Stress Urinary IncontinenceNCT02617472
Effectiveness of Kegel Exercise Device in Strengthening Pelvic Floor and Treating Urinary Incontinence (UI)
A study testing Pelvic floor exerciser in people with Stress Urinary Incontinence and Sexual Dysfunction, run by Lelo Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 69 years, women only
- Conditions the study is for
- Stress Urinary Incontinence, Sexual Dysfunction
- What is being tested?
- Pelvic floor exerciser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 69 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Banner University Medical Center
Phoenix, Arizona, 85006
About this study
Official title: 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.
Read the 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
- Being tested
- Pelvic floor exerciser
- Medical subject headings
- Urinary Incontinence, Stress, Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic floor exerciserDevice
Also called KegelSmart pelvic floor trainer
Daily exercise using the study device
| Study group | Role | What they receive |
|---|---|---|
| Pelvic floor exercise | Experimental | Pelvic floor exerciser, daily use Receives: Device: Pelvic floor exerciser |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (2)
Frequency of bladder leaks.
Reporting of weekly incidence of bladder leaks.
Measured: 12 weeks
Volume of bladder leaks
Reporting of weekly average volume of bladder leaks.A subject assessment with very distinct category gradations.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2015 (estimated)
- Study startNov 2015
- Primary completionJul 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lelo Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Banner Health
- Responsible party
- Sponsor
- Investigators
- Debra Wickman, MD, Principal investigator, FACOG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02617472
- Sponsor's protocol ID
- INT001KSUS
- Status last verified
- Aug 2017
- First submitted
- 30 Oct 2015
- Last updated
- 14 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Effectiveness of a Pelvic Exercise Device in Strengthening Pelvic Floor Muscles and Treating Urinary Incontinence
- ClinicalTrials.gov ID
- NCT02617472
- Acronym / sponsor ID
- INT001KSUS
- Conditions
- Stress Urinary Incontinence, Sexual Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Lelo Inc.Industry (pharma, biotech, devices)
- Collaborators
- Banner Health
- Study start
- Nov 2015 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 1 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pelvic floor exercise | Experimental | Device: Pelvic floor exerciserPelvic floor exerciser, daily use |
Who may qualify
- Ages
- 20 to 69 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pelvic floor exerciserAlso: KegelSmart pelvic floor trainerDaily exercise using the study device | Device | Pelvic floor exercise |
Primary outcome
Change in pelvic floor strength
Time frame: 12 weeks
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.
2 secondary outcomes
Frequency of bladder leaks.
Time frame: 12 weeks
Volume of bladder leaks
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Debra Wickman, MD principal investigator
FACOG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pelvic floor exerciser in people with Stress Urinary Incontinence and Sexual Dysfunction, run by Lelo Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pelvic floor strength (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2017.