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Value of Urodynamics Prior to Stress Incontinence Surgery 2

NCT00814749 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2008-12-25

No results posted yet for this study

Summary

To test the value of preoperatively performed urodynamics with regard to outcome of surgery for stress urinary incontinence (SUI) and to examine whether not performing urodynamics preoperatively is more cost effective than performing urodynamics preoperatively using the non-inferiority assumption.

Conditions

  • Stress Urinary Incontinence

Interventions

PROCEDURE

midureteral sling

midureteral sling

OTHER

surgical therapy or conservative

midureteral sling or conservative; medication, physiotherapy

Sponsors & Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

    collaborator OTHER

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • Mark Vierhout, MD, PhD · Radboud University Medical Center

  • John Heesakkers, MD, PhD · University Medical Center St. Radboud

  • Kirsten Kluivers, MD, PhD · University Medical Center St. Radboud

  • Sanne van Leijsen, MD · University Medical Center St. Radboud

  • Ben Willem Mol, MD, PhD · Academic Medical Centre Amsterdam

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
FACTORIAL

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2010-01-31
Completion
2011-01-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00814749 on ClinicalTrials.gov