Erectile DysfunctionNCT06543628
Evaluation of Tadalafil Combined With LIPUS for Treating Erectile Dysfunction
A study testing Tadalafil 5mg and LIPUS (Low Intensity Pulsed Ultrasound) in people with Erectile Dysfunction, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
This study aims to evaluate the clinical efficacy and histological changes of tadalafil combined with low-intensity pulsed ultrasound (LIPUS) in patients with erectile dysfunction (ED) through a randomized controlled trial. Read more about this study
- Who is it for?
- Ages 21 to 65 years, men only
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- Tadalafil 5mg and LIPUS (Low Intensity Pulsed Ultrasound)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteChina
- Study dates
- 11 Aug 2024to 3 Mar 2025
- 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 21 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 21 and 65 years old.
- An International Index of Erectile Function-5 (IIEF-5) score of 21 or less.
- First-time diagnosis of erectile dysfunction (ED) without prior treatment from traditional Chinese or Western medicine.
- A stable heterosexual relationship for at least 3 months.
- Agreement to attempt sexual intercourse at least four times every four weeks during the study period.
- Signing of an informed consent form.
Who cannot join
- Erectile dysfunction caused by spinal/neural injury or radical prostatectomy.
- History of priapism or penile anatomical abnormalities.
- Use of a penile prosthesis.
- Severe and poorly controlled psychological disorders.
- Untreated endocrine disorders, such as hypogonadism, hypothyroidism, or pituitary dysfunction.
- History of myocardial infarction, stroke, life-threatening arrhythmias, or potential cardiovascular risks during sexual activity within the six months prior to enrollment.
- Inability to complete the participant records required for the trial.
- Allergic constitution and multiple drug allergies.
Trial locations and contacts
1 site in 1 country.
China1 site
The 2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310009
About this study
Official title: Tadalafil Combined With Low-Energy Pulsed Ultrasound (LIPUS) for the Treatment of Erectile Dysfunction: A Prospective, Randomized Controlled Clinical Trial
This study aims to evaluate the clinical efficacy and histological changes of tadalafil combined with low-intensity pulsed ultrasound (LIPUS) in patients with erectile dysfunction (ED) through a randomized controlled trial.
Read the detailed description
Erectile dysfunction (ED) is defined as the persistent inability to achieve and maintain a sufficient erection for satisfactory sexual performance for more than six months. Low-intensity pulsed ultrasound (LIPUS), a non-invasive therapy, improves the pathological changes in the corpora cavernosa and penile hemodynamics by promoting the regeneration of connective tissue, blood vessels, and cavernous nerves, as well as reducing inflammation.
This study will recruit 114 patients diagnosed with ED and use simple random sampling to allocate them into a treatment group and a control group in a 1:1 ratio. The treatment group will receive daily 5mg tadalafil combined with LIPUS therapy twice a week for 4 weeks, followed by a 4-week interval without LIPUS treatment, and then repeat the treatment. The control group will receive only daily 5mg tadalafil.
Efficacy will be evaluated primarily through the minimal clinically important difference (MCID) of the International Index of Erectile Function-5 (IIEF-5) at each follow-up point, combined with Erectile Hardness Score (EHS), penile blood flow parameters, and elasticity values for comprehensive assessment.
This trial may provide additional clinical evidence for the efficacy, safety, and cost-effectiveness of tadalafil combined with LIPUS in treating ED patients. The inclusion of penile blood flow parameters and two-dimensional shear wave elastography will help establish a comprehensive evaluation system combining ED symptoms with histological assessment, providing new methods for efficacy evaluation.
- Conditions
- Erectile Dysfunction
- Being tested
- Tadalafil 5mg, LIPUS (Low Intensity Pulsed Ultrasound)
- Keywords
- Tadalafil, LIPUS, Randomized Controlled Trial, protocol
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tadalafil 5mgDrug
Also called Cialis
Participants will take tadalafil once daily at a dose of 5 mg for 6 months.
