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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
29
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.
Kingston General Hospital
Kingston, Ontario, Canada
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.
Time frame: baseline and 4 weeks
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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: baseline and at 4 weeks of ring use.
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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
Time frame: 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.
Time frame: 4 weeks
Post Void Residual
Post void residual measured by catheter after free flow uroflowmetry
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.