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

Lelo Inc.

Status: Completed

Conditions: Stress Urinary Incontinence; Sexual Dysfunction

Treatments: Device: Pelvic floor exerciser

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02617472

INT001KSUS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 93 patients

Sex: Female

Ages: 20 to 69 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. 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
2. Has had prior surgery for incontinence, prolapse or vaginal tightening
3. Has been diagnosed with pelvic organ prolapse more severe than grade 2
4. Suffers from vaginal penetration difficulties
5. Has had more than 3 urinary tract infections in the past 12 months
6. Has any conditions of the bladder that effect continence
7. Suffer from vaginal/vulvar/pelvic pain
8. Is currently taking any medication for incontinence
9. Is pregnant or trying to become pregnant
10. Has given birth less than 6 weeks prior to enrollment
11. Has been diagnosed obese - BMI > 30
12. Is a heavy smoker - > 20 cigarettes per day
13. Has a history of neurological conditions - Parkinson's, multiple sclerosis and other
14. Suffers from chronic constipation

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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93 participants in 1 patient group

Pelvic floor exercise

Experimental group

Description:

Pelvic floor exerciser, daily use

Treatment:

Device: Pelvic floor exerciser