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Athena Pelvic Muscle Trainer - DUETS Trial

NCT01073878 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 462

Last updated 2011-07-14

No results posted yet for this study

Summary

The purpose of this study is to determine if the Athena Pelvic Muscle Trainer device effectively treats stress, urge or mixed incontinence in women by strengthening the pelvic floor muscles by collecting data from the patient on the

1. Over Active Bladder Questionnaire
2. The 7-Day Urine Diary questionnaire

This study will also look at whether or not there is an improvement in sexual health after using the device by collecting data frm the patient on the
3. Female Sexual Function Index questionnaire

Conditions

Interventions

DEVICE

Athena Pelvic Muscle Trainer

The Athena PMT is a vaginally inserted electrical stimulator that induces the pelvic floor muscles to contract and relax, similar to Kegel exercises intended to strengthen the pelvic floor muscles.

Sponsors & Collaborators

  • Athena Feminine Technologies, Inc.

    lead INDUSTRY

Principal Investigators

  • Julia Shaw, MD · Director of Women's Health, Yale University

Study Design

Allocation
NA
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2011-06-30
Completion
2011-06-30

Countries

  • United States
  • Virgin Islands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01073878 on ClinicalTrials.gov