LIPUS (Low Intensity Pulsed Ultrasound)Device
Participants will receive LIPUS treatment applied twice a week for 4 weeks, with the cycle repeated after a 4-week interval without treatment.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Participants will take tadalafil once daily at a dose of 5 mg for 6 months, in combination with LIPUS applied twice a week for 4 weeks, with the cycle repeated after a 4-week interval without treatment. Receives: Drug: Tadalafil 5mg; Device: LIPUS (Low Intensity Pulsed Ultrasound) |
| Control group | Active comparator | Participants will take tadalafil once daily at a dose of 5 mg for 6 months. Receives: Drug: Tadalafil 5mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
MCID based on IIEF-5
The primary outcome measure is based on the Minimum Clinically Important Difference (MCID) derived from the International Index of Erectile Function-5 (IIEF-5) scores. The MCID will be determined by the changes in IIEF-5 scores at 0 months, 2 months, 4 months, and 6 months. The IIEF-5 scale ranges from a minimum of 5 to a maximum of 25, with higher scores indicating better erectile function.
Measured: 0 months, 2 months, 4 months, 6 months
Secondary outcomes (6)
IIEF-5 Score
The secondary outcome measure is the change in the International Index of Erectile Function-5 (IIEF-5) scores at 0 months, 2 months, 4 months, and 6 months. The scale is titled International Index of Erectile Function-5 (IIEF-5), with a minimum score of 5 and a maximum score of 25. The interpretation of the scores is that higher scores indicate better erectile function.
Measured: 0 months, 2 months, 4 months, 6 months
EHS
The scale title is Erection Hardness Score (EHS), with a minimum value of 1 and a maximum value of 4. A higher score indicates better erection hardness. The changes in the EHS will be measured at 0 months, 2 months, 4 months, and 6 months.
Measured: 0 months, 2 months, 4 months, 6 months
PSV
The change in Peak Systolic Velocity (PSV) measured by Doppler ultrasound at 0 months and 6 months.
Measured: 0 months, 6 months
EDV
The change in End-Diastolic Velocity (EDV) measured by Doppler ultrasound at 0 months and 6 months.
Measured: 0 months, 6 months
YM value at the tip of the corpus cavernosum
The change in Young's Modulus (YM) value measured by elastography at 0 months and 6 months.
Measured: 0 months, 6 months
YM value at the base of the corpus cavernosum
The change in Young's Modulus (YM) value measured by elastography at 0 months and 6 months.
Measured: 0 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start11 Aug 2024
- Primary completion1 Mar 2025
- Study completion3 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bodong Lv, MD, Study chair, 2ndAffiliated Hospital, School of Medicine, Zhejiang University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06543628
- Sponsor's protocol ID
- 2024-0401
- Status last verified
- Aug 2024
- First submitted
- 5 Aug 2024
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang Q, Lv B, Yu H, Fu Y, Xu R, Liao Z, Zhang X, Fu Y, Huang W, Huang X. Evaluation of tadalafil in combination with Low-Intensity Pulsed Ultrasound (LIPUS) for erectile dysfunction: a protocol for a randomized controlled trial (SPIRIT Compliant). Trials. 2025 Nov 25;26(1):591. doi: 10.1186/s13063-025-09298-4.
PubMed 41291823
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tadalafil Combined With Low-Energy Pulsed Ultrasound (LIPUS) for the Treatment of Erectile Dysfunction: A Prospective, Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06543628
- Acronym / sponsor ID
- 2024-0401
- Conditions
- Erectile Dysfunction
- Keywords
- Tadalafil, LIPUS, Randomized Controlled Trial, protocol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 11 Aug 2024 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 3 Mar 2025 (actual)
- First posted
- 9 Aug 2024 (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.
This study aims to evaluate the clinical efficacy and histological changes of tadalafil combined with low-intensity pulsed ultrasound (LIPUS) in patients with erectile dysfunction (ED) through a randomized controlled trial.
Detailed description
Erectile dysfunction (ED) is defined as the persistent inability to achieve and maintain a sufficient erection for satisfactory sexual performance for more than six months. Low-intensity pulsed ultrasound (LIPUS), a non-invasive therapy, improves the pathological changes in the corpora cavernosa and penile hemodynamics by promoting the regeneration of connective tissue, blood vessels, and cavernous nerves, as well as reducing inflammation.
This study will recruit 114 patients diagnosed with ED and use simple random sampling to allocate them into a treatment group and a control group in a 1:1 ratio. The treatment group will receive daily 5mg tadalafil combined with LIPUS therapy twice a week for 4 weeks, followed by a 4-week interval without LIPUS treatment, and then repeat the treatment. The control group will receive only daily 5mg tadalafil.
