Status:
COMPLETED
The Purpose of This Study is to Look at Pelvic Support Problems, Also Commonly Known as Pelvic Organ Prolapse
Lead Sponsor:
University of Oklahoma
Conditions:
Pelvic Organ Prolapse
Eligibility:
FEMALE
18-99 years
Phase:
NA
Brief Summary
FemmeJock is a pelvic floor support system developed by pelvic floor physiotherapists for patients with pelvic organ prolapse in order to ameliorate symptoms of pelvic floor pressure and discomfort. T...
Detailed Description
This will be a prospective pilot study in order to determine the efficacy and tolerability of FemmeJock in patients with pelvic organ prolapse. We plan to enroll 30 patients who will be recruited from...
Eligibility Criteria
Inclusion
- Pelvic organ prolapse, \> stage II
- 1 or more prolapse associated symptoms:
- Herniation symptoms
- Pelvic pressure
- Bulging tissue
- Sexual dysfunction
- Patient willingness to enroll
- Available for 3 months of follow-up
Exclusion
- Pregnancy or planning pregnancy within the next 3 months
- Perineal ulcers or trauma
- Anticipating relocation in next 3 months
- Current pessary use
- Dementia or inability to complete questionnaires
- Chronic inflammatory or infectious vulvar condition (i.e., dermatologic conditions: lichen sclerosis or lichen planus, or vulvar candidiasis)
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00964197
Start Date
November 1 2008
End Date
April 1 2014
Last Update
March 5 2021
Active Locations (1)
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1
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104