search
Back to results

Value of Urodynamics Prior to Stress Incontinence Surgery 2 (VUSIS 2)

Primary Purpose

Stress Urinary Incontinence

Status
Unknown status
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
midureteral sling
surgical therapy or conservative
Sponsored by
Radboud University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Stress Urinary Incontinence focused on measuring stress urinary incontinence, urodynamics, randomized clinical trial, surgery

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Symptoms of stress urinary incontinence and/or mixed urinary incontinence, predominantly stress incontinence
  • Signs of stress urinary incontinence on physical examination or voiding-diary
  • Patient is a candidate for surgical treatment (as based on history and physical examination)
  • Patient has attended at least 3 months of physiotherapy
  • Patient accepts randomisation
  • Patient is capable to fill out bladder diary's, pad tests and questionnaires
  • Patient understands the Dutch written and spoken language
  • ASA 1 or 2

Exclusion Criteria:

  • Previous incontinence surgery
  • Mixed urinary incontinence, urge component is predominant
  • Prolapse >= 1cm beyond the hymen on Valsalva in supine position
  • Postvoid urinary residual > 150ml
  • Present urinary tract infection
  • The need for additional pelvic surgery (prolapse and/or hysterectomy)
  • Patient is or wants to become pregnant
  • Prior pelvic radiotherapy

Sites / Locations

  • University Medical Center St. RadboudRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

surgical therapy

individual management

Arm Description

Outcomes

Primary Outcome Measures

Non inferiority of the improvement of the urinary distress inventory one year after treatment.

Secondary Outcome Measures

Cure of incontinence as measured with voiding diary. Complications of surgery for stress urinary incontinence, in particular re-operations and overactive bladder symptoms. Quality of life as measured by RAND-36, Euroqol and IIQ.

Full Information

First Posted
December 24, 2008
Last Updated
December 24, 2008
Sponsor
Radboud University Medical Center
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development
search

1. Study Identification

Unique Protocol Identification Number
NCT00814749
Brief Title
Value of Urodynamics Prior to Stress Incontinence Surgery 2
Acronym
VUSIS 2
Official Title
a Multicentered Randomised Controlled Trial to Test the Cost Effectiveness of Urodynamics in Women With Symptoms of Stress Urinary Incontinence in Whom Surgical Treatment is Considered
Study Type
Interventional

2. Study Status

Record Verification Date
December 2008
Overall Recruitment Status
Unknown status
Study Start Date
November 2008 (undefined)
Primary Completion Date
January 2010 (Anticipated)
Study Completion Date
January 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Radboud University Medical Center
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence
Keywords
stress urinary incontinence, urodynamics, randomized clinical trial, surgery

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
surgical therapy
Arm Type
Active Comparator
Arm Title
individual management
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
midureteral sling
Intervention Description
midureteral sling
Intervention Type
Other
Intervention Name(s)
surgical therapy or conservative
Intervention Description
midureteral sling or conservative; medication, physiotherapy
Primary Outcome Measure Information:
Title
Non inferiority of the improvement of the urinary distress inventory one year after treatment.
Time Frame
one year
Secondary Outcome Measure Information:
Title
Cure of incontinence as measured with voiding diary. Complications of surgery for stress urinary incontinence, in particular re-operations and overactive bladder symptoms. Quality of life as measured by RAND-36, Euroqol and IIQ.
Time Frame
2 years

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Symptoms of stress urinary incontinence and/or mixed urinary incontinence, predominantly stress incontinence Signs of stress urinary incontinence on physical examination or voiding-diary Patient is a candidate for surgical treatment (as based on history and physical examination) Patient has attended at least 3 months of physiotherapy Patient accepts randomisation Patient is capable to fill out bladder diary's, pad tests and questionnaires Patient understands the Dutch written and spoken language ASA 1 or 2 Exclusion Criteria: Previous incontinence surgery Mixed urinary incontinence, urge component is predominant Prolapse >= 1cm beyond the hymen on Valsalva in supine position Postvoid urinary residual > 150ml Present urinary tract infection The need for additional pelvic surgery (prolapse and/or hysterectomy) Patient is or wants to become pregnant Prior pelvic radiotherapy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sanne van Leijsen, M.D.
Phone
+31-6-41520114
Email
sannevanleijsen@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mark Vierhout, M.D. PhD
Phone
+31243613635
Email
m.vierhout@obgyn.umcn.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Vierhout, MD, PhD
Organizational Affiliation
Radboud University Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
John Heesakkers, MD, PhD
Organizational Affiliation
University Medical Center St. Radboud
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kirsten Kluivers, MD, PhD
Organizational Affiliation
University Medical Center St. Radboud
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sanne van Leijsen, MD
Organizational Affiliation
University Medical Center St. Radboud
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ben Willem Mol, MD, PhD
Organizational Affiliation
Academic Medical Centre Amsterdam
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Center St. Radboud
City
Nijmegen
State/Province
Gelderland
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sanne van Leijsen, MD
Phone
+31641520114
Email
sannevanleijsen@hotmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
23635736
Citation
van Leijsen SAL, Kluivers KB, Mol BWJ, Hout J', Milani AL, Roovers JWR, Boon JD, Vaart CHV, Langen PH, Hartog FE, Dietz V, Tiersma ESM, Hovius MC, Bongers MY, Spaans W, Heesakkers JPFA, Vierhout ME; Dutch Urogynecology Consortium*. Value of urodynamics before stress urinary incontinence surgery: a randomized controlled trial. Obstet Gynecol. 2013 May;121(5):999-1008. doi: 10.1097/AOG.0b013e31828c68e3.
Results Reference
derived
PubMed Identifier
19622153
Citation
van Leijsen SA, Kluivers KB, Mol BW, Broekhuis SR, Milani FL, van der Vaart CH, Roovers JP, Bongers MY, den Boon J, Spaans WA, de Leeuw JW, Dietz V, Kleinjan JH, Brolmann HA, Roos EJ, Schaafstra J, Heesakkers JP, Vierhout ME. Protocol for the value of urodynamics prior to stress incontinence surgery (VUSIS) study: a multicenter randomized controlled trial to assess the cost effectiveness of urodynamics in women with symptoms of stress urinary incontinence in whom surgical treatment is considered. BMC Womens Health. 2009 Jul 21;9:22. doi: 10.1186/1472-6874-9-22.
Results Reference
derived

Learn more about this trial

Value of Urodynamics Prior to Stress Incontinence Surgery 2

We'll reach out to this number within 24 hrs