Efficacy will be evaluated primarily through the minimal clinically important difference (MCID) of the International Index of Erectile Function-5 (IIEF-5) at each follow-up point, combined with Erectile Hardness Score (EHS), penile blood flow parameters, and elasticity values for comprehensive assessment.
This trial may provide additional clinical evidence for the efficacy, safety, and cost-effectiveness of tadalafil combined with LIPUS in treating ED patients. The inclusion of penile blood flow parameters and two-dimensional shear wave elastography will help establish a comprehensive evaluation system combining ED symptoms with histological assessment, providing new methods for efficacy evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: Tadalafil 5mg, Device: LIPUS (Low Intensity Pulsed Ultrasound)Participants will take tadalafil once daily at a dose of 5 mg for 6 months, in combination with LIPUS applied twice a week for 4 weeks, with the cycle repeated after a 4-week interval without treatment. |
| Control group | Active comparator | Drug: Tadalafil 5mgParticipants will take tadalafil once daily at a dose of 5 mg for 6 months. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age between 21 and 65 years old.
- An International Index of Erectile Function-5 (IIEF-5) score of 21 or less.
- First-time diagnosis of erectile dysfunction (ED) without prior treatment from traditional Chinese or Western medicine.
- A stable heterosexual relationship for at least 3 months.
- Agreement to attempt sexual intercourse at least four times every four weeks during the study period.
Key exclusion criteria (8 listed)
- Erectile dysfunction caused by spinal/neural injury or radical prostatectomy.
- History of priapism or penile anatomical abnormalities.
- Use of a penile prosthesis.
- Severe and poorly controlled psychological disorders.
- Untreated endocrine disorders, such as hypogonadism, hypothyroidism, or pituitary dysfunction.
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 |
|---|---|---|
| Tadalafil 5mgAlso: CialisParticipants will take tadalafil once daily at a dose of 5 mg for 6 months. | Drug | Control group, Treatment group |
| LIPUS (Low Intensity Pulsed Ultrasound)Participants will receive LIPUS treatment applied twice a week for 4 weeks, with the cycle repeated after a 4-week interval without treatment. | Device | Treatment group |
Primary outcome
MCID based on IIEF-5
Time frame: 0 months, 2 months, 4 months, 6 months
The primary outcome measure is based on the Minimum Clinically Important Difference (MCID) derived from the International Index of Erectile Function-5 (IIEF-5) scores. The MCID will be determined by the changes in IIEF-5 scores at 0 months, 2 months, 4 months, and 6 months. The IIEF-5 scale ranges from a minimum of 5 to a maximum of 25, with higher scores indicating better erectile function.
6 secondary outcomes
IIEF-5 Score
Time frame: 0 months, 2 months, 4 months, 6 months
EHS
Time frame: 0 months, 2 months, 4 months, 6 months
PSV
Time frame: 0 months, 6 months
EDV
Time frame: 0 months, 6 months
YM value at the tip of the corpus cavernosum
Time frame: 0 months, 6 months
YM value at the base of the corpus cavernosum
Time frame: 0 months, 6 months
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 10 Mar 2025.
- Derived from this study: PubMed 41291823Zhang Q, Lv B, Yu H, Fu Y, Xu R, Liao Z, Zhang X, Fu Y, Huang W, Huang X. Evaluation of tadalafil in combination with Low-Intensity Pulsed Ultrasound (LIPUS) for erectile dysfunction: a protocol for a randomized controlled trial (SPIRIT Compliant). Trials. 2025 Nov 25;26(1):591. doi: 10.1186/s13063-025-09298-4.
- 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.
Bodong Lv, MD study chair
2ndAffiliated Hospital, School of Medicine, Zhejiang University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tadalafil 5mg and LIPUS (Low Intensity Pulsed Ultrasound) in people with Erectile Dysfunction, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
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 6 inclusion and 8 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 10 Mar 2025. 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 China. 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?
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?
MCID based on IIEF-5 (time frame: 0 months, 2 months, 4 months, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06543628, which also lists 1 linked publication.
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 10 Mar 2025; AzTrials last refreshed its copy on 6 Nov 2026.