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

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.

Study Overview

• Status: Completed
• Conditions: Sexual Dysfunction; Stress Urinary Incontinence
• Intervention / Treatment: Device: Pelvic floor exerciser

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.

• Study Type: Interventional
• Enrollment (Actual): 93
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Banner University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 69 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Pelvic floor exercise; Pelvic floor exerciser, daily use	Device: Pelvic floor exerciser; Daily exercise using the study device; Other Names: KegelSmart pelvic floor trainer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of bladder leaks.	Reporting of weekly incidence of bladder leaks.	12 weeks
Volume of bladder leaks	Reporting of weekly average volume of bladder leaks.A subject assessment with very distinct category gradations.	12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective assessment of vaginal tightness	Subjective assessment of increased vaginal tone.	12 weeks
Subjective assessment of sexual sensations	Subjective assessment based on questions that rate this quality of life parameter.	12 weeks

Collaborators and Investigators

• Sponsor: Lelo Inc.
• Collaborators: Banner Health
• Investigators: Principal Investigator: Debra Wickman, MD, FACOG

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2015
• Primary Completion (ACTUAL): July 1, 2017
• Study Completion (ACTUAL): August 1, 2017

Study Registration Dates

• First Submitted: October 30, 2015
• First Submitted That Met QC Criteria: November 25, 2015
• First Posted (ESTIMATE): December 1, 2015

Study Record Updates

• Last Update Posted (ACTUAL): August 14, 2017
• Last Update Submitted That Met QC Criteria: August 10, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: INT001KSUS