Erectile Dysfunction Due to Diseases Classified ElsewhereNCT05615454
Effect of Bio-electromagnetic Energy Regulation Therapy on Erectile Dysfunction in Patients With Multiple Sclerosis
A study testing bio-electromagnetic energy regulation therapy (BEMER) machine model type: B.BOX CLASSIC, model NO: 420100, 12-15 Volt, (BEMER Int.AG, Liechtenstein product). in people with Erectile Dysfunction Due to Diseases Classified Elsewhere and Multiple Sclerosis, Relapsing-Remitting, run by Imam Abdulrahman Bin Faisal University at 2 sites in Saudi Arabia.
Trial summary
Multiple sclerosis (MS) is an inflammatory disease that affects the brain and spinal cord. There are potential impacts on neurological functions, including sensory and autonomic functions. The Primary observed in males with MS is erectile dysfunction (ED), which substantially impacts the quality of life. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men only
- Conditions the study is for
- Erectile Dysfunction Due to Diseases Classified Elsewhere, Multiple Sclerosis, Relapsing-Remitting
- What is being tested?
- bio-electromagnetic energy regulation therapy (BEMER) machine model type: B.BOX CLASSIC, model NO: 420100, 12-15 Volt, (BEMER Int.AG, Liechtenstein product).
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 2 sitesSaudi Arabia
- Study dates
- 28 Feb 2023to 30 Mar 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 18 to 40 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of MS according to the McDonald Revised criteria.
- Score 6-25 on the International Index of Erectile Function 15 (IIEF-15) will be recruited.
- Had sexual activity in the past month.
- Have Relapsing-remitting MS (RRMS) type and one month of clinical relapse, at least before the experimental study date.
Who cannot join
- If they have cognitive impairment that causes problems in answering the questionnaire.
- History of major chronic illness or other neurological disorders.
- Received any treatment for ED in the past seven days
- Previous therapy with a pulsed electromagnetic field, epilepsy, pacemaker, and acute bacterial infection with fever.
Trial locations and contacts
2 sites in 1 country.
Saudi Arabia2 sites, 2 recruiting
- Recruiting
Ali Muteb Alshami
Dammam, 31451
Ali M Alshami, Assoc Prof, +966552225548, alshami@iau.edu.sa
Turki S Abualait, Assist Prof, +966545555912, tsabualait@iau.edu.sa
- Recruiting
Imam Abdulrahman Bin Faisal University
Dammam, 31451
Ali M Alshami, Assoc Pro, +966552225548, alshami@iau.edu.sa
Turki S Abualait, Assist Prof, +966545555912, tsabualait@iau.edu.sa
About this study
Multiple sclerosis (MS) is an inflammatory disease that affects the brain and spinal cord. There are potential impacts on neurological functions, including sensory and autonomic functions. The Primary observed in males with MS is erectile dysfunction (ED), which substantially impacts the quality of life. There is increasing literature on electromagnetic fields' biological and clinical effects, particularly on ED.
Read the detailed description
The study aims to examine the bio-electromagnetic energy regulation therapy (BEMER) on erectile dysfunction with MS. We will recruit participants with MS having ED in a Triple-blind randomized clinical trial study. All participants will be randomly assigned to either an experimental group (receive the BEMER therapy) or a comparison group (receive placebo BEMER therapy) for five days/week for three weeks. Participants will also receive pelvic floor exercises in both groups.
- Conditions
- Erectile Dysfunction Due to Diseases Classified Elsewhere, Multiple Sclerosis, Relapsing-Remitting
- Being tested
- bio-electromagnetic energy regulation therapy (BEMER) machine model type: B.BOX CLASSIC, model NO: 420100, 12-15 Volt, (BEMER Int.AG, Liechtenstein product)., placebo BEMER
- Keywords
- BEMER, Erectile Dysfunction, Multiple Sclerosis, bio-electromagnetic energy regulation therapy
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Erectile Dysfunction, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bio-electromagnetic energy regulation therapy (BEMER) machine model type: B.BOX CLASSIC, model NO: 420100, 12-15 Volt, (BEMER Int.AG, Liechtenstein product).Device
The experimental group (receive the BEMER therapy) for five sessions/week for three weeks. Plus, pelvic floor exercise.
