Effectiveness of Kegel Exercise Device in Strengthening Pelvic Floor and Treating Urinary Incontinence (UI)

Completed · Not applicable

Conditions studied: Stress Urinary Incontinence, Sexual Dysfunction

In brief

This study will assess the effectiveness of a new pelvic floor exercise device in strengthening pelvic floor muscles and treating urinary incontinence among women who are experiencing symptoms of pelvic floor weakness. The study will be conducted over 12 weeks and results will be collected through self-assessment questionnaires and clinical pelvic examination. Effectiveness outcomes will be tracked over the duration of the trial and measured against historical symptoms.

Key facts

Study ID

NCT02617472

Run by

Lelo Inc.

People needed

93

Starts

2015-11-01

Expected to finish

2017-08-01

Last updated by the study team

2017-08-14

Who can join

Age: 20 and older, up to 69. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Subject provides written informed consent and HIPAA authorization before any study procedures are conducted;
• Experience urinary incontinence and/or vaginal laxity and/or decreased sexual sensation for a period of 6 weeks or more.

You may not qualify if…

• Subject has any condition or exhibits behavior that indicates to the Principal Investigator that the Subject is unlikely to be compliant with study procedures and visits
• Has had prior surgery for incontinence, prolapse or vaginal tightening
• Has been diagnosed with pelvic organ prolapse more severe than grade 2
• Suffers from vaginal penetration difficulties
• Has had more than 3 urinary tract infections in the past 12 months
• Has any conditions of the bladder that effect continence
• Suffer from vaginal/vulvar/pelvic pain
• Is currently taking any medication for incontinence
• Is pregnant or trying to become pregnant
• Has given birth less than 6 weeks prior to enrollment
• Has been diagnosed obese - BMI > 30
• Is a heavy smoker - > 20 cigarettes per day
• Has a history of neurological conditions - Parkinson's, multiple sclerosis and other
• Suffers from chronic constipation

Where it is running

• Banner University Medical Center — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.