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

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.

Study Overview

• Status: Recruiting
• Conditions: Erectile Dysfunction
• Intervention / Treatment: Drug: PDE5 inhibitor (tadalafil); Combination product: PDE5 inhibitor (tadalafil) and BTL-6000 fSWT

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.

• Study Type: Interventional
• Enrollment (Anticipated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ivan Labetov; Phone Number: 8(812)317-69-58; Email: ivanlabetov@gmail.com

Study Locations

• Russian Federation
  • Saint Petersburg, Russian Federation
    • Recruiting
    • SBPSU
    • Contact: Ivan Labetov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Medication group; PDE5 inhibitor tadalafil in dosage 5 mg daily by 1 month	Drug: 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.
Experimental: 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	Drug: 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.; Combination product: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
PGI-I	The Patient Global Imression of Improvement (PGI-I) is a global index that may be used to rate the response of a condition to a therapy. This is a transition scale that is a single question asking the patient to rate their urinary tract condition now, as compared with how it was prior to before beginning treatment on a scale from 1-Very much better to 7-Very much worse.	14 days,30 days, 60days.
Likert scale (7-point preferably) satisfaction questionnaire	Likert Scale questions offer a range of answer options from either end of the spectrum for the respondents to choose from, where 1-extremely dissatisfied, 7- extremely satisfied	14 days,30 days, 60days.
Therapy comfort survey	Modified scale indicating how comfort patients feel about therapy, where 1is totally uncomfortable, and 7 is very comfortable.	14 days,30 days, 60days.
Number of successful intercourse per week	Number of successful intercourse per week	14 days,30 days, 60days.

Collaborators and Investigators

• Sponsor: Saint Petersburg State University, Russia

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): February 1, 2024

Study Registration Dates

• First Submitted: April 10, 2023
• First Submitted That Met QC Criteria: April 10, 2023
• First Posted (Actual): April 21, 2023

Study Record Updates

• Last Update Posted (Estimate): May 4, 2023
• Last Update Submitted That Met QC Criteria: May 2, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Erectile Dysfunction; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Urological Agents; Enzyme Inhibitors; Phosphodiesterase Inhibitors; Tadalafil; Phosphodiesterase 5 Inhibitors
• Other Study ID Numbers: ESWT_tadalafil_in_ED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No