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Low-Intensity Extracorporeal Shockwave Therapy for Penile Rehabilitation in Post-Radical Prostatectomy Patients

Primary Purpose

Erectile Dysfunction Following Radical Prostatectomy

Status
Recruiting
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Low-Intensity Extracorporeal Shockwave Therapy (LiEWST) - Active
Low-Intensity Extracorporeal Shockwave Therapy (LiEWST) - Sham
Sponsored by
Hospital Pengajar Universiti Putra Malaysia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Erectile Dysfunction Following Radical Prostatectomy

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Sultan Abdul Aziz Shah, Universiti Putra Malaysia (previously known as HPUPM)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Standard Care + Active LiESWT

Standard Care + Sham LiESWT

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
Safety and Adverse Events
Number of Participants With Treatment-Related Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0

Full Information

First Posted
July 23, 2023
Last Updated
October 3, 2023
Sponsor
Hospital Pengajar Universiti Putra Malaysia
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1. Study Identification

Unique Protocol Identification Number
NCT06076850
Brief Title
Low-Intensity Extracorporeal Shockwave Therapy for Penile Rehabilitation in Post-Radical Prostatectomy Patients
Official Title
Extracorporeal Shockwave Therapy for Penile Rehabilitation in Post-Radical Prostatectomy Patients: A Randomized, Double-Blinded, Sham-Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2023 (Actual)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Pengajar Universiti Putra Malaysia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 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.
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction Following Radical Prostatectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard Care + Active LiESWT
Arm Type
Active Comparator
Arm Description
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
Arm Title
Standard Care + Sham LiESWT
Arm Type
Sham Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Low-Intensity Extracorporeal Shockwave Therapy (LiEWST) - Active
Other Intervention Name(s)
Dornier Aries 2 (Dornier MedTech, Germany)
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Low-Intensity Extracorporeal Shockwave Therapy (LiEWST) - Sham
Other Intervention Name(s)
Dornier Aries 2 (Dornier MedTech, Germany)
Intervention Description
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
Primary Outcome Measure Information:
Title
Sexual Function
Description
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
Secondary Outcome Measure Information:
Title
Stretched Penile Length
Description
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
Title
Urinary Function
Description
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
Title
Safety and Adverse Events
Description
Number of Participants With Treatment-Related Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Time Frame
12 months

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Male patient
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vincent Khor, ChM(Urol)
Phone
+603-9769 9220
Email
khorweisheng@upm.edu.my
First Name & Middle Initial & Last Name or Official Title & Degree
Omar Fahmy, FRCS(Urol)
Phone
+603-9769 9220
Email
omarfahmy.ahmed@upm.edu.my
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vincent Khor, ChM(Urol)
Organizational Affiliation
Universiti Putra Malaysia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Sultan Abdul Aziz Shah, Universiti Putra Malaysia (previously known as HPUPM)
City
Serdang
State/Province
Selangor
ZIP/Postal Code
43400
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vincent Khor, ChM(Urol)
Phone
+603-9769 9220
Email
khorweisheng@upm.edu.my
First Name & Middle Initial & Last Name & Degree
Omar Fahmy, FRCS(Urol)
Phone
+603-9769 9220
Email
omarfahmy.ahmed@upm.edu.my

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Low-Intensity Extracorporeal Shockwave Therapy for Penile Rehabilitation in Post-Radical Prostatectomy Patients

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