placebo BEMERDevice
Comparison group (receive placebo BEMER therapy) for five sessions/week for three weeks. Plus, pelvic floor exercise.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | (BEMER activated) Receives: Device: bio-electromagnetic energy regulation therapy (BEMER) machine model type: B.BOX CLASSIC, model NO: 420100, 12-15 Volt, (BEMER Int.AG, Liechtenstein product). |
| Comparison group | Placebo comparator | (BEMER deactivated) Receives: Device: placebo BEMER |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Index of Erectile Function - Erectile Function (IIEF-EF)
International Index of Erectile Function Erectile Function domain (IIEF-EF domain score) this means only questions 1, 2, 3, 4, 5, and 15 of IIEF-15.
Measured: Change from Baseline Erectile Function at 3 weeks
Secondary outcomes (3)
The Arizona Sexual Experience (ASEX) Scale
The ASEX was designed to assess five significant aspects of sexual dysfunction: drive, arousal, penile erection/vaginal lubrication, capability to achieve orgasm, and orgasmic satisfaction. Items are measured on a 6-point scale (1-6), with higher scores reflecting impaired sexual function. This scale allows for quick detection of sexual dysfunction. Sexual dysfunction was defined as one ASEX total score of ≥19, 2, any one item with a score of 5 or 3, or any three items with a score of ≥4
Measured: Within immediately of completion of the 3-week intervention period.
Modified Fatigue Impact Scale (MFIS)
The MFIS is a 21-item, multidimensional questionnaire that collects information about the effects of physical (9-item), psychosocial (2-item), and cognition (10-item) fatigue over the past four weeks. Participants ranked the 21 items on a 5-point Likert scale with anchors of never (0) and always (4). The optimal cutoff scores of the overall MFIS-A, physical/social, and cognitive subscales indicative of fatigue are 35.5, 18.5, and 15.5, respectively. Changes of 14.68 points or more may indicate a clinically significant change in fatigue in multiple sclerosis patients.
Measured: Within immediately of completion of the 3-week intervention period.
The Multiple Sclerosis, Intimacy, and Sexuality Questionnaire (MSISQ-19)
The MSISQ-19 is the most accurate and widely used tool for exploring the impact of MS on sexual function, assessing all aspects of sexual life and all three levels of sexual dysfunction (Domingo et al., 2018). It is a 19-item self-report questionnaire assessing the effect of MS symptoms on sexual activity and general sexual satisfaction during the previous six months (Carotenuto et al., 2021). Each item is scored on a Likert scale (1=never, 2=rarely, 3=sometimes, 4=often, and 5=always). In addition to the overall score, the MSISQ-19 provides scores on three different subscales: primary sexual dysfunction (calculated by items 12, 16, 17, 18, and 19) , Secondary sexual dysfunction (calculated by items 1, 2, 3, 4, 5, 6, 8, 10, and 11) and tertiary sexual dysfunction (described by items 7, 9, 13, 14, and 15) (Carotenuto et al., 2021)
Measured: Within immediately of completion of the 3-week intervention period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start28 Feb 2023
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (32)Papers the sponsor has linked to this study.
- Other trials for Erectile Dysfunction Due to Diseases Classified ElsewhereStudies 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
- Model description
- The intervention will be provided by a treating therapist who has a clinical experience of more than 13 years. The intervention for both groups will be for three consecutive weeks, five days per week (a total of 15 sessions)
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imam Abdulrahman Bin Faisal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdulaziz Alzahrani, Imam Abdulrahman Bin Faisal University
- Investigators
- Abdulaziz A Alzahrani, PhDcandidate, Principal investigator, imam abdurhman bin faisal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05615454
- Sponsor's protocol ID
- BEMER
- Status last verified
- Mar 2023
- First submitted
- 6 Nov 2022
- Last updated
- 9 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abdulla FA, Albagmi FM, Al-Khamis FA. Factors that influence quality of life in patients with multiple sclerosis in Saudi Arabia. Disabil Rehabil. 2022 Aug;44(17):4775-4783. doi: 10.1080/09638288.2021.1919929. Epub 2021 May 9.
