NCT02510131

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 20, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 29, 2015

Completed
3 days until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

May 22, 2018

Status Verified

May 1, 2018

Enrollment Period

5.3 years

First QC Date

July 20, 2015

Last Update Submit

May 17, 2018

Conditions

Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • intravaginal biofeedback measurements

    6 months

Study Arms (2)

Pelvic floor exercise

ACTIVE COMPARATOR

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

Hyacinth exercise

EXPERIMENTAL

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

Interventions

ExercisesBEHAVIORAL

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

Hyacinth exercisePelvic floor exercise

Eligibility Criteria

Age55 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Woman aged above 55 with urinary incontinence.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Malaya Medical Center

Kuala Lumpur, Kuala Lumpur, 59100, Malaysia

RECRUITING

Related Publications (1)

  • Hay-Smith EJC, Starzec-Proserpio M, Moller B, Aldabe D, Cacciari L, Pitangui ACR, Vesentini G, Woodley SJ, Dumoulin C, Frawley HC, Jorge CH, Morin M, Wallace SA, Weatherall M. Comparisons of approaches to pelvic floor muscle training for urinary incontinence in women. Cochrane Database Syst Rev. 2024 Dec 20;12(12):CD009508. doi: 10.1002/14651858.CD009508.pub2.

    PMID: 39704322DERIVED

MeSH Terms

Conditions

Urinary Incontinence

Interventions

Exercise

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Tan Maw Pin

CONTACT

0163328600mptan@ummc.edu.my

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2015

First Posted

July 29, 2015

Study Start

August 1, 2015

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

May 22, 2018

Record last verified: 2018-05

Locations

MY(1)