Urinary Incontinence, StressNCT03614611
Canadian Experience With Contiform Intravaginal Device For The Treatment Of Stress Incontinence
A study testing Contiform pessary in people with Urinary Incontinence, Stress, run by CHU de Quebec-Universite Laval at 1 site in Canada.
Trial summary
Stress urinary incontinence (SUI) is a highly prevalent condition of involuntary urine leakage associated with coughing, sneezing or exertion. Midurethral slings (MUS) are a safe and efficacious surgical option to treat SUI and is considered the best treatment by recognized organizations. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urinary Incontinence, Stress
- What is being tested?
- Contiform pessary
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteCanada
- Study dates
- 13 Nov 2018to 14 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Complain of stress incontinence
- Sufficient manual dexterity to insert and remove the device;
- Ability to speak French or English and understand written informed consent as per local ethical committee approval.
Who cannot join
- a main complaint of urgency symptoms, bacterial cystitis (symptomatic or proven UTI) at the time of insertion, recent pelvic surgery within the last 3 months, previous pelvic radiotherapy, current pregnancy, failed use of an incontinence pessary, a functional bladder capacity on bladder diary less than 250 mL, prolapse of any vaginal compartment beyond the level of the hymen, post-void residual urine volume greater than 100 mL, hematuria, undiagnosed pelvic or vaginal bleeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Canadian Experience With Contiform Intravaginal Device For The Treatment Of Stress Incontinence: Effectiveness And Patient Acceptability
Stress urinary incontinence (SUI) is a highly prevalent condition of involuntary urine leakage associated with coughing, sneezing or exertion. Midurethral slings (MUS) are a safe and efficacious surgical option to treat SUI and is considered the best treatment by recognized organizations. Nevertheless, it remains a surgical intervention exposing patients to risks, possible recurrence and is not recommended to women planning to have more children. Incontinence pessaries offer an alternative to surgery with a similar mechanism of action as MUS. However, there is a paucity of literature on the outcomes of incontinence pessary treatment of SUI, with only two prospective studies have been published on the Uresta pessary and one australian case-series on Contiform pessary.
The objective of the study is to evaluate the effectiveness of the self-positioning Contiform intravaginal pessary used as a conservative method to address stress urinary incontinence in women in order to provide Canadian real-world data.
Read more
The 3-month efficacy, adverse events and global patient satisfaction (including comfort and ease of insertion) will be assessed.
It is hypothesized that the Contiform device will be well tolerated by 60-70% of patients, with no serious adverse events. It will cure SUI for about 50% of them.
Read the detailed description
Patient who will present to the investigator's tertiary urology clinic with the main complaint of stress incontinence will be invited to consider the Contiform device. A total of 50 women will be recruited and followed over 3 months.
The evaluation of enrolled women will include a medical history and physical examination, a urinalysis, a urine culture, three-day voiding diary and post-void residual (PVR). Urodynamic testing will not be required. Kegel assessment will be performed on physical pelvic exam based on the Oxford subjective scale, which ranged from 0 (no palpable contraction) to 5 (very strong contraction). Demographic and baseline characteristics of the participants will be recorded, medical condition and medication.
Patients will be offered the Contiform device and invited to join the study as one treatment option for their stress leak. Patients will be asked to use the device for 12 weeks and to become comfortable with self-insertion and self-removal. All postmenopausal women will be given topical vaginal estrogen therapy before or on the day of starting using the device. No other treatment will be initiated during the trial period.
Once enrolled, patients will be given brief verbal and written instructions on pessary insertion and cleaning, and then allowed to select and insert the pessary themselves at home. They will be provided with a New User Kit which comprises three available sizes (Small, Medium \& Large) and a Silicone Removal Strap.
Patient enrolled will have to sign a informed consent form and agree that all information obtained during the research will be kept and treated confidentially within the limits of the law. The results of this study may be published or communicated in other ways; however, no identity or any other identifying information will not be disclosed in any reports or publications. The confidential records and data may be kept up to 10 years.
Patient will have to come to 3 visits. The first one for enrolment and baseline data collection with an urologist, a second visit at 4 weeks with a research nurse assistant and a last one at 3 months with the urologist. On each visit, any adverse event not by the patient of find on physical examination will be note. Test, exam and questionnaire will also be performed (urinalysis and urine culture, to exclude Urinary Tract Infection, residual urine estimation by ultrasonography, a 3-day voiding diary, a 24 hours pad weight test, a vaginal speculum exam performed to look for abrasions or other abnormalities and the completion of questionnaire on quality of like (PGI-I, ICIQ, UDI-6 and a pessary use questionnaire)
Statistical analysis will be performed using the Statistical Package for the Social Sciences (SPSS) (version13, SPSS Inc, Chicago, IL). All data will be described as the median value plus the interquartile range (IQR), as the data will probably not be normally distributed. Wilcoxon's and the Mann-Whitney U tests will be used for paired and unpaired data, respectively.
- Conditions
- Urinary Incontinence, Stress
- Being tested
- Contiform pessary
- Keywords
- pessaries, Urinary Incontinence/therapy, Patient Satisfaction, Female, Surveys and Questionnaires, Treatment Outcome
- Medical subject headings
- Urinary Incontinence, Stress, Urinary Incontinence, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contiform pessaryDevice
Patients will be asked to use the device for 12 weeks and to become comfortable with self-insertion and self-removal. The device can be worn continuously for 1 month. When placed in the vagina it retains its shape and supports the urethra during episodes of varied intraabdominal pressure. During the assessment test (24 hours pad test), patients will be encouraged to undertake any activity that would normally induce stress leakage.
The contiform device is approved by Health Canada since 2017-04-10 (Licence No.: 98950, Company ID: 134089, Device identifier: SKU 184)
| Study group | Role | What they receive |
|---|---|---|
| Contiform pessary | Experimental | Enrolled participants will be part of the intervention arm. They will use of the Contiform Intravaginal pessary for the treatment of stress urinary incontinence, for a period of 3 months. Receives: Device: Contiform pessary |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of the Contiform intravaginal pessary to achievement a change of 50 % or greater reduction in pad weight at 3 months compare to baseline
The primary outcome measure will be the 24-h pad test before and after device placement. In order to determine whether the device is equally effective in mild or more severe leakage, two groups will be analyzed separately. A leakage of <100 g/24h will be categorized as "mild loss" and >100 g/24h will be termed "moderate/severe loss". A weight of less than 2 g will be considered normal. Baseline data will be compare to 3 months to assess change.
Measured: 3 months
Secondary outcomes (8)
Assessment of any new adverse symptoms
Assessment by a nurse or doctor for any new symptoms reported by the patient. Symptoms could range from a feeling of incomplete emptying, pain/discomfort, urgency, bowel symptoms to hemoserous staining/discharge. Assessment will be taken at the fourth week and the third month visits.
Measured: 4 weeks and 3 months
Assessment of device defect
Assessment by a nurse or doctor for any defects appearing on the device, at the fourth week and the third month visits.
Measured: 4 weeks and 3 months
Assessment of augmentation of residual urine volume as an adverse event
Assessment by a nurse or doctor for the adverse event of augmentation of residual urine volume (mL), measure by bladder scan (ultrasound) after a full miction. Assessment will be taken at the fourth week and the third month visits.
Measured: 4 weeks and 3 months
Assessment of vaginal adverse event
Assessment by a nurse or doctor for any new vaginal adverse event caused by the device, such as vaginal abrasion or other abnormality. Assessment will be done by a speculum vaginal exam at the fourth week and the third month visits.
Measured: 4 weeks and 3 months
Patient quality of life and urinary incontinence symptoms as assessed by the ICIQ
Patients will be asked to complete the International Consultation on Incontinence Questionnaire (ICIQ). The total score is report, with the minimum result being 0 (no symptoms of urinary incontinence) and the maximum being 21 (maximum urinary incontinence as report by this self-taken questionnaire). This questionnaire will be assess at the fourth week and the third month visits.
