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

Stress Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02617472
• Other study ID #: INT001KSUS
• Status: Completed
• Phase: N/A
• First received: October 30, 2015
• Last updated: August 10, 2017
• Start date: November 2015
• Est. completion date: August 2017

Study information

• Verified date: August 2017
• Source: Lelo Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: August 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Sexual Dysfunction
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Device:
• Pelvic floor exerciser
Daily exercise using the study device

Locations

Country	Name	City	State
United States	Banner University Medical Center	Phoenix	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Lelo Inc.	Banner Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Subjective assessment of vaginal tightness	Subjective assessment of increased vaginal tone.	12 weeks
Other	Subjective assessment of sexual sensations	Subjective assessment based on questions that rate this quality of life parameter.	12 weeks
Primary	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.	12 weeks
Secondary	Frequency of bladder leaks.	Reporting of weekly incidence of bladder leaks.	12 weeks
Secondary	Volume of bladder leaks	Reporting of weekly average volume of bladder leaks.A subject assessment with very distinct category gradations.	12 weeks