Incontinence Ring on Stress Urinary Incontinence

NCT00427778 | Terminated Results

• 1 other identifier: obgy-160-06
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress Urinary Incontinence; Urinary Incontinence

Keywords

incontinence ring; pessary; urinary incontinence; urodynamic study; quality of life; crossover trial; randomised trial

Outcome Measures

Primary Outcomes (1)

• Number of Participants With 50% or More Reduction in Number of Incontinence Episode Per Week

  number of women who experienced 50% or more reduction in number of incontinence episode per week on diary while using the incontinence ring, compared to baseline period.

  baseline and 4 weeks

Secondary Outcomes (7)

• Score on Question 3 of UDI 6

  4 weeks

• UDI Overall Score

  4 weeks

• Objective Cure Rate

  4 weeks

• Urodynamic Effect of the Incontinence Ring on Flow Rate

  baseline and at 4 weeks of ring use.

• Impact on I-QOL

  4 weeks

Study Arms (2)

Incontinence ring then no intervention

EXPERIMENTAL

Participants first were fitted with an incontinence ring, which they wore continuously for 4 weeks. The ring wa then removed and a washout period of 2 weeks followed. Then the second 4-week period with no ring was completed.

Device: incontinence ring

No intervention then incontinence ring

EXPERIMENTAL

Participants spend the first study 4-week period with no intervention. Then, a wasout period of 2 weeks followed. Participants were then fitted with an incontinence ring, which they wore continuously for 4 weeks.

Device: incontinence ring

Interventions

incontinence ring DEVICE

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.

Also known as: Silicone Flexible Pessary, Milex code: KPCON

Incontinence ring then no intervention; No intervention then incontinence ring

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Queen's University: lead
• The Physicians' Services Incorporated Foundation: collaborator

Study Sites (1)

Kingston General Hospital

Kingston, Ontario, K7L2V7, Canada

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress; Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

small sample size. slow recruitment

Results Point of Contact

• Title: Dr Marie-Andree Harvey
• Organization: Queen's University

harveym@queensu.ca

613-548-6115

Study Officials

• Marie-Andree Harvey, MD MSc

  Queen's University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 25, 2007
• First Posted: January 29, 2007
• Study Start: June 1, 2006
• Primary Completion: April 1, 2008
• Study Completion: May 1, 2008
• Last Updated: September 27, 2017
• Results First Posted: September 27, 2017

Record last verified: 2017-09

Locations

CA (1)