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

• Status: Recruiting
• Trial end date: 2024-02-01
• Target enrollment: 0
• Participant gender: Male

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.

We 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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Saint Petersburg State University, Russia
• Treatments: Phosphodiesterase 5 Inhibitors; Tadalafil

Criteria

Inclusion Criteria:• Age 20 to 45;

• Married or have had a permanent sex partner for at least 3 months;

• IIEF-5 questionnaire scores below 20

Exclusion Criteria:

• History of previous use of PDE-5 inhibitors or fSWT;

• Patients with diabetes mellitus;

• Patients after the radical prostatectomy or major pelvic surgery;

• Patients with a confirmed neurological disease that may have caused the ED (Multiple Sclerosis, Parkinson's Disease, spinal cord injury);

• Patients with contraindications to the use of PDE-5 inhibitors and/or fSWT;