Comparison of Conservative Treatment Options in the Management of Erectile Dysfunction

Study Overview
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Brief Summary
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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).

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

Conditions
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Erectile Dysfunction

Intervention / Treatment
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* Procedure: LISWT Group
* Procedure: NARFT Group
* Procedure: Sham Group


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LISWT Group<br>Participants who will submitted to active procedure with Low Intensuty Shockwave Therapy. | Procedure: LISWT Group<br>* 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.<br>|
| Experimental: NARFT Group<br>Participants who will submitted to active procedure with Non-Ablative Radiofrequency Therapy | Procedure: NARFT Group<br>* 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.<br>|
| Sham Comparator: Sham Group<br>Participants who submitted to sham procedure with vaccum therapy. | Procedure: Sham Group<br>* 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.<br>|

What is the study measuring?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Extracorporeal Shockwave Therapy, Radiofrequency Therapy