Erectile DysfunctionNCT04416802
Combined Treatment of Platelet-rich Plasma (PRP) and Low-intensity Extracorporeal Shockwave Therapy (Li-ESWT) on Erectile Dysfunction (ED)
A study testing autologous platelet-rich plasma and low-intensity extracorporeal shockwave therapy in people with Erectile Dysfunction, run by Taipei Medical University Hospital at 1 site in Taiwan.
Trial summary
The purpose of this clinical study is mainly to use platelet-rich plasma combined with low-intensity extracorporeal shockwave therapy to treat patients with erectile dysfunction and observe the improvement results. Read more about this study
- Who is it for?
- Ages 30 to 80 years, men only
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- autologous platelet-rich plasma and low-intensity extracorporeal shockwave therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTaiwan
- Study dates
- 28 Dec 2020to Oct 2024
- 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 30 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Impotence for more than three months
- International index of erectile function, (IIEF) less than 21( including 21)
- Erectile hardness score, (EHS) less than 3( including 3)
- Age over 30 years old
Who cannot join
- Hypogonadism
- Bleeding tendency
- Could not cooperate with the treatment
- AIDS, syphilis and condyloma victim
- Received radical prostatectomy
- Prostate cancer or pelvis malignant tumor victim
Show all 14Show fewer
- Gonad dysfunction
- Penis deformities
- Penile prosthesis implantation
- Psychiatric disease victim
- Neural disease ( multiple myeloma , brain atrophy, etc)
- Pacemaker implantation
- Not suitable join this trial judged by Investigator
- Alcohol or drug abuse
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Medical University Hospital
Taipei, 110
Ming-Che Liu, MD
About this study
Official title: A Clinical Study of the Combined Treatment of Platelet-rich Plasma and Low-intensity Extracorporeal Shockwave Therapy on Erectile Dysfunction
The purpose of this clinical study is mainly to use platelet-rich plasma combined with low-intensity extracorporeal shockwave therapy to treat patients with erectile dysfunction and observe the improvement results.
Read the detailed description
According to statistics from the Taiwan Society of Andrology, 18 to 25 years old male population in Taiwan having erectile dysfunction (ED) trouble is as high as 5 to 10 percent. At the same time, statistics from the Taiwan Sexual Dysfunction Counseling Training Committee show that as many as 50 percent of men between 40 and 70 years old have erectile dysfunction. Erectile dysfunction is the most common sexual dysfunction in men and is believed to be related to nerve or blood vessel damage, and often significantly affects the patients' quality of life.
PRP is the abbreviation of "platelet-rich plasma". It can release growth factors and cytokines in the body to further promote tissue repair. The results of pre-clinical and clinical trials show that PRP can promote the repair of cavernous tissue, protect erection function of nerve, and stimulate the regeneration of nerve.
Low-intensity extracorporeal shockwave therapy (Li-ESWT) is a non-invasive treatment. Under this treatment, it will help body producing angiogenesis-related proteins, stimulating the formation of small blood vessels, generating new blood vessels at the site to be treated, and increasing the perfusion flow of local tissues. Li-ESWT has been clinically shown to have a significant effect on erectile dysfunction.
The purpose of this clinical study is mainly to use platelet-rich plasma combined with low-intensity extracorporeal shockwave therapy to treat patients with erectile dysfunction and observe the improvement results.
- Conditions
- Erectile Dysfunction
- Being tested
- autologous platelet-rich plasma and low-intensity extracorporeal shockwave therapy
- Keywords
- erectile dysfunction, platelet-rich plasma, low-intensity extracorporeal shockwave therapy
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous platelet-rich plasma and low-intensity extracorporeal shockwave therapyCombination product
The patient who encounters sexual dysfunction and visits our Outpatient Department (OPD) could enter this trial if he meets the inclusion criteria and exclusion criteria.
- To fill the questionnaires of International index of erectile function (IIEF) and erectile hardness score (EHS) before starting treatment.
- Li-ESWT treatment weekly for three weeks and PRP injection at the same day after the last Li-ESWT treatment.
- Coming back at the fourth week and check is there any side effect and fill the questionnaires of IIEF and EHS.
