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

NCT03614611 | Terminated

• 1 other identifier: Contiform 2019-4215
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Incontinence, Stress

Keywords

pessaries; Urinary Incontinence/therapy; Patient Satisfaction; Female; Surveys and Questionnaires; Treatment Outcome

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Secondary Outcomes (8)

• Assessment of any new adverse symptoms

  4 weeks and 3 months

• Assessment of device defect

  4 weeks and 3 months

• Assessment of augmentation of residual urine volume as an adverse event

  4 weeks and 3 months

• Assessment of vaginal adverse event

  4 weeks and 3 months

• Patient quality of life and urinary incontinence symptoms as assessed by the ICIQ

  4 weeks and 3 months

Study Arms (1)

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.

Device: Contiform pessary

Interventions

Contiform pessary 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)

Contiform pessary

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: 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.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• CHU de Quebec-Universite Laval: lead
• Canadian Urological Association: collaborator

Study Sites (1)

Hopital St-François d'Assise

Québec, Quebec, G1L 3L5, Canada

Location

Related Publications (4)

• 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.

  PMID: 18183342 BACKGROUND

• 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.

  PMID: 17466709 BACKGROUND

• 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.

  PMID: 27438055 BACKGROUND

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

  BACKGROUND

MeSH Terms

Conditions

Urinary Incontinence, Stress; Urinary Incontinence; Patient Satisfaction

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Genevieve Nadeau, MD,MSc,FRCSC

  CHU de Québec - Université Laval

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: July 19, 2018
• First Posted: August 3, 2018
• Study Start: November 13, 2018
• Primary Completion: March 1, 2022
• Study Completion: March 14, 2022
• Last Updated: March 31, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)