Value of Urodynamics Prior to Stress Incontinence Surgery 2 | NCT00814749

Studies
Value of Urodynamics Prior to Stress Incontinence Surgery 2

NCT00814749

Sponsor

Radboud University Medical Center

Status

Unknown status

Last Update Posted

Dec 25, 2008Estimated

Enrollment

600Estimated

Phase

Not Applicable

Conditions

Stress Urinary Incontinence

Interventions

midureteral sling
surgical therapy or conservative

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2008

Primary Completion Date

Jan 2010Estimated

Completion Date

Jan 2011Estimated

First Submitted Date

Dec 24, 2008

First Submission Date that Met QC Criteria

Dec 24, 2008

First Posted Date

Dec 25, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 24, 2008

Last Update Posted Date

Dec 25, 2008Estimated

Name	Class
ZonMw: The Netherlands Organisation for Health Research and Development	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

600Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
surgical therapy	Active Comparator		Procedure: midureteral sling
individual management	Active Comparator		Other: surgical therapy or conservative

Interventions

Name	Type	Description	Arm Group Labels	Other Names
midureteral sling	Procedure	midureteral sling	surgical therapy
surgical therapy or conservative

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Non inferiority of the improvement of the urinary distress inventory one year after treatment.		one year

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sanne van Leijsen, M.D.	Contact	+31-6-41520114		sannevanleijsen@hotmail.com
Mark Vierhout, M.D. PhD	Contact	+31243613635		m.vierhout@obgyn.umcn.nl

Overall Officials

Name	Affiliation	Role
Mark Vierhout, MD, PhD	Radboud University Medical Center	Principal Investigator
John Heesakkers, MD, PhD	University Medical Center St. Radboud	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Medical Center St. Radboud	Recruiting	Nijmegen	Gelderland		Netherlands

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23635736	Derived	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.
19622153

ID	Term
D014549	Urinary Incontinence
D014555	Urination Disorders
D014570	Urologic Diseases
D052776	Female Urogenital Diseases