Comparison of Conservative Treatment Options in the Management of Erectile Dysfunction

Erectile Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04885101
• Other study ID #: CAAP DE
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: July 2024

Study information

• Verified date: December 2023
• Source: Centro de Atenção ao Assoalho Pélvico
• Contact: Patrícia V Lordêlo, PhD
• Phone: +5571988592400
• Email: pvslordelo[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 30 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

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.
• 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 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.

Locations

Country	Name	City	State
Brazil	Centro de Atenção ao Assoalho Pelvico	Salvador	Ba

Sponsors (2)

Lead Sponsor	Collaborator
Centro de Atenção ao Assoalho Pélvico	Indústria Brasileira Equipamentos Médicos - IBRAMED

Country where clinical trial is conducted

Brazil, 

References & Publications (11)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.