Sexual DysfunctionNCT06058832
Effects of Low-intensity Shockwave Therapy Versus Kegel Exercises on Arteriogenic Erectile Dysfunction in DM Patients
A study testing Low-intensity Shockwave Therapy and Kegel Exercises in people with Sexual Dysfunction and Shock Wave, run by Cairo University at 1 site in Egypt.
Trial summary
To assess the effectiveness of low-intensity shockwave therapy (Li-ESWT) in the management of Arteriogenic erectile dysfunction in diabetic patients. To assess the effectiveness of Kegel Exercises in the management of Arteriogenic erectile dysfunction in diabetic patients. Read more about this study
- Who is it for?
- Ages 35 to 55 years, men only
- Conditions the study is for
- Sexual Dysfunction, Shock Wave
- What is being tested?
- Low-intensity Shockwave Therapy and Kegel Exercises
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Jan 2024to 6 Sep 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 35 to 55 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Ninety married men were diagnosed with T2DM participated in this study.
- The patients complained from arteriogenic ED > 6 months (Reisman et al., 2015) before the participation in this study
- All patients aged between 35-55 years old.
- Glycated hemoglobin (HbA1c) less than 9%.
- Body mass index of the patients was < 30 Kg/m2.
Who cannot join
- Alcohol-abuse, illegal drug consumer patients.
- Patients with cardiac diseases that prevent or affect sexual activity (heart attack, stroke, heart failure, myocardial infarction life-threatening, arrhythmia, etc within the previous 6 months).
- Patients with any pulmonary, liver, or kidney diseases.
- Patients with neurological insults, spinal cord injuries, stroke, polyneuropathy, etc.
- Patients with diagnosed psychiatric/mental complaints.
- Patients with blood pressure of more than 140/90 mmHg.
Show all 16Show fewer
- Patients with peripheral vascular disease.
- Patients with venogenic ED.
- Patients with past radical prostatectomy, extensive pelvic surgery, or previous pelvic trauma.
- Patients recovering from cancer in the past 5 years
- Penile anatomical abnormalities.
- Patients with clinically significant chronic hematological disease.
- Patients who received Anti-androgens or radiotherapy treatment of pelvic region.
- Patients with untreated hypogonadism.
- Patients with psychogenic ED (normal nocturnal penile tumescence parameters)
- Patient with penile prosthesis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Low-intensity Shockwave Therapy Versus Kegel Exercises on Arteriogenic Erectile Dysfunction in Diabetic Patients
- To assess the effectiveness of low-intensity shockwave therapy (Li-ESWT) in the management of Arteriogenic erectile dysfunction in diabetic patients.
- To assess the effectiveness of Kegel Exercises in the management of Arteriogenic erectile dysfunction in diabetic patients.
- To compare the effectiveness of Li-ESWT and Kegel Exercises in the management of Arteriogenic erectile dysfunction in diabetic patients.
Read the detailed description
Erectile dysfunction is defined as the persistent inability to attain and maintain an erection enough to permit satisfactory sexual performance. Although ED is a benign disorder, it may affect physical and psychosocial health and may have a significant impact on the quality of life of sufferers and their partners.
According to the underlying causes, ED can be classified as psychogenic, endocrinologic, neurogenic, and vasculogenic. Vasculogenic erectile dysfunction is defined as an inability to get or keep an erection firm enough for sexual intercourse due to diseases such as diabetes mellitus and atherosclerotic vascular occlusive disease .
ED has been reported to occur in ≥50% of men with DM worldwide. It is usually present within 10 years of diagnosis of DM. The incidence of ED was reported to be higher in men with DM than for men without DM and up to 12% of men who present with ED were found to have previously undiagnosed DM.
Low-intensity extracorporeal shock wave therapy (Li-ESWT) was used in both in vitro and in vivo studies and the results showed that this energy can stimulate angiogenesis. The idea of applying Li-ESWT to the penis came from animal studies in which Li-ESWT was applied to the myocardium of pigs, where it has been reported that there was an improvement in ischemia-induced myocardial dysfunction.
