VUSIS 2: Value of Urodynamics Prior to Stress Incontinence Surgery 2

Sponsor

Radboud University Medical Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT00814749

Collaborator

ZonMw: The Netherlands Organisation for Health Research and Development (Other)

600

Enrollment

Location

Arms

Duration (Months)

23.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Stress Urinary Incontinence	Procedure: midureteral sling Other: surgical therapy or conservative	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

600 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

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 Start Date :

Nov 1, 2008

Anticipated Primary Completion Date :

Jan 1, 2010

Anticipated Study Completion Date :

Jan 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: surgical therapy	Procedure: midureteral sling midureteral sling
Active Comparator: individual management	Other: surgical therapy or conservative midureteral sling or conservative; medication, physiotherapy

Arm

Intervention/Treatment

Active Comparator: surgical therapy

Procedure: midureteral sling

midureteral sling

Active Comparator: individual management

Other: surgical therapy or conservative

midureteral sling or conservative; medication, physiotherapy

Outcome Measures

Primary Outcome Measures

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

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. [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Medical Center St. Radboud	Nijmegen	Gelderland	Netherlands

Sponsors and Collaborators

Radboud University Medical Center
ZonMw: The Netherlands Organisation for Health Research and Development

Investigators

Principal Investigator: Mark Vierhout, MD, PhD, Radboud University Medical Center
Principal Investigator: John Heesakkers, MD, PhD, University Medical Center St. Radboud
Principal Investigator: Kirsten Kluivers, MD, PhD, University Medical Center St. Radboud
Principal Investigator: Sanne van Leijsen, MD, University Medical Center St. Radboud
Principal Investigator: Ben Willem Mol, MD, PhD, Academic Medical Centre Amsterdam