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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01445834
Other study ID # KEK-ZH2011/0299/0
Secondary ID
Status Completed
Phase N/A
First received September 23, 2011
Last updated December 1, 2015
Start date June 2011
Est. completion date November 2011

Study information

Verified date December 2015
Source University of Zurich
Contact n/a
Is FDA regulated No
Health authority Switzerland: Federal Office of Public Health
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date November 2011
Est. primary completion date October 2011
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 99 Years
Eligibility 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

Study Design

Time Perspective: Retrospective


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Zurich

Outcome

Type Measure Description Time frame Safety issue
Primary Patients reported outcome regarding their urinary incontinence 2003-2009 (up to 6 years) No
Secondary Physiotherapists reported outcome after finishing the pelvic floor muscle training 2003-2008 (up to 5 years) No
Secondary need of incontinence surgery after conservative treatment in the follow up of at least 2 years follow up of at least 2 years after physiotherapy that was performed between 2003-2008 No
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