PubMed 33966564Alawami AS, Abdulla FA. Psychometric properties of an Arabic translation of the modified fatigue impact scale in patients with multiple sclerosis. Disabil Rehabil. 2021 Nov;43(22):3251-3259. doi: 10.1080/09638288.2020.1731853. Epub 2020 Feb 28.
PubMed 32109166AlJumah M, Bunyan R, Al Otaibi H, Al Towaijri G, Karim A, Al Malik Y, Kalakatawi M, Alrajeh S, Al Mejally M, Algahtani H, Almubarak A, Cupler E, Alawi S, Qureshi S, Nahrir S, Almalki A, Alhazzani A, Althubaiti I, Alzahrani N, Mohamednour E, Saeedi J, Ishak S, Almudaiheem H, El-Metwally A, Al-Jedai A. Rising prevalence of multiple sclerosis in Saudi Arabia, a descriptive study. BMC Neurol. 2020 Feb 8;20(1):49. doi: 10.1186/s12883-020-1629-3.
PubMed 32035478Ben-Zacharia AB. Therapeutics for multiple sclerosis symptoms. Mt Sinai J Med. 2011 Mar-Apr;78(2):176-91. doi: 10.1002/msj.20245.
PubMed 21425263Carotenuto A, De Giglio L, Chiodi A, Petracca M, Rosa L, Bianchi M, Ferrante I, Lauro F, Moccia M, Ianniello A, Pozzilli C, Brescia Morra V, Lanzillo R. Validation of the Italian version of the Multiple Sclerosis Intimacy and Sexuality Questionnaire-19. Neurol Sci. 2021 Jul;42(7):2903-2910. doi: 10.1007/s10072-020-04873-w. Epub 2020 Nov 21.
PubMed 33222102Compston A, Coles A. Multiple sclerosis. Lancet. 2008 Oct 25;372(9648):1502-17. doi: 10.1016/S0140-6736(08)61620-7.
PubMed 18970977Dastoorpoor M, Zamanian M, Moradzadeh R, Nabavi SM, Kousari R. Prevalence of sexual dysfunction in men with multiple sclerosis: a systematic review and meta-analysis. Syst Rev. 2021 Jan 6;10(1):10. doi: 10.1186/s13643-020-01560-x.
PubMed 33407874Doig GS, Simpson F. Randomization and allocation concealment: a practical guide for researchers. J Crit Care. 2005 Jun;20(2):187-91; discussion 191-3. doi: 10.1016/j.jcrc.2005.04.005.
PubMed 16139163Dorey 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 15527607Dorey G, Speakman MJ, Feneley RC, Swinkels A, Dunn CD. Pelvic floor exercises for erectile dysfunction. BJU Int. 2005 Sep;96(4):595-7. doi: 10.1111/j.1464-410X.2005.05690.x.
PubMed 16104916Gandhi F, Jhaveri S, Avanthika C, Singh A, Jain N, Gulraiz A, Shah P, Nasir F. Impact of Vitamin D Supplementation on Multiple Sclerosis. Cureus. 2021 Oct 5;13(10):e18487. doi: 10.7759/cureus.18487. eCollection 2021 Oct.
PubMed 34754649Gerbild H, Larsen CM, Graugaard C, Areskoug Josefsson K. Physical Activity to Improve Erectile Function: A Systematic Review of Intervention Studies. Sex Med. 2018 Jun;6(2):75-89. doi: 10.1016/j.esxm.2018.02.001. Epub 2018 Apr 13.
PubMed 29661646Goldstein I, Lue TF, Padma-Nathan H, Rosen RC, Steers WD, Wicker PA. Oral sildenafil in the treatment of erectile dysfunction. Sildenafil Study Group. N Engl J Med. 1998 May 14;338(20):1397-404. doi: 10.1056/NEJM199805143382001.
PubMed 9580646Gyulai F, Raba K, Baranyai I, Berkes E, Bender T. BEMER Therapy Combined with Physiotherapy in Patients with Musculoskeletal Diseases: A Randomised, Controlled Double Blind Follow-Up Pilot Study. Evid Based Complement Alternat Med. 2015;2015:245742. doi: 10.1155/2015/245742. Epub 2015 May 20.
