Erectile DysfunctionNCT04219462
Effect of ESWT on ED in Type 2 Diabetics
A study testing active extracorporeal shock wave in people with Erectile Dysfunction and Diabetes Mellitus, Type 2, run by Cairo University at 1 site in Egypt.
Trial summary
Diabetes mellitus (DM) is known not only for its widespread prevalence, but also for its significant complications including cerebrovascular disease, coronary artery disease, renal failure, vision loss, and neuropathy. Read more about this study
- Who is it for?
- Ages 40 to 60 years, men only
- Conditions the study is for
- Erectile Dysfunction, Diabetes Mellitus, Type 2
- What is being tested?
- active extracorporeal shock wave
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Dec 2019to 15 Aug 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 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Forty married diabetic type 2 men with mild and moderate ED score (21-8) on Five-Item Version of the International Index of Erectile Function.
- Patients who will have erectile dysfunction ( ED) from 6 months.
- Patients with diabetes mellitus ( DM )duration ≥ 5 years with fasting blood glucose level of ≥ 126 mg/dl and glycosalyated haemoglobin (HbA1c ) ≥ 6.5% mg dl.
- Body mass index ( BMI) will be < 30 kg/m²
- The age of patients will be between 40- 60 years.
Who cannot join
- History of pelvic trauma, pelvic surgery, psychiatric disease.
- Patients with neuromuscular disorders, cardiovascular or pulmonary problems and spinal cord injuries.
- Vascular surgical intervention that recommended for the patients.
- Other renal conditions, respiratory disease, liver failure.
- Prostatectomy and patients with prostatic disease.
- Patients lacking complete follow-up data.
- hypogonadism.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Physical Therapy
Giza, 12511
ali m mohamed, lecturer, 01005154209, ali.mohamed@pt.cu.edu.eg
About this study
Official title: Effect of Extracorporeal Shock Wave Therapy (ESWT) on Erectile Dysfunction in Type 2 Diabetes Mellitus Patients
Diabetes mellitus (DM) is known not only for its widespread prevalence, but also for its significant complications including cerebrovascular disease, coronary artery disease, renal failure, vision loss, and neuropathy. Of particular importance to sexual medicine, diabetes has also been strongly associated with erectile dysfunction (ED).ED is defined as the inability to obtain and/or maintain the erection firm enough to achieve a successful sexual intercourse on a regular basis. It is a more common condition in males with type 2 DM. In the field of sexual medicine numerous studies have shown that extracorporal shock wave therapy (ESWT) is safe, noninvasive, and, most importantly, an effective method for treating vascular ED
Read the detailed description
ED in DM is often complex and caused by several mechanisms including vascular disease, autonomic neuropathy, hormonal imbalance, and psychogenic factors. However, as the endothelial dysfunction is an important factor contributing to the development of ED in diabetic patients, such patients can be resistant to phosphodiesterase 5 inhibitors (PDE5I) like sildenafil therapy. There are reports of lower efficacy of sildenafil in DM patients compared to general population.In the field of sexual medicine numerous studies have shown that ESWT is safe, noninvasive, and, most importantly, an effective method for treating vascular ED
Before starting the study, clearance will be obtained from the institutional ethical committee and prior informed consent of all the participants will be obtained before conducting the study. Patients will be recruited from outpatient clinic of andrology (Cairo University Hospitals). The patients were randomly divided into two equal groups:
Group (1): (Study group): Men in this group (n= 20) men receive extracorporeal shock wave (ESWT) twice weekly for 3 consecutive weeks and repeated after a 3-week rest period, for a total of 12 treatment sessions+sildenafil 5mg) Group (2): (Control group):) will receive sham treatment underwent identical therapy with ESWT application with a similar appearance and sound as the active low intensity ESWT+sildenafil 5mg
- Conditions
- Erectile Dysfunction, Diabetes Mellitus, Type 2
- Being tested
- active extracorporeal shock wave, sham extracorporeal shock wave
- Keywords
- extracorporal shock wave
- Medical subject headings
- Erectile Dysfunction, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active extracorporeal shock waveDevice
Ultrasound gel was used as a coupling agent, and the applicator of extracorpral shock wave therapy (ESWT) will be held perpendicular to the treatment surface throughout the treatment. Men in this group (n= 20) men receive ESWT twice weekly for 3 consecutive weeks and repeated after a 3-week rest period, for a total of 12 treatment sessions. The patients will receive ESWT for 15 minutes at an energy level of 0.09 and a frequency of 120 shocks/min (1800 pulses per session). Shockwaves were delivered to the distal, mid, and proximal penile shaft, as well as to the left and right crura + 5 mg sildnafil once daily for 3 months
sham extracorporeal shock waveDevice
twenty men will receive sham treatment underwent identical therapy with ESWT application with a similar appearance and sound as the active extracorporal shock wave therapy (ESWT), although shock wave propagation to the tissue wills be blocked by a metal plate that will inserted into the sham applicator + sildenafil 5mg once daily for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| study group | Active comparator | twenty men receive extracorporeal shock wave (ESWT) twice weekly for 3 consecutive weeks and repeated after a 3-week rest period, for a total of 12 treatment sessions. The patients will receive ESWT for 15 minutes at an energy level of 0.09 and a frequency of 120 shocks/min (1800 pulses per session). Shockwaves were delivered to the distal, mid, and proximal penile shaft, as well as to the left and right crura +sildenafil 5mg once daily for 3 months. Receives: Device: active extracorporeal shock wave |
| control group | Sham comparator | twenty men will receive sham treatment underwent identical therapy with Extracorporal shock wave therapy (ESWT) application with a similar appearance and sound as the active low intensity extracorporal shock wave therapy (ESWT), although shock wave propagation to the tissue wills be blocked by a metal plate that will inserted into the sham applicator + sildenafil 5mg once daily for 3 months. Receives: Device: sham extracorporeal shock wave |
What is being measured
The primary outcome is the main question the study is designed to answer.
