Erectile DysfunctionNCT04721834
LI-ESWT Versus Sham Therapy in Men With ED
A study testing Low-intensity Extracorporeal Shockwave Therapy in people with Erectile Dysfunction, run by Hospital Authority, Hong Kong.
Trial summary
Hong Kong has an aging population. By the year of 2036, more than 30% of our population will be older than 65 years old1. Aging in male has been shown to correlate with the risk of erectile dysfunction(ED). The demand in ED treatment is expected to increase. Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- Low-intensity Extracorporeal Shockwave Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- No sites listed yet
- Study dates
- Jan 2021to Jan 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 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 50 years old
- ED > 6 months
- Stable heterosexual relationship > 6 months
- Sexual Health Inventory for Men (SHIM) score <= 16
- Suboptimal response after first line phosphodiesterase type 5 inhibitor treatment
Who cannot join
- Penile anatomical abnormality
- History of pelvic radiotherapy
- History of radical prostatectomy
- History of penile implantations
- Neurological diseases
- Hypogonadism or on anti-androgen therapy
- Unstable psychiatric conditions or under active psychiatric treatment
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Efficacy of Low-Intensity Extracorporeal Shockwave Therapy in Treatment of Erectile Dysfunction - A Randomized Controlled Trial With Sham Therapy
Hong Kong has an aging population. By the year of 2036, more than 30% of our population will be older than 65 years old1. Aging in male has been shown to correlate with the risk of erectile dysfunction(ED). The demand in ED treatment is expected to increase.
Several ED treatment options are available, ranging from oral or intracavernosal drug treatments, to vacuum erection therapy or even penile prosthesis implantation. However, none of these treatment are curative nor rectify the pathophysiology of ED. Low-intensity extra-corporeal shockwave therapy(LI-ESWT) has been introduced since 2010 for treatment of ED. The first randomized-controlled trial by Vardi et al. had proved the efficacy of ESWT in improving the International Index of Erectile Function(IIEF) score3. The International Index of Erectile Function-Erectile Function domain score(IIEF-EF) was significantly greater in the treatment group compared with the sham therapy group. The efficacy of LI-ESWT was also confirmed in meta-analyses. Nonetheless, the available studies were criticized for the variations in shockwave generators, energy parameters and treatment protocol. Most studies used focused electrohydraulic machines, did not include NPT as part of the outcomes assessment, and only reported the short-term outcomes.
Read more
Currently LI-ESWT machine was used in few Hong Kong public hospitals for the treatment of erectile dysfunction. In KEC, few pilot cases have been done using the linear LI-ESWT machine. No adverse events were seen. Local published data is lacking. Yee et al. has published a double-blinded randomized placebo-controlled trial on LI-ESWT in 20144. Using an electrohydraulic machine with a focused shockwave source, they concluded no significant differences in IIEF-EF and Erectile Hardness Score(EHS) between treatment and sham therapy after 13 weeks of treatment. In subgroup analysis significant improvement was noted in men with severe baseline erectile dysfunction (LI-ESWT IIEF-EF improvement: 10.1 ± 4.1 vs sham therapy IIEF-ED domain improvement: 3.2 ± 3.3; P = 0.003). There were several limitations in this study. These include the small number of participants included in the subgroup analysis (ranges from 18 to 21 men in each subgroups), the lack of physical measurement of erectile function. The percentage of patients with 5 points or more IIEF-EF improvement and the Erection Hardness Score(EHS) were also not reported. They have also used an old design with focused energy source, instead of the linear energy source.
In light of the limitations of the previous international and local studies, the investigators plan to investigate the efficacy of a linear electromagnetic LI-ESWT machine in men with moderate and severe ED. In addition, the intermediate-term outcomes would be studied, in terms of patients-reported erection scores and nocturnal tumescence and rigidity measurement.
Read the detailed description
Objectives
- To investigate the efficacy and safety of LI-ESWT in treatment of moderate and severe ED
- To investigate the effect of LI-ESWT on nocturnal penile tumescence and rigidity.
