Clinical trial NCT00247286: Weighted Vaginal Cones Versus Biofeedback in the Treatment of Urodynamic Stress Incontinence: a Randomized Trial.
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Urinary Incontinence, Stress
Keywords: urodynamic stress incontinence
weighted vaginal cones
pelvic floor biofeedback
randomized controlled trial
Lead sponsor: Queen's University
Sponsor class: OTHER
First posted: 2005-11-01
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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 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.

Method

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.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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)

Primary outcomes:
measure: Urodynamic studies
timeFrame: 6 months
Secondary outcomes:
measure: Cough stress test
timeFrame: 6 months
measure: Standardized fixed bladder volume pad test
timeFrame: 6 months
measure: I-QOL questionnaire
timeFrame: 6 months
measure: Urogenital Distress Inventory
timeFrame: 6 months
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Kingston General Hospital, Queen's University
state: Ontario
Study officials:
affiliation: Queen's University
name: Marie-Andree Harvey, MD MSc
role: PRINCIPAL_INVESTIGATOR
References: