Incontinence Ring on Stress Urinary Incontinence

This study has been terminated.
(Slow recruitment)
Sponsor:
Collaborator:
PSI Foundation inc
Information provided by:
Queen's University
ClinicalTrials.gov Identifier:
NCT00427778
First received: January 25, 2007
Last updated: May 30, 2008
Last verified: May 2008
  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.

Resource links provided by NLM:


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
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:
  • Silicone Flexible Pessary
  • Milex code: KPCON
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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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 July 29, 2014