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

Sponsor
University of Malaya (Other)
Overall Status
Unknown status
CT.gov ID
NCT02510131
Collaborator
(none)
180
1
2
64
2.8

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Exercises
N/A

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

Study Type:
Interventional
Anticipated 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 :
Aug 1, 2015
Anticipated Primary Completion Date :
Dec 1, 2020
Anticipated Study Completion Date :
Dec 1, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Female pelvic floor questionnaires scoring [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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
55 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Malaya Medical Center Kuala Lumpur Wilayah Persekutuan Malaysia 59100

Sponsors and Collaborators

  • University of Malaya

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Malaya
ClinicalTrials.gov Identifier:
NCT02510131
Other Study ID Numbers:
  • PISA
First Posted:
Jul 29, 2015
Last Update Posted:
May 22, 2018
Last Verified:
May 1, 2018
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 22, 2018