Research Plan and Methodology
- Study Design This is a prospective, two-centre randomized controlled trial involving United Christian Hospital and Tseung Kwan O Hospital. The study will be conducted in accordance with the Declaration of Helsinki and the International Conference on Harmonisation, Good Clinical Practice Guidelines (ICH-GCP). This RCT will be registered with ClinicalTrials.gov.
- Patient selection and recruitment Patients would be recruited in the urology outpatient clinics. Subjects who fulfilled selection criteria would be counselled to participate in the study. Written consent would be obtained.
- Randomisation, allocation concealment and blinding Patients are randomised to either LI-ESWT or sham therapy in a ratio of 1:1. Randomisation is performed with a random number table. The designated operator who perform the procedure is not blinded. Patients were blinded throughout the procedures, during clinical follow-up and data analysis.
- Study Intervention Patients would undergo a 4-week washout period of oral phosphodiesterase inhibitors after recruitment. Severity of ED would be assessed by the International Index of Erectile Function - Erectile Function Domain (IIEF-EF) \& International Index of Erectile Function (IIEF-5) questionnaires and Erection Hardness Score(EHS) after the washout. Nocturnal penile tumescence (NPT) and rigidity would be measured by the Rigiscan at the night prior to the first treatment. All procedures would be performed by a designated nurse consultant(co-investigator) in an office setting using an electromagnetic linear shockwave machine. The nurse consultant has received overseas andrology training, as well as on-hand machine operation training by ESWT product specialist. Patient would be positioned in a supine position. Shockwaves would be delivered to the stretched penis at proximal, mid and distal penile shaft and bilateral crura of penis. (Energy: 0.1-0.25 mJ/mm2; 3000pulses per session; Frequency 3Hz) Treatment consists of 6 sessions over 5 weeks in total. It would be a twice-weekly treatment with one-week interval of resting period. Patient would be discharged home after each treatment session. Sham therapy would be given with a modified probe which no shockwave would be emitted. A working noise would still be generated which mimicked active treatment.
- Post-procedure management Clinical assessment would be conducted at week 4, week 26 and week 52 after completion of treatment. NPT would be measured at week 4. At all follow-up the IIEF-EF and EHS would be assessed. Any complications would be assessed and documented according to Clavien-Dindo classification.
- Sample Size Calculation In a recent meta-analysis, the mean improvement in IIEF-EF was 4.23. At 5% significance level and 80% power, 33 subjects were needed in each treatment and sham group (Total 66 subjects). Overall 84 subjects would be recruited with 20% of drop out expected (i.e. 42 subjects in each group).
- Study Period The expected study period would last for 44 months, including 30 months of subject enrolment, 2 months of treatment and 12 months of follow-up.
- Statistical Analysis The results would be analysed according to intention-to-treat principle. Mann-whitney U test would be used to study the IIEF-EF results, as well as all other non-parametric continuous variables in secondary outcomes. Chi-square test would be used for categorical variable, independent samples t-test would be used for parametric continuous variable.
Ethical Concern All identifiable personal data will be anonymised and will follow the HA policy on handling of patient data privacy.
- Conditions
- Erectile Dysfunction
- Being tested
- Low-intensity Extracorporeal Shockwave Therapy, Sham Therapy
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-intensity Extracorporeal Shockwave TherapyDevice
Low intensity shockwave energy would be delivered to stimulate angiogenesis in corporal tissue. Therapy would be delivered through a linear probe in 6 sessions. It would be conducted as a day procedure.
