Pessary Use for Stress Urinary Incontinence in Pregnancy
Launched by UNIVERSITY OF BRITISH COLUMBIA · Oct 10, 2020
Trial Information
Current as of April 30, 2025
Unknown status
Keywords
ClinConnect Summary
Specific Aims To determine if an incontinence pessary will improve condition-specific quality of life for women with stress urinary incontinence (SUI) in the third trimester of pregnancy and collect pilot data to inform sample size and feasibility for a larger randomized controlled trial.
Background/Significance The prevalence of antenatal urinary incontinence (UI) in nulliparous women is 30-40%; the prevalence increases with multiparity and prior vaginal delivery. Stress urinary incontinence (SUI) and mixed urinary incontinence (MUI) are reported by 37% and 58% of gravidas respectively. F...
Gender
FEMALE
Eligibility criteria
- Inclusion Criteria:
- • English speaking women over 19 years old
- • Nulliparous and multiparous women over 26 weeks gestational age with a healthy singleton pregnancy
- • Bothersome symptoms of stress urinary incontinence or stress-predominant mixed urinary incontinence with a minimal PDFI score of 25 on the UDI-6 section.
- Exclusion Criteria:
- • Stage 3 or greater pelvic organ prolapse
- • Contraindication to pessary use (known pelvic infection, vaginal or cervical lesions)
- • Previous surgery for urinary incontinence
- • History of preterm delivery and current threatened preterm labour
- • Premature preterm rupture of membranes
- • Short cervix
- • Hospitalization in the current pregnancy
- • Antepartum hemorrhage
- • Fetal anomaly
- • Prior trial of pessary or current pessary use
- • Vulvodynia
About University Of British Columbia
The University of British Columbia (UBC) is a leading research institution located in Vancouver, Canada, renowned for its commitment to advancing health sciences through innovative research and education. As a prominent clinical trial sponsor, UBC leverages its interdisciplinary expertise and state-of-the-art facilities to conduct rigorous clinical studies aimed at improving patient outcomes across various medical fields. The university fosters collaborations with healthcare professionals, industry partners, and community stakeholders to translate research findings into practical applications, thereby contributing to the global advancement of medicine and public health.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Vancouver, British Columbia, Canada
Patients applied
Trial Officials
Catherine Smith, MD
Principal Investigator
University of British Columbia
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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