Low-intensity extracorporeal SW therapy (Li-ESWT) of the penis would improve penile blood flow and endothelial function by stimulating angiogenesis in the corpora.
Oral phosphodiesterase-5 inhibitors (PDE-5 inhibitors), such as sildenafil and tadalafil, are usually the first-line treatment of erectile dysfunction. They are effective in a wide range of etiologies including cardiovascular disease, diabetes, and hypogonadism.
Contraction of the ischiocavernosus participates in the process of enhancing erectile rigidity by compressing the roots of the corpora cavernosa and inducing short-term suprasystolic intracavernosal pressures.
Further, bulbospongiosus contraction leads to temporary engorgement of the glans penis and corpus spongiosum and results in similar short-term increases in intra spongiosal pressures.
- Conditions
- Sexual Dysfunction, Shock Wave
- Being tested
- Low-intensity Shockwave Therapy, Kegel Exercises
- Medical subject headings
- Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-intensity Shockwave TherapyDevice
patients will receive 6 sessions, once per week of low-intensity extracorporeal shock wave with the following parameters: - 3000 SWs (energy intensity of 0.09 mJ/mm2) to each of five different sites: three along the penile shaft and two at the crural level plus Sildenafil 25mg of daily dose and 50mg on-demand dose one hour before intercourse for 6 weeks.
Kegel ExercisesOther
- The patient was asked to perform short (1 second) and long-lasting (6-10 seconds) contractions of the target muscles. Later, the exercises will do with the patient sitting or standing.
- Patient asked to repeat the contractions daily. Each patient performed 15 short and 15 long-lasting contractions in a prone, sitting, or standing position. Patients asked to do 30 contractions in the morning 30 contractions in the evening
| Study group | Role | What they receive |
|---|---|---|
| Low-intensity Shockwave Therapy | Experimental | patients will receive 6 sessions, once per week of low-intensity extracorporeal shock wave with the following parameters: - 3000 SWs (energy intensity of 0.09 mJ/mm2) to each of five different sites: three along the penile shaft and two at the crural level plus Sildenafil 25mg of daily dose and 50mg on-demand dose one hour before intercourse for 6 weeks. Receives: Device: Low-intensity Shockwave Therapy |
| Kegel Exercises | Experimental | kegel exercises plus sildenafil 25mg of daily dose and 50mg on-demand dose one hour before intercourse for 6 weeks. Receives: Other: Kegel Exercises |
| control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Penile color-coded Duplex scanning
for exclusion of psychogenic and venogenic erectile dysfunction (ED) and confirm arteriogenic ED. It will be used at baseline and post-intervention.
Measured: baseline
International Index of Erectile Function (IIEF-EF) questionnaire
At baseline and post-intervention, patients will be assessed and scored according to the five-item version of the International Index of Erectile Function (IIEF-5), which consists of five questions. Its score ranges from 1 to 25 and classifies ED severity with the following breakpoints: severe (1-7/25), moderate (8-11/25), mild to moderate (12-16/25), mild (17-21/25), and no ED (22-25/25)
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start5 Jan 2024
- Primary completion30 Aug 2024
- Study completion6 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Sexual 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elsayed Hassan Elsayed Abosteit, Cairo University
- Investigators
- Elsayed Abosteit, PhD, Principal investigator, physical therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06058832
- Sponsor's protocol ID
- Shockwave in ED
- Status last verified
- Oct 2024
- First submitted
- 22 Sep 2023
- Last updated
- 1 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cohen D, Gonzalez J, Goldstein I. The Role of Pelvic Floor Muscles in Male Sexual Dysfunction and Pelvic Pain. Sex Med Rev. 2016 Jan;4(1):53-62. doi: 10.1016/j.sxmr.2015.10.001. Epub 2016 Jan 8.
PubMed 27872005Dorey G, Speakman M, Feneley R, Swinkels A, Dunn C, Ewings P. Randomised controlled trial of pelvic floor muscle exercises and manometric biofeedback for erectile dysfunction. Br J Gen Pract. 2004 Nov;54(508):819-25.
