Low-intensity shockwave therapy for erectile dysfunction after prostate surgery
Extracorporeal Shockwave Therapy for Penile Rehabilitation in Post-Radical Prostatectomy Patients: A Randomized, Double-Blinded, Sham-Controlled Study
This study is testing if a new type of shockwave therapy, along with a daily pill, can help men regain erectile function after prostate surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 40 Years to 75 Years |
| Sex | Male |
| Sponsor | Hospital Pengajar Universiti Putra Malaysia Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Serdang, Selangor) |
| Trial ID | NCT06076850 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of low-intensity extracorporeal shockwave therapy (LiESWT) combined with daily Tadalafil in improving erectile function in patients who have undergone nerve-sparing radical prostatectomy. Participants will be randomly assigned to receive either the active LiESWT treatment or a sham therapy over six weeks, alongside a daily dose of Tadalafil for twelve months. The study aims to assess sexual outcomes using validated measures such as the International Index of Erectile Function (IIEF) and the Erectile Hardness Score (EHS). The hypothesis is that this combined approach will enhance recovery of erectile function compared to the control group.
Who should consider this trial
Good fit: Ideal candidates are sexually active men who have undergone nerve-sparing radical prostatectomy for low to intermediate-risk prostate cancer.
Not a fit: Patients with erectile dysfunction due to neuropathological, endocrine, or psychogenic causes may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve sexual function and quality of life for men experiencing erectile dysfunction after prostate surgery.
How similar studies have performed: Previous studies have shown promising results for LiESWT in treating erectile dysfunction, particularly in patients with vascular issues, suggesting potential success in this context as well.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients who underwent radical prostatectomy (open, laparoscopic or robotic-assisted) with nerve-sparing (unilateral or bilateral). * Low / intermediate-risk prostate cancer * PSA \< 20 ng/ml * Gleason score \< 8 * Prostate cancer pathological stage \</= T2b * Sexually active with IIEF-5 score 3 18, with or without use of erectogenic aid / PDE5i. Exclusion Criteria: * Tumour upstaging beyond T2b * Neurovascular bundle tissues bilaterally in the histopathological report. * Scheduled treatment with pelvic radiotherapy and / or androgen deprivation therapy post-RP. * Men with ED of neuropathological, endocrine or psychogenic origin. * Previous pelvic surgery or radiation therapy. * Patients with uncontrolled psychiatric conditions. * Patients with major post-operative complications that could impact safety or effectiveness of ESWT. * Patients with heart disease - unable to take PDE5i or prohibited from sexual activity. * Patients on anticoagulation / antiplatelets except aspirin up to 100mg daily. * Inflammation in the shockwave area or having penile pathology such as Peyronie's disease.
Where this trial is running
Serdang, Selangor
- Hospital Sultan Abdul Aziz Shah, Universiti Putra Malaysia (previously known as HPUPM) — Serdang, Selangor, Malaysia (Recruiting)
Study contacts
- Principal investigator: Vincent Khor, ChM(Urol) — Universiti Putra Malaysia
- Study coordinator: Vincent Khor, ChM(Urol)
- Email: khorweisheng@upm.edu.my
- Phone: +603-9769 9220
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.