Value of Urodynamics Prior to Stress Incontinence Surgery 2 (VUSIS 2)

Radboud University Medical Center

Status: Unknown

Conditions: Stress Urinary Incontinence

Treatments: Procedure: midureteral sling; Other: surgical therapy or conservative

Study type: Interventional

Funder types: Other

Identifiers

NCT00814749

2006/197

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

---

600 participants in 2 patient groups

surgical therapy

Active Comparator group

Treatment:

Procedure: midureteral sling

individual management

Active Comparator group

Treatment:

Other: surgical therapy or conservative