Using shock wave therapy to improve erectile dysfunction after prostate surgery
Low Intensity Shock Wave Therapy in the Rehabilitation Treatment of Erectile Dysfunction After Robotic Radical Prostatectomy: Randomized Controlled Trial
This study is testing whether combining shock wave therapy with a common erectile dysfunction pill can help men recover their sexual function better after prostate surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 158 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Male |
| Sponsor | Regina Elena Cancer Institute Academic / other |
| Locations | 1 site (Rome) |
| Trial ID | NCT06442020 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of Low-intensity Extracorporeal Shock Wave Therapy (LiESWT) combined with the early use of PDE5 inhibitors, like Tadalafil, for rehabilitating erectile dysfunction following robotic radical prostatectomy. It is a prospective randomized controlled trial aimed at comparing the outcomes of patients receiving both treatments against those receiving only PDE5 inhibitors. The study focuses on measuring the recovery of erectile function and overall sexual health through validated questionnaires over a short and medium-term follow-up period.
Who should consider this trial
Good fit: Ideal candidates are men aged 75 or younger with low-risk prostate cancer who are undergoing nerve-sparing robotic prostatectomy.
Not a fit: Patients with major postoperative complications or those with cardiovascular contraindications to PDE5 inhibitors may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance the recovery of erectile function in men after prostate surgery.
How similar studies have performed: Previous studies have shown promising results with similar shock wave therapies for erectile dysfunction, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged ≤75 yrs; * Low-risk PCa (PSA \<10 ng/mL and GS \<7, ISUP grade 1, and cT1-2a) undergoing nerve sparing RARP; * preoperative IIEF-5 score ≥ 17; * First PSA (45d after surgery) \<0.2 * compliants patients able to follow the study protocol and fill in IIEF-5 scores and EORTC quality of life questionnaires; * patients able to provide a written informed consent for the trial. Exclusion Criteria: * anaesthesiologic contraindications to robotic surgery; * patients submitted to pelvic radiotherapy or androgen deprivation; * patients reporting major postoperative complications (CD≥3); * cardiovascular contraindications to PDE5i medical treatment.
Where this trial is running
Rome
- "Regina Elena" National Cancer Institute — Rome, Italy (Recruiting)
Study contacts
- Study coordinator: Giuseppe Simone, Doctor
- Email: giuseppe.simone@ifo.it
- Phone: 06-5266.5005
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.