Erectile rehabilitation with intracavernous alprostadil after radical prostatectomy: refusal and dropout rates.

UNLABELLED: Study Type--Therapy (outcomes) Level of Evidence 2a. What's known on the subject? and What does the study add? Erectile dysfunction (ED) is a well known implication of radical prostatectomy (RP). Despite the search for technical improvement in the surgical procedure (e.g. nerve-sparing surgery, robot-assisted RP), many patients still suffer from an inability to achieve a satisfactory erection after surgery. In the last 20 years a great effort has been made to re-establish good sexual function in these patients. Many different approaches have been used, such as intracavernous prostaglandin E1 (PGE1), phosphodiesterase-5 inhibitors, vacuum devices and penile prostheses. Although many studies have addressed the main questions about efficacy of different approaches to ED, there is a lack of data about adherence to therapy and the main reasons why patients drop out of these treatment programmes. In the present study, a cohort of men treated with RP underwent a postoperative rehabilitation protocol with PGE1 intracavernous injections. During the follow-up period, we were able to assess a real-life practice pattern of adherence and dropout, evaluating the main causes of therapy discontinuation. This could be of help in the counselling of these patients during the path towards erection recovery.

OBJECTIVES: • To assess the rate of compliance in the first 6 months of a rehabilitation protocol that includes intracavernous alprostadil administration in patients undergoing radical retropubic prostatectomy. • To determine the reasons for and timings of dropout from the protocol by the patients and their subsequent outcomes.

PATIENTS AND METHODS: • All patients undergoing radical prostatectomy (RP) at our institution between 1 January 2007 and 31 December 2009 were considered for a protocol of postoperative intracavernous sexual rehabilitation and were administered entry questionnaires to evaluate their preoperative sexual activity. • Four weeks after surgery, the patients were invited to return for a first visit, where the aim of the protocol and possible risks and benefits were explained. For those who agreed to attend, subsequent visits to include assisted self-administration of increasing doses of intracavernous alprostadil and a period of autonomous homely self-administration were planned. • Patients were followed up at 3-month intervals, where data on functional outcomes, patient satisfaction, and the number of patients who dropped out and their reasons, were recorded by means of appropriate questionnaires. • Statistical analysis was performed using Student's t-test or a chi-squared test, where appropriate.

RESULTS: • Of 430 patients, 157 (36.5%) refused to undergo the protocol of rehabilitation and 18.6% of the patients who began the protocol dropped out over the first 6 months. • Reasons for refusal were: patient's lack of sexual interest (51.6%); lack of interest by the partner (30.2%); and presence of transitory incontinence (26.7%). • Reasons for dropout were: disappointment with treatment efficacy (64.7%); injection pain (45%); and difficulties with or fear of performing the injection by themselves or by the partner (35.2%). No patient claimed the cost of the drug to be a cause for dropout.

CONCLUSIONS: • The protocol we used, involving intracavernous alprostadil injection, proved to be a safe and efficient way of achieving sexual rehabilitation in patients who have undergone RP. Nevertheless, high patient motivation and adherence to the protocol were required. • Factors influencing patients refusal and early-to-medium time dropout were both patient- and partner-related. Appropriate information, counselling and support of the couple before the beginning and at all stages of the rehabilitation play a fundamental role in reducing the dropout rate. • The situation regarding those patients who still need adjuvant therapy after surgery is less clear and further research on this is required.