Comparison of Conservative Treatment Options in the Management of Erectile

Status Recruiting

Clinical Trial 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).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Erectile Dysfunction

Clinical Trial Details

NCT number	NCT04885101
Study type	Interventional
Source	Centro de Atenção ao Assoalho Pélvico
Contact	Patrícia V Lordêlo, PhD
Phone	+5571988592400
Email	pvslordelo@hotmail.com
Status	Recruiting
Phase	N/A
Start date	October 1, 2021
Completion date	July 2024

View Details

See also
Status	Clinical Trial	Phase
Not yet recruiting	`NCT05366504` - LiST Plus PRP Injection Therapy vs LiST Monotherapy for ED Treatment	Phase 2/Phase 3
Recruiting	`NCT02745808` - Injectable Collagen Scaffold™ Combined With HUC-MSCs for the Improvement of Erectile Function in Men With Diabetes	Phase 1
Recruiting	`NCT02573805` - the Diagnostic Value of Rigiscan Test (Nocturnal Penile Tumescence and Rigidity, NPTR) in Chinese Males	N/A
Withdrawn	`NCT02579148` - Collagen Scaffolds Loaded With HUCMSCs for the Improvement of Erectile Function in Men With Diabetes	Phase 1
Withdrawn	`NCT01967251` - Efficacy, Safety and Dose-response of Udenafil in Patients With Benign Prostatic Hyperplasia and Erectile Dysfunction	Phase 2
Recruiting	`NCT02225548` - Sagene 2014 - Parkinson's Disease and Erectile Dysfunction	Phase 4
Completed	`NCT02587988` - Trial to Evaluate the Efficacy and Safety of HCP1302	Phase 3
Completed	`NCT02945462` - Bone Marrow Mesenchymal Stem Cells in Erectile Dysfunction (ED)	Phase 1
Completed	`NCT01937871` - A Study of Tadalafil in Men With Benign Prostatic Hyperplasia (BPH) and Erectile Dysfunction (ED)	Phase 3
Completed	`NCT01698684` - Research Evaluating a PDE5 Inhibitor for Erectile Dysfunction	Phase 4
Not yet recruiting	`NCT01321489` - A Study to Evaluate a Possible Superiority Expressed by the Faster Onset of Action and the Efficacy and Safety of Sildenafil Citrate 20mg Sublingual Tablet in the Treatment of Erectile Dysfunction of Different Etiologies	Phase 3
Completed	`NCT02226237` - Effectiveness of Physiotherapy to Treat the Urinary Incontinence and Erectile Dysfunction Post Retropubic Prostatectomy	N/A
Terminated	`NCT01262833` - Pudendal Assessment in Erectile Dysfunction	N/A
Completed	`NCT01230541` - Effect of Udenafil on Spermatogenesis	Phase 1
Completed	`NCT01037244` - Treatment of Erectile Dysfunction I	Phase 3
Completed	`NCT01037218` - Treatment of Erectile Dysfunction II	Phase 3
Recruiting	`NCT00313898` - Effect of Sildenafil on Quality of Sexual Life in Mild to Normally Sexually Functioning Males	Phase 4
Completed	`NCT00663728` - Assessment of Duration of Erection With Vardenafil 10 mg	Phase 4
Completed	`NCT00667979` - Evaluating the Efficacy of Vardenafil in Subjects With Erectile Dysfunction (ED) Administered 12, 18 or 24 Hours Prior to Intercourse	Phase 4
Completed	`NCT00421083` - Efficacy and Safety of Tadalafil in Subjects With Erectile Dysfunction Caused by Spinal Cord Injury	Phase 3

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Comparison of Conservative Treatment Options in the Management of Erectile Dysfunction

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms