Stress Urinary Incontinence, Urinary Incontinence
Conditions
Keywords
incontinence ring, pessary, urinary incontinence, urodynamic study, quality of life, crossover trial, randomised trial
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.
Interventions
DEVICEincontinence 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.
Sponsors
The Physicians' Services Incorporated Foundation
Queen's University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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). |
| 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 |
| 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 |
Countries
Canada
Participant flow
Recruitment details
87 women were screened for eligibility between June 2006 and February 2008, at an academic specialty center
Pre-assignment details
29 out of 87 were randomised. of those not randomized, 52 declined to participate and 6 did not meet inclusion criteria.
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants All participants who were randomised to a treatment sequence group | 26 |
| Total | 26 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Intervention (4 Weeks) | anxious about using ring | 1 | 0 |
| First Intervention (4 Weeks) | no longer interested | 1 | 0 |
| First Intervention (4 Weeks) | Not successfully fitted with ring | 2 | 0 |
| First Intervention (4 Weeks) | unable to manipulate ring due to OA | 0 | 1 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Continuous | 52.2 years STANDARD_DEVIATION 11.2 |
| BMI | 29 kg/m^2 STANDARD_DEVIATION 6.8 |
| incontinence episodes per week | 10 number of incontinence episodes per week |
| MCS12 | 47.9 units on a scale STANDARD_DEVIATION 11.1 |
| Menopausal status | 8 Participants |
| Parity | 2 previous vaginal births |
| PCS12 | 51.2 units on a scale STANDARD_DEVIATION 8.3 |
| Peak flow rate (ml/sec) | 22.9 ml/sec STANDARD_DEVIATION 15.1 |
| Pop stage stage 0 | 2 Participants |
| Pop stage stage 1 | 7 Participants |
| Pop stage stage 2 | 17 Participants |
| Post void residual (ml) | 19.6 ml STANDARD_DEVIATION 21 |
| Score to question #3 on UDI-6 | 3 units on a scale |
| Sex: Female, Male Female | 26 Participants |
| Sex: Female, Male Male | 0 Participants |
| Smoking status | 2 Participants |
| UDI score | 1.5 units on a scale |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 26 |
| other Total, other adverse events | 0 / 26 | 0 / 26 |
| serious Total, serious adverse events | 0 / 26 | 0 / 26 |
Outcome results
Primary
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
Population: All participants who were randomized and fitted with a ring are included in this intent to treat analysis. Patients for whom a ring could not be successfully fitted were considered failure (\<50%) improvement)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Incontinence Ring | Number of Participants With 50% or More Reduction in Number of Incontinence Episode Per Week | 14 Participants |
| Controls | Number of Participants With 50% or More Reduction in Number of Incontinence Episode Per Week | 10 Participants |
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Incontinence Ring | Impact on I-QOL | 89.1 units on a scale |
| Controls | Impact on I-QOL | 70.9 units on a scale |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Incontinence Ring | Objective Cure Rate | 0 Participants |
| Controls | Objective Cure Rate | 0 Participants |
Secondary
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
Population: Women did not fill out this VAS when not wearing the incontinence ring.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Incontinence Ring | Patient Acceptability (10 cm VAS) | 0.6 cm | Standard Deviation 0.9 |
Secondary
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.
Population: All uroflow were obtained on arrival of the patient in the UDS suite and prior to instrumentation. patients were asked to arrive with a full bladder, but some did not, explaining the lower number of women with available results.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Incontinence Ring | Post Void Residual | 15.9 ml | Standard Deviation 19.1 |
| Controls | Post Void Residual | 51.5 ml | Standard Deviation 67.9 |
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Incontinence Ring | Score on Question 3 of UDI 6 | 1 units on a scale |
| Controls | Score on Question 3 of UDI 6 | 3 units on a scale |
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Incontinence Ring | UDI Overall Score | 0.7 units on a scale |
| Controls | UDI Overall Score | 1.3 units on a scale |
Secondary
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Incontinence Ring | Urodynamic Effect of the Incontinence Ring on Flow Rate | 24.1 ml/sec | Standard Deviation 11.6 |
| Controls | Urodynamic Effect of the Incontinence Ring on Flow Rate | 22.9 ml/sec | Standard Deviation 15.1 |