Extended Pessary Interval for Care (EPIC Study)

NCT01644214 | Unknown

• 1 other identifier: PessaryProtocol
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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 3 or 6 month 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 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.

Conditions

Pelvic Organ Prolapse; Pessary

Keywords

Pelvic organ prolapse; Pessary

Outcome Measures

Primary Outcomes (2)

• Patient satisfaction

  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.

  At 6 months from study enrollment

• Patient satisfaction

  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.

  At 12 months from study enrollment

Secondary Outcomes (1)

• Pessary associated complications

  Checked at all follow-up visits (3 and 6 months, depending on study group)

Study Arms (2)

Pessary Check at 3 months

NO INTERVENTION

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.

6 month Pessary Check

EXPERIMENTAL

Those that will be seen at 6 month follow-up visits for pessary maintenance will be considered the experimental group of the study.

Other: 6 month follow up for pessary check in the clinic setting

Interventions

6 month follow up for pessary check in the clinic setting OTHER

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.

6 month Pessary Check

Eligibility Criteria

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

You may qualify if:

• Females with POP who have opted for conservative management with a pessary
• 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

You may not qualify if:

• Current presence of vaginal bleeding, vaginal abrasions or ulcers, or vaginal infection
• 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)

Sponsors & Collaborators

• Unity Health Toronto: lead
• Women's College Hospital: collaborator
• Mount Sinai Hospital, Canada: collaborator

Study Sites (1)

Women's College Hospital/Mount Sinai Hospital

Toronto, Ontario, M5G 1Z5, Canada

Location

Related Publications (16)

• 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.

  PMID: 9988790 BACKGROUND

• 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.

  PMID: 11192101 BACKGROUND

• 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.

  PMID: 16816061 BACKGROUND

• 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.

  PMID: 16012231 BACKGROUND

• 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.

  PMID: 19932415 BACKGROUND

• Pott-Grinstein E, Newcomer JR. Gynecologists' patterns of prescribing pessaries. J Reprod Med. 2001 Mar;46(3):205-8.

  PMID: 11304859 BACKGROUND

• 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.

  PMID: 12028982 BACKGROUND

• 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.

  PMID: 19906018 BACKGROUND

• 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.

  PMID: 18441734 BACKGROUND

• 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.

  PMID: 21195956 BACKGROUND

• 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.

  PMID: 21472447 BACKGROUND

• 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.

  PMID: 9397117 BACKGROUND

• 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.

  PMID: 19274547 BACKGROUND

• 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.

  PMID: 15106231 BACKGROUND

• 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.

  PMID: 12626086 BACKGROUND

• 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

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

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

Study Officials

• Colleen D McDermott, MD, FRCSC

  St. Michael's Hospital, Women's College Hospital, University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2012
• First Posted: July 19, 2012
• Study Start: November 1, 2016
• Primary Completion: November 1, 2019
• Study Completion: March 1, 2020
• Last Updated: December 4, 2019

Record last verified: 2019-12

Locations

CA (1)