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NCT00964197 · ClinicalTrials.gov registry record · NA

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

A NA study of Pelvic Organ Prolapse, sponsored by University of Oklahoma.

Completed
Registry status
NA
Development phase
100
Enrollment target
1
Study location

NCT00964197 is a NA study of Pelvic Organ Prolapse that has completed, run by University of Oklahoma. The registered enrollment target is 100 participants, below the 143-participant average among 40 other Pelvic Organ Prolapse trials with a reported enrollment target (30% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00964197, a NA study of Pelvic Organ Prolapse, has completed, sponsored by University of Oklahoma.

COMPLETED
Registry status
NA
Development phase
100 participants
Enrollment target
1
Study location

Study 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.

Conditions Studied

Interventions

  • DEVICE FemmeJock

Study Locations (1)

Oklahoma

  • University of Oklahoma Health Sciences Center - Oklahoma City

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2008-11
Est. Completion 2014-04
Phase NA

Sponsor

University of Oklahoma

358 total trials

What the Registry Record Tells You About NCT00964197

The ClinicalTrials.gov registry entry for NCT00964197 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 143-participant average among 40 other Pelvic Organ Prolapse trials with a reported enrollment target (30% lower). The listed sponsor is University of Oklahoma, which has 358 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Pelvic Organ Prolapse appearing as the primary indexed condition, and to 1 intervention - of which FemmeJock is the first listed.

NCT00964197 reports 1 study location spanning 1 distinct geographic area - top geographies include Oklahoma.

Frequently Asked Questions

What is clinical trial NCT00964197 about?

NCT00964197 is a clinical study titled "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 the...

What is the current status of trial NCT00964197?

This trial is currently completed. It is a NA study. The enrollment target is 100 participants. The study started on 2008-11. Estimated completion is 2014-04.

What conditions does trial NCT00964197 study?

This clinical trial studies the following conditions: Pelvic Organ Prolapse.

What interventions are being tested in trial NCT00964197?

The interventions under investigation include: FemmeJock (DEVICE).

Who is sponsoring clinical trial NCT00964197?

This trial is sponsored by University of Oklahoma, which has 358 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00964197 being conducted?

This trial has 1 study location across Oklahoma. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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