PubMed 26078768Kalyvianakis D, Hatzichristou D. Low-Intensity Shockwave Therapy Improves Hemodynamic Parameters in Patients With Vasculogenic Erectile Dysfunction: A Triplex Ultrasonography-Based Sham-Controlled Trial. J Sex Med. 2017 Jul;14(7):891-897. doi: 10.1016/j.jsxm.2017.05.012.
PubMed 28673433
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Bio-electromagnetic Energy Regulation Therapy on Erectile Dysfunction in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT05615454
- Acronym / sponsor ID
- BEMER
- Conditions
- Erectile Dysfunction Due to Diseases Classified Elsewhere, Multiple Sclerosis, Relapsing-Remitting
- Keywords
- BEMER, Erectile Dysfunction, Multiple Sclerosis, bio-electromagnetic energy regulation therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Imam Abdulrahman Bin Faisal UniversityUniversity, hospital or other
- Study start
- 28 Feb 2023 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Mar 2024 (estimated)
- First posted
- 14 Nov 2022 (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.
Multiple sclerosis (MS) is an inflammatory disease that affects the brain and spinal cord. There are potential impacts on neurological functions, including sensory and autonomic functions. The Primary observed in males with MS is erectile dysfunction (ED), which substantially impacts the quality of life. There is increasing literature on electromagnetic fields' biological and clinical effects, particularly on ED.
Detailed description
The study aims to examine the bio-electromagnetic energy regulation therapy (BEMER) on erectile dysfunction with MS. We will recruit participants with MS having ED in a Triple-blind randomized clinical trial study. All participants will be randomly assigned to either an experimental group (receive the BEMER therapy) or a comparison group (receive placebo BEMER therapy) for five days/week for three weeks. Participants will also receive pelvic floor exercises in both groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The intervention will be provided by a treating therapist who has a clinical experience of more than 13 years. The intervention for both groups will be for three consecutive weeks, five days per week (a total of 15 sessions)
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: bio-electromagnetic energy regulation therapy (BEMER) machine model type: B.BOX CLASSIC, model NO: 420100, 12-15 Volt, (BEMER Int.AG, Liechtenstein product).(BEMER activated) |
| Comparison group | Placebo comparator | Device: placebo BEMER(BEMER deactivated) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Diagnosis of MS according to the McDonald Revised criteria.
- Score 6-25 on the International Index of Erectile Function 15 (IIEF-15) will be recruited.
- Had sexual activity in the past month.
- Have Relapsing-remitting MS (RRMS) type and one month of clinical relapse, at least before the experimental study date.
Key exclusion criteria (4 listed)
- If they have cognitive impairment that causes problems in answering the questionnaire.
- History of major chronic illness or other neurological disorders.
- Received any treatment for ED in the past seven days
- Previous therapy with a pulsed electromagnetic field, epilepsy, pacemaker, and acute bacterial infection with fever.
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 |
|---|---|---|
| bio-electromagnetic energy regulation therapy (BEMER) machine model type: B.BOX CLASSIC, model NO: 420100, 12-15 Volt, (BEMER Int.AG, Liechtenstein product).The experimental group (receive the BEMER therapy) for five sessions/week for three weeks. Plus, pelvic floor exercise. | Device | Experimental group |
| placebo BEMERComparison group (receive placebo BEMER therapy) for five sessions/week for three weeks. Plus, pelvic floor exercise. | Device | Comparison group |
Primary outcome
International Index of Erectile Function - Erectile Function (IIEF-EF)
Time frame: Change from Baseline Erectile Function at 3 weeks
International Index of Erectile Function Erectile Function domain (IIEF-EF domain score) this means only questions 1, 2, 3, 4, 5, and 15 of IIEF-15.
3 secondary outcomes
The Arizona Sexual Experience (ASEX) Scale
Time frame: Within immediately of completion of the 3-week intervention period.
Modified Fatigue Impact Scale (MFIS)
Time frame: Within immediately of completion of the 3-week intervention period.
The Multiple Sclerosis, Intimacy, and Sexuality Questionnaire (MSISQ-19)
Time frame: Within immediately of completion of the 3-week intervention period.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2023.
