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Timing of Pessary Care

NCT02371083 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2019-08-28

No results posted yet for this study

Summary

This is a prospective trial to investigate optimal timing of care for vaginal pessaries. A vaginal pessary is a silicone device that is placed in the vagina to support the pelvic organs of a woman who has pelvic organ prolapse. Some women are willing and able to remove their own pessary on a regular basis. In women who are either unwilling or unable to remove their own pessary, complete pessary care is provided in the urogynecology office. Complete pessary care involves regular removal and cleaning of the pessary with a vaginal examination. In our practice, the investigators typically remove vaginal pessaries and examine the vagina every 3 months in patients for whom the investigators provide complete pessary care. Interval of pessary removal varies widely between practitioners. In the literature, removal intervals vary from weekly to yearly. In this study, the investigators will randomize participants to pessary care with removal every 12 weeks or every 24 weeks.

Conditions

  • Pelvic Organ Prolapse

Interventions

OTHER

Extended timing of pessary care

Sponsors & Collaborators

  • Hartford Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2018-05-31
Completion
2018-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02371083 on ClinicalTrials.gov