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Trial record 23 of 163 for:    Recruiting, Not yet recruiting, Available Studies | "Enuresis"

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

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ClinicalTrials.gov Identifier: NCT02510131
Recruitment Status : Recruiting
First Posted : July 29, 2015
Last Update Posted : May 22, 2018
Sponsor:
Information provided by (Responsible Party):
University of Malaya

Brief 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.

Condition or disease Intervention/treatment Phase
Urinary Incontinence Behavioral: Exercises Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Is Hyacinth Exercise Better Than Kegel's Exercise in Women With Urinary Incontinence?
Study Start Date : August 2015
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02510131


Contacts
Contact: Tan Maw Pin 0163328600 mptan@ummc.edu.my

Locations
Malaysia
University Malaya Medical Center Recruiting
Kuala Lumpur, Wilayah Persekutuan, Malaysia, 59100
Contact: Chua Shiao Chuan, MBBS    0060129818110    kiyaya620@yahoo.com   
Contact: Khong Su Yen, FRCOG    0060129388096    khongsuyen@gmail.com   
Sponsors and Collaborators
University of Malaya

Responsible Party: University of Malaya
ClinicalTrials.gov Identifier: NCT02510131     History of Changes
Other Study ID Numbers: PISA
First Posted: July 29, 2015    Key Record Dates
Last Update Posted: May 22, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Urinary Incontinence
Enuresis
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders