Erectile Dysfunction Following Radical Prostatectomy Clinical Trial
Official title:
Extracorporeal Shockwave Therapy for Penile Rehabilitation in Post-Radical Prostatectomy Patients: A Randomized, Double-Blinded, Sham-Controlled Study
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 complications after RP. Despite the advancement of prostate cancer treatment, ED post-RP remains a significant morbidity especially for patients who are sexually active pre-operatively. To improve the sexual function post-surgery, numerous strategies have been described including preservation of neurovascular bundles intra-operatively, post-operative physiotherapy, on-demand phosphodiesterase 5-inhibitors (PDE5i), regular PDE5i, intra-carvenosal injection or vacuum suction device. Low-intensity extracorporeal shockwave therapy (LiESWT) is an emerging treatment modality of ED with promising result, and it is a well-established treatment of ED in patients with diabetes mellitus or vasculopathy. Most of the pre-clinical studies were done on post-RP ED rat models with bilateral cavernous nerve crush injury. LiESWT was observed to improve nerve-impaired ED significantly compared to sham procedures. There are currently one pilot study and one randomized controlled trial (RCT) published in the literature on this field. However, the published RCT was an open label study with no sham-controlled arm which could contribute to reporting bias and the treatment intensity might not be adequate. In our proposed study, we make a hypothesis that LiESWT and very early PDE5i can improve erectile function in patients after nerve-sparing radical prostatectomy.
Status | Recruiting |
Enrollment | 70 |
Est. completion date | June 30, 2025 |
Est. primary completion date | June 30, 2025 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 40 Years to 75 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Malaysia | Hospital Sultan Abdul Aziz Shah, Universiti Putra Malaysia (previously known as HPUPM) | Serdang | Selangor |
Lead Sponsor | Collaborator |
---|---|
Hospital Pengajar Universiti Putra Malaysia |
Malaysia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sexual Function | Measurement of average change in IIEF-5 score from baseline (pre-RP) to specified time-points at 1,3,6 and 12 months after completion of treatment - 22-25: No erectile dysfunction 17-21: Mild erectile dysfunction 12-16: Mild to moderate erectile dysfunction 8-11: Moderate erectile dysfunction 5-7: Severe erectile dysfunction 5 being the worst outcome | 12 months | |
Secondary | Stretched Penile Length | Clinical measurement of change in stretched flaccid penile length from baseline specified time-points at 1,3,6 and 12 months after completion of treatment. | 12 months | |
Secondary | Urinary Function | Measurement of average change in EPIC questionnaire score from baseline (pre-RP) to specified time-points at 1,3,6 and 12 months after completion of treatment. | 12 months | |
Secondary | Safety and Adverse Events | Number of Participants With Treatment-Related Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 | 12 months |
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