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

Primary Purpose

Stress Urinary Incontinence, Sexual Dysfunction

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pelvic floor exerciser
Sponsored by
Lelo Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Urinary Incontinence

Eligibility Criteria

20 Years - 69 Years (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Banner University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pelvic floor exercise

Arm Description

Pelvic floor exerciser, daily use

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
October 30, 2015
Last Updated
August 10, 2017
Sponsor
Lelo Inc.
Collaborators
Banner Health
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1. Study Identification

Unique Protocol Identification Number
NCT02617472
Brief Title
Effectiveness of Kegel Exercise Device in Strengthening Pelvic Floor and Treating Urinary Incontinence (UI)
Official Title
Assessment of the Effectiveness of a Pelvic Exercise Device in Strengthening Pelvic Floor Muscles and Treating Urinary Incontinence
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
November 2015 (Actual)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lelo Inc.
Collaborators
Banner Health

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence, Sexual Dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
93 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pelvic floor exercise
Arm Type
Experimental
Arm Description
Pelvic floor exerciser, daily use
Intervention Type
Device
Intervention Name(s)
Pelvic floor exerciser
Other Intervention Name(s)
KegelSmart pelvic floor trainer
Intervention Description
Daily exercise using the study device
Primary Outcome Measure Information:
Title
Change in pelvic floor strength
Description
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 Outcome Measure Information:
Title
Frequency of bladder leaks.
Description
Reporting of weekly incidence of bladder leaks.
Time Frame
12 weeks
Title
Volume of bladder leaks
Description
Reporting of weekly average volume of bladder leaks.A subject assessment with very distinct category gradations.
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Subjective assessment of vaginal tightness
Description
Subjective assessment of increased vaginal tone.
Time Frame
12 weeks
Title
Subjective assessment of sexual sensations
Description
Subjective assessment based on questions that rate this quality of life parameter.
Time Frame
12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject provides written informed consent and HIPAA authorization before any study procedures are conducted; Experience urinary incontinence and/or vaginal laxity and/or decreased sexual sensation for a period of 6 weeks or more. Exclusion Criteria: 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 Has had prior surgery for incontinence, prolapse or vaginal tightening Has been diagnosed with pelvic organ prolapse more severe than grade 2 Suffers from vaginal penetration difficulties Has had more than 3 urinary tract infections in the past 12 months Has any conditions of the bladder that effect continence Suffer from vaginal/vulvar/pelvic pain Is currently taking any medication for incontinence Is pregnant or trying to become pregnant Has given birth less than 6 weeks prior to enrollment Has been diagnosed obese - BMI > 30 Is a heavy smoker - > 20 cigarettes per day Has a history of neurological conditions - Parkinson's, multiple sclerosis and other Suffers from chronic constipation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Debra Wickman, MD
Organizational Affiliation
FACOG
Official's Role
Principal Investigator
Facility Information:
Facility Name
Banner University Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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