Timing of Pessary Care

Completed · Not applicable

Conditions studied: Pelvic Organ Prolapse

In brief

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.

Key facts

Study ID

NCT02371083

Run by

Hartford Hospital

People needed

130

Starts

2015-01-01

Expected to finish

2018-06-01

Last updated by the study team

2019-08-28

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• female sex
• age greater than 17 years
• able and willing to participate
• patients who are currently wearing a ring, gellhorn, or incontinence dish pessary to treat pelvic organ prolapse and/or incontinence

You may not qualify if…

• male sex
• age less than 18 years
• unable/unwilling to participate
• patients who do not wear a pessary
• patients wearing a pessary that is not a ring or a gellhorn
• presence of vaginal granulation tissue
• erosions, or fistula, patients who perform pessary self-care

Where it is running

• Hartford Hospital, Urogynecology Division — Hartford, Connecticut, United States

Full record on ClinicalTrials.gov

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