Incontinence Ring on Stress Urinary Incontinence
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.
Stress Urinary Incontinence
Device: incontinence ring (Milex)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Effect of the Incontinence Ring on Urodynamic Stress Urinary Incontinence: A Randomized Trial.|
- number of incontinence episode per week [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- subjective cure rate (answer 0 on question #3 or UDI) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- objective cure rate (no stress incontinence during provocation at multichannel UDS) [ Time Frame: 2-4 weeks ] [ Designated as safety issue: No ]
- urodynamic effect on leak point pressure, flow rate, post void residual, Pdet at mas flow [ Time Frame: 2-4 weeks ] [ Designated as safety issue: Yes ]
- impact on QOL (IQOL) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- patient acceptability (10 cm VAS) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||January 2007|
|Study Completion Date:||May 2008|
|Primary Completion Date:||April 2008 (Final data collection date for primary outcome measure)|
Use of incontinence ring
Device: incontinence ring (Milex)
Incontinence ring fitted to patient's anatomy (by choosing appropriate size). It is worn continually for the duration of the treatment period.
Intravaginal incontinence ring placed proximally in the posterior vaginal fornix. Knob located at mid-urethra.
|No Intervention: B|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00427778
|Kingston General Hospital|
|Kingston, Ontario, Canada, K7L2V7|
|Principal Investigator:||Marie-Andree Harvey, MD MSc||Queen's University|