PubMed 15527607Gruenwald I, Kitrey ND, Appel B, Vardi Y. Low-Intensity Extracorporeal Shock Wave Therapy in Vascular Disease and Erectile Dysfunction: Theory and Outcomes. Sex Med Rev. 2013 Jul;1(2):83-90. doi: 10.1002/smrj.9. Epub 2015 Oct 18.
PubMed 27784587Ahmad AM, Abosteit EH, Said Kadah A, Draz RS. Low-intensity shockwave therapy and pelvic floor muscle training each mitigate erectile dysfunction in men with diabetes: a randomised controlled trial. J Physiother. 2026 Apr;72(2):122-127. doi: 10.1016/j.jphys.2026.03.009. Epub 2026 Apr 2.
PubMed 41933953
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Low-intensity Shockwave Therapy Versus Kegel Exercises on Arteriogenic Erectile Dysfunction in Diabetic Patients
- ClinicalTrials.gov ID
- NCT06058832
- Acronym / sponsor ID
- Shockwave in ED
- Conditions
- Sexual Dysfunction, Shock Wave
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 5 Jan 2024 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 6 Sep 2024 (actual)
- First posted
- 28 Sep 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.
- To assess the effectiveness of low-intensity shockwave therapy (Li-ESWT) in the management of Arteriogenic erectile dysfunction in diabetic patients.
- To assess the effectiveness of Kegel Exercises in the management of Arteriogenic erectile dysfunction in diabetic patients.
- To compare the effectiveness of Li-ESWT and Kegel Exercises in the management of Arteriogenic erectile dysfunction in diabetic patients.
Detailed description
Erectile dysfunction is defined as the persistent inability to attain and maintain an erection enough to permit satisfactory sexual performance. Although ED is a benign disorder, it may affect physical and psychosocial health and may have a significant impact on the quality of life of sufferers and their partners.
According to the underlying causes, ED can be classified as psychogenic, endocrinologic, neurogenic, and vasculogenic. Vasculogenic erectile dysfunction is defined as an inability to get or keep an erection firm enough for sexual intercourse due to diseases such as diabetes mellitus and atherosclerotic vascular occlusive disease .
ED has been reported to occur in ≥50% of men with DM worldwide. It is usually present within 10 years of diagnosis of DM. The incidence of ED was reported to be higher in men with DM than for men without DM and up to 12% of men who present with ED were found to have previously undiagnosed DM.
Low-intensity extracorporeal shock wave therapy (Li-ESWT) was used in both in vitro and in vivo studies and the results showed that this energy can stimulate angiogenesis. The idea of applying Li-ESWT to the penis came from animal studies in which Li-ESWT was applied to the myocardium of pigs, where it has been reported that there was an improvement in ischemia-induced myocardial dysfunction.
Low-intensity extracorporeal SW therapy (Li-ESWT) of the penis would improve penile blood flow and endothelial function by stimulating angiogenesis in the corpora.
Oral phosphodiesterase-5 inhibitors (PDE-5 inhibitors), such as sildenafil and tadalafil, are usually the first-line treatment of erectile dysfunction. They are effective in a wide range of etiologies including cardiovascular disease, diabetes, and hypogonadism.
Contraction of the ischiocavernosus participates in the process of enhancing erectile rigidity by compressing the roots of the corpora cavernosa and inducing short-term suprasystolic intracavernosal pressures.
Further, bulbospongiosus contraction leads to temporary engorgement of the glans penis and corpus spongiosum and results in similar short-term increases in intra spongiosal pressures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low-intensity Shockwave Therapy | Experimental | Device: Low-intensity Shockwave Therapypatients will receive 6 sessions, once per week of low-intensity extracorporeal shock wave with the following parameters: - 3000 SWs (energy intensity of 0.09 mJ/mm2) to each of five different sites: three along the penile shaft and two at the crural level plus Sildenafil 25mg of daily dose and 50mg on-demand dose one hour before intercourse for 6 weeks. |
| Kegel Exercises | Experimental | Other: Kegel Exerciseskegel exercises plus sildenafil 25mg of daily dose and 50mg on-demand dose one hour before intercourse for 6 weeks. |
| control group | No intervention | – |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Ninety married men were diagnosed with T2DM participated in this study.
