Value of Urodynamics Prior to Stress Incontinence Surgery 2

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00814749

Acronym

VUSIS 2

Enrollment

600

Registered

2008-12-25

Start date

2008-11-30

Completion date

2011-01-31

Last updated

2008-12-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stress Urinary Incontinence

Keywords

stress urinary incontinence, urodynamics, randomized clinical trial, surgery

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.

Interventions

PROCEDUREmidureteral sling

midureteral sling

OTHERsurgical therapy or conservative

midureteral sling or conservative; medication, physiotherapy

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

FEMALE

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

Design outcomes

Primary

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

Secondary

Measure	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

Countries

Netherlands

Contacts

Primary ContactSanne van Leijsen, M.D.

sannevanleijsen@hotmail.com+31-6-41520114

Backup ContactMark Vierhout, M.D. PhD

m.vierhout@obgyn.umcn.nl+31243613635

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 2, 2026