Incontinence Ring on Stress Urinary Incontinence
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Stress Urinary Incontinence Urinary Incontinence |
Device: incontinence ring (Milex) |
Phase 4 |
| Study Type: | Interventional |
| 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 ]
| Enrollment: | 29 |
| Study Start Date: | January 2007 |
| Study Completion Date: | May 2008 |
| Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A
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. Other Names:
|
| No Intervention: B |
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| Canada, Ontario | |
| Kingston General Hospital | |
| Kingston, Ontario, Canada, K7L2V7 | |
| Principal Investigator: | Marie-Andree Harvey, MD MSc | Queen's University |
More Information
No publications provided
| Responsible Party: | Marie-Andree Harvey, Queens' University |
| ClinicalTrials.gov Identifier: | NCT00427778 History of Changes |
| Other Study ID Numbers: | obgy-160-06 |
| Study First Received: | January 25, 2007 |
| Last Updated: | May 30, 2008 |
| Health Authority: | Canada: Health Canada |
Keywords provided by Queen's University:
|
incontinence ring pessary urinary incontinence urodynamic study |
quality of life crossover trial randomised trial |
Additional relevant MeSH terms:
|
Urinary Incontinence Urinary Incontinence, Stress Urination Disorders |
Urologic Diseases Urological Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on May 22, 2013