Comparison of Conservative Treatment Options in the Management of Erectile Dysfunction

Not Applicable

Recruiting

• Conditions: Erectile Dysfunction
• Interventions: Procedure: LISWT Group; Procedure: Sham Group; Procedure: NARFT Group

• Registration Number: NCT04885101
• Lead Sponsor: 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-24
• Study First Submitted QC: 2021-05-09
• Study First Posted: 2021-05-13
• Study Start: 2021-10-01
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-04
• Last Update Posted: 2023-12-05
• Primary Completion: 2024-07
• Study Completion: 2024-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LISWT Group	LISWT Group	Participants who will submitted to active procedure with Low Intensuty Shockwave Therapy.
Sham Group	Sham Group	Participants who submitted to sham procedure with vaccum therapy.
NARFT Group	NARFT Group	Participants who will submitted to active procedure with Non-Ablative Radiofrequency Therapy

Primary Outcome Measures

Name	Time	Method
Change in cavernous artery diameter	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.
Change in peak systolic velocity	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
Change in end diastolic velocity	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

Secondary Outcome Measures

Name	Time	Method
Change in International Index of Erectile Function	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.
Change in Questionnaire of Erectile Quality	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.
Change in measurement of penis length and diameter.	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.

Trial Locations

Locations (1)

Centro de Atenção ao Assoalho Pelvico; 🇧🇷 Salvador, Ba, Brazil