Skip to main content
OpenTrials
Completed

NCT Number: NCT00964197

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pelvic Organ Prolapse Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Prolapse

Age range

18 year–99 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

FemmeJock

Device

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.

Primary outcomes

  1. to assess patient satisfaction and continuation of use of the FemmeJock support system after 3 months of treatment.

    Time frame: 2 years

Secondary outcomes

  1. To describe, if any, the reasons for discontinuation associated with the use of this product.

    Time frame: 2 years

  2. To assess whether women experience improvement of pelvic floor symptoms after using this product.

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Registry information

Official study 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.

Important dates

Study start
2008
Primary completion
2014
Study completion
2014
First posted
Aug 24, 2009
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.