the Five-Version of International Index of Erectile function
Each patient will self- administrated the Arabic translated five- Item Version of International Index of Erectile Function (IIEF-5) (in which every patient in both groups will be asked about erectile dysfunction (ED) over their last four weeks). The procedure of IIEF-5 conducted in the following steps:
- The patient will be asked to answer each item by choosing an answer from the five answers of each five items
- The number opposite to each answer from the five answers will be determined
- The final number obtained by the sum of the ordinal responses to the five items.
- The improvement of erectile dysfunction will be detected according ED severity classification: no ED (score 25-22) mild ED (score 21-17), mild to moderate ED (score 16-12), moderate ED (score 11-8) and severe ED (score 7-1).
- Measurements will be done before initial session in both groups. Follow up will be after the sixth treatment and at 1, 3, 6 months in both groups.
Measured: 6 months after last treatment session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2020
- Study start2 Dec 2019
- Primary completion15 Jul 2020 (estimated)
- Study completion15 Aug 2020 (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.
- More trials run by Cairo UniversityThe 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
- Crossover
- Model description
- 40 patients assigned to two groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Al Shaymaa Shaaban Abd El Azeim, Cairo University
- Investigators
- Al shymaa s abdelazem, lecturer, Principal investigator, lecturer of basic sciences- faculty of physical therapy- cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04219462
- Sponsor's protocol ID
- P.T.REC/012/002577
- Status last verified
- Jan 2020
- First submitted
- 1 Jan 2020
- Last updated
- 7 Jan 2020
- 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 7 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Extracorporeal Shock Wave Therapy (ESWT) on Erectile Dysfunction in Type 2 Diabetes Mellitus Patients
- ClinicalTrials.gov ID
- NCT04219462
- Acronym / sponsor ID
- P.T.REC/012/002577
- Conditions
- Erectile Dysfunction, Diabetes Mellitus, Type 2
- Keywords
- extracorporal shock wave
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 2 Dec 2019 (actual)
- Primary completion
- 15 Jul 2020 (estimated)
- Study completion
- 15 Aug 2020 (estimated)
- First posted
- 7 Jan 2020 (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.
