NCT02617472

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

Assessment of the Effectiveness of a Pelvic Exercise Device in Strengthening Pelvic Floor Muscles and Treating Urinary Incontinence

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 93 (actual)
• Sponsor: Lelo Inc. · Industry
• Sex: Female
• Age: 20 Years – 69 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The objective of the study is to test the device with women who are experiencing symptoms of pelvic floor weakness, namely urinary incontinence, vaginal laxity and sexual sensation problems, to assess the changes in pelvic floor muscle strength, before and after the intervention. The study device is a pelvic floor exercise device that provides biofeedback and exercise guidance. Women who meet the inclusion criteria will be recruited from the regular patients at the investigation site and given the device to use at home daily for 12 weeks. Subjects will submit information regarding their experience with the device and self-assessed improvements in their symptoms. A pelvic examination will be conducted at the start and conclusion of the study to measure a pelvic floor muscle strength reading. The research hypothesis is that strength level, subjective assessment of vaginal tightness and sexual sensations will be greater at the end of the study than at the baseline and the mean value of frequency and volume of bladder leaks will be less than at the baseline.

Conditions

• Stress Urinary Incontinence
• Sexual Dysfunction

Interventions

Type	Name	Description
DEVICE	Pelvic floor exerciser	Daily exercise using the study device

Timeline

• Start date: 2015-11-01
• Primary completion: 2017-07-01
• Completion: 2017-08-01
• First posted: 2015-12-01
• Last updated: 2017-08-14

Locations

1 site across 1 country: United States