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

Primary Purpose

Pelvic Organ Prolapse

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
FemmeJock
Sponsored by
University of Oklahoma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Pelvic Organ Prolapse focused on measuring FemmeJock, Pelvic Organ Prolapse

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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)

Sites / Locations

  • University of Oklahoma Health Sciences Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FemmeJock

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

To describe, if any, the reasons for discontinuation associated with the use of this product.
To assess whether women experience improvement of pelvic floor symptoms after using this product.

Full Information

First Posted
July 17, 2009
Last Updated
March 4, 2021
Sponsor
University of Oklahoma
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1. Study Identification

Unique Protocol Identification Number
NCT00964197
Brief Title
The Purpose of This Study is to Look at Pelvic Support Problems, Also Commonly Known as Pelvic Organ Prolapse
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.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oklahoma

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Organ Prolapse
Keywords
FemmeJock, Pelvic Organ Prolapse

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FemmeJock
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
FemmeJock
Intervention Description
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 Outcome Measure Information:
Title
to assess patient satisfaction and continuation of use of the FemmeJock support system after 3 months of treatment.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
To describe, if any, the reasons for discontinuation associated with the use of this product.
Time Frame
2 years
Title
To assess whether women experience improvement of pelvic floor symptoms after using this product.
Time Frame
2 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lieschen H. Quiroz, M.D.
Organizational Affiliation
University of Oklahoma
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States

12. IPD Sharing Statement

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

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