Proposal of a new rehabilitation protocal based on the use of intracavernous injections and Tadalafil: preliminary results from a pilot study
Ventimiglia, E1; Barbieri, L1; Capogrosso, P1; Gandaglia, G1; Dehò, F1; Briganti, A1; Mirone, V2; Gaboardi, F1; Salonia, A1; Montorsi, F1
1: San Raffaele Hospital, Italy; 2: University of Naples Federico II, Italy
Objectives: We propose a new rehabilitation protocol based on early intracavernous injections (ICI) combined with tadalafil (TAD) administration following nerve sparing robot-assisted radical prostatectomy (nsRARP)
Methods: We enrolled 35 men treated with nsRARP from Jan 2017 with normal preoperative erectile function. ICI were started within the first month following RARP using 0.2 ml of a four-drug mixture (papaverine hydrochloride 4 mg/ml, prostaglandin E1 4 micrograms/ml, phentolamine mesylate 0.25 mg/ml, and atropine 0.05 mg/ml) 3 times/week with up/down-titration according to clinical response. A qualified nurse provided close ICI tutoring during the study period. TAD 20mg was given 2h before masturbation/sexual intercourse on the days when ICI were not used. Study period lasted 6 months followed by 2-month drug-washout. Efficacy outcomes were: ICI dose down titration, spontaneous erections (tumescence>50%), and satisfactory intercourse. We further monitored penile deformity/shortening and orgasmic function. Over the rehabilitation protocol, IIEF-EF was evaluated after the first 3 months, comparing scores obtained with ICI and TAD. Logistic regression tested the association between patients’ characteristics and spontaneous erections at study end.
Results: 3 men (9%) had technical issues with ICI, which were solved after additional tutoring. Four men (11%) discontinued TAD due to side effects and 2 (6%) due to lack of efficacy. Overall, 29 (74%) men completed the study protocol. Median IIEF-EF score was 22 (20-27) with ICI and 12 (8-15) with TAD20 (p<0.001) at 3-mo assessment. Of those patients who completed the combined treatment protocol, ICI dose down-titration was observed in 19 men (66%), morning/spontaneous erections in 13 (44%), and satisfactory intercourse in 27 (93%) at study end. Two (7%) men reported acquired penile deformity, whereas impaired OF was observed in 9 (31%) men. A small difference between IIEF-EF obtained with ICI and TAD at three months (i.e. a good EF with both ICI and PDE5) was the only factor significantly associated with spontaneous tumescence/erections recovery (OR 0.9, 95% CIs 0.81–0.99; p: 0.03). No adverse event related to ICI was observed.
Conclusions: The new protocol showed an acceptable level of efficacy and patient satisfaction, with limited safety issues. Early IIEF-EF assessment might serve as prognostic factor of spontaneous tumescence recovery. Expert tutoring for ICI must be adopted in every patient in order to minimize treatment discontinuation.
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