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Pessary

Cooper Surgical Ring Pessary with Incontinence Knob for Stress Incontinence

N/A
Waitlist Available
Led By Catherine Smith, MD
Research Sponsored by University of British Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights
No Placebo-Only Group

Summary

When women are pregnant they are more likely to leak urine which can severely affect their quality of life. This problem could be fixed by using a pessary. A pessary is a silicone ring that goes into the vagina which can stop or improve urinary leakage. These devices have been safely used for hundreds of years. However, pessaries has not been studied for urinary leakage in pregnancy. The investigators would like to compare severity of urinary leakage using a number of questionnaires during the last 3 months of pregnancy for women using a pessary versus women without a pessary.

Eligible Conditions
  • Stress Incontinence
  • Pregnancy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
PFDI-20 score difference and variance
Secondary study objectives
Abdominal Pain
Bladder Diary
Delivery
+17 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: PessaryExperimental Treatment1 Intervention
Study Participants who are fitted with a pessary for urinary incontinence. This group will be given an information pamphlet on pelvic floor (Kegel) exercises in pregnancy and pessary use in pregnancy. They will continue to have standard antenatal care with their maternity provider.
Group II: ControlActive Control1 Intervention
Study Participants who do not receive a pessary. This group will be given an information pamphlet on pelvic floor (Kegel) exercises in pregnancy and will continue to have standard antenatal care with their maternity provider.

Find a Location

Who is running the clinical trial?

University of British ColumbiaLead Sponsor
1,465 Previous Clinical Trials
2,485,437 Total Patients Enrolled
Catherine Smith, MDPrincipal InvestigatorUniversity of British Columbia
1 Previous Clinical Trials
90 Total Patients Enrolled
~13 spots leftby Nov 2025