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

Erectile Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05823506
• Other study ID #: ESWT_tadalafil_in_ED
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: February 1, 2024

Study information

• Verified date: May 2023
• Source: Saint Petersburg State University, Russia
• Contact: Ivan Labetov
• Phone: 8(812)317-69-58
• Email: ivanlabetov[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: February 1, 2024
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

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;

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

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.

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.

Locations

Country	Name	City	State
Russian Federation	SBPSU	Saint Petersburg

Sponsors (1)

Lead Sponsor	Collaborator
Saint Petersburg State University, Russia

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	Number of successful intercourse per week	Number of successful intercourse per week	14 days,30 days, 60days.