Urinary Incontinence,StressNCT05529238
Kegel Exercises for Stress Urinary Incontinence
A study testing biofeedback training in people with Urinary Incontinence,Stress, run by Charles Darwin University at 1 site in Australia.
Trial summary
Study about a targeted group of women suffering from self-reported stress urinary incontinence, attend a Kegel exercise training program. The group was divided into two; supervised and unsupervised. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Incontinence,Stress
- What is being tested?
- biofeedback training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteAustralia
- Study dates
- 18 Jun 2019to 18 Aug 2019
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- being female
- aged over 18 years
- suffer from SUI (their subjective disclosure was based on a description provided for their reference)
- did not perform Kegel exercises
- be available for duration of 12-week program
Who cannot join
- pregnancy and breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Supervised Kegel Exercises Using Bio-feedback Versus Unsupervised Kegel Exercises on Stress Urinary Incontinence: A Quasi-experimental Study
Study about a targeted group of women suffering from self-reported stress urinary incontinence, attend a Kegel exercise training program. The group was divided into two; supervised and unsupervised. Whilst both groups benefited from initially seeing a women's health physiotherapist for a pelvic floor muscle assessment and a bespoke Kegel exercise program, only the supervised group continued to see the physiotherapist for monthly bio-feedback training. The unsupervised group relied on their own motivation to perform their Kegel exercises as prescribed. At the end of the twelve week program, both groups had a final pelvic floor muscle strength assessment by the physiotherapist to determine any changes and subsequent improvements in urinary incontinence.
Aim : Investigate and compare the efficacy of supervised Kegel exercises with biofeedback on Stress Urinary Incontinence (SUI) and Pelvic Floor Muscle Strength (PFMS) compared to unsupervised Kegel exercises.
The primary goal of this study was to determine the effectiveness of supervised Kegel exercises using BT versus unsupervised Kegel exercises without biofeedback training, on SUI. A secondary outcome was to establish whether an improvement was observed in PFMS and subsequently, the effect of this on SUI. It was hypothesized that regular support and visual motivation and direction of BT from the physiotherapist, would provide greater results.
- Conditions
- Urinary Incontinence,Stress
- Being tested
- biofeedback training
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biofeedback trainingBehavioural
participants received biofeedback training for kegel exercises in the supervised group. the unsupervised group practised their Kegel exercises at home
| Study group | Role | What they receive |
|---|---|---|
| supervised group during study | Other | monthly physiotherapist appointment for half of the cohort including pelvic floor examination by physiotherapist including digital palpation and perineometry. Receives: Behavioral: biofeedback training |
| unsupervised group during study | No intervention | No intervention. Participants to practice kegel exercises at home. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incontinence severity index (ISI) tool
self-reported questionnaire describing frequency/severity of urinary incontinence. the higher the number, the higher the impact.
Measured: Week 0
Incontinence severity (ISI) index tool
self-reported questionnaire describing frequency/severity of urinary incontinence. the higher the number, the higher the impact.
Measured: Week 12
Pelvic floor assessment from physiotherapist
pelvic floor muscle strength
Measured: week 0
Pelvic floor assessment from physiotherapist
pelvic floor muscle strength
Measured: week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2022
- Study start18 Jun 2019
- Primary completion18 Aug 2019
- Study completion18 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Incontinence,StressStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charles Darwin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Donelle Cross, Charles Darwin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05529238
- Sponsor's protocol ID
- Interventional
- Status last verified
- Feb 2023
- First submitted
- 26 Aug 2022
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Supervised Kegel Exercises Using Bio-feedback Versus Unsupervised Kegel Exercises on Stress Urinary Incontinence: A Quasi-experimental Study
- ClinicalTrials.gov ID
- NCT05529238
- Acronym / sponsor ID
- Interventional
- Conditions
- Urinary Incontinence,Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Charles Darwin UniversityUniversity, hospital or other
- Study start
- 18 Jun 2019 (actual)
- Primary completion
- 18 Aug 2019 (actual)
- Study completion
- 18 Aug 2019 (actual)
- First posted
- 7 Sep 2022 (actual)
- 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.
Study about a targeted group of women suffering from self-reported stress urinary incontinence, attend a Kegel exercise training program. The group was divided into two; supervised and unsupervised. Whilst both groups benefited from initially seeing a women's health physiotherapist for a pelvic floor muscle assessment and a bespoke Kegel exercise program, only the supervised group continued to see the physiotherapist for monthly bio-feedback training. The unsupervised group relied on their own motivation to perform their Kegel exercises as prescribed. At the end of the twelve week program, both groups had a final pelvic floor muscle strength assessment by the physiotherapist to determine any changes and subsequent improvements in urinary incontinence.
Aim : Investigate and compare the efficacy of supervised Kegel exercises with biofeedback on Stress Urinary Incontinence (SUI) and Pelvic Floor Muscle Strength (PFMS) compared to unsupervised Kegel exercises.
The primary goal of this study was to determine the effectiveness of supervised Kegel exercises using BT versus unsupervised Kegel exercises without biofeedback training, on SUI. A secondary outcome was to establish whether an improvement was observed in PFMS and subsequently, the effect of this on SUI. It was hypothesized that regular support and visual motivation and direction of BT from the physiotherapist, would provide greater results.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| supervised group during study | Other | Behavioral: biofeedback trainingmonthly physiotherapist appointment for half of the cohort including pelvic floor examination by physiotherapist including digital palpation and perineometry. |
| unsupervised group during study | No intervention | –No intervention. Participants to practice kegel exercises at home. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- being female
- aged over 18 years
- suffer from SUI (their subjective disclosure was based on a description provided for their reference)
- did not perform Kegel exercises
- be available for duration of 12-week program
Key exclusion criteria (1 listed)
- pregnancy and breastfeeding
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 |
|---|---|---|
| biofeedback trainingparticipants received biofeedback training for kegel exercises in the supervised group. the unsupervised group practised their Kegel exercises at home | Behavioural | supervised group during study |
Primary outcome
Incontinence severity index (ISI) tool
Time frame: Week 0
self-reported questionnaire describing frequency/severity of urinary incontinence. the higher the number, the higher the impact.
Incontinence severity (ISI) index tool
Time frame: Week 12
self-reported questionnaire describing frequency/severity of urinary incontinence. the higher the number, the higher the impact.
Pelvic floor assessment from physiotherapist
Time frame: week 0
pelvic floor muscle strength
Pelvic floor assessment from physiotherapist
Time frame: week 12
pelvic floor muscle strength
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 8 Feb 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing biofeedback training in people with Urinary Incontinence,Stress, run by Charles Darwin University at 1 site in Australia.
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 5 inclusion and 1 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 8 Feb 2023. 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 Australia. 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?
Incontinence severity index (ISI) tool (time frame: Week 0). The study lists 4 primary outcomes in all. 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 8 Feb 2023.