Sham TherapyDevice
Same device as the active treatment arm would be used, with the addition of sham probe which block all shockwaves.
| Study group | Role | What they receive |
|---|---|---|
| Low-intensity ESWT | Active comparator | Patient would be positioned in a supine position. Shockwaves would be delivered to the stretched penis at proximal, mid and distal penile shaft and bilateral crura of penis. (Energy: 0.1-0.25 mJ/mm2; 3000pulses per session; Frequency 3Hz) Treatment consists of 6 sessions over 5 weeks in total. It would be a twice-weekly treatment with one-week interval of resting period. Patient would be discharged home after each treatment session. Receives: Device: Low-intensity Extracorporeal Shockwave Therapy |
| Sham ESWT | Sham comparator | Sham therapy would be given with a modified probe which no shockwave would be emitted. A working noise would still be generated which mimicked active treatment. Receives: Device: Sham Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in International Index of Erectile Function - Erectile Function Domain (IIEF-EF) score
Validated questionnaire in assessing the erectile function over the past 4 weeks Minimum value - 1 Maximum values - 30 Higher scores represent a better outcome
Measured: One month after treatment, compared with pre-op level
Secondary outcomes (7)
Erection Hardness Score (EHS)
Hardness score of penis. Minimum value is 1, maximum is 4. Higher score represents better erection hardness.
Measured: At week 4, 26 and 52 after treatment
Percentage of patients with 5-points International Index of Erectile Function - Erectile Function Domain improvement
The percentage(%) of patients with 5 points or more International Index of Erectile Function - Erectile Function improvement compared with pre-study baseline level.
Measured: At week 4, 26 and 52 after treatment
Percentage of patients with Erection Hardness Score improved to 3 or above
The percentage(%) of patients with Erection Hardness Score improved to 3 or above.
Measured: At week 4, 26 and 52 after treatment
Frequency of nocturnal erections
A non-invasive ambulatory diagnostic machine Rigiscan would be used to provide an objective measure of the frequency of nocturnal erections at night. (number of erections during sleeping)
Measured: At week 4 and 52 after treatment
Duration of nocturnal erections
A non-invasive ambulatory diagnostic machine Rigiscan would be used to provide an objective measure of the duration of nocturnal erections.(Time in seconds)
Measured: At week 4 and 52 after treatment
Change in nocturnal penile tumescence
A non-invasive ambulatory diagnostic machine Rigiscan would be used to provide an objective measure of the change in penile girth at penile base and penile tip during nocturnal erections.(in cm)
Measured: At week 4 and 52 after treatment
Complications after the procedure
Number of participants reported penile pain or urethral bleeding during treatment or within 4 weeks after the treatment.
Measured: Within 4 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2021
- Study startJan 2021 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Authority, Hong Kong
- Sponsor type
- Other government
- Responsible party
- Principal investigator, CHENG Kwun-Chung, Hospital Authority, Hong Kong
- Investigators
- Kwun Chung CHENG, FRCS, Principal investigator, Hospital Authority, Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04721834
- Sponsor's protocol ID
- KEC-ESWT-RCT
- Status last verified
- Jan 2021
- First submitted
- 15 Oct 2020
- Last updated
- 25 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Feldman HA, Goldstein I, Hatzichristou DG, Krane RJ, McKinlay JB. Impotence and its medical and psychosocial correlates: results of the Massachusetts Male Aging Study. J Urol. 1994 Jan;151(1):54-61. doi: 10.1016/s0022-5347(17)34871-1.
PubMed 8254833Vardi Y, Appel B, Kilchevsky A, Gruenwald I. Does low intensity extracorporeal shock wave therapy have a physiological effect on erectile function? Short-term results of a randomized, double-blind, sham controlled study. J Urol. 2012 May;187(5):1769-75. doi: 10.1016/j.juro.2011.12.117. Epub 2012 Mar 15.
PubMed 22425129Yee CH, Chan ES, Hou SS, Ng CF. Extracorporeal shockwave therapy in the treatment of erectile dysfunction: a prospective, randomized, double-blinded, placebo controlled study. Int J Urol. 2014 Oct;21(10):1041-5. doi: 10.1111/iju.12506. Epub 2014 Jun 17.
PubMed 24942563Clavijo RI, Kohn TP, Kohn JR, Ramasamy R. Effects of Low-Intensity Extracorporeal Shockwave Therapy on Erectile Dysfunction: A Systematic Review and Meta-Analysis. J Sex Med. 2017 Jan;14(1):27-35. doi: 10.1016/j.jsxm.2016.11.001. Epub 2016 Dec 13.