Diabetes mellitus (DM) is known not only for its widespread prevalence, but also for its significant complications including cerebrovascular disease, coronary artery disease, renal failure, vision loss, and neuropathy. Of particular importance to sexual medicine, diabetes has also been strongly associated with erectile dysfunction (ED).ED is defined as the inability to obtain and/or maintain the erection firm enough to achieve a successful sexual intercourse on a regular basis. It is a more common condition in males with type 2 DM. In the field of sexual medicine numerous studies have shown that extracorporal shock wave therapy (ESWT) is safe, noninvasive, and, most importantly, an effective method for treating vascular ED
Detailed description
ED in DM is often complex and caused by several mechanisms including vascular disease, autonomic neuropathy, hormonal imbalance, and psychogenic factors. However, as the endothelial dysfunction is an important factor contributing to the development of ED in diabetic patients, such patients can be resistant to phosphodiesterase 5 inhibitors (PDE5I) like sildenafil therapy. There are reports of lower efficacy of sildenafil in DM patients compared to general population.In the field of sexual medicine numerous studies have shown that ESWT is safe, noninvasive, and, most importantly, an effective method for treating vascular ED
Before starting the study, clearance will be obtained from the institutional ethical committee and prior informed consent of all the participants will be obtained before conducting the study. Patients will be recruited from outpatient clinic of andrology (Cairo University Hospitals). The patients were randomly divided into two equal groups:
Group (1): (Study group): Men in this group (n= 20) men receive extracorporeal shock wave (ESWT) twice weekly for 3 consecutive weeks and repeated after a 3-week rest period, for a total of 12 treatment sessions+sildenafil 5mg) Group (2): (Control group):) will receive sham treatment underwent identical therapy with ESWT application with a similar appearance and sound as the active low intensity ESWT+sildenafil 5mg
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- 40 patients assigned to two groups
| Arm | Type | Receives |
|---|---|---|
| study group | Active comparator | Device: active extracorporeal shock wavetwenty men receive extracorporeal shock wave (ESWT) twice weekly for 3 consecutive weeks and repeated after a 3-week rest period, for a total of 12 treatment sessions. The patients will receive ESWT for 15 minutes at an energy level of 0.09 and a frequency of 120 shocks/min (1800 pulses per session). Shockwaves were delivered to the distal, mid, and proximal penile shaft, as well as to the left and right crura +sildenafil 5mg once daily for 3 months. |
| control group | Sham comparator | Device: sham extracorporeal shock wavetwenty men will receive sham treatment underwent identical therapy with Extracorporal shock wave therapy (ESWT) application with a similar appearance and sound as the active low intensity extracorporal shock wave therapy (ESWT), although shock wave propagation to the tissue wills be blocked by a metal plate that will inserted into the sham applicator + sildenafil 5mg once daily for 3 months. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Forty married diabetic type 2 men with mild and moderate ED score (21-8) on Five-Item Version of the International Index of Erectile Function.
- Patients who will have erectile dysfunction ( ED) from 6 months.
- Patients with diabetes mellitus ( DM )duration ≥ 5 years with fasting blood glucose level of ≥ 126 mg/dl and glycosalyated haemoglobin (HbA1c ) ≥ 6.5% mg dl.
- Body mass index ( BMI) will be < 30 kg/m²
- The age of patients will be between 40- 60 years.
Key exclusion criteria (7 listed)
- History of pelvic trauma, pelvic surgery, psychiatric disease.
- Patients with neuromuscular disorders, cardiovascular or pulmonary problems and spinal cord injuries.
- Vascular surgical intervention that recommended for the patients.
- Other renal conditions, respiratory disease, liver failure.
- Prostatectomy and patients with prostatic disease.
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 |
|---|---|---|
| active extracorporeal shock waveUltrasound gel was used as a coupling agent, and the applicator of extracorpral shock wave therapy (ESWT) will be held perpendicular to the treatment surface throughout the treatment. Men in this group (n= 20) men receive ESWT twice weekly for 3 consecutive weeks and repeated after a 3-week rest period, for a total of 12 treatment sessions. The patients will receive ESWT for 15 minutes at an energy level of 0.09 and a frequency of 120 shocks/min (1800 pulses per session). Shockwaves were delivered to the distal, mid, and proximal penile shaft, as well as to the left and right crura + 5 mg sildnafil once daily for 3 months | Device | study group |
| sham extracorporeal shock wavetwenty men will receive sham treatment underwent identical therapy with ESWT application with a similar appearance and sound as the active extracorporal shock wave therapy (ESWT), although shock wave propagation to the tissue wills be blocked by a metal plate that will inserted into the sham applicator + sildenafil 5mg once daily for 3 months. | Device | control group |
Primary outcome
the Five-Version of International Index of Erectile function
Time frame: 6 months after last treatment session
Each patient will self- administrated the Arabic translated five- Item Version of International Index of Erectile Function (IIEF-5) (in which every patient in both groups will be asked about erectile dysfunction (ED) over their last four weeks). The procedure of IIEF-5 conducted in the following steps: 1. The patient will be asked to answer each item by choosing an answer from the five answers of each five items 2. The number opposite to each answer from the five answers will be determined 3. The final number obtained by the sum of the ordinal responses to the five items. 4. The improvement of erectile dysfunction will be detected according ED severity classification: no ED (score 25-22) mild ED (score 21-17), mild to moderate ED (score 16-12), moderate ED (score 11-8) and severe ED (score 7-1). 5. Measurements will be done before initial session in both groups. Follow up will be after the sixth treatment and at 1, 3, 6 months in both groups.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2020.
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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.
Al shymaa s abdelazem, lecturer principal investigator
lecturer of basic sciences- faculty of physical therapy- cairo university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing active extracorporeal shock wave in people with Erectile Dysfunction and Diabetes Mellitus, Type 2, run by Cairo University at 1 site in Egypt.
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 7 Jan 2020. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Al shymaa s abdelazem, lecturer (02 01033771553, shimaashaaban30@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the Five-Version of International Index of Erectile function (time frame: 6 months after last treatment session). 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 7 Jan 2020; AzTrials last refreshed its copy on 6 Nov 2026.