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Weighted Vaginal Cones Versus Biofeedback in the Treatment of Urodynamic Stress Incontinence: a Randomized Trial.

NCT00247286 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2016-01-27

No results posted yet for this study

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 genuine stress urinary incontinence in females: weighted vaginal cones and formal supervised pelvic floor physiotherapy with biofeedback.

Hypothesis: Assuming a minimum of six months of treatment, weighted vaginal cones are as effective as a formal supervised program of pelvic floor physiotherapy with biofeedback for the treatment of uncomplicated genuine stress urinary incontinence in females.

Conditions

  • Urinary Incontinence, Stress

Interventions

BEHAVIORAL

weighted vaginal cones

BEHAVIORAL

Biofeedback

Pelvic floor muscles exercises performed with a biofeedback machine

Sponsors & Collaborators

  • Queen's University

    lead OTHER

Principal Investigators

  • Marie-Andree Harvey, MD MSc · Queen's University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2001-09-30
Primary Completion
2007-01-31
Completion
2007-10-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00247286 on ClinicalTrials.gov