Single incision sling versus Bulkamid in treating SUI

Recruiting

Conditions: Stress urinary incontinence

Registration Number: NL-OMON23096

Lead Sponsor: one

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 224

Inclusion Criteria

•Predominant stress urinary incontinence (e.g. on a weekly basis more incontinence episodes related to physical exercise, coughing or sneezing, as compared to incontinence associated with a feeling of urgency).
•The stress urinary incontinence is confirmed during physical examination, stress test or urodynamic assessment.
•Moderate to severe incontinence as identified by use of the Sandvik score
•Women should be able to understand the Dutch language both verbally as well as in writing.

Exclusion Criteria

•A post voiding bladder volume of more than 100 ml, as determined by bladder catheterisation or ultrasound (Bladderscan®)
•History of anti-incontinence surgery
•Genital prolapse Stage 2 (Ba >0) or more according to the POP-Q classification
•Patients desire for future pregnancy and childbirth
•Co-morbidity which is associated with increased surgical risks, for instance women with ASA 3 or 4 classification > up to the physician to decide.
•History of recurrent lower urinary tract infection (> 3 times/year)
•History of current major psychiatric illness, as subjectively assessed by the physician
•History of chronic or current neurological disease, as subjectively assessed by the physician
•Poor cognitive function, as subjectively assessed by the physician

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To record patient satisfaction to treatment of stress incontinence (Patient Global Impression of Improvement) at 1 year follow up after Altis® procedures administered under conscious sedation with local infiltration or Bulkamid (PAHG).

Secondary Outcome Measures

Name	Time	Method
1. Subjective cure of stress incontinence at 3 months, 1 year and 5 years after surgery<br>2. Objective cure of stress incontinence at 3 months, 1 year and 5 years after surgery<br>3. Complications during and after the procedure<br>4. Pain scores postoperative<br>5. Cost-effectiveness of the treatment