Combined Treatment of Platelet-rich Plasma (PRP) and Low-intensity Extracorporeal Shockwave Therapy (Li-ESWT) on Erectile Dysfunction (ED)
NCT ID: NCT04416802
Last Updated: 2022-10-06
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
20 participants
INTERVENTIONAL
2020-12-28
2024-10-31
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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PRP and Li-ESWT treatment
Participants diagnosed with erectile dysfunction will receive the combined treatment of platelet-rich plasma and low-intensity extracorporeal shockwave therapy.
autologous platelet-rich plasma and low-intensity extracorporeal shockwave therapy
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.
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.
Interventions
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autologous platelet-rich plasma and low-intensity extracorporeal shockwave therapy
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Bleeding tendency
* Could not cooperate with the treatment
* AIDS, syphilis and condyloma victim
* Received radical prostatectomy
* Prostate cancer or pelvis malignant tumor victim
* 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
30 Years
80 Years
MALE
No
Sponsors
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Taipei Medical University Hospital
OTHER
Responsible Party
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Ming-Che Liu, MD
Director of Clinical Research Center
Principal Investigators
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Ming-Che Liu, MD
Role: PRINCIPAL_INVESTIGATOR
Taipei Medical University Hospital
Locations
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Taipei Medical University Hospital
Taipei, , Taiwan
Countries
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Central Contacts
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References
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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.
Rosenthal 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.
Wu 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.
Wu 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.
Ruan 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.
Scott 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.
Dong 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.
Patel 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.
Other Identifiers
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N201907013
Identifier Type: -
Identifier Source: org_study_id
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