Canadian Experience With Contiform Intravaginal Device For The Treatment Of Stress Incontinence

NCT03614611

Last updated date
Study Location
Hopital St-François d'Assise
Quebec, , G1L 3L5, Canada
Contact
418-266-2876

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Stress Urinary Incontinence
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Female
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Advanced Information
Descriptive Information
Brief Title  ICMJE Canadian Experience With Contiform Intravaginal Device For The Treatment Of Stress Incontinence
Official Title  ICMJE Canadian Experience With Contiform Intravaginal Device For The Treatment Of Stress Incontinence: Effectiveness And Patient Acceptability
Brief 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. 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment
Condition  ICMJE Urinary Incontinence, Stress
Intervention  ICMJE Device: Contiform pessary

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 Arms  ICMJE Experimental: Contiform pessary
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.
Intervention: Device: Contiform pessary
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 2, 2018)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 1, 2021
Estimated Primary Completion Date January 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Gender Based Eligibility:Yes
Gender Eligibility Description:The goal 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. It can only be use in women.
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Genevieve Nadeau, MD,MSc,FRCSC418-266-2876[email protected]
Contact: Marie-Pier St-Laurent, MD418-266-2876[email protected]
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03614611
Other Study ID Numbers  ICMJE Contiform 2019-4215
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Responsible Party CHU de Quebec-Universite Laval
Study Sponsor  ICMJE CHU de Quebec-Universite Laval
Collaborators  ICMJE CUA-Pfizer Urology Grant Program
Investigators  ICMJE
Principal Investigator:Genevieve Nadeau, MD,MSc,FRCSCCHU de Québec - Université Laval
PRS Account CHU de Quebec-Universite Laval
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP