Injectable Bulking Agent to Treat Postprostatectomy Urinary Incontinence: A Safety and Effectiveness Pilot Study

Abstract EN

Objectives.

To evaluate the safety and effectiveness of the injectable bulking agent Opsys® (Promedon, Cordoba, Argentina) for treating minimal postprostatectomy stress urinary incontinence (SUI).

Patients and Methods.

Single-centre, pilot study on ten male patients with SUI, < 30 g urine loss/ 24 h, more than 1 year after radical prostatectomy.

Patients were treated by endoscopic transurethral injections of bulking agent in the presphincteric zone of the urethral submucosa.

The results were evaluated using a pad weight test to quantify the differences in urine loss at 1, 3, and 6 months after intervention.

Subsequently, the results of treatment were also evaluated by International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF), Incontinence Impact Questionnaire (IIQ-7), Urogenital Distress Inventory Short Form (UDI-6-SF), and the Patient Global Impression of Improvement (PGI-I) at 1, 3, and 6 months after intervention.

Results.

The primary outcome was the absolute result of the 24-hour pad weight test after treatment.

Treatment success was defined as <3 g urine loss/24 h, improvement as ≥50% decrease in urine loss/ 24h, failure as <50% decrease in urine loss/24 h, or worsening of urine loss.

Success was demonstrated in one, improvement in one, and failure in eight patients one month after treatment.

One patient improved and 9 failed 3 and 6 months after treatment.

The median 24-hour pad weight test was higher at all three moments of follow-up (1, 3, and 6 months after treatment).

The median 24-hour pad weight test was before treatment 17.3g (6.4-20.9) and 1, 3, and 6 months after treatment, respectively, 40.3g (5.9-130.6) p= 0.038, 38.3g (18.3-202.1) p= 0.014, 55.0g (16.5-314.6) p= 0.028.

The ICIQ-SF was significantly higher at 3 and 6 months, respectively 15.0 (12.0-18.5) p= 0.007 and 16.0 (12.5-17.5) p=0.012 versus 10.0 (9.0-12.0) before injection.

No significant differences were found between IIQ-7, UDI-6-SF, and PGI-I before and after injection.

Complications occurred in four patients: two patients reported spontaneously resolved haematuria and two patients reported urinary frequency.

All complications were classified as Clavien–Dindo 1.

Conclusion.

Injection therapy with Opsys® bulking agent is not an effective treatment option for male SUI after radical prostatectomy.

It is not a safe treatment option, due to worsening urine loss after treatment.