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

Pelvic Organ Prolapse Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00964197
• Other study ID #: FemmeJock
• Status: Completed
• Phase: N/A
• Start date: November 2008
• Est. completion date: April 2014

Study information

• Verified date: March 2021
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 99 Years

Eligibility

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)

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Intervention

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.

Locations

Country	Name	City	State
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	to assess patient satisfaction and continuation of use of the FemmeJock support system after 3 months of treatment.		2 years
Secondary	To describe, if any, the reasons for discontinuation associated with the use of this product.		2 years
Secondary	To assess whether women experience improvement of pelvic floor symptoms after using this product.		2 years