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

Primary Purpose

Urinary Incontinence

Status
Unknown status
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Exercises
Sponsored by
University of Malaya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Incontinence

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • University Malaya Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Pelvic floor exercise

Hyacinth exercise

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
July 20, 2015
Last Updated
May 17, 2018
Sponsor
University of Malaya
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1. Study Identification

Unique Protocol Identification Number
NCT02510131
Brief Title
Is Hyacinth Exercise Better Than Kegel's Exercise in Women With Urinary Incontinence?
Official Title
Is Hyacinth Exercise Better Than Kegel's Exercise in Women With Urinary Incontinence?
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 2015 (undefined)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Malaya

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pelvic floor exercise
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Hyacinth exercise
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Exercises
Intervention Description
To compare Hyacinth exercise with Kegel's exercise in improving urinary incontinence
Primary Outcome Measure Information:
Title
Female pelvic floor questionnaires scoring
Description
to assess woman's urinary incontinence scoring at 0, 2 and 6 months, to look for improvement from baseline to 6 months after exercises
Time Frame
6 months
Secondary Outcome Measure Information:
Title
intravaginal biofeedback measurements
Description
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
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tan Maw Pin
Phone
0163328600
Email
mptan@ummc.edu.my
Facility Information:
Facility Name
University Malaya Medical Center
City
Kuala Lumpur
State/Province
Wilayah Persekutuan
ZIP/Postal Code
59100
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chua Shiao Chuan, MBBS
Phone
0060129818110
Email
kiyaya620@yahoo.com
First Name & Middle Initial & Last Name & Degree
Khong Su Yen, FRCOG
Phone
0060129388096
Email
khongsuyen@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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