Timing of Pessary Care

Description

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 subjects to pessary care with removal every 12 weeks or every 24 weeks.

Study Start Date

January 2015

Estimated Completion Date

June 2017

Interventions

  • Other: Extended timing of pessary care

Specialties

  • Obstetrics & Gynecology: Preventive Medicine
  • Physician Assistant: Obstetrics/Gynecology

MeSH Terms

  • Pelvic Organ Prolapse

Study ID

Hartford Hospital -- HHC-2014-0112

Status

Unknown

Trial ID

NCT02371083

Study Type

Interventional

Trial Phase

N/A

Enrollment Quota

126

Sponsor

Hartford Hospital

Inclusion Criteria

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

Exclusion Criteria

  • 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

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (1)

Study Location Distance Name Phone Email
Hartford Hospital Urogynecology Division - Hartford, Connecticut 92.3 miles Katie Propst MD 860-972-1908 katie.propst@hhchealth.org

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