Is Hyacinth Exercise Better Than Kegel's Exercise in Women With Urinary Incontinence?

May 17, 2018 updated by: University of Malaya
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
    • Wilayah Persekutuan
      • Kuala Lumpur, Wilayah Persekutuan, Malaysia, 59100
        • Recruiting
        • University Malaya Medical Center
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Pelvic floor exercise

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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
intravaginal biofeedback measurements
Time Frame: 6 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Malaya

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

July 20, 2015

First Submitted That Met QC Criteria

July 24, 2015

First Posted (Estimate)

July 29, 2015

Study Record Updates

Last Update Posted (Actual)

May 22, 2018

Last Update Submitted That Met QC Criteria

May 17, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PISA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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