Back to results

Extended Pessary Interval for Care (EPIC Study) (EPIC)

Primary Purpose

Pelvic Organ Prolapse, Pessary

Status

Unknown status

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

6 month follow up for pessary check in the clinic setting

About this trial

This is an interventional treatment trial for Pelvic Organ Prolapse focused on measuring Pelvic organ prolapse, Pessary

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

Women's College Hospital/Mount Sinai Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Pessary Check at 3 months

6 month Pessary Check

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT01644214

First Posted

June 27, 2012

Last Updated

December 3, 2019

Sponsor

Unity Health Toronto

Collaborators

Women's College Hospital, Mount Sinai Hospital, Canada

1. Study Identification

Unique Protocol Identification Number

NCT01644214

Brief Title

Extended Pessary Interval for Care (EPIC Study)

Acronym

EPIC

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2019

Overall Recruitment Status

Unknown status

Study Start Date

November 2016 (undefined)

Primary Completion Date

November 2019 (Actual)

Study Completion Date

March 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Unity Health Toronto

Collaborators

Women's College Hospital, Mount Sinai Hospital, Canada

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pelvic Organ Prolapse, Pessary

Keywords

Pelvic organ prolapse, Pessary

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

13 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Pessary Check at 3 months

Arm Type

No Intervention

Arm Description

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.

Arm Title

6 month Pessary Check

Arm Type

Experimental

Arm Description

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

Intervention Type

Other

Intervention Name(s)

6 month follow up for pessary check in the clinic setting

Intervention Description

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.

Primary Outcome Measure Information:

Title

Patient satisfaction

Description

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.

Time Frame

At 6 months from study enrollment

Title

Patient satisfaction

Description

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.

Time Frame

At 12 months from study enrollment

Secondary Outcome Measure Information:

Title

Pessary associated complications

Description

Time Frame

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

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Colleen D McDermott, MD, FRCSC

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

Women's College Hospital/Mount Sinai Hospital

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 1Z5

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

9988790

Citation

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.

Results Reference

background

PubMed Identifier

11192101

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. doi: 10.1111/j.1471-0528.2000.tb11669.x.

Results Reference

background

PubMed Identifier

16816061

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. doi: 10.1097/01.AOG.0000222903.38684.cc.

Results Reference

background

PubMed Identifier

16012231

Citation

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.

Results Reference

background

PubMed Identifier

19932415

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.

Results Reference

background

PubMed Identifier

11304859

Citation

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

Results Reference

background

PubMed Identifier

12028982

Citation

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.

Results Reference

background

PubMed Identifier

19906018

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.

Results Reference

background

PubMed Identifier

18441734

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.

Results Reference

background

PubMed Identifier

21195956

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.

Results Reference

background

PubMed Identifier

21472447

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.

Results Reference

background

PubMed Identifier

9397117

Citation

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.

Results Reference

background

PubMed Identifier

19274547

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.

Results Reference

background

PubMed Identifier

15106231

Citation

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.

Results Reference

background

PubMed Identifier

12626086

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. doi: 10.1089/154099902762203704.

Results Reference

background

PubMed Identifier

33207004

Citation

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.

Results Reference

derived

Learn more about this trial

Extended Pessary Interval for Care (EPIC Study)

We'll reach out to this number within 24 hrs