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ID
Source
Brief title
Health condition
Stress urinary incontinence
Sponsors and support
Intervention
Outcome measures
Primary outcome
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
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
Background summary
Stress urinary incontinence (SUI) is a common complaint which significantly impacts the quality of life of many women. If the first-line treatment for SUI, the training of pelvic floor muscles, is insufficient, treatment options consist of transurethral bulking injection or midurethral sling placement. Midurethral slings are considered the gold standard for the treatment of SUI, with an efficacy as high as 90%. Bulking agents create an artificial mass into the urethral submucosa and according to hypothesis improve urethral coaptation and restore continence especially when abdominal pressure is increased. The efficacy of bulking agents in treating stress urinary incontinence has varied from 64% to 74% depending on the treated patient group, however, urethral injections have a lower risk of complications than midurethral sling surgery.
Studies comparing urethral injection treatment and single incision mid-urethral slings in women with pure stress urinary incontinence are scarce. Recently, a Finnish study group published their results on retropubic TVT versus PAHG-injections with Bulkamid ®. TVT was superior to Bulkamid ® in curing stress urinary incontinence. However, there were no complications in the Bulkamid ® group and patient satisfaction (‘would you choose this procedure again’?) was equal in both groups. Since single-incision slings are more often used than retropubic TVTs in the treatment of stress urinary incontinence in the Netherlands, this prospective observational cohort study compares the single-incision sling (Altis ®) and Bulkamid®-injections in treatment of SUI.
Study objective
The patient satisfaction between urethral injection treatment and single incision mid-urethral slings in women with pure stress urinary incontinence will be comparable. Patients treated with single incision mid-urethral slings will be more objectively dry, but patients treated with urethral injections will have less complications.
Study design
6 weeks, 3 months, 1 year
Intervention
• Single incision mid-urethral sling (Altis)
• Urethral injection treatment (Bulkamid)
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
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9353 |
| Other | METC Isala : METC201114 |