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

Lelo Inc.93 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Stress Urinary Incontinence Sexual Dysfunction

Interventions

Pelvic floor exerciserDEVICE

Daily exercise using the study device

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 69 Years

Medical Language ↔ Plain English

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

Locations (1)

Banner University Medical Center

Phoenix, Arizona, United States

Outcomes

Primary Outcomes

Change in pelvic floor strength

Pelvic floor strength measured by a clinical perineometer in cm H2O. A baseline measurement of resting and peak muscle contraction values will be recorded at the start before the intervention and after the 12 weeks of treatment.

Time frame: 12 weeks

Secondary Outcomes

Frequency of bladder leaks.

Reporting of weekly incidence of bladder leaks.

Time frame: 12 weeks

Volume of bladder leaks

Reporting of weekly average volume of bladder leaks.A subject assessment with very distinct category gradations.

Time frame: 12 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.