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

NCT05823506 | Unknown

• 1 other identifier: ESWT_tadalafil_in_ED
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Erectile Dysfunction

Outcome Measures

Primary Outcomes (1)

• IIEF-5

  IIEF-5 (International Index of Erectile Function-5) is validated erectile function assessment questionnaire. The possible scores for the IIEF-5 range from 5 to 25, with lower values representing poorer sexual function.

  60 days

Secondary Outcomes (4)

• PGI-I

  14 days,30 days, 60days.

• Likert scale (7-point preferably) satisfaction questionnaire

  14 days,30 days, 60days.

• Therapy comfort survey

  14 days,30 days, 60days.

• Number of successful intercourse per week

  14 days,30 days, 60days.

Study Arms (2)

Medication group

ACTIVE COMPARATOR

PDE5 inhibitor tadalafil in dosage 5 mg daily by 1 month

Drug: PDE5 inhibitor (tadalafil)

Combination group

EXPERIMENTAL

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

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

Interventions

PDE5 inhibitor (tadalafil) and BTL-6000 fSWT 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.

Combination group

PDE5 inhibitor (tadalafil) 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; Medication group

Eligibility Criteria

• Age: 20 Years - 45 Years
• Gender Eligibility Details: because the study examines the effects of PDE-5 inhibitors or fSWT on erectile function in men
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Married or have had a permanent sex partner for at least 3 months;
• IIEF-5 questionnaire scores below 20

You may not qualify if:

• 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;

Sponsors & Collaborators

• Saint Petersburg State University, Russia: lead

Study Sites (1)

SBPSU

Saint Petersburg, Russia

RECRUITING

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Phosphodiesterase 5 Inhibitors; Tadalafil

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Phosphodiesterase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Carbolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indole Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Central Study Contacts

Ivan Labetov

CONTACT

8(812)317-69-58; ivanlabetov@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The head of outpatient urology department, phD

Study Record Dates

• First Submitted: April 10, 2023
• First Posted: April 21, 2023
• Study Start: February 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: February 1, 2024
• Last Updated: May 6, 2023

Record last verified: 2023-05

Locations

RU (1)