's University
Conditions:
Urinary Incontinence, Stress
Eligibility:
FEMALE
18-65 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine the objective (urodynamic) cure rates and effect on patient quality of life after six months of treatment for two different nonsurgical management options for...
Detailed Description
Background and Rationale Urinary incontinence is a widespread and debilitating medical problem, with an estimated prevalence of between 17-45% in adult women. Genuine stress incontinence is the most c...
Eligibility Criteria
Inclusion
- Females, between the ages of 18-65 years, will be entered into this study. Additional inclusion criteria are a history of urinary stress incontinence and multichannel cystometry confirming the presence of genuine stress incontinence (GSI).
Exclusion
- urodynamic identification detrusor instability
- active (untreated or resistant) urinary tract infection
- any other disease that is felt by the investigators to potentially interfere with participation (e.g. arthritis limiting dexterity and thus interfering with the insertion and removal of vaginal cones)
- previous treatment with pelvic floor physiotherapy with biofeedback or functional electric stimulation for urinary incontinence
- previous use of weighted vaginal cones
- previous anti-incontinence surgery
- significant pelvic organ prolapse or those with abnormal vaginal anatomy (the Pelvic Organ Prolapse Quantification (POP-Q) system of scoring for prolapse will be used, Grade \> III)
- use of concomitant treatments during the trial or the start of new medications that may alter continence mechanism
- inability to understand instructions in French or English or provide informed consent (e.g., psychiatric disease).
- pregnancy (which may alter pelvic anatomy may over the course of the study and thus make evaluation of treatment methods impossible)
Key Trial Info
Start Date :
September 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00247286
Start Date
September 1 2001
End Date
October 1 2007
Last Update
January 27 2016
Active Locations (1)
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1
Kingston General Hospital, Queen's University
Kingston, Ontario, Canada, K7L 4P8