AIMS OF STUDY: Since there only a few reports in the literature [1,2], a prospective clinical trial was undertaken to evaluate the safety and efficacy of a urethral bulking agent Macroplastique® in the treatment of mild to moderate stress urinary incontinence (SUI) after radical prostatectomy (RP). Primary endpoint was change incontinence grade and secondary was change in urine loss.
METHODS: Males with SUI that was not improving at least 1 year after RP were selected. Baseline evaluation included clinical assessment, incontinence grade (Stamey), Quality of Life (QoL), urodynamics, and 2-hour pad weights. Injection of Macroplastique® was done transurethrally under general or regional anaesthesia as an outpatient. Follow-up evaluation with incontinence grade, QoL, pad weights was scheduled at intervals after injection. Up to 2 retreatments were undertaken after an interval of 3 months. A pad weight of 2 gm or less was classified as cure, and pad weights of more than 2 gm were classified as improved. Overall success was defined as a decrease in incontinence grade and pad weight reduction of 50% or more.
RESULTS: Of 18 men screened, 15 with a mean age of 63.9 years (range 51-74) were treated. All of the patients except 1, who had 1 treatment, have undergone a total of 3 treatments. The minimum follow-up of the group is 6 months after the last injection (range 6 to 21). Overall success has been seen in 10 patients (67%). Two patients (13%) have been cured at 12 and 21 months after last injection. The 8 improved patients (53%) had a mean pad weight of 41 gm pre-treatment and 20 gm post-treatment, a reduction of 51% (P>0.05). These patients decreased their pad requirement from 3 to 1.8 pads per day (P<0.5). Of the 5 patients who failed (33%), 1 experienced an increase in pad requirement. Adverse events were seen in 3 patients who needed 5 days of catheterization for retention. No other significant morbidity was seen. Four patients had undergone post RP radiation and of these 1 failed and 3 improved. The failed irradiated patient required transurethral removal of the implant after erosion into the urethra.
CONCLUSIONS: Intraurethral Macroplastique® is a safe and reasonably effective treatment for post RP SUI. Patient acceptance and willingness to complete treatment is high and morbidity is low.
1. Colombo T, Augustin H, Breinl E, Schips L, Hubmer G: The use of polydimethylsiloxane in the treatment of incontinence after radical prostatectomy. Brit J Urol 1997; 80:923-926
2. Bugel H, Pfister C, Sibert L, Cappele O, Khalaf A, Grise P. Intraurethral Macroplastic injections in the treatment of urinary incontinence after prostatic surgery. Progres en Urologie 1999; 9:1068-1076.
Source: Original Abstract