Comparison of Conservative Treatment Options in the Management of Erectile Dysfunction

NCT04885101 | Unknown

• 1 other identifier: CAAP DE
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Erectile Dysfunction

Keywords

Extracorporeal Shockwave Therapy; Radiofrequency Therapy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Change in International Index of Erectile Function

  Change from baseline International Index of Erectile Function immediately after intervention.

• Change in Questionnaire of Erectile Quality

  Change from baseline Questionannaire of Erectile Quality immediately after intervention.

• Change in measurement of penis length and diameter.

  Change from baseline measurement of penis lenght and diameter immediately after intervention.

Study Arms (3)

LISWT Group

EXPERIMENTAL

Participants who will submitted to active procedure with Low Intensuty Shockwave Therapy.

Procedure: LISWT Group

NARFT Group

EXPERIMENTAL

Participants who will submitted to active procedure with Non-Ablative Radiofrequency Therapy

Procedure: NARFT Group

Sham Group

SHAM COMPARATOR

Participants who submitted to sham procedure with vaccum therapy.

Procedure: Sham Group

Interventions

LISWT Group PROCEDURE

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.

LISWT Group

NARFT Group PROCEDURE

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.

NARFT Group

Sham Group PROCEDURE

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.

Sham Group

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years.
• Men with a report of complaints of erectile dysfunction.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centro de Atenção ao Assoalho Pélvico: lead
• Indústria Brasileira Equipamentos Médicos - IBRAMED: collaborator

Study Sites (1)

Centro de Atenção ao Assoalho Pelvico

Salvador, Estado de Bahia, 40.290-000, Brazil

RECRUITING

Related Publications (11)

• NIH Consensus Conference. Impotence. NIH Consensus Development Panel on Impotence. JAMA. 1993 Jul 7;270(1):83-90. No abstract available.

  PMID: 8510302 BACKGROUND

• 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.

  PMID: 16422984 BACKGROUND

• 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.

  PMID: 28751439 BACKGROUND

• 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.

  PMID: 8254833 BACKGROUND

• 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.

  PMID: 16985979 BACKGROUND

• 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.

  PMID: 10731462 BACKGROUND

• Mobley D, Baum N. Smoking: Its Impact on Urologic Health. Rev Urol. 2015;17(4):220-5.

  PMID: 26839519 BACKGROUND

• 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.

  PMID: 16530932 BACKGROUND

• 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.

  PMID: 23343170 BACKGROUND

• 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.

  PMID: 6108446 BACKGROUND

• 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.

  PMID: 29119841 BACKGROUND

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Officials

• Patrícia V Lordêlo, PhD

  Centro de Atenção Pélvica - CAAP

  STUDY CHAIR

Central Study Contacts

Patrícia V Lordêlo, PhD

CONTACT

+5571988592400; pvslordelo@hotmail.com

Carlos S Mamede, MD

CONTACT

+5571988683967; carlosandrejpa@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The investigator won't be aware where participants will be allocated.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study will be conducted men diagnosed with Erectile Dysfunction alocated in three groups: Non-Ablative Radiofrequency Therapy (NARFT), Low Intensity Shockwave Therapy (LISWT) or Sham.

Study Record Dates

• First Submitted: November 24, 2020
• First Posted: May 13, 2021
• Study Start: October 1, 2021
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: December 5, 2023

Record last verified: 2023-12

Locations

BR (1)