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

NCT02617472 | Completed

• 1 other identifier: INT001KSUS
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress Urinary Incontinence; Sexual Dysfunction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Frequency of bladder leaks.

  12 weeks

• Volume of bladder leaks

  12 weeks

Other Outcomes (2)

• Subjective assessment of vaginal tightness

  12 weeks

• Subjective assessment of sexual sensations

  12 weeks

Study Arms (1)

Pelvic floor exercise

EXPERIMENTAL

Pelvic floor exerciser, daily use

Device: Pelvic floor exerciser

Interventions

Pelvic floor exerciser DEVICE

Daily exercise using the study device

Also known as: KegelSmart pelvic floor trainer

Pelvic floor exercise

Eligibility Criteria

• Age: 20 Years - 69 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Lelo Inc.: lead
• Banner Health: collaborator

Study Sites (1)

Banner University Medical Center

Phoenix, Arizona, 85006, United States

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress; Sexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Genital Diseases

Study Officials

• Debra Wickman, MD

  FACOG

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2015
• First Posted: December 1, 2015
• Study Start: November 1, 2015
• Primary Completion: July 1, 2017
• Study Completion: August 1, 2017
• Last Updated: August 14, 2017

Record last verified: 2017-08

Locations

US (1)