Incontinence Ring on Stress Urinary Incontinence

Not Applicable

Terminated

Conditions: Stress Urinary Incontinence
Urinary Incontinence

Interventions: Device: incontinence ring

Registration Number: NCT00427778

Lead Sponsor: Queen's University

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.

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: Female

Target Recruitment: 29

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
No intervention then incontinence ring	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.
Incontinence ring then no intervention	incontinence ring	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With 50% or More Reduction in Number of Incontinence Episode Per Week	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

Name	Time	Method
Objective Cure Rate	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.
Patient Acceptability (10 cm VAS)	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	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
Score on Question 3 of UDI 6	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	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.
Urodynamic Effect of the Incontinence Ring on Flow Rate	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	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