Efficacy and Safety of Focused Shockwave Therapy Plus Tadalafil vs Tadalafil Alone in Patient With Erectile Dysfunction
- Conditions
- Erectile Dysfunction
- Interventions
- Drug: PDE5 inhibitor (tadalafil)Combination Product: PDE5 inhibitor (tadalafil) and BTL-6000 fSWT
- Registration Number
- NCT05823506
- Lead Sponsor
- Saint Petersburg State University, Russia
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 36
• Age 20 to 45;
- Married or have had a permanent sex partner for at least 3 months;
- IIEF-5 questionnaire scores below 20
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Medication group PDE5 inhibitor (tadalafil) PDE5 inhibitor tadalafil in dosage 5 mg daily by 1 month Combination group PDE5 inhibitor (tadalafil) and BTL-6000 fSWT 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 group PDE5 inhibitor (tadalafil) 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
- Primary Outcome Measures
Name Time Method IIEF-5 60 days 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.
- Secondary Outcome Measures
Name Time Method PGI-I 14 days,30 days, 60days. 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.
Likert scale (7-point preferably) satisfaction questionnaire 14 days,30 days, 60days. 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
Therapy comfort survey 14 days,30 days, 60days. Modified scale indicating how comfort patients feel about therapy, where 1is totally uncomfortable, and 7 is very comfortable.
Number of successful intercourse per week 14 days,30 days, 60days. Number of successful intercourse per week
Trial Locations
- Locations (1)
SBPSU
🇷🇺Saint Petersburg, Russian Federation