PubMed 27986492Campbell JD, Trock BJ, Oppenheim AR, Anusionwu I, Gor RA, Burnett AL. Meta-analysis of randomized controlled trials that assess the efficacy of low-intensity shockwave therapy for the treatment of erectile dysfunction. Ther Adv Urol. 2019 Mar 29;11:1756287219838364. doi: 10.1177/1756287219838364. eCollection 2019 Jan-Dec.
PubMed 30956690
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Low-Intensity Extracorporeal Shockwave Therapy in Treatment of Erectile Dysfunction - A Randomized Controlled Trial With Sham Therapy
- ClinicalTrials.gov ID
- NCT04721834
- Acronym / sponsor ID
- KEC-ESWT-RCT
- Conditions
- Erectile Dysfunction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Hospital Authority, Hong KongOther government
- Study start
- Jan 2021 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 25 Jan 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.
Hong Kong has an aging population. By the year of 2036, more than 30% of our population will be older than 65 years old1. Aging in male has been shown to correlate with the risk of erectile dysfunction(ED). The demand in ED treatment is expected to increase.
Several ED treatment options are available, ranging from oral or intracavernosal drug treatments, to vacuum erection therapy or even penile prosthesis implantation. However, none of these treatment are curative nor rectify the pathophysiology of ED. Low-intensity extra-corporeal shockwave therapy(LI-ESWT) has been introduced since 2010 for treatment of ED. The first randomized-controlled trial by Vardi et al. had proved the efficacy of ESWT in improving the International Index of Erectile Function(IIEF) score3. The International Index of Erectile Function-Erectile Function domain score(IIEF-EF) was significantly greater in the treatment group compared with the sham therapy group. The efficacy of LI-ESWT was also confirmed in meta-analyses. Nonetheless, the available studies were criticized for the variations in shockwave generators, energy parameters and treatment protocol. Most studies used focused electrohydraulic machines, did not include NPT as part of the outcomes assessment, and only reported the short-term outcomes.
Currently LI-ESWT machine was used in few Hong Kong public hospitals for the treatment of erectile dysfunction. In KEC, few pilot cases have been done using the linear LI-ESWT machine. No adverse events were seen. Local published data is lacking. Yee et al. has published a double-blinded randomized placebo-controlled trial on LI-ESWT in 20144. Using an electrohydraulic machine with a focused shockwave source, they concluded no significant differences in IIEF-EF and Erectile Hardness Score(EHS) between treatment and sham therapy after 13 weeks of treatment. In subgroup analysis significant improvement was noted in men with severe baseline erectile dysfunction (LI-ESWT IIEF-EF improvement: 10.1 ± 4.1 vs sham therapy IIEF-ED domain improvement: 3.2 ± 3.3; P = 0.003). There were several limitations in this study. These include the small number of participants included in the subgroup analysis (ranges from 18 to 21 men in each subgroups), the lack of physical measurement of erectile function. The percentage of patients with 5 points or more IIEF-EF improvement and the Erection Hardness Score(EHS) were also not reported. They have also used an old design with focused energy source, instead of the linear energy source.
In light of the limitations of the previous international and local studies, the investigators plan to investigate the efficacy of a linear electromagnetic LI-ESWT machine in men with moderate and severe ED. In addition, the intermediate-term outcomes would be studied, in terms of patients-reported erection scores and nocturnal tumescence and rigidity measurement.
Detailed description
Objectives
- To investigate the efficacy and safety of LI-ESWT in treatment of moderate and severe ED
- To investigate the effect of LI-ESWT on nocturnal penile tumescence and rigidity.
Research Plan and Methodology
- Study Design This is a prospective, two-centre randomized controlled trial involving United Christian Hospital and Tseung Kwan O Hospital. The study will be conducted in accordance with the Declaration of Helsinki and the International Conference on Harmonisation, Good Clinical Practice Guidelines (ICH-GCP). This RCT will be registered with ClinicalTrials.gov.
