Early Shockwave Therapy for Post-RP ED
Erectile Dysfunction Following Radical Prostatectomy
About this trial
This is an interventional treatment trial for Erectile Dysfunction Following Radical Prostatectomy
Eligibility Criteria
Inclusion Criteria:
- Men scheduled for robotic bilateral nerve-sparing radical prostatectomy
Diagnosed with low/intermediate-risk prostate cancer:
- PSA < 20 ng/ml
- Gleason score < 8
- PCa stage =< T2b
- Baseline IIEF-ED 22-30 without erectogenic aids
- No urinary incontinence (no usage of urinary pads)
- Sexually active, in a stable heterosexual relationship
- Able to understand and complete patient questionnaires
- Consent to participate
Exclusion Criteria:
- Anatomical abnormalities in the genitalia or pelvic region
- Post-RP complications that could impact safety or effectiveness of ESWT (eg. hematoma, fistula, unresolved anastomotic leak)
- Incomplete tumor removal (positive surgical margin)
- Tumor upstaging beyond T2b
- Nerve sparing score < 4
- Previous or scheduled treatment with pelvic radiotherapy and/or androgen deprivation therapy
- Untreated hypogonadism (serum total testosterone < 300 mg/dL)
- Anti-coagulant medication, or any blood coagulation disorders (INR > 3)
- Any other condition that would prevent the patient from completing the study, as judged by the principle investigator
Sites / Locations
- Hospital Universitari de BellvitgeRecruiting
Arms of the Study
Arm 1
Arm 2
Sham Comparator
Active Comparator
Sham ESWT + 5mg Tadalafil
Active ESWT + 5mg Tadalafil
Patients will receive shockwave treatments (12 sessions for all subjects, 5000 shockwaves at each session), using a sham applicator which is highly similar to the active applicator except that the sham applicator does not emit shockwaves, twice a week (total of 6 weeks) without treatment interval. Patients will receive Tadalafil 5mg for 24 weeks daily beginning the day of removal of the urinary catheter.
Patients will receive shockwave treatments (12 sessions for all subjects, 5000 shockwaves at each session), twice a week (total of 6 weeks). Patients will receive Tadalafil 5mg for 24 weeks daily beginning the day of removal of the urinary catheter.