Weighted Vaginal Cones Versus Biofeedback in the Treatment of Urodynamic Stress Incontinence: a Randomized Trial.
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|ClinicalTrials.gov Identifier: NCT00247286|
Recruitment Status : Terminated (slow recruitment)
First Posted : November 1, 2005
Last Update Posted : January 27, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Urinary Incontinence, Stress||Behavioral: weighted vaginal cones Behavioral: Biofeedback||Phase 4|
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 common form of urinary incontinence in women, with objective diagnosis made via urodynamics. Urinary continence is maintained when the urethral resistance (pressure) is greater than the intravesical pressure. Genuine stress incontinence occurs when pressure transmission to the urethra is compromised by poor anatomic support of the proximal urethra resulting from weakened pelvic floor musculature and/or defective endopelvic fascia. While the gold standard for treatment of genuine stress incontinence is still considered to be surgical, there is renewed interest among both patients and surgeons for nonsurgical (conservative) management. The goal of conservative therapy is to restrengthen and retrain the pelvic floor muscles to improve urethral pressure transmission and thus improve the continence mechanism.
Nonsurgical therapies include PFME with or without biofeedback, and weighted vaginal cones. PFME with biofeedback are widely accepted as an effective conservative treatment for genuine stress incontinence, with subjective cure rates estimated to be as high as 70 percent. However, to date, objective cure rates as defined by urodynamics have not been well documented. Similarly, while limited studies suggest that vaginal cone therapy results in a subjective cure rate of 60%, objective cure rates still have not been determined. With growing clinic and surgical waiting lists and rising hospital costs, weighted vaginal cones, if objectively proven to be a comparably effective alternative to physiotherapy, will offer an effective management option for stress incontinence, thus, perhaps avoiding referral to a tertiary hospital for physiotherapy, and surgery.
We hypothesize that following a minimum of six months of treatment, weighted vaginal cones would be as effective as a formal supervised program of pelvic floor physiotherapy with biofeedback for the treatment of uncomplicated genuine stress urinary incontinence in females. We are thus seeking to evaluate the feasibility of a randomized clinical trial.
An estimated 60 women identified from ambulatory clinics with multichannel urodynamics documenting genuine stress urinary incontinence will be needed to participate in this single-blind, randomized pilot study. Once entered, patients will be randomized to receive one of two different nonsurgical treatments: PFME with biofeedback or weighted vaginal cones. The patients will chart compliance to treatment for the duration of the study. A quality of life questionnaire will be completed at the beginning and end of the trial, along with a subjective assessment of incontinence severity via a standardized questionnaire. The study period will be six months. Upon completion of the study, patients will undergo repeat multichannel urodynamics and perineal pad testing to determine if genuine stress incontinence is present or absent and thus whether objective cure has been achieved. Results will be analyzed and compared statistically.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||A Randomised, Single-Blind Comparison of Pelvic Floor Muscle Exercises With Biofeedback Versus Weighted Vaginal Cones in the Management of Genuine Stress Incontinence : A Pilot Study|
|Study Start Date :||September 2001|
|Actual Primary Completion Date :||January 2007|
|Actual Study Completion Date :||October 2007|
Weighted vaginal cones used to perform pelvic floor exercises
|Behavioral: weighted vaginal cones|
Active Comparator: b
Pelvic floor muscles exercises performed with a biofeedback machine
- Urodynamic studies [ Time Frame: 6 months ]
- Cough stress test [ Time Frame: 6 months ]
- Standardized fixed bladder volume pad test [ Time Frame: 6 months ]
- I-QOL questionnaire [ Time Frame: 6 months ]
- Urogenital Distress Inventory [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00247286
|Kingston General Hospital, Queen's University|
|Kingston, Ontario, Canada, K7L 4P8|
|Principal Investigator:||Marie-Andree Harvey, MD MSc||Queen's University|