Status:
UNKNOWN
Low-Intensity Extracorporeal Shockwave Therapy for Penile Rehabilitation in Post-Radical Prostatectomy Patients
Lead Sponsor:
Hospital Pengajar Universiti Putra Malaysia
Conditions:
Erectile Dysfunction Following Radical Prostatectomy
Eligibility:
MALE
40-75 years
Phase:
NA
Brief Summary
Radical prostatectomy (RP) is one of the curative treatment modalities for localized or locally advanced prostate cancer. Urinary incontinence and erectile dysfunction (ED) are two most common complic...
Detailed Description
Urinary incontinence and erectile dysfunction (ED) are two most common complications after RP. Despite the advancement of prostate cancer treatment, erectile dysfunction post-prostatectomy remains as ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2025
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06076850
Start Date
July 1 2023
End Date
June 30 2025
Last Update
October 11 2023
Active Locations (1)
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1
Hospital Sultan Abdul Aziz Shah, Universiti Putra Malaysia (previously known as HPUPM)
Serdang, Selangor, Malaysia, 43400