Urinary IncontinenceNCT02510131
Is Hyacinth Exercise Better Than Kegel's Exercise in Women With Urinary Incontinence?
A study testing Exercises in people with Urinary Incontinence, run by University of Malaya at 1 site in Malaysia.
Trial summary
To determine whether Hyacinth exercises are more effective than Kegel's exercise at improving pelvic floor weakness among women aged 55 and above with urinary incontinence. Read more about this study
- Who is it for?
- Ages 55 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- Exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteMalaysia
- Study dates
- Aug 2015to Dec 2020
- 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 55 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Woman aged above 55 with urinary incontinence.
Who cannot join
- Individuals who are unable or unwilling to provide written informed consent.
- Stage 3 and 4 pelvic organ prolapse.
- Individuals who have physical weakness and are unable to do kegel plus exercises.
- Neuropathic injury of pelvic floor muscles.
Trial locations and contacts
1 site in 1 country.
Malaysia1 site, 1 recruiting
- Recruiting
University Malaya Medical Center
Kuala Lumpur, Kuala Lumpur, 59100
Chua Shiao Chuan, MBBS, 0060129818110, kiyaya620@yahoo.com
Khong Su Yen, FRCOG, 0060129388096, khongsuyen@gmail.com
About this study
To determine whether Hyacinth exercises are more effective than Kegel's exercise at improving pelvic floor weakness among women aged 55 and above with urinary incontinence.
Read the detailed description
Individuals who admit to have urinary leakage will be examined to determine the nature of their problem and individuals for whom Kegel exercises are likely to be for benefit will be recruited into this study.
One hundred and eighty women who participants who agree to be randomized to Kegel's or Hyacinth exercises will be randomized.
The treatment allocation will be sealed opaque enveloped and stored in a secure location.
Participants will be blinded from the treatment arm, and as much as possible, participants in different arms of the study would be given different appointment dates to avoid contamination.
Exercises will be prescribed by a trained personnel, and flexibility is added to the routine to enable tailoring to individual lifestyles and choices.
- Conditions
- Urinary Incontinence
- Being tested
- Exercises
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExercisesBehavioural
To compare Hyacinth exercise with Kegel's exercise in improving urinary incontinence
| Study group | Role | What they receive |
|---|---|---|
| Pelvic floor exercise | Active comparator | Participants randomized to Kegel's exercises will be asked to contract their pelvic floor muscle for 1-10 seconds, followed by 10 seconds' relaxation.
Length of duration of exercise is tailored to individual's ability in contracting her pelvic floor muscle.
Each cycle is equivalent to 1 contraction and 1 relaxation phase. Participants will be asked to perform 3 sessions per day, and to perform their Kegel exercises at home daily.
1 session of Kegel's exercise is consists of 20 cycles of slow twitch fibre contraction and 30 repetitions of fast twitch fibre for 1 minute. Receives: Behavioral: Exercises |
| Hyacinth exercise | Experimental | In this arm participants are also taught Kegel's exercises but will be additionally taught extra steps which mirrored Muslim's praying steps.
As well as their Kegel's exercises, participants will be asked to perform the extra steps at least 63 minutes per week.
Participants may choose to perform these at the same time or at a different time from their Kegel's exercises. Participants will be asked to perform 1 cycle (3 minutes and 1 second) for 3 sessions a day for daily.
Each cycle is consists of repetition of 4 positions: standing upright- 90 degree bow- prostration-sitting. Receives: Behavioral: Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Female pelvic floor questionnaires scoring
to assess woman's urinary incontinence scoring at 0, 2 and 6 months, to look for improvement from baseline to 6 months after exercises
Measured: 6 months
Secondary outcomes (1)
intravaginal biofeedback measurements
to measure the strength of pelvic floor muscle by Femiscan at 0,2 and 6 months, to look for change from baseline to 6 months after exercises
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2015 (estimated)
- Study startAug 2015
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02510131
- Sponsor's protocol ID
- PISA
- Status last verified
- May 2018
- First submitted
- 20 Jul 2015
- Last updated
- 22 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Hay-Smith EJC, Starzec-Proserpio M, Moller B, Aldabe D, Cacciari L, Pitangui ACR, Vesentini G, Woodley SJ, Dumoulin C, Frawley HC, Jorge CH, Morin M, Wallace SA, Weatherall M. Comparisons of approaches to pelvic floor muscle training for urinary incontinence in women. Cochrane Database Syst Rev. 2024 Dec 20;12(12):CD009508. doi: 10.1002/14651858.CD009508.pub2.
