Study design, materials and methods
The primary efficacy end point was improvement in 24-hour pad weight test. Other efficacy measures included the cough stress test, Urogenital Distress Inventory-Short Form, Incontinence Impact Questionnaire-Short Form, Patient Global Impression of Improvement and 3-day voiding diary. Safety was evaluated through assessment of device and procedure related adverse events.
Patients were evaluated pre-operatively, and post-operatively at 3 and 6 months, then yearly for a medium total of three years
Patients: A total of 47 patients who underwent for stress urinary incontinence treatment.
The patients were reassessed 5 years after surgery. Primary outcome measures were objective and subjective cure rates as well as total failure rate.
Results
The mean operative time was 12 min (range 6-30) with a catheterisation time of 0,9 day (range 0-2).
No severe bleeding was observed.
Total follow up was 60 months (range 40 to 64). Objective success was evaluated using a 1-hour pad test, and subjective cure was evaluated using a questionnaire score (Incontinence Impact Questionnaire, Urinary Distress Inventory, and International Consultation on Incontinence Questionnaire Short Form).
The objective cure in the tissue fixation system group were 94.5% . The 12-month rates decreased from 94.5% (3-months postoperative) to 91.3% (12-month postoperative) The difference in decreased cure rates between 5 and 3 years was 7%
The median reductions in UDI-6 and IIQ-7 scores was 5.0 (2.5, 9.0 IQR) and 12.0 (6.0, 16.0 IQR) (p<0.0001)
No perforations of the urethra or of the bladder occurred during the surgery
In two cases when the injury was not recognised during the procedure.
Additionally, 97.4% of subjects reported "very much better" or "much better" on the Patient Global Impression of Improvement.
There were a single mesh migration. In one patient a re-intervention was necessary for tape removal for a urinary retention.
Interpretation of results
In this study emerges that this technique is safe and with few side effects. The results are maintained over time and appear similar results to Trans-obturator vaginal tape (TOT) for female stress .The single incision sling procedure is associated with low postoperative pain
however, the surgical procedure is paradoxically more difficult to learn correctly than theTrans-obturator vaginal tape (TOT)