The Purpose of This Study is to Look at Pelvic Support Problems, Also Commonly Known as Pelvic Organ Prolapse

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT00964197
First received: July 17, 2009
Last updated: May 5, 2014
Last verified: May 2014
  Purpose

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.

Condition Intervention
Pelvic Organ Prolapse
Device: FemmeJock

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by University of Oklahoma:

Primary Outcome Measures:
  • to assess patient satisfaction and continuation of use of the FemmeJock support system after 3 months of treatment. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To describe, if any, the reasons for discontinuation associated with the use of this product. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • To assess whether women experience improvement of pelvic floor symptoms after using this product. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: November 2008
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FemmeJock
The participant will be fitted with the girdle. The participant will use the girdle for the next 3 months. The girdle is only to be worn during the daytime during times of physical activity. The length of time you choose to wear it during the day is the patients choice. In two weeks the participant will be asked to fill out a 5 question survey in a follow up visit. The participant will be asked to return 3 months after wearing the FemmeJock girdle and to fill out a 5 question survey, as well as to complete a 20 question survey.
Device: FemmeJock
The participant will be fitted with the girdle. The participant will use the girdle for the next 3 months. The girdle is only to be worn during the daytime during times of physical activity. The length of time you choose to wear it during the day is the patients choice. In two weeks the participant will be asked to fill out a 5 question survey in a follow up visit. The participant will be asked to return 3 months after wearing the FemmeJock girdle and to fill out a 5 question survey, as well as to complete a 20 question survey.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00964197

Locations
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Sponsors and Collaborators
University of Oklahoma
Investigators
Principal Investigator: Lieschen H. Quiroz, M.D. University of Oklahoma
  More Information

No publications provided

Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT00964197     History of Changes
Other Study ID Numbers: FemmeJock
Study First Received: July 17, 2009
Last Updated: May 5, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Oklahoma:
FemmeJock
Pelvic Organ Prolapse

Additional relevant MeSH terms:
Prolapse
Pelvic Organ Prolapse
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on August 20, 2014