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

NCT ID: NCT03614611

Last Updated: 2022-03-31

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-13
• Study Completion Date: 2022-03-14

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.

Conditions

Urinary Incontinence, Stress

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Contiform pessary

Intervention Type: DEVICE

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)

Interventions

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)

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Canadian Urological Association

INDUSTRY

Sponsor Role: collaborator

CHU de Quebec-Universite Laval

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Genevieve Nadeau, MD,MSc,FRCSC

Role: PRINCIPAL_INVESTIGATOR

CHU de Québec - Université Laval

Locations

Hopital St-François d'Assise

Québec, Quebec, Canada

Countries

Canada

References

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.

Reference Type: BACKGROUND

PMID: 18183342 (View on PubMed)

Farrell 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.

Reference Type: BACKGROUND

PMID: 17466709 (View on PubMed)

Lovatsis 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.

Reference Type: BACKGROUND

PMID: 27438055 (View on PubMed)

Wein AJ, Kavoussi LR, Partin AW, Peters C. Campbell-Walsh urology. 11e ed. Philadelphia, Pennsylvania: Elsevier; 2016

Reference Type: BACKGROUND

Other Identifiers

Contiform 2019-4215

Identifier Type: -

Identifier Source: org_study_id