- Li-ESWT treatment weekly for three weeks starts on fifth week and PRP injection at the same day after the last Li-ESWT treatment.
- Coming back at the eighth week and check is there any side effect and fill the questionnaires of IIEF and EHS.
- Coming back at the twelfth week and check is there any side effect and fill the questionnaires of IIEF and EHS.
| Study group | Role | What they receive |
|---|---|---|
| PRP and Li-ESWT treatment | Experimental | Participants diagnosed with erectile dysfunction will receive the combined treatment of platelet-rich plasma and low-intensity extracorporeal shockwave therapy. Receives: Combination Product: autologous platelet-rich plasma and low-intensity extracorporeal shockwave therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Change in Erectile Function
Using the International Index of Erectile Function (IIEF) questionnaire.
Measured: Baseline, the 4th week, 8th week, and 12th weeks
The Change in Erectile Function
Using the Erectile Hardness Scale (EHS) questionnaire to evaluate the efficacy of combined treatment of PRP and Li-ESWT
Measured: Baseline, the 4th week, 8th week, and 12th weeks
Secondary outcomes (1)
Incidents of Side Effects
To observe whether there are side effects
Measured: the 4th week, 8th week, and 12th weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start28 Dec 2020
- Primary completionJul 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Erectile DysfunctionStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ming-Che Liu, MD, Taipei Medical University Hospital
- Investigators
- Ming-Che Liu, MD, Principal investigator, Taipei Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04416802
- Sponsor's protocol ID
- N201907013
- Status last verified
- Oct 2022
- First submitted
- 2 Jun 2020
- Last updated
- 6 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sanderson LM, Bryant A. Effectiveness and safety of prolotherapy injections for management of lower limb tendinopathy and fasciopathy: a systematic review. J Foot Ankle Res. 2015 Oct 20;8:57. doi: 10.1186/s13047-015-0114-5. eCollection 2015.
PubMed 26500703Rosenthal AR, Harbury C, Egbert PR, Rubenstein E. Use of a platelet-fibrinogen-thrombin mixture as a corneal adhesive: experiments with sutureless lamellar keratoplasty in the rabbit. Invest Ophthalmol. 1975 Nov;14(11):872-5.
PubMed 1102485Wu YN, Wu CC, Sheu MT, Chen KC, Ho HO, Chiang HS. Optimization of platelet-rich plasma and its effects on the recovery of erectile function after bilateral cavernous nerve injury in a rat model. J Tissue Eng Regen Med. 2016 Oct;10(10):E294-E304. doi: 10.1002/term.1806. Epub 2013 Aug 16.
PubMed 23950105Wu CC, Wu YN, Ho HO, Chen KC, Sheu MT, Chiang HS. The neuroprotective effect of platelet-rich plasma on erectile function in bilateral cavernous nerve injury rat model. J Sex Med. 2012 Nov;9(11):2838-48. doi: 10.1111/j.1743-6109.2012.02881.x. Epub 2012 Aug 20.
PubMed 22906160Ruan Y, Zhou J, Kang N, Reed-Maldonado AB, Tamaddon A, Wang B, Wang HS, Wang G, Banie L, Lin G, Liu J, Lue TF. The effect of low-intensity extracorporeal shockwave therapy in an obesity-associated erectile dysfunction rat model. BJU Int. 2018 Jul;122(1):133-142. doi: 10.1111/bju.14202. Epub 2018 Apr 17.
PubMed 29573106Scott S, Roberts M, Chung E. Platelet-Rich Plasma and Treatment of Erectile Dysfunction: Critical Review of Literature and Global Trends in Platelet-Rich Plasma Clinics. Sex Med Rev. 2019 Apr;7(2):306-312. doi: 10.1016/j.sxmr.2018.12.006. Epub 2019 Mar 2.
PubMed 30833169Dong L, Chang D, Zhang X, Li J, Yang F, Tan K, Yang Y, Yong S, Yu X. Effect of Low-Intensity Extracorporeal Shock Wave on the Treatment of Erectile Dysfunction: A Systematic Review and Meta-Analysis. Am J Mens Health. 2019 Mar-Apr;13(2):1557988319846749. doi: 10.1177/1557988319846749.
PubMed 31027441Patel P, Huang C, Molina M, Ramasamy R. Clinical trial update on shockwave therapy and future of erectile function restoration. Int J Impot Res. 2019 May;31(3):206-208. doi: 10.1038/s41443-019-0115-1. Epub 2019 Jan 22.
PubMed 30670840
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study of the Combined Treatment of Platelet-rich Plasma and Low-intensity Extracorporeal Shockwave Therapy on Erectile Dysfunction
- ClinicalTrials.gov ID
- NCT04416802
- Acronym / sponsor ID
- N201907013
- Conditions
- Erectile Dysfunction
- Keywords
- erectile dysfunction, platelet-rich plasma, low-intensity extracorporeal shockwave therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Taipei Medical University HospitalUniversity, hospital or other
- Study start
- 28 Dec 2020 (actual)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 4 Jun 2020 (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.
The purpose of this clinical study is mainly to use platelet-rich plasma combined with low-intensity extracorporeal shockwave therapy to treat patients with erectile dysfunction and observe the improvement results.
Detailed description
According to statistics from the Taiwan Society of Andrology, 18 to 25 years old male population in Taiwan having erectile dysfunction (ED) trouble is as high as 5 to 10 percent. At the same time, statistics from the Taiwan Sexual Dysfunction Counseling Training Committee show that as many as 50 percent of men between 40 and 70 years old have erectile dysfunction. Erectile dysfunction is the most common sexual dysfunction in men and is believed to be related to nerve or blood vessel damage, and often significantly affects the patients' quality of life.
PRP is the abbreviation of "platelet-rich plasma". It can release growth factors and cytokines in the body to further promote tissue repair. The results of pre-clinical and clinical trials show that PRP can promote the repair of cavernous tissue, protect erection function of nerve, and stimulate the regeneration of nerve.
Low-intensity extracorporeal shockwave therapy (Li-ESWT) is a non-invasive treatment. Under this treatment, it will help body producing angiogenesis-related proteins, stimulating the formation of small blood vessels, generating new blood vessels at the site to be treated, and increasing the perfusion flow of local tissues. Li-ESWT has been clinically shown to have a significant effect on erectile dysfunction.
The purpose of this clinical study is mainly to use platelet-rich plasma combined with low-intensity extracorporeal shockwave therapy to treat patients with erectile dysfunction and observe the improvement results.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PRP and Li-ESWT treatment | Experimental | Combination Product: autologous platelet-rich plasma and low-intensity extracorporeal shockwave therapyParticipants diagnosed with erectile dysfunction will receive the combined treatment of platelet-rich plasma and low-intensity extracorporeal shockwave therapy. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Impotence for more than three months
- International index of erectile function, (IIEF) less than 21( including 21)
- Erectile hardness score, (EHS) less than 3( including 3)
- Age over 30 years old
Key exclusion criteria (14 listed)
- Hypogonadism
- Bleeding tendency
- Could not cooperate with the treatment
- AIDS, syphilis and condyloma victim
- Received radical prostatectomy
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 |
|---|---|---|
| autologous platelet-rich plasma and low-intensity extracorporeal shockwave therapyThe patient who encounters sexual dysfunction and visits our Outpatient Department (OPD) could enter this trial if he meets the inclusion criteria and exclusion criteria. 1. To fill the questionnaires of International index of erectile function (IIEF) and erectile hardness score (EHS) before starting treatment. 2. Li-ESWT treatment weekly for three weeks and PRP injection at the same day after the last Li-ESWT treatment. 3. Coming back at the fourth week and check is there any side effect and fill the questionnaires of IIEF and EHS. 4. Li-ESWT treatment weekly for three weeks starts on fifth week and PRP injection at the same day after the last Li-ESWT treatment. 5. Coming back at the eighth week and check is there any side effect and fill the questionnaires of IIEF and EHS. 6. Coming back at the twelfth week and check is there any side effect and fill the questionnaires of IIEF and EHS. | Combination product | PRP and Li-ESWT treatment |
Primary outcome
The Change in Erectile Function
Time frame: Baseline, the 4th week, 8th week, and 12th weeks
Using the International Index of Erectile Function (IIEF) questionnaire.
