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Efficacy and Safety of Focused Shockwave Therapy Plus Tadalafil vs Tadalafil Alone in Patient With Erectile Dysfunction - Trial NCT05823506

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.

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NCT05823506
Recruiting
combination product
Trial Details
ClinicalTrials.gov โ€ข NCT05823506
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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

Study Focus

Erectile Dysfunction

PDE5 inhibitor (tadalafil) and BTL-6000 fSWT

Interventional

combination product

Sponsor & Location

Saint Petersburg State University, Russia

Saint Petersburg, Russian Federation

Timeline & Enrollment

N/A

Feb 01, 2023

Feb 01, 2024

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 dysfunction
Other disorders of penis
Other specified disorders of penis
Sexual dysfunction, not caused by organic disorder or disease
Testicular dysfunction

Data Source

ClinicalTrials.gov

NCT05823506

Non-Device Trial