Clinical trial NCT04885101: Comparison of Conservative Treatment Options in the Management of Erectile Dysfunction
Official title: Comparison of Conservative Treatment Options in the Management of Erectile Dysfunction: Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Erectile Dysfunction
Keywords: Extracorporeal Shockwave Therapy
Radiofrequency Therapy
Lead sponsor: Centro de Atenção ao Assoalho Pélvico
Sponsor class: OTHER
Collaborators: name: Indústria Brasileira Equipamentos Médicos - IBRAMED
First posted: 2021-05-13
Enrollment: 60
Sex: MALE
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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).


Eligibility 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.

Primary outcomes:
measure: Change in peak systolic velocity
timeFrame: Change from baseline peak systolic velocity immediately after intervention.
measure: Change in end diastolic velocity
timeFrame: Change from baseline end diastolic velocity immediately after intervention.
measure: Change in cavernous artery diameter
timeFrame: Change from baseline cavernous artery diameter immediately after intervention.
Secondary outcomes:
measure: Change in International Index of Erectile Function
timeFrame: Change from baseline International Index of Erectile Function immediately after intervention.
measure: Change in Questionnaire of Erectile Quality
timeFrame: Change from baseline Questionannaire of Erectile Quality immediately after intervention.
measure: Change in measurement of penis length and diameter.
timeFrame: Change from baseline measurement of penis lenght and diameter immediately after intervention.
Other outcomes:
Locations:
city: Salvador
country: Brazil
facility: Centro de Atenção ao Assoalho Pelvico
state: Ba
Study officials:
affiliation: Centro de Atenção Pélvica - CAAP
name: Patrícia V Lordêlo, PhD
role: STUDY_CHAIR
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