Age-stratified Outcome of Pelvic Floor Muscle Exercise for Urinary Incontinence

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cornelia Betschart, University of Zurich
ClinicalTrials.gov Identifier:
NCT01445834
First received: September 23, 2011
Last updated: November 23, 2011
Last verified: November 2011
  Purpose

In this retrospective study the outcome of pelvic floor muscle training in 150 women will be tested regarding patients reported satisfaction and achievement of the incontinence improvement.

Comparison of two age groups, controlled for BMI, parity and previous incontinence operations.


Condition
Stress Urinary Incontinence
Urge Urinary Incontinence

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Retrospective Study About the Age-stratified Outcome of Pelvic Floor Muscle Exercise for Stress (SUI), Mixed (MUI) and Urgency Urinary Incontinence (UUI) 2003-2008

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • Patients reported outcome regarding their urinary incontinence [ Time Frame: 2003-2009 (up to 6 years) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Physiotherapists reported outcome after finishing the pelvic floor muscle training [ Time Frame: 2003-2008 (up to 5 years) ] [ Designated as safety issue: No ]
  • need of incontinence surgery after conservative treatment in the follow up of at least 2 years [ Time Frame: follow up of at least 2 years after physiotherapy that was performed between 2003-2008 ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: June 2011
Study Completion Date: November 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Incontinent women

Detailed Description:

Pelvic floor muscle exercise is an established conservative treatment for female urinary incontinence. Up to now, the investigators don't know whether treatment outcome in elderly women is as good as in younger premenopausal women. The International Incontinence Society states 2009: "There is no good evidence to date to suggest that "healthy" older women with urinary incontinence do not benefit from pelvic floor muscle training as much as younger women".

In this retrospective study the investigators analyze patient charts from 2003-2008 regarding subjective patients and physiotherapists reported outcome after physiotherapy as well as for objective parameters like the need of an incontinence surgery in the follow-up of at least 2 years.

Eligibility criteria are age younger than 50 years (premenopausal) and age older than 65 years and a urodynamically proven urinary incontinence. As incontinence forms the investigators include in this study the following three form: stress urinary incontinence, mixed urinary incontinence and urgency urinary incontinence.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

women from a tertiary referral center with urodynamically proven incontinence willig to perform physiotherapy

Criteria

Inclusion Criteria:

  • premenopausal women (<50 years) with urodynamically proven urinary incontinence
  • postmenopausal women (>65 years) with urodynamically proven urinary incontinence
  • 9 sessions of pelvic floor muscle exercise in a professional kinesiological setting inbetween 2003-2008
  • follow up regarding need of incontinence operation up to June 2011

Exclusion Criteria:

  • women aged 50-65 years with urodynamically proven urinary incontinence
  • stool incontinence
  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: NCT01445834

Sponsors and Collaborators
University of Zurich
Investigators
Principal Investigator: Cornelia Betschart, MD University Hospital of Zürich
  More Information

No publications provided

Responsible Party: Cornelia Betschart, Attending Urogynecology, MD, University of Zurich
ClinicalTrials.gov Identifier: NCT01445834     History of Changes
Other Study ID Numbers: KEK-ZH2011/0299/0
Study First Received: September 23, 2011
Last Updated: November 23, 2011
Health Authority: Switzerland: Federal Office of Public Health

Keywords provided by University of Zurich:
outcome of pelvic floor muscle physiotherapy
female
stress urinary incontinence
urgency urinary incontinence
mixed urinary incontinence

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

ClinicalTrials.gov processed this record on September 22, 2014