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Incontinence Ring on Stress Urinary Incontinence

This study has been terminated.
(Slow recruitment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00427778
First Posted: January 29, 2007
Last Update Posted: September 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
The Physicians' Services Incorporated Foundation
Information provided by (Responsible Party):
Dr. Marie-Andree Harvey, Queen's University
  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
Stress Urinary Incontinence Urinary Incontinence Device: incontinence ring

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Treatment of Stress Urinary Incontinence Using an Incontinence Ring: A Randomized, Cross-over Trial

Resource links provided by NLM:


Further study details as provided by Dr. Marie-Andree Harvey, Queen's University:

Primary Outcome Measures:
  • Number of Participants With 50% or More Reduction in Number of Incontinence Episode Per Week [ Time Frame: baseline and 4 weeks ]
    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.


Secondary Outcome Measures:
  • Score on Question 3 of UDI 6 [ Time Frame: 4 weeks ]
    Score (0-3) of response to question #3 (stress incontinence specific) of Urogenital Distress inventory - short form. The UDI is a 6-question validated questionnaire assessing the urinary tract symptoms and their bothersomeness. Question three asks specifically about "Leakage related to activity, coughing, or sneezing", i.e. stress urinary incontinence. Answer is scored from 0-3 (3 most bothersome).

  • UDI Overall Score [ Time Frame: 4 weeks ]
    Urogenital Distress inventory - short form. The UDI is a 6-question validated questionnaire assessing the urinary tract symptoms and their bothersomeness. Answers are scored from 0-3 (3 most bothersome). An average score is then obtained, ranging from 0-3.

  • Objective Cure Rate [ Time Frame: 4 weeks ]
    Number of Participants Without Urinary Stress Incontinence During Provocation testing during urodynamic studies (UDS). Provocations included valsalva and cough, first at 300 ml while lying then standing, followed, if no leakage was seen, to provocations at maximum cystometric capacity while standing.

  • Urodynamic Effect of the Incontinence Ring on Flow Rate [ Time Frame: baseline and at 4 weeks of ring use. ]
    Peak flow rate (ml/sec) during uninstrumented uroflow. The 'no treatment' flow rate was obtained during baseline urodynamic studies (UDS) and the 'incontinence ring' flow rate was obtained at the end of the ring period for each participants, while wearing the ring.

  • Impact on I-QOL [ Time Frame: 4 weeks ]
    The I-QOL (Incontinence-Quality of Life) is a valid and reproducible self-administered measure for assessing quality of life of patients with urinary incontinence. Items are scored on a 4-point Likert response scale (very much, moderately, a little, not at all). Scoring the I-QOL questionnaire involves summing the responses into a single score. The sum score is transformed to a 0-100 scale, with a higher number representing a better quality of life

  • Patient Acceptability (10 cm VAS) [ Time Frame: 4 weeks ]
    participants completed a 10 cm visual analogue scale at the end of 4 weeks of ring use, rating their pelvic discomfort on a 10 cm scale; 0= none, 10= max.

  • Post Void Residual [ Time Frame: The UDS while wearing the ring was done 2-4 weeks into the 'ring' treatment period, at patient's convenience, the UDS done at baseline was considered representative of "no treatment" UDS. ]
    Post void residual measured by catheter after free flow uroflowmetry


Enrollment: 29
Actual Study Start Date: June 2006
Study Completion Date: May 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Incontinence ring then no intervention
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

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
Experimental: No intervention then incontinence ring
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

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

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00427778


Locations
Canada, Ontario
Kingston General Hospital
Kingston, Ontario, Canada, K7L2V7
Sponsors and Collaborators
Queen's University
The Physicians' Services Incorporated Foundation
Investigators
Principal Investigator: Marie-Andree Harvey, MD MSc Queen's University
  More Information

Responsible Party: Dr. Marie-Andree Harvey, Principal Investigator, Queen's University
ClinicalTrials.gov Identifier: NCT00427778     History of Changes
Other Study ID Numbers: obgy-160-06
First Submitted: January 25, 2007
First Posted: January 29, 2007
Results First Submitted: November 29, 2016
Results First Posted: September 27, 2017
Last Update Posted: September 27, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Dr. Marie-Andree Harvey, Queen's University:
incontinence ring
pessary
urinary incontinence
urodynamic study
quality of life
crossover trial
randomised trial

Additional relevant MeSH terms:
Urinary Incontinence
Enuresis
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders