Pelvic Organ ProlapseEPICNCT01644214
Extended Pessary Interval for Care (EPIC Study)
A study testing 6 month follow up for pessary check in the clinic setting in people with Pelvic Organ Prolapse and Pessary, run by Unity Health Toronto at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Organ Prolapse, Pessary
- What is being tested?
- 6 month follow up for pessary check in the clinic setting
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2016to Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Canada1 site
Women's College Hospital/Mount Sinai Hospital
Toronto, Ontario, M5G 1Z5
About this study
Official title: Extended Pessary Interval for Care (EPIC Study): Patient Preference for 3 Verus 6 Month Follow-up
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
- Being tested
- 6 month follow up for pessary check in the clinic setting
- Keywords
- Pelvic organ prolapse, Pessary
- Medical subject headings
- Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6 month follow up for pessary check in the clinic settingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: 6 month follow up for pessary check in the clinic setting |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At 12 months from study enrollment
Secondary outcomes (1)
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.
Measured: Checked at all follow-up visits (3 and 6 months, depending on study group)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2012 (estimated)
- Study startNov 2016
- Primary completionNov 2019
- Study completionMar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Women's College Hospital, Mount Sinai Hospital, Canada
- Responsible party
- Sponsor
- Investigators
- Colleen D McDermott, MD, FRCSC, Principal investigator, St. Michael's Hospital, Women's College Hospital, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01644214
- Sponsor's protocol ID
- PessaryProtocol
- Acronym
- EPIC
- Status last verified
- Dec 2019
- First submitted
- 27 Jun 2012
- Last updated
- 4 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 9988790MacLennan 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.
PubMed 11192101Fernando 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.
PubMed 16816061Schaffer 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.
PubMed 16012231Atnip 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.
PubMed 19932415Pott-Grinstein E, Newcomer JR. Gynecologists' patterns of prescribing pessaries. J Reprod Med. 2001 Mar;46(3):205-8.
PubMed 11304859Thakar 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.
PubMed 12028982Sarma 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.
PubMed 19906018Powers 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.
PubMed 18441734Ko 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.
PubMed 21195956Lamers 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.
PubMed 21472447Wu 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.
PubMed 9397117Gorti 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.
PubMed 19274547Adams 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.
PubMed 15106231Crandall 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.
PubMed 12626086
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extended Pessary Interval for Care (EPIC Study): Patient Preference for 3 Verus 6 Month Follow-up
- ClinicalTrials.gov ID
- NCT01644214
- Acronym / sponsor ID
- EPIC / PessaryProtocol
- Conditions
- Pelvic Organ Prolapse, Pessary
- Keywords
- Pelvic organ prolapse, Pessary
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Collaborators
- Women's College Hospital, Mount Sinai Hospital, Canada
- Study start
- Nov 2016
- Primary completion
- Nov 2019 (actual)
- Study completion
- Mar 2020 (estimated)
- First posted
- 19 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: 6 month follow up for pessary check in the clinic settingThose that will be seen at 6 month follow-up visits for pessary maintenance will be considered the experimental group of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 6 month follow up for pessary check in the clinic settingThe 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. | Other | 6 month Pessary Check |
Primary outcome
Patient satisfaction
Time frame: At 6 months from study enrollment
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 months from study enrollment
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.
1 secondary outcome
Pessary associated complications
Time frame: Checked at all follow-up visits (3 and 6 months, depending on study group)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2019.
- Background: PubMed 9988790Samuelsson 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.
- Background: PubMed 11192101MacLennan 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.
- Background: PubMed 16816061Fernando 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.
- Background: PubMed 16012231Schaffer 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.
- Background: PubMed 19932415Atnip 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.
- Background: PubMed 11304859Pott-Grinstein E, Newcomer JR. Gynecologists' patterns of prescribing pessaries. J Reprod Med. 2001 Mar;46(3):205-8.
- Background: PubMed 12028982Thakar 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.
- Background: PubMed 19906018Sarma 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.
- Background: PubMed 18441734Powers 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.
- Background: PubMed 21195956Ko 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.
- Background: PubMed 21472447Lamers 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.
- Background: PubMed 9397117Wu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Colleen D McDermott, MD, FRCSC principal investigator
St. Michael's Hospital, Women's College Hospital, University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 6 month follow up for pessary check in the clinic setting in people with Pelvic Organ Prolapse and Pessary, run by Unity Health Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient satisfaction (time frame: At 6 months from study enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01644214, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2019.