Value of Urodynamics Prior to Stress Incontinence Surgery 2

NCT00814749 | Unknown DMC

• 1 other identifier: 2006/197
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress Urinary Incontinence

Keywords

stress urinary incontinence; urodynamics; randomized clinical trial; surgery

Outcome Measures

Primary Outcomes (1)

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

  one year

Secondary Outcomes (1)

• 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

Study Arms (2)

surgical therapy

ACTIVE COMPARATOR

Procedure: midureteral sling

individual management

ACTIVE COMPARATOR

Other: surgical therapy or conservative

Interventions

midureteral sling PROCEDURE

midureteral sling

surgical therapy

surgical therapy or conservative OTHER

midureteral sling or conservative; medication, physiotherapy

individual management

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

University Medical Center St. Radboud

Nijmegen, Gelderland, Netherlands

RECRUITING

Related Publications (2)

• 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.

  PMID: 23635736 DERIVED

• 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.

  PMID: 19622153 DERIVED

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sanne van Leijsen, M.D.

CONTACT

+31-6-41520114; sannevanleijsen@hotmail.com

Mark Vierhout, M.D. PhD

CONTACT

+31243613635; m.vierhout@obgyn.umcn.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 24, 2008
• First Posted: December 25, 2008
• Study Start: November 1, 2008
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2011
• Last Updated: December 25, 2008

Record last verified: 2008-12

Locations

NL (1)