NCT01445834

Brief 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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2011

Shorter than P25 for all trials

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

June 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 23, 2011

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 4, 2011

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

December 3, 2015

Status Verified

December 1, 2015

Enrollment Period

4 months

First QC Date

September 23, 2011

Last Update Submit

December 1, 2015

Conditions

Stress Urinary IncontinenceUrge Urinary Incontinence

Keywords

outcome of pelvic floor muscle physiotherapyfemalestress urinary incontinenceurgency urinary incontinencemixed urinary incontinence

Outcome Measures

Primary Outcomes (1)

  • Patients reported outcome regarding their urinary incontinence

    2003-2009 (up to 6 years)

Secondary Outcomes (2)

  • Physiotherapists reported outcome after finishing the pelvic floor muscle training

    2003-2008 (up to 5 years)

  • 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

Study Arms (1)

Incontinent women

Eligibility Criteria

Age18 Years - 99 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • premenopausal women (\<50 years) with urodynamically proven urinary incontinence
  • postmenopausal women (\>65 years) with urodynamically proven urinary incontinence
  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Urinary Incontinence, StressUrinary Incontinence, Urge

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

  • Cornelia Betschart, MD

    University Hospital of Zürich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Urogynecology, MD

Study Record Dates

First Submitted

September 23, 2011

First Posted

October 4, 2011

Study Start

June 1, 2011

Primary Completion

October 1, 2011

Study Completion

November 1, 2011

Last Updated

December 3, 2015

Record last verified: 2015-12