Erectile DysfunctionNCT05043896
The Effect of Combination Therapy Using Li-ESWT and PDE-5 Inhibitor in Patients With Erectile Dysfunction
A study testing Li-ESWT and Tadalafil 2.5Mg Tab in people with Erectile Dysfunction, run by Dr. Soetomo General Hospital at 1 site in Indonesia.
Trial summary
to compare the effect of combination of li-eswt and pde-5 inhibitor to pde-5 alone in erectile dysfunction patients Read more about this study
- Who is it for?
- Ages 40 to 55 years, men only
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- Li-ESWT and Tadalafil 2.5Mg Tab
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteIndonesia
- Study dates
- 10 Dec 2019to 30 Jun 2020
- 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 40 to 55 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Mild to Moderate Erectile dysfunction
- Married
- Sexually active
- Consenting to participate in the trial
Who cannot join
- Psychological problems
- Spinal injury
- History of malignancy
- Penile anatomy abnormalities
- Allergic and Contraindications to tadalafil
- On anti-mitotic drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Combination Therapy Using Li-ESWT (Low Intensity Extracorporeal Shockwave Therapy) and PDE-5 Inhibitor in Patients With Erectile Dysfunction
to compare the effect of combination of li-eswt and pde-5 inhibitor to pde-5 alone in erectile dysfunction patients
Read the detailed description
Comparing the effect of Combination therapy (Li-ESWT combined with PDE5-inhibitor) vs SIngle therapy (PDE5-inhibitor) in mild to moderate Erectile Dysfunction patients.
Parameters used for comparation are EHS score, IIEF-5 score, VEGF level and PSV
- Conditions
- Erectile Dysfunction
- Being tested
- Li-ESWT, Tadalafil 2.5Mg Tab
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Li-ESWTProcedure or surgery
Also called Shockwave Therapy
Li-ESWT twice weekly for 4 weeks
Tadalafil 2.5Mg TabDrug
Also called Standard First Line Therapy
tadalafil 2.5mg once daily
| Study group | Role | What they receive |
|---|---|---|
| Combination therapy | Experimental | Li-ESWT + tadalafil Receives: Procedure: Li-ESWT; Drug: Tadalafil 2.5Mg Tab |
| Single Therapy | Sham comparator | tadalafil only Receives: Drug: Tadalafil 2.5Mg Tab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Erectile Hardness Score (EHS)
Developed in 1998, the EHS is a single-item Likert scale that men can use on their own.
The tool asks them to consider the question "How would you rate the hardness of your erection?" and select one of the following options:
0 Penis does not enlarge
- Penis is larger, but not hard
- Penis is hard, but not hard enough for penetration
- Penis is hard enough for penetration, but not completely hard
- Penis is completely hard and fully rigid
The EHS score was taken pre and post intervention
Measured: 4 weeks
International Index of Erectile Function (IIEF-5) score
IIEF-5 is a tool for ED (Erectile Dysfunction)diagnosis. The possible scores for the IIEF-5 range from 5 to 25, and ED was classified into five categories based on the scores: severe (5-7), moderate (8-11), mild to moderate (12-16), mild (17-21), and no ED (22-25)
IIEF-5 score was taken pre and post intervention
Measured: 4 weeks
Peak Systolic Velocity (PSV)
PSV was measured in cm/s, by using Doppler Ultrasonography. The probe is located at the penis, to be precise in the penoscrotal junction, to measure the velocity of the blood flow in the cavernous arteries.
The test was done in flaccid state of the penis Measurement was taken by an experienced ultrasonographer in the radiology unit. Measurement was taken pre and post intervention
Measured: 4 weeks
Vascular Endothelial Growth Factor (VEGF) level in plasma
VEGF was measured in pg/ml. VEGF test were done by blood test in the laboratory using the VEGF-A ELISA Kit.
