The Purpose of This Study is to Look at Pelvic Support Problems, Also Commonly Known as Pelvic Organ Prolapse
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Pelvic Organ Prolapse |
Device: FemmeJock |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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. |
- to assess patient satisfaction and continuation of use of the FemmeJock support system after 3 months of treatment. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- To describe, if any, the reasons for discontinuation associated with the use of this product. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- To assess whether women experience improvement of pelvic floor symptoms after using this product. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 30 |
| Study Start Date: | November 2008 |
| Estimated Study Completion Date: | November 2014 |
| Estimated Primary Completion Date: | November 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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.
|
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.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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)
Contacts and Locations| Contact: Michelle Davis, RN | 405-271-8001 ext 48285 | michelle-davis@ouhsc.edu |
| Contact: Christy Zornes, MHR | 405-271-8001 ext 48137 | christina-zornes@ouhsc.edu |
| United States, Oklahoma | |
| University of Oklahoma Health Sciences Center | Recruiting |
| Oklahoma City, Oklahoma, United States, 73104 | |
| Principal Investigator: Lieschen H Quiroz | |
| Principal Investigator: | Lieschen H. Quiroz, M.D. | University of Oklahoma |
More Information
No publications provided
| Responsible Party: | University of Oklahoma |
| ClinicalTrials.gov Identifier: | NCT00964197 History of Changes |
| Other Study ID Numbers: | FemmeJock |
| Study First Received: | July 17, 2009 |
| Last Updated: | February 4, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Oklahoma:
|
FemmeJock Pelvic Organ Prolapse |
Additional relevant MeSH terms:
|
Prolapse Pelvic Organ Prolapse Pathological Conditions, Anatomical |
ClinicalTrials.gov processed this record on May 19, 2013