Incontinence Ring on Stress Urinary Incontinence - Full Text View

Sponsors and Collaborators:	Queen's University PSI Foundation inc
Information provided by:	Queen's University
ClinicalTrials.gov Identifier:	NCT00427778

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 IV

MedlinePlus related topics: Pelvic Support Problems Urinary Incontinence

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Crossover Assignment, Safety/Efficacy Study
Official Title:	Effect of the Incontinence Ring on Urodynamic Stress Urinary Incontinence: A Randomized Trial.

Further study details as provided by Queen's University:

Primary Outcome Measures:

number of incontinence episode per week [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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
A: Experimental 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.
B: No Intervention

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00427778

Locations

Canada, Ontario
Kingston General Hospital
Kingston, Ontario, Canada, K7L2V7

Sponsors and Collaborators

Queen's University

PSI Foundation inc

Investigators

Principal Investigator:

Marie-Andree Harvey, MD MSc

Queen's University

More Information

Responsible Party:	Queens' University ( Marie-Andree Harvey )
Study ID Numbers:	obgy-160-06
Study First Received:	January 25, 2007
Last Updated:	May 30, 2008
ClinicalTrials.gov Identifier:	NCT00427778
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

Study placed in the following topic categories:

Signs and Symptoms
Urinary Incontinence, Stress
Urologic Diseases
Urination Disorders

Quality of Life
Stress
Urinary Incontinence

Additional relevant MeSH terms:

Urological Manifestations
Pathologic Processes

ClinicalTrials.gov processed this record on January 13, 2009