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

NCT00964197 | Completed DMC

• 1 other identifier: FemmeJock
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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. 1.to assess patient satisfaction and continuation of use of the FemmeJock support system after 3 months of treatment.
2. 2.to describe, if any, the reasons for discontinuation associated with the use of this product, and
3. 3.to assess whether women experience improvement of pelvic floor symptoms after using this product.

Conditions

Pelvic Organ Prolapse

Keywords

FemmeJock; Pelvic Organ Prolapse

Outcome Measures

Primary Outcomes (1)

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

  2 years

Secondary Outcomes (2)

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

  2 years

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

  2 years

Study Arms (1)

FemmeJock

EXPERIMENTAL

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

Interventions

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.

FemmeJock

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pelvic organ prolapse, \> stage II
• or more prolapse associated symptoms:
• Herniation symptoms
• Pelvic pressure
• Bulging tissue
• Sexual dysfunction
• Patient willingness to enroll
• Available for 3 months of follow-up

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Lieschen H. Quiroz, M.D.

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2009
• First Posted: August 24, 2009
• Study Start: November 1, 2008
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: March 5, 2021

Record last verified: 2021-03

Locations

US (1)