Measured: 4 weeks and 3 months
Patient quality of life and discomfort regarding their urinary incontinence symptoms as assessed by the UDI-6
Patients will be asked to complete the urogenital distress inventory (UDI-6) questionnaire. Each item is scored between 0 (no problem) to 3 (bothered greatly). All scores are summed and divided by 6, then multiplied by 33.3 for the scale score. Higher score (100) indicate higher disability. This questionnaire will be assess at the fourth week and the third month visits.
Measured: 4 weeks and 3 months
Patient perception of efficacy and their acceptability of the device as assessed by the PGI-I
Patients will be asked to complete the Patient Global Impression of Improvement (PGI-I). The scale is from 1 to 7, with the highest result being a impression of having a much worse condition with the treatment, and the lowest result (1) is the impression of a very good improvement.This questionnaire will be assess at the fourth week and the third month visits.
Measured: 4 weeks and 3 months
Patient acceptability and use of the device, as assessed by the Pessary Use Questionnaire
Patients will be asked to complete the pessary use questionnaire. The minimum score is 0 and the maximum is 18. The highest result is associated with a better outcome in terms of acceptability and improvement of quality of life. The first 4 questions are using a Likert-type scale (0 to 4), with the maximum associated with a better outcome (improvement or utilisation acceptability), and the last 2 are polar questions. This questionnaire will be assess at the fourth week and the third month visits.
Measured: 4 weeks and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2018
- Study start13 Nov 2018
- Primary completion1 Mar 2022
- Study completion14 Mar 2022
Why it stopped: Lack of fund
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Urinary Incontinence, StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participants who accept to take part in this study will be assigned to the intervention group. There will be no randomisation or controlled group. This study will be taking place in Canada, with the intervention device being approved by Health Canada (Licence No.: 98950, Company ID: 134089, Device identifier: SKU 184)
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Quebec-Universite Laval
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Urological Association
- Responsible party
- Sponsor
- Investigators
- Genevieve Nadeau, MD,MSc,FRCSC, Principal investigator, CHU de Québec - Université Laval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03614611
- Sponsor's protocol ID
- Contiform 2019-4215
- Status last verified
- Mar 2022
- First submitted
- 19 Jul 2018
- Last updated
- 31 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Allen WA, Leek H, Izurieta A, Moore KH. Update: the "Contiform" intravaginal device in four sizes for the treatment of stress incontinence. Int Urogynecol J Pelvic Floor Dysfunct. 2008 Jun;19(6):757-61. doi: 10.1007/s00192-007-0519-1.
PubMed 18183342Farrell SA, Baydock S, Amir B, Fanning C. Effectiveness of a new self-positioning pessary for the management of urinary incontinence in women. Am J Obstet Gynecol. 2007 May;196(5):474.e1-8. doi: 10.1016/j.ajog.2006.11.038.
PubMed 17466709Lovatsis D, Best C, Diamond P. Short-term Uresta efficacy (SURE) study: a randomized controlled trial of the Uresta continence device. Int Urogynecol J. 2017 Jan;28(1):147-150. doi: 10.1007/s00192-016-3090-9. Epub 2016 Jul 20.
PubMed 27438055Wein AJ, Kavoussi LR, Partin AW, Peters C. Campbell-Walsh urology. 11e ed. Philadelphia, Pennsylvania: Elsevier; 2016
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Canadian Experience With Contiform Intravaginal Device For The Treatment Of Stress Incontinence: Effectiveness And Patient Acceptability
- ClinicalTrials.gov ID
- NCT03614611
- Acronym / sponsor ID
- Contiform 2019-4215
- Conditions
- Urinary Incontinence, Stress
- Keywords
- pessaries, Urinary Incontinence/therapy, Patient Satisfaction, Female, Surveys and Questionnaires, Treatment Outcome
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of fund
- Enrolment
- 39 participants (actual)
- Lead sponsor
- CHU de Quebec-Universite LavalUniversity, hospital or other
- Collaborators
- Canadian Urological Association
- Study start
- 13 Nov 2018 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 14 Mar 2022 (actual)
- First posted
- 3 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Stress urinary incontinence (SUI) is a highly prevalent condition of involuntary urine leakage associated with coughing, sneezing or exertion. Midurethral slings (MUS) are a safe and efficacious surgical option to treat SUI and is considered the best treatment by recognized organizations. Nevertheless, it remains a surgical intervention exposing patients to risks, possible recurrence and is not recommended to women planning to have more children. Incontinence pessaries offer an alternative to surgery with a similar mechanism of action as MUS. However, there is a paucity of literature on the outcomes of incontinence pessary treatment of SUI, with only two prospective studies have been published on the Uresta pessary and one australian case-series on Contiform pessary.
