Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
13 participants
INTERVENTIONAL
2016-11-30
2020-03-31
Brief Summary
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Hypothesis: The investigators hypothesize that there will be higher patient satisfaction in the group randomized to 6 month 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 3 or 6 month follow-up intervals over 1 year.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Pessary Check at 3 months
Patients seen at 3 month intervals for pessary check-ups is the most common interval check in our clinic so this arm is considered the control group.
No interventions assigned to this group
6 month Pessary Check
Those that will be seen at 6 month follow-up visits for pessary maintenance will be considered the experimental group of the study.
6 month follow up for pessary check in the clinic setting
The standard of care is considered to be pessary checks every 3 months, therefore those that are checked every 6 months will be considered to be in the intervention group.
Interventions
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6 month follow up for pessary check in the clinic setting
The standard of care is considered to be pessary checks every 3 months, therefore those that are checked every 6 months will be considered to be in the intervention group.
Eligibility Criteria
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Inclusion Criteria
* Able to read and write English
* First time pessary users
* Successful fitting with a covered ring or Gellhorn pessary, as determined at the usual early follow-up visit 2-4 weeks after initial fitting (successful defined as: no expulsion on movement, squatting or valsalva, no urinary retention, no discomfort, and still retained pessary after 2 weeks)
* Patients agree to use vaginal estrogen (either tablet or cream twice weekly) during the study period; patients may not use a vaginal estrogen ring since this requires changing every 3 months, and will interfere with the study follow-up schedule
Exclusion Criteria
* Significant cognitive impairment
* Pessary used for indication other than POP (ie. urinary incontinence)
* Use of a pessary that is not a covered ring or Gellhorn (i.e exclude cube, donut, etc.)
* 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)
18 Years
FEMALE
No
Sponsors
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Women's College Hospital
OTHER
Mount Sinai Hospital, Canada
OTHER
Unity Health Toronto
OTHER
Responsible Party
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Principal Investigators
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Colleen D McDermott, MD, FRCSC
Role: PRINCIPAL_INVESTIGATOR
St. Michael's Hospital, Women's College Hospital, University of Toronto
Locations
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Women's College Hospital/Mount Sinai Hospital
Toronto, Ontario, Canada
Countries
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References
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Samuelsson EC, Victor FT, Tibblin G, Svardsudd KF. Signs of genital prolapse in a Swedish population of women 20 to 59 years of age and possible related factors. Am J Obstet Gynecol. 1999 Feb;180(2 Pt 1):299-305. doi: 10.1016/s0002-9378(99)70203-6.
MacLennan AH, Taylor AW, Wilson DH, Wilson D. The prevalence of pelvic floor disorders and their relationship to gender, age, parity and mode of delivery. BJOG. 2000 Dec;107(12):1460-70. doi: 10.1111/j.1471-0528.2000.tb11669.x.
Fernando RJ, Thakar R, Sultan AH, Shah SM, Jones PW. Effect of vaginal pessaries on symptoms associated with pelvic organ prolapse. Obstet Gynecol. 2006 Jul;108(1):93-9. doi: 10.1097/01.AOG.0000222903.38684.cc.
Schaffer JI, Wai CY, Boreham MK. Etiology of pelvic organ prolapse. Clin Obstet Gynecol. 2005 Sep;48(3):639-47. doi: 10.1097/01.grf.0000170428.45819.4e. No abstract available.
Atnip SD. Pessary use and management for pelvic organ prolapse. Obstet Gynecol Clin North Am. 2009 Sep;36(3):541-63. doi: 10.1016/j.ogc.2009.08.010.
Pott-Grinstein E, Newcomer JR. Gynecologists' patterns of prescribing pessaries. J Reprod Med. 2001 Mar;46(3):205-8.
Thakar R, Stanton S. Management of genital prolapse. BMJ. 2002 May 25;324(7348):1258-62. doi: 10.1136/bmj.324.7348.1258. No abstract available.
Sarma S, Ying T, Moore KH. Long-term vaginal ring pessary use: discontinuation rates and adverse events. BJOG. 2009 Dec;116(13):1715-21. doi: 10.1111/j.1471-0528.2009.02380.x.
Powers K, Grigorescu B, Lazarou G, Greston WM, Weber T. Neglected pessary causing a rectovaginal fistula: a case report. J Reprod Med. 2008 Mar;53(3):235-7.
Ko PC, Lo TS, Tseng LH, Lin YH, Liang CC, Lee SJ. Use of a pessary in treatment of pelvic organ prolapse: quality of life, compliance, and failure at 1-year follow-up. J Minim Invasive Gynecol. 2011 Jan-Feb;18(1):68-74. doi: 10.1016/j.jmig.2010.09.006.
Lamers BH, Broekman BM, Milani AL. Pessary treatment for pelvic organ prolapse and health-related quality of life: a review. Int Urogynecol J. 2011 Jun;22(6):637-44. doi: 10.1007/s00192-011-1390-7. Epub 2011 Apr 7.
Wu V, Farrell SA, Baskett TF, Flowerdew G. A simplified protocol for pessary management. Obstet Gynecol. 1997 Dec;90(6):990-4. doi: 10.1016/s0029-7844(97)00481-x.
Gorti M, Hudelist G, Simons A. Evaluation of vaginal pessary management: a UK-based survey. J Obstet Gynaecol. 2009 Feb;29(2):129-31. doi: 10.1080/01443610902719813.
Adams E, Thomson A, Maher C, Hagen S. Mechanical devices for pelvic organ prolapse in women. Cochrane Database Syst Rev. 2004;(2):CD004010. doi: 10.1002/14651858.CD004010.pub2.
Crandall C. Vaginal estrogen preparations: a review of safety and efficacy for vaginal atrophy. J Womens Health (Larchmt). 2002 Dec;11(10):857-77. doi: 10.1089/154099902762203704.
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.
Other Identifiers
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PessaryProtocol
Identifier Type: -
Identifier Source: org_study_id
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