NCT00222248

Brief Summary

To determine the effect of pelvic floor muscle training in women aged 70 years and over, who have proven stress urinary incontinence. The hypotheses to be tested are:

  1. 1.That pelvic floor muscle training is effective in relief of symptoms of stress urinary incontinence as measured by a greater reduction in the number of episodes of incontinence, quantity of urine lost and improvement of quality of life.
  2. 2.That women who undertake pelvic floor muscle training will show greater improvement of pelvic floor muscle function than women who have behavioural (bladder) training, as measured by real time transabdominal ultrasound.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
83

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2003

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 3, 2003

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 6, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 6, 2006

Completed
Last Updated

May 3, 2021

Status Verified

April 1, 2021

Enrollment Period

3 years

First QC Date

September 13, 2005

Last Update Submit

April 28, 2021

Conditions

Stress Urinary Incontinence

Keywords

Stress urinary incontinencePelvic floor muscle trainingBladder trainingOlder women

Outcome Measures

Primary Outcomes (2)

  • Quantity of urine lost over a 7-day period measured by self-report.

    Self report of urine leakage

    1, 3, 5 (end of intervention) and 12 months

  • Urine lost on stress test measured by pad weigh test.

    Pad weight following stress test

    1, 3, 5 (end of intervention) and 12 months

Secondary Outcomes (4)

  • King's Health Questionnaire.

    1, 3, 5 (end of intervention) and 12 months

  • Degree of bother

    1, 3, 5 (end of intervention) and 12 months

  • Severity of stress incontinence

    1, 3, 5 (end of intervention) and 12 months

  • Displacement of pelvic floor during muscle contraction

    1, 3, 5 (end of intervention) and 12 months

Study Arms (2)

Pelvic floor muscle training

EXPERIMENTAL

Weekly group session of education and exercise to music incorporating pelvic floor muscle training incorporating motor control, strength, endurance, power and functional training in a variety of different positions.

Behavioral: Pelvic floor muscle training and bladder training

Bladder training

ACTIVE COMPARATOR

Weekly group session of education regarding deferral techniques, timed voiding parameters and gentle exercise to music.

Behavioral: Pelvic floor muscle training and bladder training

Interventions

Pelvic floor muscle training and bladder trainingBEHAVIORAL
Bladder trainingPelvic floor muscle training

Eligibility Criteria

Age65 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Community-dwelling women aged over 65 years
  • urodynamically proven stress incontinence
  • Medically stable

You may not qualify if:

  • Already receiving physiotherapy intervention
  • Neurogenic incontinence
  • Cannot comply with training program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Austin Health

Melbourne, Victoria, 3084, Australia

Location

Related Publications (1)

  • Sherburn M, Bird M, Carey M, Bo K, Galea MP. Incontinence improves in older women after intensive pelvic floor muscle training: an assessor-blinded randomized controlled trial. Neurourol Urodyn. 2011 Mar;30(3):317-24. doi: 10.1002/nau.20968. Epub 2011 Jan 31.

    PMID: 21284022RESULT

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

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

Study Officials

  • Mary P Galea, PhD

    University of Melbourne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 22, 2005

Study Start

March 3, 2003

Primary Completion

March 6, 2006

Study Completion

March 6, 2006

Last Updated

May 3, 2021

Record last verified: 2021-04

Locations

AU(1)