The Change in Erectile Function
Time frame: Baseline, the 4th week, 8th week, and 12th weeks
Using the Erectile Hardness Scale (EHS) questionnaire to evaluate the efficacy of combined treatment of PRP and Li-ESWT
1 secondary outcome
Incidents of Side Effects
Time frame: the 4th week, 8th week, and 12th weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2022.
- Background: PubMed 26500703Sanderson LM, Bryant A. Effectiveness and safety of prolotherapy injections for management of lower limb tendinopathy and fasciopathy: a systematic review. J Foot Ankle Res. 2015 Oct 20;8:57. doi: 10.1186/s13047-015-0114-5. eCollection 2015.
- Background: PubMed 1102485Rosenthal AR, Harbury C, Egbert PR, Rubenstein E. Use of a platelet-fibrinogen-thrombin mixture as a corneal adhesive: experiments with sutureless lamellar keratoplasty in the rabbit. Invest Ophthalmol. 1975 Nov;14(11):872-5.
- Background: PubMed 23950105Wu YN, Wu CC, Sheu MT, Chen KC, Ho HO, Chiang HS. Optimization of platelet-rich plasma and its effects on the recovery of erectile function after bilateral cavernous nerve injury in a rat model. J Tissue Eng Regen Med. 2016 Oct;10(10):E294-E304. doi: 10.1002/term.1806. Epub 2013 Aug 16.
- Background: PubMed 22906160Wu CC, Wu YN, Ho HO, Chen KC, Sheu MT, Chiang HS. The neuroprotective effect of platelet-rich plasma on erectile function in bilateral cavernous nerve injury rat model. J Sex Med. 2012 Nov;9(11):2838-48. doi: 10.1111/j.1743-6109.2012.02881.x. Epub 2012 Aug 20.
- Background: PubMed 29573106Ruan Y, Zhou J, Kang N, Reed-Maldonado AB, Tamaddon A, Wang B, Wang HS, Wang G, Banie L, Lin G, Liu J, Lue TF. The effect of low-intensity extracorporeal shockwave therapy in an obesity-associated erectile dysfunction rat model. BJU Int. 2018 Jul;122(1):133-142. doi: 10.1111/bju.14202. Epub 2018 Apr 17.
- Background: PubMed 30833169Scott S, Roberts M, Chung E. Platelet-Rich Plasma and Treatment of Erectile Dysfunction: Critical Review of Literature and Global Trends in Platelet-Rich Plasma Clinics. Sex Med Rev. 2019 Apr;7(2):306-312. doi: 10.1016/j.sxmr.2018.12.006. Epub 2019 Mar 2.
- Background: PubMed 31027441Dong L, Chang D, Zhang X, Li J, Yang F, Tan K, Yang Y, Yong S, Yu X. Effect of Low-Intensity Extracorporeal Shock Wave on the Treatment of Erectile Dysfunction: A Systematic Review and Meta-Analysis. Am J Mens Health. 2019 Mar-Apr;13(2):1557988319846749. doi: 10.1177/1557988319846749.
- Background: PubMed 30670840Patel P, Huang C, Molina M, Ramasamy R. Clinical trial update on shockwave therapy and future of erectile function restoration. Int J Impot Res. 2019 May;31(3):206-208. doi: 10.1038/s41443-019-0115-1. Epub 2019 Jan 22.
- 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.
Ming-Che Liu, MD principal investigator
Taipei Medical University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing autologous platelet-rich plasma and low-intensity extracorporeal shockwave therapy in people with Erectile Dysfunction, run by Taipei Medical University Hospital at 1 site in Taiwan.
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 4 inclusion and 14 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 6 Oct 2022. 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 Taiwan. 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. 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 Ming-Che Liu, MD (886-2-2737-2181 ext. 1981, d204097002@tmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Change in Erectile Function (time frame: Baseline, the 4th week, 8th week, and 12th weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04416802, which also lists 8 linked publications.
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 6 Oct 2022.