Stress urinary incontinence
Conditions
Interventions
• Single incision mid-urethral sling (Altis)
• Urethral injection treatment (Bulkamid)
Sponsors
None
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 1. Subjective cure of stress incontinence at 3 months, 1 year and 5 years after surgery 2. Objective cure of stress incontinence at 3 months, 1 year and 5 years after surgery 3. Complications during and after the procedure 4. Pain scores postoperative 5. Cost-effectiveness of the treatment | — |
Contacts
Public ContactNienke Osse
Isala
Outcome results
None listed