Urinary Incontinence,StressNCT05527639
Kegel Exercises Prior to Strength Training to Improvestress Urinary Incontinence
A study testing strength training program in people with Urinary Incontinence,Stress, run by Charles Darwin University at 1 site in Australia.
Trial summary
This comparative pre-post intervention study investigates the feasibility and benefits of Kegel exercises amongst incontinent women, prior to commencing resistance training, to reduce the risk of stress urinary incontinence compared to a group of women without prior Kegel exercises. 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?
- strength training program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteAustralia
- Study dates
- 18 May 2019to 18 Dec 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
- over eighteen years of age
- suffer from stress urinary incontinence
- did not perform Kegel exercises
- had no experience in regular resistance/strength training
- completed a physical activity readiness questionnaire (PAR-Q) form.
Who cannot join
- pregnancy, breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does a Kegel Exercise Program Prior to Resistance Training Reduce the Risk of Stress Urinary Incontinence?
This comparative pre-post intervention study investigates the feasibility and benefits of Kegel exercises amongst incontinent women, prior to commencing resistance training, to reduce the risk of stress urinary incontinence compared to a group of women without prior Kegel exercises.
Read the detailed description
The aim of the study is to determine whether a program of Kegel exercises prior to a resistance training program will result in reduction of stress urinary incontinence and whether this should be prescribed to incontinent women prior to performing resistance training. It is hypothesized that performing kegel exercises prior to resistance training would improve pelvic floor muscle strength and reduces the odds of experiencing SUI during resistance training.
- Conditions
- Urinary Incontinence,Stress
- Being tested
- strength training program
- 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.
strength training programBehavioural
12-weeks of strength training consisting of warm ups, dead-lifts, squats and cool down exercises
| Study group | Role | What they receive |
|---|---|---|
| intervention group during study | Other | all participants completed a 12 week strength training program consisting of warm up exercises, dead-lifts and squats. They had all completed a program of Kegel exercise prior. Receives: Behavioral: strength training program |
| control group during study | Other | all participants completed a 12 week strength training program consisting of warm up exercises, dead-lifts and squats Receives: Behavioral: strength training program |
What is being measured
The primary outcome is the main question the study is designed to answer.
incontinence severity index (ISI) tool
questionnaire for self-reported frequency and severity of urinary incontinence. the higher the score, the higher the impact of incontinence
Measured: Week 0
incontinence severity index (ISI) tool
questionnaire for self-reported frequency and severity of urinary incontinence. the higher the score, the higher the impact of incontinence
Measured: Week 12
pelvic floor muscle strength
physiotherapist report from digital palpation and perineometry
Measured: week 0
pelvic floor muscle strength
physiotherapist report from digital palpation and perineometry
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 posted2 Sep 2022
- Study start18 May 2019
- Primary completion18 Dec 2019
- Study completion18 Dec 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
- Single group
- Model description
- A comparative study using data from 2 separate studies. Data used for the resistance training (RT) group from a foundational single cohort that investigated impact of RT on stress urinary incontinence (SUI) in a group of women participating in a RT program who had not previously done Kegel exercises (KE). New data for the KE+RT group was from 2 consecutive studies where the women completed a program of supervised / unsupervised KE. These 19 women took part in 12 weeks of RT to compare against the KE group. The findings of two separate studies in which the effect of RT on SUI and pelvic floor muscle strength was compared between women who completed 12 weeks of RT with or without prior KE. The RT group consisted of 14 women who did not have an experience in RT or KE and completed 12 weeks of RT. Women in the KE plus RT group (n=19) completed 12 weeks of Kegel exercise under the supervision of a qualified pelvic floor specialist; then completed the identical RT program as the RT group
- Masking
- None (open label)
- Enrolment
- 24 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
- NCT05527639
- Sponsor's protocol ID
- CharlesDarwinU
- Status last verified
- Aug 2023
- First submitted
- 26 Aug 2022
- Last updated
- 7 Aug 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 7 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does a Kegel Exercise Program Prior to Resistance Training Reduce the Risk of Stress Urinary Incontinence?
- ClinicalTrials.gov ID
- NCT05527639
- Acronym / sponsor ID
- CharlesDarwinU
- Conditions
- Urinary Incontinence,Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Charles Darwin UniversityUniversity, hospital or other
- Study start
- 18 May 2019 (actual)
- Primary completion
- 18 Dec 2019 (actual)
- Study completion
- 18 Dec 2019 (actual)
- First posted
- 2 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.
This comparative pre-post intervention study investigates the feasibility and benefits of Kegel exercises amongst incontinent women, prior to commencing resistance training, to reduce the risk of stress urinary incontinence compared to a group of women without prior Kegel exercises.
Detailed description
The aim of the study is to determine whether a program of Kegel exercises prior to a resistance training program will result in reduction of stress urinary incontinence and whether this should be prescribed to incontinent women prior to performing resistance training. It is hypothesized that performing kegel exercises prior to resistance training would improve pelvic floor muscle strength and reduces the odds of experiencing SUI during resistance training.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A comparative study using data from 2 separate studies. Data used for the resistance training (RT) group from a foundational single cohort that investigated impact of RT on stress urinary incontinence (SUI) in a group of women participating in a RT program who had not previously done Kegel exercises (KE). New data for the KE+RT group was from 2 consecutive studies where the women completed a program of supervised / unsupervised KE. These 19 women took part in 12 weeks of RT to compare against the KE group. The findings of two separate studies in which the effect of RT on SUI and pelvic floor muscle strength was compared between women who completed 12 weeks of RT with or without prior KE. The RT group consisted of 14 women who did not have an experience in RT or KE and completed 12 weeks of RT. Women in the KE plus RT group (n=19) completed 12 weeks of Kegel exercise under the supervision of a qualified pelvic floor specialist; then completed the identical RT program as the RT group
| Arm | Type | Receives |
|---|---|---|
| intervention group during study | Other | Behavioral: strength training programall participants completed a 12 week strength training program consisting of warm up exercises, dead-lifts and squats. They had all completed a program of Kegel exercise prior. |
| control group during study | Other | Behavioral: strength training programall participants completed a 12 week strength training program consisting of warm up exercises, dead-lifts and squats |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- being female
- over eighteen years of age
- suffer from stress urinary incontinence
- did not perform Kegel exercises
- had no experience in regular resistance/strength training
Key exclusion criteria (1 listed)
- pregnancy, 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 |
|---|---|---|
| strength training program12-weeks of strength training consisting of warm ups, dead-lifts, squats and cool down exercises | Behavioural | control group during study, intervention group during study |
Primary outcome
incontinence severity index (ISI) tool
Time frame: Week 0
questionnaire for self-reported frequency and severity of urinary incontinence. the higher the score, the higher the impact of incontinence
incontinence severity index (ISI) tool
Time frame: Week 12
questionnaire for self-reported frequency and severity of urinary incontinence. the higher the score, the higher the impact of incontinence
pelvic floor muscle strength
Time frame: week 0
physiotherapist report from digital palpation and perineometry
pelvic floor muscle strength
Time frame: week 12
physiotherapist report from digital palpation and perineometry
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 7 Aug 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 strength training program 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 6 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 7 Aug 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 7 Aug 2023.