Clinical trial NCT02617472: 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
Overall status: COMPLETED
Phase: NA
Conditions: Stress Urinary Incontinence
Sexual Dysfunction
Lead sponsor: Lelo Inc.
Sponsor class: INDUSTRY
Collaborators: name: Banner Health
First posted: 2015-12-01
Enrollment: 93
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in pelvic floor strength
timeFrame: 12 weeks
Secondary outcomes:
measure: Frequency of bladder leaks.
timeFrame: 12 weeks
measure: Volume of bladder leaks
timeFrame: 12 weeks
Other outcomes:
measure: Subjective assessment of vaginal tightness
timeFrame: 12 weeks
measure: Subjective assessment of sexual sensations
timeFrame: 12 weeks
Locations:
city: Phoenix
country: United States
facility: Banner University Medical Center
state: Arizona
Study officials:
affiliation: FACOG
name: Debra Wickman, MD
role: PRINCIPAL_INVESTIGATOR
References: