Comparison of Conservative Treatment Options in the Management of Erectile Dysfunction

Centro de Atenção ao Assoalho Pélvico

Status: Enrolling

Conditions: Erectile Dysfunction

Treatments: Procedure: Sham Group; Procedure: LISWT Group; Procedure: NARFT Group

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04885101

CAAP DE

Details and patient eligibility

About

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).

Enrollment: 60 estimated patients

Sex: Male

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 3 patient groups

LISWT Group

Experimental group

Description:

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

Treatment:

Procedure: LISWT Group

NARFT Group

Experimental group

Description:

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

Treatment:

Procedure: NARFT Group

Sham Group

Sham Comparator group

Description:

Participants who submitted to sham procedure with vaccum therapy.

Treatment:

Procedure: Sham Group