Low-Intensity Extracorporeal Shockwave Therapy for Penile Rehabilitation in Post-Radical Prostatectomy Patients
NCT ID: NCT06076850
Last Updated: 2023-10-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
70 participants
INTERVENTIONAL
2023-07-01
2025-06-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Standard Care + Active LiESWT
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
Low-Intensity Extracorporeal Shockwave Therapy (LiEWST) - Active
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
Standard Care + Sham LiESWT
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
Low-Intensity Extracorporeal Shockwave Therapy (LiEWST) - Sham
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
Interventions
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Low-Intensity Extracorporeal Shockwave Therapy (LiEWST) - Active
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
Low-Intensity Extracorporeal Shockwave Therapy (LiEWST) - Sham
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
40 Years
75 Years
MALE
No
Sponsors
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Hospital Pengajar Universiti Putra Malaysia
OTHER
Responsible Party
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Principal Investigators
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Vincent Khor, ChM(Urol)
Role: PRINCIPAL_INVESTIGATOR
Universiti Putra Malaysia
Locations
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Hospital Sultan Abdul Aziz Shah, Universiti Putra Malaysia (previously known as HPUPM)
Serdang, Selangor, Malaysia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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JKEUPM-2023-073
Identifier Type: -
Identifier Source: org_study_id
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