- Patient selection and recruitment Patients would be recruited in the urology outpatient clinics. Subjects who fulfilled selection criteria would be counselled to participate in the study. Written consent would be obtained.
- Randomisation, allocation concealment and blinding Patients are randomised to either LI-ESWT or sham therapy in a ratio of 1:1. Randomisation is performed with a random number table. The designated operator who perform the procedure is not blinded. Patients were blinded throughout the procedures, during clinical follow-up and data analysis.
- Study Intervention Patients would undergo a 4-week washout period of oral phosphodiesterase inhibitors after recruitment. Severity of ED would be assessed by the International Index of Erectile Function - Erectile Function Domain (IIEF-EF) \& International Index of Erectile Function (IIEF-5) questionnaires and Erection Hardness Score(EHS) after the washout. Nocturnal penile tumescence (NPT) and rigidity would be measured by the Rigiscan at the night prior to the first treatment. All procedures would be performed by a designated nurse consultant(co-investigator) in an office setting using an electromagnetic linear shockwave machine. The nurse consultant has received overseas andrology training, as well as on-hand machine operation training by ESWT product specialist. Patient would be positioned in a supine position. Shockwaves would be delivered to the stretched penis at proximal, mid and distal penile shaft and bilateral crura of penis. (Energy: 0.1-0.25 mJ/mm2; 3000pulses per session; Frequency 3Hz) Treatment consists of 6 sessions over 5 weeks in total. It would be a twice-weekly treatment with one-week interval of resting period. Patient would be discharged home after each treatment session. Sham therapy would be given with a modified probe which no shockwave would be emitted. A working noise would still be generated which mimicked active treatment.
- Post-procedure management Clinical assessment would be conducted at week 4, week 26 and week 52 after completion of treatment. NPT would be measured at week 4. At all follow-up the IIEF-EF and EHS would be assessed. Any complications would be assessed and documented according to Clavien-Dindo classification.
- Sample Size Calculation In a recent meta-analysis, the mean improvement in IIEF-EF was 4.23. At 5% significance level and 80% power, 33 subjects were needed in each treatment and sham group (Total 66 subjects). Overall 84 subjects would be recruited with 20% of drop out expected (i.e. 42 subjects in each group).
- Study Period The expected study period would last for 44 months, including 30 months of subject enrolment, 2 months of treatment and 12 months of follow-up.
- Statistical Analysis The results would be analysed according to intention-to-treat principle. Mann-whitney U test would be used to study the IIEF-EF results, as well as all other non-parametric continuous variables in secondary outcomes. Chi-square test would be used for categorical variable, independent samples t-test would be used for parametric continuous variable.
Ethical Concern All identifiable personal data will be anonymised and will follow the HA policy on handling of patient data privacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-intensity ESWT | Active comparator | Device: Low-intensity Extracorporeal Shockwave TherapyPatient would be positioned in a supine position. Shockwaves would be delivered to the stretched penis at proximal, mid and distal penile shaft and bilateral crura of penis. (Energy: 0.1-0.25 mJ/mm2; 3000pulses per session; Frequency 3Hz) Treatment consists of 6 sessions over 5 weeks in total. It would be a twice-weekly treatment with one-week interval of resting period. Patient would be discharged home after each treatment session. |
| Sham ESWT | Sham comparator | Device: Sham TherapySham therapy would be given with a modified probe which no shockwave would be emitted. A working noise would still be generated which mimicked active treatment. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age > 50 years old
- ED > 6 months
- Stable heterosexual relationship > 6 months
- Sexual Health Inventory for Men (SHIM) score <= 16
- Suboptimal response after first line phosphodiesterase type 5 inhibitor treatment
