Erectile DysfunctionNCT05823506
Efficacy and Safety of Focused Shockwave Therapy Plus Tadalafil vs Tadalafil Alone in Patient With Erectile Dysfunction
A study testing PDE5 inhibitor (tadalafil) and BTL-6000 fSWT and PDE5 inhibitor (tadalafil) in people with Erectile Dysfunction, run by Saint Petersburg State University, Russia at 1 site in Russia.
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. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men only
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- PDE5 inhibitor (tadalafil) and BTL-6000 fSWT and PDE5 inhibitor (tadalafil)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteRussia
- Study dates
- 1 Feb 2023to 1 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Married or have had a permanent sex partner for at least 3 months;
- IIEF-5 questionnaire scores below 20
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Erectile Dysfunction
- Being tested
- PDE5 inhibitor (tadalafil) and BTL-6000 fSWT, PDE5 inhibitor (tadalafil)
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PDE5 inhibitor (tadalafil) and BTL-6000 fSWTCombination 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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Medication group | Active comparator | PDE5 inhibitor tadalafil in dosage 5 mg daily by 1 month Receives: 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 Receives: Combination Product: PDE5 inhibitor (tadalafil) and BTL-6000 fSWT; Drug: PDE5 inhibitor (tadalafil) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 60 days
Secondary outcomes (4)
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.
Measured: 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
Measured: 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.
Measured: 14 days,30 days, 60days.
Number of successful intercourse per week
Number of successful intercourse per week
Measured: 14 days,30 days, 60days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2023
- Study start1 Feb 2023
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saint Petersburg State University, Russia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gleb Kovalev, Saint Petersburg State University, Russia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05823506
- Sponsor's protocol ID
- ESWT_tadalafil_in_ED
- Status last verified
- May 2023
- First submitted
- 10 Apr 2023
- Last updated
- 6 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Focused Shockwave Therapy Plus Tadalafil vs Tadalafil Alone in Patient With Erectile Dysfunction: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05823506
- Acronym / sponsor ID
- ESWT_tadalafil_in_ED
- Conditions
- Erectile Dysfunction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Saint Petersburg State University, RussiaUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Feb 2024 (estimated)
- First posted
- 21 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medication group | Active comparator | Drug: PDE5 inhibitor (tadalafil)PDE5 inhibitor tadalafil in dosage 5 mg daily by 1 month |
| Combination group | Experimental | Combination Product: PDE5 inhibitor (tadalafil) and BTL-6000 fSWT, Drug: 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 |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Married or have had a permanent sex partner for at least 3 months;
- IIEF-5 questionnaire scores below 20
Key exclusion criteria (5 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PDE5 inhibitor (tadalafil) and BTL-6000 fSWTThe 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 product | Combination group |
| 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. | Drug | Combination group, Medication group |
Primary outcome
IIEF-5
Time frame: 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.
4 secondary outcomes
PGI-I
Time frame: 14 days,30 days, 60days.
Likert scale (7-point preferably) satisfaction questionnaire
Time frame: 14 days,30 days, 60days.
Therapy comfort survey
Time frame: 14 days,30 days, 60days.
Number of successful intercourse per week
Time frame: 14 days,30 days, 60days.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PDE5 inhibitor (tadalafil) and BTL-6000 fSWT and PDE5 inhibitor (tadalafil) in people with Erectile Dysfunction, run by Saint Petersburg State University, Russia at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ivan Labetov (8(812)317-69-58, ivanlabetov@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IIEF-5 (time frame: 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.