This pilot study aims to explore the feasibility, safety and effectiveness of two different extracorporeal shock wave therapy (ESWT) protocols for patients receiving nerve-sparing radical prostatectomy (RP).
This is an open-label, randomized, 2-parallel-arm trial (n=94). All patients will receive (A) sham (n=47) or (B) active ESWT (n=47) twice/week for 6 weeks (12 sessions total). Concurrently, all patients will receive daily tadalafil 5mg for 24 weeks. Patients will then undergo a 4 week washout period without erectogenic aids, and return for a 28-week evaluation. Subsequently, patients requiring further erectogenic aids after 28 weeks will be offered intracavernosal injections (ICI) of prostaglandin E1 (PGE1). Random assignment will be performed by computer program (eg. randomizer.org), in a design that obtains equal sample size per group. All patients will be followed for a period of 24 months post-RP. Follow-up protocol includes evaluation of the IIEF, EHS, GAQ, ICI usage and tolerability, stretched flaccid penile length, urinary incontinence, and oncologic status.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
94
Active ESWT: 5000 shockwaves per session. 2 ESWT sessions per week, 12 sessions in total.
Sham ESWT - No shockwave administered
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
RECRUITINGThe difference in average Erectile Function (EF) domain score of the International Index of Erectile Function (IIEF) between the groups at 28-week follow up
EF domain of the IIEF questionnaire will be completed. IIEF-EF consists of items 1,2,3,4,5,15 of the IIEF questionnaire.According to the score of the iIEF-EF there are five categories of erectile function: 1-10 (Severe Erectile Dysfunction), 11-16(Moderate dysfunction), 17-21(Mild to moderate dysfunction), 22-25(Mild dysfunction), 26-30 (No dysfunction)
Time frame: 28-week follow up visit
The difference in average Erectile Function (EF) domain score of the International Index of Erectile Function (IIEF) between the groups at 24-month follow up
EF domain of the IIEF questionnaire will be completed. IIEF-EF consists of items 1,2,3,4,5,15 of the IIEF questionnaire.According to the score of the iIEF-EF there are five categories of erectile function: 1-10 (Severe Erectile Dysfunction), 11-16(Moderate dysfunction), 17-21(Mild to moderate dysfunction), 22-25(Mild dysfunction), 26-30 (No dysfunction)
Time frame: 24-month follow up visit
Proportion of patients achieving Erectile Function (EF) domain score of the International Index of Erectile Function (IIEF) of 22-30 in each group
The proportion of patients achieving Erectile Function (EF) domain score of the International Index of Erectile Function (IIEF) of 22-30 (indicating mild to no erectile dysfunction) in each group. EF domain of the IIEF questionnaire will be completed. IIEF-EF consists of items 1,2,3,4,5,15 of the IIEF questionnaire.According to the score of the iIEF-EF there are five categories of erectile function: 1-10 (Severe Erectile Dysfunction), 11-16(Moderate dysfunction), 17-21(Mild to moderate dysfunction), 22-25(Mild dysfunction), 26-30 (No dysfunction).
Time frame: baseline, 12-weeks post-RP, 24-weeks post-RP, 28-weeks post-RP, 52-weeks post-RP, 18-months post-RP and 24-months post-RP
Change in each domain of the full International Index of Erectile Function (IIEF) score
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Change in each domain of the full International Index of Erectile Function (IIEF) score from baseline and from each follow-up. EF domain of the IIEF questionnaire will be completed. IIEF-EF consists of items 1,2,3,4,5,15 of the IIEF questionnaire.According to the score of the iIEF-EF there are five categories of erectile function: 1-10 (Severe Erectile Dysfunction), 11-16(Moderate dysfunction), 17-21(Mild to moderate dysfunction), 22-25(Mild dysfunction), 26-30 (No dysfunction)
Time frame: baseline, 12-weeks post-RP, 24-weeks post-RP, 28-weeks post-RP, 52-weeks post-RP, 18-months post-RP and 24-months post-RP
Change in Erection Hardness Score
The Erection Hardness Score (EHS) is a single-item Likert scale to assess erectile dysfunction. Male patients have to answer the question "How would you rate the hardness of your erection?". They answer by selecting from the following options: 0 = Penis does not enlarge; 1 = Penis is large, but not hard; 2 = Penis is hard, but not hard enough for penetration; 3 = Penis is hard enough for penetration, but not completely hard; 4 = Penis is completely hard and fully rigid.
Time frame: baseline, 12-weeks post-RP, 24-weeks post-RP, 28-weeks post-RP, in-office ICI visits, 52-weeks post-RP, 18-months post-RP and 24-months post-RP
Change in Global Assessment Questionnaire (GAQ) score
The Global Assessment Questionnaire (GAQ) is a tool to evaluate the efficacy of the treatment. Patients will be asked and provide scores (on a scale of 1 to 5) for treatment related, with a score of 1 being least favourable and 5 being most favourable.
Time frame: 12-weeks post-RP, 24-weeks post-RP, 28-weeks post-RP, 52-weeks post-RP, 18-months post-RP and 24-months post-RP
Change in stretched flaccid penile length
The flaccid penis of each patient will be stretched and measured from the base of the penis to the tip of the glans.
Time frame: baseline, 12-weeks post-RP, 24-weeks post-RP, 52-weeks post-RP, 18-months post-RP and 24-months post-RP
Change in degree of incontinence
Incontinence will be determined by the number of pads used per day and the time to achieve 0-1 pad will be compared between the groups.
Time frame: First treatment session, 12-weeks post-RP, 24-weeks post-RP, 52-weeks post-RP, 18-months post-RP and 24-months post-RP
Oncologic status
The oncologic status of each patient will be evaluated determined by the serum prostate specific antigen (PSA) levels.
Time frame: 12-weeks post-RP, 24-weeks post-RP, 52-weeks post-RP, 18-months post-RP and 24-months post-RP
Time to recovery of penetration erection hardness without erectogenic aids
Penetration erection hardness is having an EHS score of 3-4. The Erection Hardness Score (EHS) is a single-item Likert scale to assess erectile dysfunction. Male patients have to answer the question "How would you rate the hardness of your erection?". They answer by selecting from the following options: 0 = Penis does not enlarge; 1 = Penis is large, but not hard; 2 = Penis is hard, but not hard enough for penetration; 3 = Penis is hard enough for penetration, but not completely hard; 4 = Penis is completely hard and fully rigid.
Time frame: baseline, 12-weeks post-RP, 24-weeks post-RP, 28-weeks post-RP, in-office ICI visits, 52-weeks post-RP, 18-months post-RP and 24-months post-RP
Tolerability to and reliance on intracavernosal injections for satisfactory erections: Visual Analog Scale for Pain
Patients who are unsatisfied with their erectile function at the 28 week visit, will be offered intracavernosal injections (10mg PGE1, 2x/week) for the remaining duration of the study. During each in-office ICI, patients will report pain tolerability (Visual Analog Scale for Pain), and maximum EHS achieved. Patients will be allowed to stop ICI if they report satisfactory erections without any erectogenic aids for 2 weeks. Patients will be allowed to resume ICI if erectile function decreases, and they report unsatisfactory erections with erectogenic aids for 2 weeks. Dates of stopping and/or resuming ICI will be recorded. At the 52 weeks, 18 and 24 months post-RP follow-up sessions, All patients will self-administer ICI of 10mg PGE1 during the visit, and report pain tolerability (Visual Analog Scale for Pain), and maximum EHS achieved.
Time frame: ICI visits, 52-weeks post-RP, 18-months post-RP and 24-months post-RP