- The patients complained from arteriogenic ED > 6 months (Reisman et al., 2015) before the participation in this study
- All patients aged between 35-55 years old.
- Glycated hemoglobin (HbA1c) less than 9%.
- Body mass index of the patients was < 30 Kg/m2.
Key exclusion criteria (16 listed)
- Alcohol-abuse, illegal drug consumer patients.
- Patients with cardiac diseases that prevent or affect sexual activity (heart attack, stroke, heart failure, myocardial infarction life-threatening, arrhythmia, etc within the previous 6 months).
- Patients with any pulmonary, liver, or kidney diseases.
- Patients with neurological insults, spinal cord injuries, stroke, polyneuropathy, etc.
- Patients with diagnosed psychiatric/mental complaints.
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 Shockwave Therapypatients will receive 6 sessions, once per week of low-intensity extracorporeal shock wave with the following parameters: - 3000 SWs (energy intensity of 0.09 mJ/mm2) to each of five different sites: three along the penile shaft and two at the crural level plus Sildenafil 25mg of daily dose and 50mg on-demand dose one hour before intercourse for 6 weeks. | Device | Low-intensity Shockwave Therapy |
| Kegel Exercises* The patient was asked to perform short (1 second) and long-lasting (6-10 seconds) contractions of the target muscles. Later, the exercises will do with the patient sitting or standing. * Patient asked to repeat the contractions daily. Each patient performed 15 short and 15 long-lasting contractions in a prone, sitting, or standing position. Patients asked to do 30 contractions in the morning 30 contractions in the evening | Other | Kegel Exercises |
Primary outcome
Penile color-coded Duplex scanning
Time frame: baseline
for exclusion of psychogenic and venogenic erectile dysfunction (ED) and confirm arteriogenic ED. It will be used at baseline and post-intervention.
International Index of Erectile Function (IIEF-EF) questionnaire
Time frame: baseline
At baseline and post-intervention, patients will be assessed and scored according to the five-item version of the International Index of Erectile Function (IIEF-5), which consists of five questions. Its score ranges from 1 to 25 and classifies ED severity with the following breakpoints: severe (1-7/25), moderate (8-11/25), mild to moderate (12-16/25), mild (17-21/25), and no ED (22-25/25)
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 1 Nov 2024.
- Background: PubMed 27872005Cohen D, Gonzalez J, Goldstein I. The Role of Pelvic Floor Muscles in Male Sexual Dysfunction and Pelvic Pain. Sex Med Rev. 2016 Jan;4(1):53-62. doi: 10.1016/j.sxmr.2015.10.001. Epub 2016 Jan 8.
- Background: PubMed 15527607Dorey G, Speakman M, Feneley R, Swinkels A, Dunn C, Ewings P. Randomised controlled trial of pelvic floor muscle exercises and manometric biofeedback for erectile dysfunction. Br J Gen Pract. 2004 Nov;54(508):819-25.
- Background: PubMed 27784587Gruenwald I, Kitrey ND, Appel B, Vardi Y. Low-Intensity Extracorporeal Shock Wave Therapy in Vascular Disease and Erectile Dysfunction: Theory and Outcomes. Sex Med Rev. 2013 Jul;1(2):83-90. doi: 10.1002/smrj.9. Epub 2015 Oct 18.
- Derived from this study: PubMed 41933953Ahmad AM, Abosteit EH, Said Kadah A, Draz RS. Low-intensity shockwave therapy and pelvic floor muscle training each mitigate erectile dysfunction in men with diabetes: a randomised controlled trial. J Physiother. 2026 Apr;72(2):122-127. doi: 10.1016/j.jphys.2026.03.009. Epub 2026 Apr 2.
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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.
Elsayed Abosteit, PhD principal investigator
physical therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-intensity Shockwave Therapy and Kegel Exercises in people with Sexual Dysfunction and Shock Wave, 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 16 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 1 Nov 2024. 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. 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?
Penile color-coded Duplex scanning (time frame: baseline). The study lists 2 primary outcomes in all. 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 NCT06058832, which also lists 4 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 1 Nov 2024.