The objective of the study is to evaluate the effectiveness of the self-positioning Contiform intravaginal pessary used as a conservative method to address stress urinary incontinence in women in order to provide Canadian real-world data.
The 3-month efficacy, adverse events and global patient satisfaction (including comfort and ease of insertion) will be assessed.
It is hypothesized that the Contiform device will be well tolerated by 60-70% of patients, with no serious adverse events. It will cure SUI for about 50% of them.
Detailed description
Patient who will present to the investigator's tertiary urology clinic with the main complaint of stress incontinence will be invited to consider the Contiform device. A total of 50 women will be recruited and followed over 3 months.
The evaluation of enrolled women will include a medical history and physical examination, a urinalysis, a urine culture, three-day voiding diary and post-void residual (PVR). Urodynamic testing will not be required. Kegel assessment will be performed on physical pelvic exam based on the Oxford subjective scale, which ranged from 0 (no palpable contraction) to 5 (very strong contraction). Demographic and baseline characteristics of the participants will be recorded, medical condition and medication.
Patients will be offered the Contiform device and invited to join the study as one treatment option for their stress leak. Patients will be asked to use the device for 12 weeks and to become comfortable with self-insertion and self-removal. All postmenopausal women will be given topical vaginal estrogen therapy before or on the day of starting using the device. No other treatment will be initiated during the trial period.
Once enrolled, patients will be given brief verbal and written instructions on pessary insertion and cleaning, and then allowed to select and insert the pessary themselves at home. They will be provided with a New User Kit which comprises three available sizes (Small, Medium \& Large) and a Silicone Removal Strap.
Patient enrolled will have to sign a informed consent form and agree that all information obtained during the research will be kept and treated confidentially within the limits of the law. The results of this study may be published or communicated in other ways; however, no identity or any other identifying information will not be disclosed in any reports or publications. The confidential records and data may be kept up to 10 years.
Patient will have to come to 3 visits. The first one for enrolment and baseline data collection with an urologist, a second visit at 4 weeks with a research nurse assistant and a last one at 3 months with the urologist. On each visit, any adverse event not by the patient of find on physical examination will be note. Test, exam and questionnaire will also be performed (urinalysis and urine culture, to exclude Urinary Tract Infection, residual urine estimation by ultrasonography, a 3-day voiding diary, a 24 hours pad weight test, a vaginal speculum exam performed to look for abrasions or other abnormalities and the completion of questionnaire on quality of like (PGI-I, ICIQ, UDI-6 and a pessary use questionnaire)
Statistical analysis will be performed using the Statistical Package for the Social Sciences (SPSS) (version13, SPSS Inc, Chicago, IL). All data will be described as the median value plus the interquartile range (IQR), as the data will probably not be normally distributed. Wilcoxon's and the Mann-Whitney U tests will be used for paired and unpaired data, respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants who accept to take part in this study will be assigned to the intervention group. There will be no randomisation or controlled group. This study will be taking place in Canada, with the intervention device being approved by Health Canada (Licence No.: 98950, Company ID: 134089, Device identifier: SKU 184)
| Arm | Type | Receives |
|---|---|---|
| Contiform pessary | Experimental | Device: Contiform pessaryEnrolled participants will be part of the intervention arm. They will use of the Contiform Intravaginal pessary for the treatment of stress urinary incontinence, for a period of 3 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Complain of stress incontinence
- Sufficient manual dexterity to insert and remove the device;
- Ability to speak French or English and understand written informed consent as per local ethical committee approval.
