The Purpose of This Study is to Look at Pelvic Support Problems, Also Commonly Known as Pelvic Organ Prolapse
Completed · Not applicable
Conditions studied: Pelvic Organ Prolapse
In brief
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. The device is a girdle to be worn on the outside of underwear. The device is machine washable and there are no documented risks with wearing it. This product is currently being used by pelvic floor physiotherapists and has been subjectively reported by individual accounts as being successful in improving pelvic floor symptoms. The efficacy of this product has not been previously studied in women with pelvic organ prolapse. The investigators are proposing a pilot study with the following specific aims: 1. to assess patient satisfaction and continuation of use of the FemmeJock support system after 3 months of treatment. 2. to describe, if any, the reasons for discontinuation associated with the use of this product, and 3. to assess whether women experience improvement of pelvic floor symptoms after using this product.
Key facts
- Study ID
- NCT00964197
- Run by
- University of Oklahoma
- People needed
- 100
- Starts
- 2008-11-01
- Expected to finish
- 2014-04-01
- Last updated by the study team
- 2026-04-07
Who can join
Age: 18 and older, up to 99. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
Full record on ClinicalTrials.gov
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