Comparison of Conservative Treatment Options in the Management of Erectile Dysfunction

Comparison of Conservative Treatment Options in the Management of Erectile Dysfunction: Randomized Controlled Clinical Trial

This is a randomized clinical trial study with the formation of three groups. After signing the informed consent form, in two copies of equal content, the patient will be evaluated by an experienced physiotherapist and will answer a questionnaire of socio-demographic data and basic anamnesis.

Then, in a private and individualized room, participants will be guided by researchers trained to complete the self-administered questionnaires: International Erectile Function Index (IIFE), Erection Quality Questionnaire (EQQ), SF-36 and Hospital Anxiety Scale and Depression (EHAD). After applying the questionnaires, a physical evaluation by an experienced physiotherapist will be performed.

To induce erection of the penis an injection of a vasoactive agent (prostaglandin E1, alprostadil) will be administered in the corpora cavernosa. Then the length of the penis (swollen, elongated and flaccid) and penile circumference will be measured. Soon after, Dynamic Doppler Ultrasonography with Penis Doppler (UDDP) will be performed. The parameters that will be used in the UDDP to provide a general vascular diagnosis include Peak Systolic Speed (VSP), Final Diastolic Speed (VDF) and Resistive Index (IR).

In the case of a controlled and randomized clinical trial, the patient may be randomly allocated to one of three groups: the Non-Ablative Radiofrequency group (NARFT); the Low Intensity Shockwave Therapy Group (LISWT) and; the Sham Group that will perform the Vacuum Therapy (SHAM). In the NARFT group, the radio frequency will be applied, the device used will be the HERTIX Radiofrequency. The shock wave therapy application protocol in the LISWT group will use the THORK Shock Wave. While in the SHAM group, the vacuum therapy will be used, the research subjects will use the automatic version with simple on / off and release valve commands.

As in the other groups, participants in the Sham group will have a session every seven days for eight weeks. The entire evaluation protocol will be applied before (pre-test) and after treatment (post-test).

Study Overview

• Status: Recruiting
• Conditions: Erectile Dysfunction
• Intervention / Treatment: Procedure: LISWT Group; Procedure: NARFT Group; Procedure: Sham Group

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Carlos S Mamede, MD; Phone Number: +5571988683967; Email: carlosandrejpa@gmail.com
• Study Contact Backup: Name: Patricia V Lordelo, Phd; Phone Number: +5571988592400; Email: pvslordelo@hotmail.com

Study Locations

• Brazil
  • Ba
    • Salvador, Ba, Brazil, 40.290-000
      • Recruiting
      • Centro de Atenção ao assoalho pélvico
      • Contact: Patricia V Lordelo, Phd; Phone Number: +5571988592400; Email: pvslordelo@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 30-80 years.
• Men with a report of complaints of erectile dysfunction.

Exclusion Criteria:

• History of neurological disease.
• History of diabetes mellitus.
• History of Peyronie's disease.
• History of psychiatric illness.
• History of prostatectomy.
• Patients with anatomical malformations in the genital region.
• Penile prosthesis users.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LISWT Group; Participants who will submitted to active procedure with Low Intensuty Shockwave Therapy.	Procedure: LISWT Group; The treatment consists of a weekly session and 4,000 pulses will be emitted each of the eight sessions totaling 32,000 pulses with a frequency of 18Hz and 100mJ of energy.
Experimental: NARFT Group; Participants who will submitted to active procedure with Non-Ablative Radiofrequency Therapy	Procedure: NARFT Group; The device used will be with an intensity of 350 Wpp; 75% pulsed operation mode; frequency of 640 kHz, 1200 kHz and 2400 kHz. Eight radio frequency sessions will be held with an interval of seven days between them.
Sham Comparator: Sham Group; Participants who submitted to sham procedure with vaccum therapy.	Procedure: Sham Group; In the RNA group, radiofrequency will be applied, the device used will be the Nèartek Esthetic Ibramed - Tecarterapia e Radiofrequency Apparatus, with an intensity of 350 Wpp; 75% pulsed operation mode; frequency of 640 kHz, 1200 kHz and 2400 kHz. The radiofrequency will be applied with the patient in the supine position on both sides of the penis with an opposite dispersion plate against the radiofrequency emitter. To perform the procedure, the therapist will use a glove. Eight radio frequency sessions will be held with an interval of seven days between them.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in peak systolic velocity	Performed by means of ultrasonography with doppler of the penis through the induction of the erection, being considered arterial insufficiency the value below 25 cm / s	Change from baseline peak systolic velocity immediately after intervention.
Change in end diastolic velocity	Performed by means of ultrasonography with doppler of the penis through the induction of the erection, being considered venous occlusive disease the value above 5 cm / s	Change from baseline end diastolic velocity immediately after intervention.
Change in cavernous artery diameter	Performed by means of ultrasonography with doppler of the penis through the induction of the erection.	Change from baseline cavernous artery diameter immediately after intervention.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in International Index of Erectile Function	It is a questionnaire with 5 questions about penile erection that can vary from 5 to 25 points. Higher scores indicate better clinical condition.	Change from baseline International Index of Erectile Function immediately after intervention.
Change in Questionnaire of Erectile Quality	It is a questionnaire with 6 questions about the quality of erection based on the Likert scale. That is, it does not offer number values.	Change from baseline Questionannaire of Erectile Quality immediately after intervention.
Change in measurement of penis length and diameter.	These measurements are made with a paper ruler with the penis flaccid and after ten minutes of induction for erection.	Change from baseline measurement of penis lenght and diameter immediately after intervention.

