Erectile Dysfunction Following Radical ProstatectomyNCT06076850
Low-Intensity Extracorporeal Shockwave Therapy for Penile Rehabilitation in Post-Radical Prostatectomy Patients
A study testing Low-Intensity Extracorporeal Shockwave Therapy (LiEWST) - Active in people with Erectile Dysfunction Following Radical Prostatectomy, run by Hospital Pengajar Universiti Putra Malaysia at 1 site in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years, men only
- Conditions the study is for
- Erectile Dysfunction Following Radical Prostatectomy
- What is being tested?
- Low-Intensity Extracorporeal Shockwave Therapy (LiEWST) - Active
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Jul 2023to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Malaysia1 site, 1 recruiting
- Recruiting
Hospital Sultan Abdul Aziz Shah, Universiti Putra Malaysia (previously known as HPUPM)
Serdang, Selangor, 43400
Vincent Khor, ChM(Urol), +603-9769 9220, khorweisheng@upm.edu.my
Omar Fahmy, FRCS(Urol), +603-9769 9220, omarfahmy.ahmed@upm.edu.my
About this study
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.
Read the 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.
- Being tested
- Low-Intensity Extracorporeal Shockwave Therapy (LiEWST) - Active, Low-Intensity Extracorporeal Shockwave Therapy (LiEWST) - Sham
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-Intensity Extracorporeal Shockwave Therapy (LiEWST) - ActiveDevice
Also called Dornier Aries 2 (Dornier MedTech, Germany)
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) - ShamDevice
Also called 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
| Study group | Role | What they receive |
|---|---|---|
| Standard Care + Active LiESWT | Active comparator | 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 Receives: Device: Low-Intensity Extracorporeal Shockwave Therapy (LiEWST) - Active |
| Standard Care + Sham LiESWT | Sham comparator | 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 Receives: Device: Low-Intensity Extracorporeal Shockwave Therapy (LiEWST) - Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2023
- Study start1 Jul 2023
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile Dysfunction Following Radical ProstatectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Pengajar Universiti Putra Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent Khor, ChM(Urol), Principal investigator, Universiti Putra Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06076850
- Sponsor's protocol ID
- JKEUPM-2023-073
- Status last verified
- Oct 2023
- First submitted
- 23 Jul 2023
- Last updated
- 11 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extracorporeal Shockwave Therapy for Penile Rehabilitation in Post-Radical Prostatectomy Patients: A Randomized, Double-Blinded, Sham-Controlled Study
- ClinicalTrials.gov ID
- NCT06076850
- Acronym / sponsor ID
- JKEUPM-2023-073
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Hospital Pengajar Universiti Putra MalaysiaUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 11 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Care + Active LiESWT | Active comparator | Device: Low-Intensity Extracorporeal Shockwave Therapy (LiEWST) - ActiveTadalafil 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 |
| Standard Care + Sham LiESWT | Sham comparator | Device: Low-Intensity Extracorporeal Shockwave Therapy (LiEWST) - ShamTadalafil 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 |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-Intensity Extracorporeal Shockwave Therapy (LiEWST) - ActiveAlso: Dornier Aries 2 (Dornier MedTech, Germany)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 | Device | Standard Care + Active LiESWT |
| Low-Intensity Extracorporeal Shockwave Therapy (LiEWST) - ShamAlso: 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 | Device | Standard Care + Sham LiESWT |
Primary outcome
Sexual Function
Time frame: 12 months
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
3 secondary outcomes
Stretched Penile Length
Time frame: 12 months
Urinary Function
Time frame: 12 months
Safety and Adverse Events
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vincent Khor, ChM(Urol) principal investigator
Universiti Putra Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-Intensity Extracorporeal Shockwave Therapy (LiEWST) - Active in people with Erectile Dysfunction Following Radical Prostatectomy, run by Hospital Pengajar Universiti Putra Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vincent Khor, ChM(Urol) (+603-9769 9220, khorweisheng@upm.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sexual Function (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2023.