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

NCT ID: NCT02617472

Last Updated: 2017-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 93 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2017-08-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pelvic floor exercise

Pelvic floor exerciser, daily use

Group Type: EXPERIMENTAL

Pelvic floor exerciser

Intervention Type: DEVICE

Daily exercise using the study device

Interventions

Pelvic floor exerciser

Daily exercise using the study device

Intervention Type: DEVICE

Other Intervention Names

KegelSmart pelvic floor trainer

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Banner Health

OTHER

Sponsor Role: collaborator

Lelo Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Debra Wickman, MD

Role: PRINCIPAL_INVESTIGATOR

FACOG

Locations

Banner University Medical Center

Phoenix, Arizona, United States

Countries

United States

Other Identifiers

INT001KSUS

Identifier Type: -

Identifier Source: org_study_id