Key exclusion criteria (1 listed)
- a main complaint of urgency symptoms, bacterial cystitis (symptomatic or proven UTI) at the time of insertion, recent pelvic surgery within the last 3 months, previous pelvic radiotherapy, current pregnancy, failed use of an incontinence pessary, a functional bladder capacity on bladder diary less than 250 mL, prolapse of any vaginal compartment beyond the level of the hymen, post-void residual urine volume greater than 100 mL, hematuria, undiagnosed pelvic or vaginal bleeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Contiform pessaryPatients will be asked to use the device for 12 weeks and to become comfortable with self-insertion and self-removal. The device can be worn continuously for 1 month. When placed in the vagina it retains its shape and supports the urethra during episodes of varied intraabdominal pressure. During the assessment test (24 hours pad test), patients will be encouraged to undertake any activity that would normally induce stress leakage. The contiform device is approved by Health Canada since 2017-04-10 (Licence No.: 98950, Company ID: 134089, Device identifier: SKU 184) | Device | Contiform pessary |
Primary outcome
Effectiveness of the Contiform intravaginal pessary to achievement a change of 50 % or greater reduction in pad weight at 3 months compare to baseline
Time frame: 3 months
The primary outcome measure will be the 24-h pad test before and after device placement. In order to determine whether the device is equally effective in mild or more severe leakage, two groups will be analyzed separately. A leakage of <100 g/24h will be categorized as "mild loss" and >100 g/24h will be termed "moderate/severe loss". A weight of less than 2 g will be considered normal. Baseline data will be compare to 3 months to assess change.
8 secondary outcomes
Assessment of any new adverse symptoms
Time frame: 4 weeks and 3 months
Assessment of device defect
Time frame: 4 weeks and 3 months
Assessment of augmentation of residual urine volume as an adverse event
Time frame: 4 weeks and 3 months
Assessment of vaginal adverse event
Time frame: 4 weeks and 3 months
Patient quality of life and urinary incontinence symptoms as assessed by the ICIQ
Time frame: 4 weeks and 3 months
Patient quality of life and discomfort regarding their urinary incontinence symptoms as assessed by the UDI-6
Time frame: 4 weeks and 3 months
Patient perception of efficacy and their acceptability of the device as assessed by the PGI-I
Time frame: 4 weeks and 3 months
Patient acceptability and use of the device, as assessed by the Pessary Use Questionnaire
Time frame: 4 weeks and 3 months
Results and safety
The study was stopped early (reason given: Lack of fund). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Background: PubMed 18183342Allen WA, Leek H, Izurieta A, Moore KH. Update: the "Contiform" intravaginal device in four sizes for the treatment of stress incontinence. Int Urogynecol J Pelvic Floor Dysfunct. 2008 Jun;19(6):757-61. doi: 10.1007/s00192-007-0519-1.
- Background: PubMed 17466709Farrell SA, Baydock S, Amir B, Fanning C. Effectiveness of a new self-positioning pessary for the management of urinary incontinence in women. Am J Obstet Gynecol. 2007 May;196(5):474.e1-8. doi: 10.1016/j.ajog.2006.11.038.
- Background: PubMed 27438055Lovatsis D, Best C, Diamond P. Short-term Uresta efficacy (SURE) study: a randomized controlled trial of the Uresta continence device. Int Urogynecol J. 2017 Jan;28(1):147-150. doi: 10.1007/s00192-016-3090-9. Epub 2016 Jul 20.
- BackgroundWein AJ, Kavoussi LR, Partin AW, Peters C. Campbell-Walsh urology. 11e ed. Philadelphia, Pennsylvania: Elsevier; 2016
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Genevieve Nadeau, MD,MSc,FRCSC principal investigator
CHU de Québec - Université Laval
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contiform pessary in people with Urinary Incontinence, Stress, run by CHU de Quebec-Universite Laval at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of fund). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of the Contiform intravaginal pessary to achievement a change of 50 % or greater reduction in pad weight at 3 months compare to baseline (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03614611, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.