Key exclusion criteria (7 listed)
- Penile anatomical abnormality
- History of pelvic radiotherapy
- History of radical prostatectomy
- History of penile implantations
- Neurological diseases
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 |
|---|---|---|
| Low-intensity Extracorporeal Shockwave TherapyLow intensity shockwave energy would be delivered to stimulate angiogenesis in corporal tissue. Therapy would be delivered through a linear probe in 6 sessions. It would be conducted as a day procedure. | Device | Low-intensity ESWT |
| Sham TherapySame device as the active treatment arm would be used, with the addition of sham probe which block all shockwaves. | Device | Sham ESWT |
Primary outcome
Change in International Index of Erectile Function - Erectile Function Domain (IIEF-EF) score
Time frame: One month after treatment, compared with pre-op level
Validated questionnaire in assessing the erectile function over the past 4 weeks Minimum value - 1 Maximum values - 30 Higher scores represent a better outcome
7 secondary outcomes
Erection Hardness Score (EHS)
Time frame: At week 4, 26 and 52 after treatment
Percentage of patients with 5-points International Index of Erectile Function - Erectile Function Domain improvement
Time frame: At week 4, 26 and 52 after treatment
Percentage of patients with Erection Hardness Score improved to 3 or above
Time frame: At week 4, 26 and 52 after treatment
Frequency of nocturnal erections
Time frame: At week 4 and 52 after treatment
Duration of nocturnal erections
Time frame: At week 4 and 52 after treatment
Change in nocturnal penile tumescence
Time frame: At week 4 and 52 after treatment
Complications after the procedure
Time frame: Within 4 weeks after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2021.
- Background: PubMed 8254833Feldman HA, Goldstein I, Hatzichristou DG, Krane RJ, McKinlay JB. Impotence and its medical and psychosocial correlates: results of the Massachusetts Male Aging Study. J Urol. 1994 Jan;151(1):54-61. doi: 10.1016/s0022-5347(17)34871-1.
- Background: PubMed 22425129Vardi Y, Appel B, Kilchevsky A, Gruenwald I. Does low intensity extracorporeal shock wave therapy have a physiological effect on erectile function? Short-term results of a randomized, double-blind, sham controlled study. J Urol. 2012 May;187(5):1769-75. doi: 10.1016/j.juro.2011.12.117. Epub 2012 Mar 15.
- Background: PubMed 24942563Yee CH, Chan ES, Hou SS, Ng CF. Extracorporeal shockwave therapy in the treatment of erectile dysfunction: a prospective, randomized, double-blinded, placebo controlled study. Int J Urol. 2014 Oct;21(10):1041-5. doi: 10.1111/iju.12506. Epub 2014 Jun 17.
- Background: PubMed 27986492Clavijo RI, Kohn TP, Kohn JR, Ramasamy R. Effects of Low-Intensity Extracorporeal Shockwave Therapy on Erectile Dysfunction: A Systematic Review and Meta-Analysis. J Sex Med. 2017 Jan;14(1):27-35. doi: 10.1016/j.jsxm.2016.11.001. Epub 2016 Dec 13.
- Background: PubMed 30956690Campbell JD, Trock BJ, Oppenheim AR, Anusionwu I, Gor RA, Burnett AL. Meta-analysis of randomized controlled trials that assess the efficacy of low-intensity shockwave therapy for the treatment of erectile dysfunction. Ther Adv Urol. 2019 Mar 29;11:1756287219838364. doi: 10.1177/1756287219838364. eCollection 2019 Jan-Dec.
- 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.
Kwun Chung CHENG, FRCS principal investigator
Hospital Authority, Hong Kong
Questions about this trial
What is this clinical trial studying?
A study testing Low-intensity Extracorporeal Shockwave Therapy in people with Erectile Dysfunction, run by Hospital Authority, Hong Kong.
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 5 inclusion and 7 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 25 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kwun Chung CHENG, FRCS (39494000, ckc640@ha.org.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in International Index of Erectile Function - Erectile Function Domain (IIEF-EF) score (time frame: One month after treatment, compared with pre-op level). 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 NCT04721834, which also lists 5 linked publications.
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 25 Jan 2021.