Clinical trial NCT00427778: Incontinence Ring on Stress Urinary Incontinence
Official title: The Treatment of Stress Urinary Incontinence Using an Incontinence Ring: A Randomized, Cross-over Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stress Urinary Incontinence
Urinary Incontinence
Keywords: incontinence ring
pessary
urinary incontinence
urodynamic study
quality of life
crossover trial
randomised trial
Lead sponsor: Queen's University
Sponsor class: OTHER
Collaborators: name: The Physicians' Services Incorporated Foundation
First posted: 2007-01-29
Enrollment: 29
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study aims as defining success rate of the incontinence ring in women with test proven stress urinary incontinence and determining factors associated with successful use.

Detailed description: The primary objective of this study is to determine if the incontinence ring is effective in decreasing the incontinence episode frequency per week. Other objectives include the determination of the cure rate (objective and subjective) with the ring, the effects to bladder function as noted on urodynamic testing, the impact on quality of life and the acceptability to this device in the treatment of stress urinary incontinence.

In this cross-over study, 40 women will undergo a two-period treatment. In one of the periods, she will spend 4 weeks wearing continuously the ring and in the other (also 4 weeks duration), she will not be using any treatment for her incontinence. Between periods, she will spend 2 weeks in "wash out" to eliminate the risk of continuous effect from the treatment in the preceding period. Each woman will be randomly assigned to the treatment sequence.

Stress urinary incontinence is a common problem affecting at almost 20% of women. Treatments currently advocated include pelvic floor exercises and surgery. Pelvic floor exercises require great motivation and usually 3 months of training to show an impact. Surgery is very effective, but costly and carries a number of complications. The use of the incontinence ring may allow women to control their symptoms with immediate result at minimal risk. This device has never been properly evaluated before its introduction into the market.

Eligibility criteria: Inclusion Criteria:

* Symptoms of urinary stress urinary incontinence (i.e. urinary leakage associated with increased intra-abdominal pressure/cough) (if mixed incontinence the urinary stress urinary incontinence symptoms must predominate)
* Urodynamic Stress urinary incontinence confirmed by urodynamic studies (i.e. urinary leakage associated with increased intra-abdominal pressure/cough in the absence of detrusor overactivity)
* Ability to understand spoken and written English

Exclusion Criteria:

* Severe pelvic organ prolapse (\> or = stage 3 on the Pelvic Organ Prolapse Quantification System - POP-Q)
* Contraindications to pessary use (including acute vaginal/urinary or pelvic infections, vaginal or cervical lesions or unexplained vaginal bleeding)
* Inability to properly fit the incontinence ring

Primary outcomes:
measure: Number of Participants With 50% or More Reduction in Number of Incontinence Episode Per Week
timeFrame: baseline and 4 weeks
Secondary outcomes:
measure: Score on Question 3 of UDI 6
timeFrame: 4 weeks
measure: UDI Overall Score
timeFrame: 4 weeks
measure: Objective Cure Rate
timeFrame: 4 weeks
measure: Urodynamic Effect of the Incontinence Ring on Flow Rate
timeFrame: baseline and at 4 weeks of ring use.
measure: Impact on I-QOL
timeFrame: 4 weeks
measure: Patient Acceptability (10 cm VAS)
timeFrame: 4 weeks
measure: Post Void Residual
timeFrame: The UDS while wearing the ring was done 2-4 weeks into the 'ring' treatment period, at patient's convenience, the UDS done at baseline was considered representative of "no treatment" UDS.
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Kingston General Hospital
state: Ontario
Study officials:
affiliation: Queen's University
name: Marie-Andree Harvey, MD MSc
role: PRINCIPAL_INVESTIGATOR
References: