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

NCT00964197 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-04-07

No results posted yet for this study

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.

Conditions

  • Pelvic Organ Prolapse

Interventions

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.

Sponsors & Collaborators

  • University of Oklahoma

    lead OTHER

Principal Investigators

  • Lieschen H. Quiroz, M.D. · University of Oklahoma

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2014-04-30
Completion
2014-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00964197 on ClinicalTrials.gov