The Purpose of This Study is to Look at Pelvic Support Problems, Also Commonly Known as Pelvic Organ Prolapse
| Status: | Completed |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/5/2014 |
| Start Date: | November 2008 |
| End Date: | November 2014 |
| Contact: | Trynisha Cheadle, LPN |
| Email: | trynisha-cheadle@ouhsc.edu |
| Phone: | 405-271-8001 |
FemmeJock: A Pilot Study to Assess Patient Satisfaction and Improvement of Pelvic Floor Symptoms Using a Pelvic Floor Support Girdle in Women With Uterovaginal Prolapse.
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.
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.
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 the OU Health Science Center. We will offer study participation to
patients who meet the inclusion criteria listed below, and who are: (1) awaiting surgical
management and desire a temporary nonsurgical option, (2) seeking permanent nonsurgical
treatment, or (3) who have a contraindication to surgical management.
of FemmeJock in patients with pelvic organ prolapse. We plan to enroll 30 patients who will
be recruited from the OU Health Science Center. We will offer study participation to
patients who meet the inclusion criteria listed below, and who are: (1) awaiting surgical
management and desire a temporary nonsurgical option, (2) seeking permanent nonsurgical
treatment, or (3) who have a contraindication to surgical management.
Inclusion Criteria:
- 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 Criteria:
- 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)
We found this trial at
1
site
940 NE 13th St
Oklahoma City, Oklahoma 73190
Oklahoma City, Oklahoma 73190
(405) 271-6458
University of Oklahoma Health Sciences Center The OU Health Sciences Center is composed of seven...
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