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NCT05823506

Efficacy and Safety of Focused Shockwave Therapy Plus Tadalafil vs Tadalafil Alone in Patient With Erectile Dysfunction

Efficacy and Safety of Focused Shockwave Therapy Plus Tadalafil vs Tadalafil Alone in Patient With Erectile Dysfunction: Randomized Controlled Trial
Saint Petersburg State University, Russia·ClinicalTrials.gov·combination productRecruiting
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Study focus
Disease/Condition
Erectile Dysfunction
Drug/Device/Intervention
PDE5 inhibitor (tadalafil) and BTL-6000 fSWT
Study type
Interventional
Intervention type
combination product
Sponsor & location
Primary sponsor
Saint Petersburg State University, Russia
Location
Saint Petersburg, Russian Federation
Timeline & enrollment
Phase
N/A
Start date
Feb 01, 2023
End date
Feb 01, 2024
Enrollment
36 participants
Primary outcome

IIEF-5

Summary

The goal of this trial is that using tadalafil plus low-intensity extracorporeal shockwave
 therapy (li-ESWT) is more effective than using tadalafil alone in improving erection rigidity
 and sexual function. The efficacy of the combination of li-ESWT and tadalafil has been
 confirmed by a number of studies, including in patients after radical prostatectomy. However,
 this method is still not a first-line method in young primary patients and its benefits in
 combination with drugs for these patients are not obvious.
 
 The investigators assume that the combination of tadalafil plus low-intensity extracorporeal
 shockwave therapy (li-ESWT) will improve the subjective state of patients assessed by points
 of validated questionnaires and Number of successful intercourse per week.

ICD-10 classifications
Orgasmic dysfunctionOther disorders of penisOther specified disorders of penisSexual dysfunction, not caused by organic disorder or diseaseTesticular dysfunction
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05823506
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT05823506 through Pure Global AI's free database. This phase not specified trial is sponsored by Saint Petersburg State University, Russia and is currently Recruiting. The study focuses on Erectile Dysfunction. Target enrollment is 36 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.