NCT04416802

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 2, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 4, 2020

Completed
7 months until next milestone

Study Start

First participant enrolled

December 28, 2020

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

October 6, 2022

Status Verified

October 1, 2022

Enrollment Period

3.5 years

First QC Date

June 2, 2020

Last Update Submit

October 4, 2022

Conditions

Erectile Dysfunction

Keywords

erectile dysfunctionplatelet-rich plasmalow-intensity extracorporeal shockwave therapy

Outcome Measures

Primary Outcomes (2)

  • The Change in Erectile Function

    Using the International Index of Erectile Function (IIEF) questionnaire.

    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

    Baseline, the 4th week, 8th week, and 12th weeks

Secondary Outcomes (1)

  • Incidents of Side Effects

    the 4th week, 8th week, and 12th weeks

Study Arms (1)

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.

Combination Product: autologous platelet-rich plasma and low-intensity extracorporeal shockwave therapy

Interventions

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. 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.

PRP and Li-ESWT treatment

Eligibility Criteria

Age30 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Hypogonadism
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Medical University Hospital

Taipei, 110, Taiwan

RECRUITING

Related Publications (8)

  • 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.

    PMID: 26500703BACKGROUND

  • 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.

    PMID: 1102485BACKGROUND

  • 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.

    PMID: 23950105BACKGROUND

  • 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.

    PMID: 22906160BACKGROUND

  • 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.

    PMID: 29573106BACKGROUND

  • 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.

    PMID: 30833169BACKGROUND

  • 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.

    PMID: 31027441BACKGROUND

  • 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.

    PMID: 30670840BACKGROUND

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Study Officials

  • Ming-Che Liu, MD

    Taipei Medical University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ming-Che Liu, MD

CONTACT

886-2-2737-2181d204097002@tmu.edu.tw

Yi-Jen Su

CONTACT

886-2-2737-2181175275@h.tmu.edu.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Clinical Research Center

Study Record Dates

First Submitted

June 2, 2020

First Posted

June 4, 2020

Study Start

December 28, 2020

Primary Completion

July 1, 2024

Study Completion

October 1, 2024

Last Updated

October 6, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)