Value of Urodynamics Prior to Stress Incontinence Surgery

NCT00509730 | Terminated DMC

• 2 other identifiers: NL14625.091.0680-007022-98-07203
• Study Type: interventional
• Target: 290
• 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 among the two groups as far as the improvement in the UDI at two years after treatment is concerned.

Secondary Outcomes (1)

• Cure of incontinence as measured by the pad test and 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.

Interventions

Urodynamics PROCEDURE

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)

UMC St.Radboud

Nijmegen, Gelderland, 6500 H.B., Netherlands

Location

Related Publications (1)

• van Leijsen SA, Kluivers KB, Mol BW, Broekhuis SR, Milani AL, Bongers MY, Aalders CI, Dietz V, Malmberg GG, Vierhout ME, Heesakkers JP. Can preoperative urodynamic investigation be omitted in women with stress urinary incontinence? A non-inferiority randomized controlled trial. Neurourol Urodyn. 2012 Sep;31(7):1118-23. doi: 10.1002/nau.22230. Epub 2012 Apr 6.

  PMID: 22488817 DERIVED

MeSH Terms

Conditions

Urinary Incontinence, Stress

Interventions

Urodynamics

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

Intervention Hierarchy (Ancestors)

Urinary Tract Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Officials

• Mark Vierhout, M.D. PhD.

  University Medical Center St. Radboud

  PRINCIPAL INVESTIGATOR

• John Heesakkers, M.D. PhD.

  University Medical Center St. Radboud

  PRINCIPAL INVESTIGATOR

• Suzan Broekhuis, M.D.

  University Medical Center St. Radboud

  PRINCIPAL INVESTIGATOR

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: July 30, 2007
• First Posted: July 31, 2007
• Study Start: March 1, 2007
• Study Completion: March 1, 2010
• Last Updated: October 7, 2009

Record last verified: 2008-06

Locations

NL (1)