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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02510131
Other study ID # PISA
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 2015
Est. completion date December 2020

Study information

Verified date May 2018
Source University of Malaya
Contact Tan Maw Pin
Phone 0163328600
Email mptan@ummc.edu.my
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 180
Est. completion date December 2020
Est. primary completion date December 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 55 Years and older
Eligibility Inclusion Criteria:

- Woman aged above 55 with urinary incontinence.

Exclusion Criteria:

- 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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Exercises
To compare Hyacinth exercise with Kegel's exercise in improving urinary incontinence

Locations

Country Name City State
Malaysia University Malaya Medical Center Kuala Lumpur Wilayah Persekutuan

Sponsors (1)

Lead Sponsor Collaborator
University of Malaya

Country where clinical trial is conducted

Malaysia, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 6 months
Secondary 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 6 months
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