Incontinence Ring on Stress Urinary Incontinence

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Stress Urinary Incontinence, Urinary Incontinence

Intervention / Treatment
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* Device: incontinence ring


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Incontinence ring then no intervention<br>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<br>* 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.<br>* Other names: Milex code: KPCON;|
| Experimental: No intervention then incontinence ring<br>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<br>* 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.<br>* Other names: Milex code: KPCON;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score on Question 3 of UDI 6 | 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). | 4 weeks | 
| UDI Overall Score | 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. | 4 weeks | 
| Objective Cure Rate | 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. | 4 weeks | 
| Urodynamic Effect of the Incontinence Ring on Flow Rate | 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. | baseline and at 4 weeks of ring use. | 
| Impact on I-QOL | 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 | 4 weeks | 
| Patient Acceptability (10 cm VAS) | 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. | 4 weeks | 
| Post Void Residual | Post void residual measured by catheter after free flow uroflowmetry | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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incontinence ring, pessary, urinary incontinence, urodynamic study, quality of life, crossover trial, randomised trial