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Comparison of Conservative Treatment Options in the Management of Erectile Dysfunction

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ClinicalTrials.gov Identifier: NCT04885101
Recruitment Status : Not yet recruiting
First Posted : May 13, 2021
Last Update Posted : May 13, 2021
Sponsor:
Collaborator:
Indústria Brasileira Equipamentos Médicos - IBRAMED
Information provided by (Responsible Party):
Centro de Atenção ao Assoalho Pélvico

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).


Condition or disease Intervention/treatment Phase
Erectile Dysfunction Procedure: LISWT Group Procedure: NARFT Group Procedure: Sham Group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Single (Investigator)
Masking Description: The investigator won't be aware where participants will be allocated.
Primary Purpose: Treatment
Official Title: Comparison of Conservative Treatment Options in the Management of Erectile Dysfunction: Randomized Controlled Clinical Trial
Estimated Study Start Date : October 2021
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Change in peak systolic velocity [ Time Frame: Change from baseline peak systolic velocity immediately after intervention. ]
    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

  2. Change in end diastolic velocity [ Time Frame: Change from baseline end diastolic velocity immediately after intervention. ]
    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

  3. Change in cavernous artery diameter [ Time Frame: Change from baseline cavernous artery diameter immediately after intervention. ]
    Performed by means of ultrasonography with doppler of the penis through the induction of the erection.


Secondary Outcome Measures :
  1. Change in International Index of Erectile Function [ Time Frame: Change from baseline International Index of Erectile Function immediately after intervention. ]
    It is a questionnaire with 5 questions about penile erection that can vary from 5 to 25 points. Higher scores indicate better clinical condition.

  2. Change in Questionnaire of Erectile Quality [ Time Frame: Change from baseline Questionannaire of Erectile Quality immediately after intervention. ]
    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.

  3. Change in measurement of penis length and diameter. [ Time Frame: Change from baseline measurement of penis lenght and diameter immediately after intervention. ]
    These measurements are made with a paper ruler with the penis flaccid and after ten minutes of induction for erection.



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04885101


Contacts
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Contact: Patrícia V Lordêlo, PhD +5571988592400 pvslordelo@hotmail.com
Contact: Carlos S Mamede, MD +5571988683967 carlosandrejpa@gmail.com

Locations
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Brazil
Centro de Atenção ao Assoalho Pelvico
Salvador, Ba, Brazil, 40.290-000
Sponsors and Collaborators
Centro de Atenção ao Assoalho Pélvico
Indústria Brasileira Equipamentos Médicos - IBRAMED
Investigators
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Study Chair: Patrícia V Lordêlo, PhD Centro de Atenção Pélvica - CAAP
Publications:

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Responsible Party: Centro de Atenção ao Assoalho Pélvico
ClinicalTrials.gov Identifier: NCT04885101    
Other Study ID Numbers: CAAP DE
First Posted: May 13, 2021    Key Record Dates
Last Update Posted: May 13, 2021
Last Verified: May 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centro de Atenção ao Assoalho Pélvico:
Extracorporeal Shockwave Therapy
Radiofrequency Therapy
Additional relevant MeSH terms:
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Erectile Dysfunction
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Mental Disorders