PubMed 39704322
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Hyacinth Exercise Better Than Kegel's Exercise in Women With Urinary Incontinence?
- ClinicalTrials.gov ID
- NCT02510131
- Acronym / sponsor ID
- PISA
- Conditions
- Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 29 Jul 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.
To determine whether Hyacinth exercises are more effective than Kegel's exercise at improving pelvic floor weakness among women aged 55 and above with urinary incontinence.
Detailed description
Individuals who admit to have urinary leakage will be examined to determine the nature of their problem and individuals for whom Kegel exercises are likely to be for benefit will be recruited into this study.
One hundred and eighty women who participants who agree to be randomized to Kegel's or Hyacinth exercises will be randomized.
The treatment allocation will be sealed opaque enveloped and stored in a secure location.
Participants will be blinded from the treatment arm, and as much as possible, participants in different arms of the study would be given different appointment dates to avoid contamination.
Exercises will be prescribed by a trained personnel, and flexibility is added to the routine to enable tailoring to individual lifestyles and choices.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pelvic floor exercise | Active comparator | Behavioral: ExercisesParticipants randomized to Kegel's exercises will be asked to contract their pelvic floor muscle for 1-10 seconds, followed by 10 seconds' relaxation. Length of duration of exercise is tailored to individual's ability in contracting her pelvic floor muscle. Each cycle is equivalent to 1 contraction and 1 relaxation phase. Participants will be asked to perform 3 sessions per day, and to perform their Kegel exercises at home daily. 1 session of Kegel's exercise is consists of 20 cycles of slow twitch fibre contraction and 30 repetitions of fast twitch fibre for 1 minute. |
| Hyacinth exercise | Experimental | Behavioral: ExercisesIn this arm participants are also taught Kegel's exercises but will be additionally taught extra steps which mirrored Muslim's praying steps. As well as their Kegel's exercises, participants will be asked to perform the extra steps at least 63 minutes per week. Participants may choose to perform these at the same time or at a different time from their Kegel's exercises. Participants will be asked to perform 1 cycle (3 minutes and 1 second) for 3 sessions a day for daily. Each cycle is consists of repetition of 4 positions: standing upright- 90 degree bow- prostration-sitting. |
Who may qualify
- Ages
- 55 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Woman aged above 55 with urinary incontinence.
Key exclusion criteria (4 listed)
- Individuals who are unable or unwilling to provide written informed consent.
- Stage 3 and 4 pelvic organ prolapse.
- Individuals who have physical weakness and are unable to do kegel plus exercises.
- Neuropathic injury of pelvic floor muscles.
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 |
|---|---|---|
| ExercisesTo compare Hyacinth exercise with Kegel's exercise in improving urinary incontinence | Behavioural | Hyacinth exercise, Pelvic floor exercise |
Primary outcome
Female pelvic floor questionnaires scoring
Time frame: 6 months
to assess woman's urinary incontinence scoring at 0, 2 and 6 months, to look for improvement from baseline to 6 months after exercises
1 secondary outcome
intravaginal biofeedback measurements
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2018.
- Derived from this study: PubMed 39704322Hay-Smith EJC, Starzec-Proserpio M, Moller B, Aldabe D, Cacciari L, Pitangui ACR, Vesentini G, Woodley SJ, Dumoulin C, Frawley HC, Jorge CH, Morin M, Wallace SA, Weatherall M. Comparisons of approaches to pelvic floor muscle training for urinary incontinence in women. Cochrane Database Syst Rev. 2024 Dec 20;12(12):CD009508. doi: 10.1002/14651858.CD009508.pub2.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercises in people with Urinary Incontinence, run by University of Malaya at 1 site in Malaysia.
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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 22 May 2018. 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 Malaysia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tan Maw Pin (0163328600, mptan@ummc.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Female pelvic floor questionnaires scoring (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02510131, which also lists 1 linked publication.
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 22 May 2018.