Extended Pessary Interval for Care (EPIC Study)

Pelvic Organ Prolapse Clinical Trial

— EPIC  

Official title:

Extended Pessary Interval for Care (EPIC Study): Patient Preference for 3 Verus 6 Month Follow-up

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01644214
• Other study ID #: PessaryProtocol
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 2016
• Est. completion date: March 2020

Study information

• Verified date: December 2019
• Source: St. Michael's Hospital, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 13
• Est. completion date: March 2020
• Est. primary completion date: November 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion criteria:

• 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)

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Pessary
• Prolapse

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Canada	Women's College Hospital/Mount Sinai Hospital	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
St. Michael's Hospital, Toronto	Mount Sinai Hospital, Canada, Women's College Hospital

Country where clinical trial is conducted

Canada, 

References & Publications (15)

Adams E, Thomson A, Maher C, Hagen S. Mechanical devices for pelvic organ prolapse in women. Cochrane Database Syst Rev. 2004;(2):CD004010. Review. Update in: Cochrane Database Syst Rev. 2013;2:CD004010. — View Citation

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. — View Citation

Crandall C. Vaginal estrogen preparations: a review of safety and efficacy for vaginal atrophy. J Womens Health (Larchmt). 2002 Dec;11(10):857-77. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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

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. — View Citation

Samuelsson EC, Victor FT, Tibblin G, Svärdsudd 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. — View Citation

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. — View Citation

Schaffer JI, Wai CY, Boreham MK. Etiology of pelvic organ prolapse. Clin Obstet Gynecol. 2005 Sep;48(3):639-47. Review. — View Citation

Thakar R, Stanton S. Management of genital prolapse. BMJ. 2002 May 25;324(7348):1258-62. Review. — View Citation

Wu V, Farrell SA, Baskett TF, Flowerdew G. A simplified protocol for pessary management. Obstet Gynecol. 1997 Dec;90(6):990-4. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Pessary associated complications	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.	Checked at all follow-up visits (3 and 6 months, depending on study group)