Trial record 9 of 333 for:    (elderly OR senior) AND incontinence AND (woman OR women OR female)

Pelvic Floor Muscle Training for Incontinence in Older Women.

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2003 by University of Melbourne.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of Melbourne
ClinicalTrials.gov Identifier:
NCT00222248
First received: September 13, 2005
Last updated: August 7, 2006
Last verified: June 2003
  Purpose

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. 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. 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.

Condition Intervention
Stress Urinary Incontinence
Behavioral: Pelvic floor muscle training and bladder training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: The Effect of Pelvic Floor Muscle Training for the Management of Incontinence in Older Women: a Single Blind Randomised Controlled Trial.

Resource links provided by NLM:


Further study details as provided by University of Melbourne:

Primary Outcome Measures:
  • Quantity of urine lost over a 7-day period measured by self-report.
  • Urine lost on stress test measured by pad weigh test.

Secondary Outcome Measures:
  • Quality of life using King's Health Questionnaire.
  • Degree of bother using a VAS.
  • Severity of stress incontinence using the ICIQ-SF.
  • Displacement of pelvic floor during muscle contraction measured using transabdominal ultrasound imaging.

Estimated Enrollment: 90
Study Start Date: March 2003
Estimated Study Completion Date: March 2006
Detailed Description:

Urinary incontinence is associated with significant personal stress, shame and social stigma and affects around one-third of women over 60 years of age. It restricts the amount of physical activity and can lead to social isolation and poor health. Pelvic floor muscle re-education by physiotherapists is the most commonly recommended method of conservative management. Although a recent Cochrane review concluded that it was an effective treatment for women with stress and mixed incontinence, there is still no strong evidence for the effectiveness of this intervention in elderly women. It has also been suggested that bladder training alone is equally effective in patients with stress urinary incontinence, urge and mixed incontinence. This is contrary to current clinical experience. It is therefore important to distinguish the relative effectiveness of these interventions used in isolation in order to ensure that urinary incontinence is managed in the most effective and efficient way.

Comparisons: pelvic floor muscle training group and bladder training.

Assessments will be conducted at baseline, 1 month, 3 months and 5 months during the intervention period. Both groups will then continue with their home program for a further 7 months until their final assessment (Assessment 5).

Outcome measures will include: volume of urine lost during a stress test, completion of accident diaries, Degree of 'bother', quality of life using the Kings Health Questionnaire, and assessment of pelvic floor function using real time transabdominal diagnostic ultrasound.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Already receiving physiotherapy intervention
  • Neurogenic incontinence
  • Cannot comply with training program
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00222248

Locations
Australia, Victoria
Austin Health
Melbourne, Victoria, Australia, 3084
Sponsors and Collaborators
University of Melbourne
Investigators
Principal Investigator: Mary P Galea, PhD The University of Melbourne
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00222248     History of Changes
Other Study ID Numbers: 251632
Study First Received: September 13, 2005
Last Updated: August 7, 2006
Health Authority: Australia: National Health and Medical Research Council

Keywords provided by University of Melbourne:
Stress urinary incontinence
Pelvic floor muscle training
Bladder training
Older women

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on July 08, 2014