NCT00427778

Incontinence Ring on Stress Urinary Incontinence

The Treatment of Stress Urinary Incontinence Using an Incontinence Ring: A Randomized, Cross-over Trial

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Queen's University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Stress Urinary Incontinence
• Urinary Incontinence

Interventions

Type	Name	Description
DEVICE	incontinence ring	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.

Timeline

• Start date: 2006-06-01
• Primary completion: 2008-04-01
• Completion: 2008-05-01
• First posted: 2007-01-29
• Last updated: 2017-09-27
• Results posted: 2017-09-27

Locations

1 site across 1 country: Canada