Status:
COMPLETED
An Intervention to Improve Prolapse Using Femmeze® (v1)
Lead Sponsor:
Royal Cornwall Hospitals Trust
Collaborating Sponsors:
Peninsula Health
Conditions:
Rectocele
Pelvic Organ Prolapse
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The main purpose of the feasibility study is to identify the patient experience of Femmeze® which is a device aimed at improving posterior vaginal compartment prolapse (rectocele) for women with obstr...
Detailed Description
Aim Evaluate the feasibility of the Femmeze® device to improve management of posterior vaginal compartment prolapse addressing implementation of the intervention and preliminary effectiveness. Object...
Eligibility Criteria
Inclusion
- Adult women (over 18 years of age) with symptoms of obstructive defaecation
- Not undergone posterior vaginal compartment prolapse surgery
Exclusion
- Cognitive impairment
- Hand disability
- Refuse to give informed consent
- Pregnancy
- Less than 12 weeks post-partum
- Neurological disease
Key Trial Info
Start Date :
October 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2019
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT02280382
Start Date
October 1 2015
End Date
March 1 2019
Last Update
March 29 2019
Active Locations (1)
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1
RoyalCornwallHT
Truro, United Kingdom, TR1 3JL