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Slow recruitment
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| Name | Class |
|---|---|
| The Physicians' Services Incorporated Foundation | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Incontinence ring then no intervention | Experimental | 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. |
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| No intervention then incontinence ring | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| incontinence ring | Device | 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. |
| 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 |
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marie-Andree Harvey, MD MSc | Queen's University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kingston General Hospital | Kingston | Ontario | K7L2V7 | Canada |
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29 out of 87 were randomised. of those not randomized, 52 declined to participate and 6 did not meet inclusion criteria.
87 women were screened for eligibility between June 2006 and February 2008, at an academic specialty center
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| ID | Title | Description |
|---|---|---|
| FG000 | Incontinence Ring, Then no Treatment | participants first were fitted to an incontinence ring, which they wore for a period of 4 weeks, then it was removed. After a washout period of 2 weeks, they continued evaluation but with no active treatment |
| FG001 | No Treatment, Then Incontinence Ring | Participants first were assessment while no active treatment was received, for a period of 4 weeks. After a washout period of 2 weeks, they continued evaluation after an incontinence ring was fitted. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (4 Weeks) |
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| Wash Out (2 Weeks) |
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| Second Intervention (4 Weeks) |
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all patients who were recruited and for whom a pessary was fitted, successfully or not.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | All participants who were randomised to a treatment sequence group |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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) | Posted | Count of Participants | Participants | baseline and 4 weeks |
|
10 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Incontinence Ring | Use of incontinence ring incontinence ring (Milex): 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. |
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small sample size. slow recruitment
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Marie-Andree Harvey | Queen's University | 613-548-6115 | harveym@queensu.ca |
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| ID | Term |
|---|---|
| D014550 | Urinary Incontinence, Stress |
| D014549 | Urinary Incontinence |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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|
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| 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. |
| unable to manipulate ring due to OA |
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| anxious about using ring |
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| NOT COMPLETED |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
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| Parity | number of previous vaginal birth | Median | Inter-Quartile Range | previous vaginal births |
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| Smoking status | Current smokers | Count of Participants | Participants |
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| Menopausal status | number of women who are postmenopausal at time of study entry | Count of Participants | Participants |
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| Pop stage | number of women at each POPQ stage. The pelvic organ prolapse quantification system is a validated method to measure prolapse in each vaginal compartments (ant, post and apical). It assesses the distance of predetermined vaginal points from the hymen during valsalva. It is divided in 5 stages: 0 (no support defect, apex no more than 'total vaginal length' minus 2 cm from hymen), 1 (leading edge >1cm above the hymen), 2 (within one cm inside or outside the hymen), 3 (more than one cm below hymen, 4 (completely out, apex more than 'total vaginal length' minus 2 cm outside from hymen) | Count of Participants | Participants |
|
| incontinence episodes per week | Median | Inter-Quartile Range | number of incontinence episodes per week |
|
| Score to question #3 on 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. A low score indicates a minimal degree of severity impact | Median | Inter-Quartile Range | units on a scale |
|
| UDI 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. | Median | Inter-Quartile Range | units on a scale |
|
| MCS12 | The SF-12 is a multipurpose short form survey with 12 questions, all selected from the SF-36 Health Survey. The questions were combined, scored, and weighted to create two scales that provide glimpses into mental and physical functioning and overall health-related-quality of life. Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of 12 questions and range from 0-100, where a 0 score indicates the lowest and 100 the highest level of health measured by the scales. In MCS section, we are looking at Mental Health composite score. | Mean | Standard Deviation | units on a scale |
|
| PCS12 | The SF-12 is a multipurpose short form survey with 12 questions, all selected from the SF-36 Health Survey. The questions were combined, scored, and weighted to create two scales that provide glimpses into mental and physical functioning and overall health-related-quality of life. Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of 12 questions and range from 0-100, where a 0 score indicates the lowest and 100 the highest level of health measured by the scales In PCS section, we are looking at Physical Health composite score. | Mean | Standard Deviation | units on a scale |
|
| Peak flow rate (ml/sec) | Patients void on a commode equipped with a flowmeter which measure the volume voided and its flow rate. | Mean | Standard Deviation | ml/sec |
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| Post void residual (ml) | The Post void Residual is measured at the end of void during urodynamic studies by measuring, using the UDS catheter already in place, the residual urine volume in the bladder | Mean | Standard Deviation | ml |
|
| Controls |
participants completed a 1-week diary during the last of 4 weeks of the 'no treatment' week. Failure is determined as <50% improvement from baseline. |
|
|
| 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). | Posted | Median | Inter-Quartile Range | units on a scale | 4 weeks |
|
|
|
| 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. | Posted | Median | Inter-Quartile Range | units on a scale | 4 weeks |
|
|
|
| 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. | Posted | Count of Participants | Participants | 4 weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | ml/sec | baseline and at 4 weeks of ring use. |
|
|
|
| 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 | Posted | Median | Inter-Quartile Range | units on a scale | 4 weeks |
|
|
|
| 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. | Women did not fill out this VAS when not wearing the incontinence ring. | Posted | Mean | Standard Deviation | cm | 4 weeks |
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| Secondary | Post Void Residual | Post void residual measured by catheter after free flow uroflowmetry | 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. | Posted | Mean | Standard Deviation | ml | 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. |
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| 0 |
| 26 |
| 0 |
| 26 |
| 0 |
| 26 |
| EG001 | No Treatment | no intervention | 0 | 26 | 0 | 26 | 0 | 26 |
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |