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Timing of Pessary Care

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ClinicalTrials.gov Identifier: NCT02371083
Recruitment Status : Completed
First Posted : February 25, 2015
Last Update Posted : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
Katie Propst, MD, Hartford Hospital

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.

Condition or disease Intervention/treatment Phase
Pelvic Organ Prolapse Other: Extended timing of pessary care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Timing of Pessary Care
Actual Study Start Date : January 2015
Actual Primary Completion Date : May 2018
Actual Study Completion Date : June 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Routine
Subjects will continue with regular pessary care every 12 weeks.
Experimental: Extended
Subjects will have extended time between pessary care visits which will occur every 24 weeks.
Other: Extended timing of pessary care



Primary Outcome Measures :
  1. vaginal epithelial abnormalities [ Time Frame: 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 ]
    this will be evaluated by vaginal examination at each study visit


Secondary Outcome Measures :
  1. Patient satisfaction [ Time Frame: final study visit (48 weeks) ]
    this will be evaluated at the final visit by asking patients if they preferred more or less frequent pessary visits

  2. Degree of bother due to vaginal discharge [ Time Frame: 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 ]
    this will be assessed by asking participants how bothersome is vaginal discharge on a 5-point likert scale

  3. Progression of Pelvic Organ Prolapse Quantification Score [ Time Frame: Change from baseline in pelvic organ prolapse quantification score at final study visit (48 weeks) ]
    this will be evaluated by measuring a pelvic organ prolapse quantification score on physical examination



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02371083


Locations
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United States, Connecticut
Hartford Hospital, Urogynecology Division
Hartford, Connecticut, United States, 06106
Sponsors and Collaborators
Hartford Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Katie Propst, MD, Fellow, Hartford Hospital
ClinicalTrials.gov Identifier: NCT02371083    
Other Study ID Numbers: HHC-2014-0112
First Posted: February 25, 2015    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019
Keywords provided by Katie Propst, MD, Hartford Hospital:
Pelvic organ prolapse managed by vaginal pessary
Additional relevant MeSH terms:
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Prolapse
Pelvic Organ Prolapse
Pathological Conditions, Anatomical