Clinical trial NCT00964197: The Purpose of This Study is to Look at Pelvic Support Problems, Also Commonly Known as Pelvic Organ Prolapse
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Organ Prolapse
Keywords: FemmeJock
Pelvic Organ Prolapse
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2009-08-24
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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. 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.

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 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.

Eligibility criteria: 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)

Primary outcomes:
measure: to assess patient satisfaction and continuation of use of the FemmeJock support system after 3 months of treatment.
timeFrame: 2 years
Secondary outcomes:
measure: To describe, if any, the reasons for discontinuation associated with the use of this product.
timeFrame: 2 years
measure: To assess whether women experience improvement of pelvic floor symptoms after using this product.
timeFrame: 2 years
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: Lieschen H. Quiroz, M.D.
role: PRINCIPAL_INVESTIGATOR
References: