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

Primary Purpose

Erectile Dysfunction

Status
Recruiting
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
PDE5 inhibitor (tadalafil) and BTL-6000 fSWT
PDE5 inhibitor (tadalafil)
Sponsored by
Saint Petersburg State University, Russia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Erectile Dysfunction

Eligibility Criteria

20 Years - 45 Years (Adult)MaleDoes not accept healthy volunteers

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;

Sites / Locations

  • SBPSURecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Medication group

Combination group

Arm Description

PDE5 inhibitor tadalafil in dosage 5 mg daily by 1 month

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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
Therapy comfort survey
Modified scale indicating how comfort patients feel about therapy, where 1is totally uncomfortable, and 7 is very comfortable.
Number of successful intercourse per week
Number of successful intercourse per week

Full Information

First Posted
April 10, 2023
Last Updated
May 2, 2023
Sponsor
Saint Petersburg State University, Russia
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1. Study Identification

Unique Protocol Identification Number
NCT05823506
Brief Title
Efficacy and Safety of Focused Shockwave Therapy Plus Tadalafil vs Tadalafil Alone in Patient With Erectile Dysfunction
Official Title
Efficacy and Safety of Focused Shockwave Therapy Plus Tadalafil vs Tadalafil Alone in Patient With Erectile Dysfunction: Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
February 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Saint Petersburg State University, Russia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Medication group
Arm Type
Active Comparator
Arm Description
PDE5 inhibitor tadalafil in dosage 5 mg daily by 1 month
Arm Title
Combination group
Arm Type
Experimental
Arm Description
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
Intervention Type
Combination Product
Intervention Name(s)
PDE5 inhibitor (tadalafil) and BTL-6000 fSWT
Intervention Description
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
Drug
Intervention Name(s)
PDE5 inhibitor (tadalafil)
Intervention Description
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.
Primary Outcome Measure Information:
Title
IIEF-5
Description
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.
Time Frame
60 days
Secondary Outcome Measure Information:
Title
PGI-I
Description
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.
Time Frame
14 days,30 days, 60days.
Title
Likert scale (7-point preferably) satisfaction questionnaire
Description
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
Time Frame
14 days,30 days, 60days.
Title
Therapy comfort survey
Description
Modified scale indicating how comfort patients feel about therapy, where 1is totally uncomfortable, and 7 is very comfortable.
Time Frame
14 days,30 days, 60days.
Title
Number of successful intercourse per week
Description
Number of successful intercourse per week
Time Frame
14 days,30 days, 60days.

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
because the study examines the effects of PDE-5 inhibitors or fSWT on erectile function in men
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ivan Labetov
Phone
8(812)317-69-58
Email
ivanlabetov@gmail.com
Facility Information:
Facility Name
SBPSU
City
Saint Petersburg
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ivan Labetov

12. IPD Sharing Statement

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

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