Collaborators and Investigators

• Sponsor: Centro de Atenção ao Assoalho Pélvico
• Collaborators: Indústria Brasileira Equipamentos Médicos - IBRAMED
• Investigators: Study Chair: Patrícia V Lordêlo, PhD, Centro de Atenção Pélvica - CAAP

Publications and helpful links

General Publications

• Feldman HA, Goldstein I, Hatzichristou DG, Krane RJ, McKinlay JB. Impotence and its medical and psychosocial correlates: results of the Massachusetts Male Aging Study. J Urol. 1994 Jan;151(1):54-61. doi: 10.1016/s0022-5347(17)34871-1.
• NIH Consensus Conference. Impotence. NIH Consensus Development Panel on Impotence. JAMA. 1993 Jul 7;270(1):83-90. No abstract available.
• McMahon CG, Abdo C, Incrocci L, Perelman M, Rowland D, Waldinger M, Xin ZC. Disorders of orgasm and ejaculation in men. J Sex Med. 2004 Jul;1(1):58-65. doi: 10.1111/j.1743-6109.2004.10109.x.
• Mobley DF, Khera M, Baum N. Recent advances in the treatment of erectile dysfunction. Postgrad Med J. 2017 Nov;93(1105):679-685. doi: 10.1136/postgradmedj-2016-134073. Epub 2017 Jul 27.
• Stein RA. Endothelial dysfunction, erectile dysfunction, and coronary heart disease: the pathophysiologic and clinical linkage. Rev Urol. 2003;5 Suppl 7(Suppl 7):S21-7.
• Feldman HA, Johannes CB, Derby CA, Kleinman KP, Mohr BA, Araujo AB, McKinlay JB. Erectile dysfunction and coronary risk factors: prospective results from the Massachusetts male aging study. Prev Med. 2000 Apr;30(4):328-38. doi: 10.1006/pmed.2000.0643.
• Mobley D, Baum N. Smoking: Its Impact on Urologic Health. Rev Urol. 2015;17(4):220-5.
• Wespes E, Amar E, Hatzichristou D, Hatzimouratidis K, Montorsi F, Pryor J, Vardi Y; EAU. EAU Guidelines on erectile dysfunction: an update. Eur Urol. 2006 May;49(5):806-15. doi: 10.1016/j.eururo.2006.01.028. Epub 2006 Feb 9.
• Porst H, Burnett A, Brock G, Ghanem H, Giuliano F, Glina S, Hellstrom W, Martin-Morales A, Salonia A, Sharlip I; ISSM Standards Committee for Sexual Medicine. SOP conservative (medical and mechanical) treatment of erectile dysfunction. J Sex Med. 2013 Jan;10(1):130-71. doi: 10.1111/jsm.12023.
• Chaussy C, Brendel W, Schmiedt E. Extracorporeally induced destruction of kidney stones by shock waves. Lancet. 1980 Dec 13;2(8207):1265-8. doi: 10.1016/s0140-6736(80)92335-1.
• Chung E, Wang J. A state-of-art review of low intensity extracorporeal shock wave therapy and lithotripter machines for the treatment of erectile dysfunction. Expert Rev Med Devices. 2017 Dec;14(12):929-934. doi: 10.1080/17434440.2017.1403897. Epub 2017 Nov 29.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: November 24, 2020
• First Submitted That Met QC Criteria: May 9, 2021
• First Posted (Actual): May 13, 2021

Study Record Updates

• Last Update Posted (Actual): December 5, 2023
• Last Update Submitted That Met QC Criteria: December 4, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Radiofrequency Therapy; Extracorporeal Shockwave Therapy
• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Erectile Dysfunction
• Other Study ID Numbers: CAAP DE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No