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

Saint Petersburg State University, Russia

Status: Enrolling

Conditions: Erectile Dysfunction

Treatments: Drug: PDE5 inhibitor (tadalafil); Combination Product: PDE5 inhibitor (tadalafil) and BTL-6000 fSWT

Study type: Interventional

Funder types: Other

Identifiers

NCT05823506

ESWT_tadalafil_in_ED

Details and patient eligibility

About

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.

Full description

The aim of the study is to test the hypothesis that using tadalafil plus shockwave in primary patient with ED treatment in more effective in improving erection rigidity and sexual function, then using tadalafil alone.

Enrollment: 36 estimated patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

Medication group

Active Comparator group

Description:

PDE5 inhibitor tadalafil in dosage 5 mg daily by 1 month

Treatment:

Drug: PDE5 inhibitor (tadalafil)

Combination group

Experimental group

Description:

PDE5 inhibitor tadalafil in dosage 5 mg daily by 1 month plus Device BTL-6000 fSWT: 6 sessions with EFD 0,09 mJ/mm2 by 5000 impulses per session in 5 points in corpora cavernosa penis

Treatment:

Drug: PDE5 inhibitor (tadalafil)

Combination Product: PDE5 inhibitor (tadalafil) and BTL-6000 fSWT