Timing of Pessary Follow-up for Pelvic Organ Prolapse

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by St. Michael's Hospital, Toronto.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:
NCT01644214
First received: June 27, 2012
Last updated: July 16, 2012
Last verified: June 2012
  Purpose

Objectives: Pelvic organ prolapse (POP) is a common condition for which pessaries are commonly used in conservative treatment. Despite their prevalence, there is no literature to guide the management of pessaries. Our objective is to determine whether patients managed with a pessary for POP are more satisfied with follow-up at 6 or 12 week intervals and if there is any difference in complications rates between the two groups.

Hypothesis: The investigators hypothesize that there will be higher patient satisfaction in the group randomized to 12 week follow-up intervals and that there will be no difference in complication rates between the two follow-up groups.

Method: The investigators will conduct a prospective randomized control trial comparing patient satisfaction and complication rates between patients with pessaries randomized to either 6 or 12 week follow-up intervals over 1 year.


Condition Intervention
Pelvic Organ Prolapse
Pessary
Other: 12 week follow up for pessary check in the clinic setting

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Timing of Pessary Follow-up for Pelvic Organ Prolapse: Patient Preference and Complication Rates

Resource links provided by NLM:


Further study details as provided by St. Michael's Hospital, Toronto:

Primary Outcome Measures:
  • Patient satisfaction [ Time Frame: At 6 months from study enrollment ] [ Designated as safety issue: No ]
    To determine if patients managed with a pessary for POP are more satisfied with follow-up at 6 or 12 weeks over a one year period.

  • Patient satisfaction [ Time Frame: At 12 monhs from study enrollment ] [ Designated as safety issue: No ]
    To determine if patients managed with a pessary for POP are more satisfied with follow-up at 6 or 12 weeks over a one year period.


Secondary Outcome Measures:
  • Pessary associated complications [ Time Frame: Checked at all follow-up visits (6 and 12 weeks, depending on study group) ] [ Designated as safety issue: Yes ]
    To determine if there is a difference in complication rates associated with indwelling pessaries between those that are seen at 6 week intervals and those that are seen at 12 week intervals, over a one year time period.


Estimated Enrollment: 70
Study Start Date: September 2012
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Pessary Check at 6 weeks
Patients seen at 6 week intervals for pessary check-ups is the most common interval check in our clinic so this arm is considered the control group.
Experimental: 12 Week Pessary Check
Those that will be seen at 12 week follow-up visits for pessary maintenance will be considered the experimental group of the study.
Other: 12 week follow up for pessary check in the clinic setting
The standard of care is considered to be pessary checks every 6 weeks, therefore those that are checked every 12 weeks will be considered to be in the intervention group.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients seen at SMH successfully fitted with a pessary for management of symptomatic POP will be eligible, females over the age of 18, able to read and write English.

Exclusion Criteria:

  • Current presence of vaginal bleeding, vaginal abrasions or ulcers, or vaginal infection;
  • significant cognitive impairment;
  • pessary used for indication other than POP;
  • use of a cube pessary; contraindications to vaginal estrogen;
  • unsuccessful pessary fitting (successful defined as: no expulsion on movement, squatting or valsalva, no urinary retention, no discomfort, and still retained pessary after 2 weeks);
  • patients that have had a successful pessary fitting but are doing their own pessary maintenance at home and do not require regular follow-up at the clinic for this device.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01644214

Contacts
Contact: Colleen D McDermott, MD, FRCSC 416-864-6060 ext 6623 colleen.mcdermott@utoronto.ca
Contact: Genevieve Lennox, MD 416-685-4500 genevieve.lennox@utoronto.ca

Locations
Canada, Ontario
St. Michael's Hospital
Toronto, Ontario, Canada, M5C 1R6
Sponsors and Collaborators
St. Michael's Hospital, Toronto
Investigators
Principal Investigator: Colleen D McDermott, MD, FRCSC St. Michael's Hospital, University of Toronto
  More Information

Publications:

Responsible Party: St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT01644214     History of Changes
Other Study ID Numbers: PessaryProtocol
Study First Received: June 27, 2012
Last Updated: July 16, 2012
Health Authority: Canada: Health Canada

Keywords provided by St. Michael's Hospital, Toronto:
Pelvic organ prolapse
Pessary

Additional relevant MeSH terms:
Prolapse
Pelvic Organ Prolapse
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on September 16, 2014