Blood for tests were drawn pre and post test
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2021
- Study start10 Dec 2019
- Primary completion3 Jun 2020
- Study completion30 Jun 2020
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Soetomo General Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Andrian, dr., Sp.And, Dr. Soetomo General Hospital
- Investigators
- Tjahjo Tanojo, dr, Principal investigator, Dr. Soetomo General Hospital, Andrology Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05043896
- Sponsor's protocol ID
- 1690/KEPK/XII/2019
- Status last verified
- Sep 2021
- First submitted
- 26 Aug 2021
- Last updated
- 14 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Combination Therapy Using Li-ESWT (Low Intensity Extracorporeal Shockwave Therapy) and PDE-5 Inhibitor in Patients With Erectile Dysfunction
- ClinicalTrials.gov ID
- NCT05043896
- Acronym / sponsor ID
- 1690/KEPK/XII/2019
- Conditions
- Erectile Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Dr. Soetomo General HospitalOther government
- Study start
- 10 Dec 2019 (actual)
- Primary completion
- 3 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 14 Sep 2021 (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.
to compare the effect of combination of li-eswt and pde-5 inhibitor to pde-5 alone in erectile dysfunction patients
Detailed description
Comparing the effect of Combination therapy (Li-ESWT combined with PDE5-inhibitor) vs SIngle therapy (PDE5-inhibitor) in mild to moderate Erectile Dysfunction patients.
Parameters used for comparation are EHS score, IIEF-5 score, VEGF level and PSV
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combination therapy | Experimental | Procedure: Li-ESWT, Drug: Tadalafil 2.5Mg TabLi-ESWT + tadalafil |
| Single Therapy | Sham comparator | Drug: Tadalafil 2.5Mg Tabtadalafil only |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Mild to Moderate Erectile dysfunction
- Married
- Sexually active
- Consenting to participate in the trial
Key exclusion criteria (6 listed)
- Psychological problems
- Spinal injury
- History of malignancy
- Penile anatomy abnormalities
- Allergic and Contraindications to tadalafil
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 |
|---|---|---|
| Li-ESWTAlso: Shockwave TherapyLi-ESWT twice weekly for 4 weeks | Procedure or surgery | Combination therapy |
| Tadalafil 2.5Mg TabAlso: Standard First Line Therapytadalafil 2.5mg once daily | Drug | Combination therapy, Single Therapy |
Primary outcome
Erectile Hardness Score (EHS)
Time frame: 4 weeks
Developed in 1998, the EHS is a single-item Likert scale that men can use on their own. The tool asks them to consider the question "How would you rate the hardness of your erection?" and select one of the following options: 0 Penis does not enlarge 1. Penis is larger, but not hard 2. Penis is hard, but not hard enough for penetration 3. Penis is hard enough for penetration, but not completely hard 4. Penis is completely hard and fully rigid The EHS score was taken pre and post intervention
International Index of Erectile Function (IIEF-5) score
Time frame: 4 weeks
IIEF-5 is a tool for ED (Erectile Dysfunction)diagnosis. The possible scores for the IIEF-5 range from 5 to 25, and ED was classified into five categories based on the scores: severe (5-7), moderate (8-11), mild to moderate (12-16), mild (17-21), and no ED (22-25) IIEF-5 score was taken pre and post intervention
Peak Systolic Velocity (PSV)
Time frame: 4 weeks
PSV was measured in cm/s, by using Doppler Ultrasonography. The probe is located at the penis, to be precise in the penoscrotal junction, to measure the velocity of the blood flow in the cavernous arteries. The test was done in flaccid state of the penis Measurement was taken by an experienced ultrasonographer in the radiology unit. Measurement was taken pre and post intervention
Vascular Endothelial Growth Factor (VEGF) level in plasma
Time frame: 4 weeks
VEGF was measured in pg/ml. VEGF test were done by blood test in the laboratory using the VEGF-A ELISA Kit. Blood for tests were drawn pre and post test
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2021.
- Individual participant dataSharing planned: No
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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.
Tjahjo Tanojo, dr principal investigator
Dr. Soetomo General Hospital, Andrology Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Li-ESWT and Tadalafil 2.5Mg Tab in people with Erectile Dysfunction, run by Dr. Soetomo General Hospital at 1 site in Indonesia.
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 4 inclusion and 6 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: finished, as of the sponsor's last update on 14 Sep 2021. 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 Indonesia. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Erectile Hardness Score (EHS) (time frame: 4 weeks). The study lists 4 primary outcomes in all. 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 14 Sep 2021.