An interventional study of Low-Intensity Extracorporeal Shockwave Therapy (LiEWST) - Active and Low-Intensity Extracorporeal Shockwave Therapy (LiEWST) - Sham in Erectile Dysfunction Following Radical Prostatectomy, sponsored by Hospital Pengajar Universiti Putra Malaysia. Recruiting at 1 site in Malaysia. Open to male participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-10-11.
Sponsored by Hospital Pengajar Universiti Putra Malaysia · Not applicable, Interventional, and Treatment
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.
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 a significant morbidity especially for patients who are sexually active pre-operatively. PDE5i such as Tadalafil, Sildenafil remains the main form of penile rehabilitation with limited success. Non-invasive treatment such as Li-ESWT has proven to be a good treatment option mainly for vasculogenic ED. This study aims to investigate the effect of Li-ESWT treatment on post-prostatectomy ED, along with regular PDE5i.
Our hypothesis is that Low intensity extracorporeal shockwave therapy and very early PDE5i can improve erectile function in patients after nerve-sparing post-radical prostatectomy.
Eligible patients will be randomized to intervention arm (LiESWT treatment for 6 weeks + Tadalafil 5mg daily for 12 months) or controlled arm (sham therapy for 6 weeks + Tadalafil 5mg daily for 12 months). The device used in this study is Dornier Aries 2, with treatment protocol as described. The vacuum pump is an option for penile rehabilitation protocol at our institution due to its expensive cost. Penile vacuum pumps are allowed for voluntary use by all participants in both groups. A sub-group analysis will be conducted at the conclusion of the study.
Sexual outcomes will be assessed using IIEF (International Index of Erectile Function), EHS (Erectile Hardness Score) and Erectile Dysfunction Inventory of Treatment Satisfaction Score (EDITS) questionnaires at 1,3,6 and 12 months after completion of therapy.
682 studies on the registry are indexed under Erectile Dysfunction; 116 are open to participants now.
This study's planned enrollment of 70 is close to the median of 72 across 541 interventional studies indexed under Erectile Dysfunction.
Browse Erectile Dysfunction studies →Hospital Pengajar Universiti Putra Malaysia is the lead sponsor of 7 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
Tadalafil 5mg daily - to start 5 days before surgery and continued for 12 months after surgery till end of study. With or without Vacuum Pump Active LiESWT
Device: Low-Intensity Extracorporeal Shockwave Therapy (LiEWST) - Active
Tadalafil 5mg daily - to start 5 days before surgery and continued for 12 months after surgery till end of study. With or without Vacuum Pump Sham LiESWT
Device: Low-Intensity Extracorporeal Shockwave Therapy (LiEWST) - Sham
Treatment protocol: * EFD 0.096 mJ/mm2 * 2 sessions / week; 5000 shocks / session * 6 weeks treatment * total: 12 sessions * Li-ESWT to start after removal of indwelling catheter
Also known as: Dornier Aries 2 (Dornier MedTech, Germany)
Treatment protocol: * EFD 0 mJ/mm2 * 2 sessions / week; 5000 shocks / session * 6 weeks treatment * total: 12 sessions * Li-ESWT to start after removal of indwelling catheter
Also known as: Dornier Aries 2 (Dornier MedTech, Germany)
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
Time frame: 12 months
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.
Time frame: 12 months
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.
Time frame: 12 months
Safety and Adverse Events
Number of Participants With Treatment-Related Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Time frame: 12 months
Plan to share: No
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Hospital Pengajar Universiti Putra Malaysia