Timing of Pessary Care

NCT02371083 | Completed

• 1 other identifier: HHC-2014-0112
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Pelvic organ prolapse managed by vaginal pessary

Outcome Measures

Primary Outcomes (1)

• vaginal epithelial abnormalities

  this will be evaluated by vaginal examination at each study visit

  Routine group: change from baseline in vaginal epithelial abnormalities at 12 weeks, 24 weeks, 36 weeks, 48 weeks. Extended group: change from baseline in vaginal epithelial abnormalities at 24 weeks, 48 weeks

Secondary Outcomes (3)

• Patient satisfaction

  final study visit (48 weeks)

• Degree of bother due to vaginal discharge

  Routine group: change from baseline in degree of bother due to vaginal discharge at 12 weeks, 24 weeks, 36 weeks, 48 weeks. Extended group: change from baseline in degree of bother due to vaginal discharge at 24 weeks, 48 weeks

• Progression of Pelvic Organ Prolapse Quantification Score

  Change from baseline in pelvic organ prolapse quantification score at final study visit (48 weeks)

Study Arms (2)

Routine

NO INTERVENTION

Subjects will continue with regular pessary care every 12 weeks.

Extended

EXPERIMENTAL

Subjects will have extended time between pessary care visits which will occur every 24 weeks.

Other: Extended timing of pessary care

Interventions

Extended timing of pessary care OTHER

Extended

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Hartford Hospital: lead

Study Sites (1)

Hartford Hospital, Urogynecology Division

Hartford, Connecticut, 06106, United States

Location

Related Publications (2)

• Bugge C, Adams EJ, Gopinath D, Stewart F, Dembinsky M, Sobiesuo P, Kearney R. Pessaries (mechanical devices) for managing pelvic organ prolapse in women. Cochrane Database Syst Rev. 2020 Nov 18;11(11):CD004010. doi: 10.1002/14651858.CD004010.pub4.

  PMID: 33207004 DERIVED

• Propst K, Mellen C, O'Sullivan DM, Tulikangas PK. Timing of Office-Based Pessary Care: A Randomized Controlled Trial. Obstet Gynecol. 2020 Jan;135(1):100-105. doi: 10.1097/AOG.0000000000003580.

  PMID: 31809432 DERIVED

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fellow

Study Record Dates

• First Submitted: January 16, 2015
• First Posted: February 25, 2015
• Study Start: January 1, 2015
• Primary Completion: May 1, 2018
• Study Completion: June 1, 2018
• Last Updated: August 28, 2019

Record last verified: 2019-08

Locations

US (1)