Native Tissue Repair With Surgical Pelvic Organ Pessary - an RCT
NCT ID: NCT02808377
Last Updated: 2016-06-21
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
120 participants
INTERVENTIONAL
2016-06-30
2020-06-30
Brief Summary
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Detailed Description
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In this study a soft silicone support (SPOP) is inserted into the vagina straight after prolapse surgery. Women who have agreed to the study will be randomly chosen to have the SPOP at the time of surgery. There will be 120 patients in the study; so 60 women will have the SPOP inserted.
The investigators think that SPOP will support the vagina as it heals, improving the results of surgery. There are already some studies of the SPOP with other surgeries that show improved results. The SPOP is inserted while the patient is sleeping and is removed four weeks after surgery. It is attached with two dissolving stiches to the vagina. After four weeks is will be removed in the out patient clinic without any discomfort. It is not usually painful or uncomfortable at any time.
The actual surgery the women have will not be any different had they not been in the study. All the women in the study will have the normal assessment prior to their operation, and will fill out some questionnaires about their symptoms too. All women involved in the study will come back the clinic to be seen after six months, one year and two years from the date of the surgery. This is regardless of whether they had the SPOP or not. When the women return they will be examined and complete the questionnaires again each visit.
The results of the study will be reported and published.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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SPOP
This arm will have the soft silicone pessary inserted post operatively and it will remain in-situ for 3 weeks.
Surgical Pelvic Organ Pessary
In participants randomized to intervention, the SPOP will be placed at the completion of surgery, following routine placement of IDC and prior to placement of vaginal pack. The SPOP is available in 4 sizes and the surgeon will select the appropriate size so that the SPOP rests snugly without undue tension inside the hymeneal remnant. The SPOP is sutured in place with 2/0 Vicryl to prevent dislodgement at the level of the hymen.
Non Intervention
Routine post operative care
No interventions assigned to this group
Interventions
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Surgical Pelvic Organ Pessary
In participants randomized to intervention, the SPOP will be placed at the completion of surgery, following routine placement of IDC and prior to placement of vaginal pack. The SPOP is available in 4 sizes and the surgeon will select the appropriate size so that the SPOP rests snugly without undue tension inside the hymeneal remnant. The SPOP is sutured in place with 2/0 Vicryl to prevent dislodgement at the level of the hymen.
Eligibility Criteria
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Inclusion Criteria
* Currently on the hospital waiting list for vaginal native tissue repair
* Willingness to participate
* Medically fit for surgery
* 18 years or over
* Reasonable level of English to complete questionnaires
* Patients have not been recommended surgery that involves colpocliesis, mesh, or laparoscopic approach
Exclusion Criteria
* Refusal to participate
* Medically unfit for surgery
* Under 18
* Unable to complete questionnaires due to poor level of english
* Patients has been recommended surgery that involves colpocliesis, mesh, or laparoscopic approach
18 Years
FEMALE
Yes
Sponsors
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Cambridge University Hospitals NHS Foundation Trust
OTHER
Responsible Party
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Dr Ivilina Pandeva
Urogynaecology Subspecialist trainee
Locations
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Department of Urogynaecology
Cambridge, Cambridgeshire, United Kingdom
Countries
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Facility Contacts
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Other Identifiers
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A094029
Identifier Type: -
Identifier Source: org_study_id
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