Recruiting

Pessary

Sponsor:

University of British Columbia

Code:

NCT04590092

Conditions

Stress Urinary Incontinence

Pregnancy Related

Eligibility Criteria

Sex: Female

Age: 19 - 60

Healthy Volunteers: Not accepted

Interventions

Cooper Surgical Ring Pessary with Incontinence Knob

Study Details

Brief 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.

Conditions

Stress Urinary Incontinence

Pregnancy Related

Study ID

NCT04590092

Start date

Feb 1, 2021

Status verified date

Jun, 2022

Completion date

Sep, 2022

Anticipated

Primary completion date

Sep, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 19 - 60

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

no intervention: Control

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.

experimental: Pessary

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.

Interventions

Cooper Surgical Ring Pessary with Incontinence Knob

A pessary is a silicone ring with a knob that in inserted into the vagina to treat urinary incontinence by providing urethral support.

Primary outcome measure

  • PFDI-20 score difference and variance [ Time Frame: At exit interview (36 weeks gestational age) ]

Central Contacts and Locations

Central contacts

Nicole Koenig

(604) 806-9829NKoenig@providencehealth.bc.ca

Locations

Providence Health Care - St Paul's Hospital

Recruiting

Vancouver, British Columbia, Canada, V6H1J7

More Information

Sponsor

University of British Columbia

Last update posted

Jun 6, 2022

Last verified

Jun, 2022

Keywords

  • Stress urinary incontinence
  • Pregnancy
  • Pessary
  • Pelvic floor

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2022-06-06.