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

NCT ID: NCT05823506

Last Updated: 2023-05-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-01
• Study Completion Date: 2024-02-01

Brief 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.

Detailed 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.

Conditions

Erectile Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Medication group

PDE5 inhibitor tadalafil in dosage 5 mg daily by 1 month

Group Type: ACTIVE_COMPARATOR

PDE5 inhibitor (tadalafil)

Intervention Type: DRUG

Tadalafil improves erectile function by inhibiting PDE5 isoenzyme, thereby blocking cGMP degradation. As a result, the PDE5 inhibitors act synergistically with NO to markedly increase the levels of cGMP, which in the presence of sexual stimulation, lead to an erection. In the absence of sexual stimulation, NO is not released locally and the PDE5 inhibitors do not affect the penis. Thus, sexual stimulation is needed to initiate the erectile mechanism for the PDE5 inhibitors to take effect.

Combination group

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

Group Type: EXPERIMENTAL

PDE5 inhibitor (tadalafil) and BTL-6000 fSWT

Intervention Type: COMBINATION_PRODUCT

The mechanism of low-intensity shockwave therapy in patients with ED based on the effect on the endothelium of the cavernous arteries, the release of NO and the enhancement of vascularization due to release of angiogenic factors.

PDE5 inhibitor (tadalafil)

Intervention Type: DRUG

Tadalafil improves erectile function by inhibiting PDE5 isoenzyme, thereby blocking cGMP degradation. As a result, the PDE5 inhibitors act synergistically with NO to markedly increase the levels of cGMP, which in the presence of sexual stimulation, lead to an erection. In the absence of sexual stimulation, NO is not released locally and the PDE5 inhibitors do not affect the penis. Thus, sexual stimulation is needed to initiate the erectile mechanism for the PDE5 inhibitors to take effect.

Interventions

PDE5 inhibitor (tadalafil) and BTL-6000 fSWT

The mechanism of low-intensity shockwave therapy in patients with ED based on the effect on the endothelium of the cavernous arteries, the release of NO and the enhancement of vascularization due to release of angiogenic factors.

Intervention Type: COMBINATION_PRODUCT

PDE5 inhibitor (tadalafil)

Tadalafil improves erectile function by inhibiting PDE5 isoenzyme, thereby blocking cGMP degradation. As a result, the PDE5 inhibitors act synergistically with NO to markedly increase the levels of cGMP, which in the presence of sexual stimulation, lead to an erection. In the absence of sexual stimulation, NO is not released locally and the PDE5 inhibitors do not affect the penis. Thus, sexual stimulation is needed to initiate the erectile mechanism for the PDE5 inhibitors to take effect.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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;

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Saint Petersburg State University, Russia

OTHER

Sponsor Role: lead

Responsible Party

Gleb Kovalev

The head of outpatient urology department, phD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

SBPSU

Saint Petersburg, , Russia

Site Status: RECRUITING

Countries

Russia

Central Contacts

Ivan Labetov

Role: CONTACT

ivanlabetov@gmail.com

8(812)317-69-58

Facility Contacts

Ivan Labetov

Role: primary

Other Identifiers

ESWT_tadalafil_in_ED

Identifier Type: -

Identifier Source: org_study_id