- Background: PubMed 33966564Abdulla FA, Albagmi FM, Al-Khamis FA. Factors that influence quality of life in patients with multiple sclerosis in Saudi Arabia. Disabil Rehabil. 2022 Aug;44(17):4775-4783. doi: 10.1080/09638288.2021.1919929. Epub 2021 May 9.
- Background: PubMed 32109166Alawami AS, Abdulla FA. Psychometric properties of an Arabic translation of the modified fatigue impact scale in patients with multiple sclerosis. Disabil Rehabil. 2021 Nov;43(22):3251-3259. doi: 10.1080/09638288.2020.1731853. Epub 2020 Feb 28.
- Background: PubMed 32035478AlJumah M, Bunyan R, Al Otaibi H, Al Towaijri G, Karim A, Al Malik Y, Kalakatawi M, Alrajeh S, Al Mejally M, Algahtani H, Almubarak A, Cupler E, Alawi S, Qureshi S, Nahrir S, Almalki A, Alhazzani A, Althubaiti I, Alzahrani N, Mohamednour E, Saeedi J, Ishak S, Almudaiheem H, El-Metwally A, Al-Jedai A. Rising prevalence of multiple sclerosis in Saudi Arabia, a descriptive study. BMC Neurol. 2020 Feb 8;20(1):49. doi: 10.1186/s12883-020-1629-3.
- Background: PubMed 21425263Ben-Zacharia AB. Therapeutics for multiple sclerosis symptoms. Mt Sinai J Med. 2011 Mar-Apr;78(2):176-91. doi: 10.1002/msj.20245.
- Background: PubMed 33222102Carotenuto A, De Giglio L, Chiodi A, Petracca M, Rosa L, Bianchi M, Ferrante I, Lauro F, Moccia M, Ianniello A, Pozzilli C, Brescia Morra V, Lanzillo R. Validation of the Italian version of the Multiple Sclerosis Intimacy and Sexuality Questionnaire-19. Neurol Sci. 2021 Jul;42(7):2903-2910. doi: 10.1007/s10072-020-04873-w. Epub 2020 Nov 21.
- Background: PubMed 18970977Compston A, Coles A. Multiple sclerosis. Lancet. 2008 Oct 25;372(9648):1502-17. doi: 10.1016/S0140-6736(08)61620-7.
- Background: PubMed 33407874Dastoorpoor M, Zamanian M, Moradzadeh R, Nabavi SM, Kousari R. Prevalence of sexual dysfunction in men with multiple sclerosis: a systematic review and meta-analysis. Syst Rev. 2021 Jan 6;10(1):10. doi: 10.1186/s13643-020-01560-x.
- Background: PubMed 16139163Doig GS, Simpson F. Randomization and allocation concealment: a practical guide for researchers. J Crit Care. 2005 Jun;20(2):187-91; discussion 191-3. doi: 10.1016/j.jcrc.2005.04.005.
- 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 16104916Dorey G, Speakman MJ, Feneley RC, Swinkels A, Dunn CD. Pelvic floor exercises for erectile dysfunction. BJU Int. 2005 Sep;96(4):595-7. doi: 10.1111/j.1464-410X.2005.05690.x.
- Background: PubMed 34754649Gandhi F, Jhaveri S, Avanthika C, Singh A, Jain N, Gulraiz A, Shah P, Nasir F. Impact of Vitamin D Supplementation on Multiple Sclerosis. Cureus. 2021 Oct 5;13(10):e18487. doi: 10.7759/cureus.18487. eCollection 2021 Oct.
- Background: PubMed 29661646Gerbild H, Larsen CM, Graugaard C, Areskoug Josefsson K. Physical Activity to Improve Erectile Function: A Systematic Review of Intervention Studies. Sex Med. 2018 Jun;6(2):75-89. doi: 10.1016/j.esxm.2018.02.001. Epub 2018 Apr 13.
- Individual participant dataSharing planned: No
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.
Abdulaziz A Alzahrani, PhDcandidate principal investigator
imam abdurhman bin faisal
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bio-electromagnetic energy regulation therapy (BEMER) machine model type: B.BOX CLASSIC, model NO: 420100, 12-15 Volt, (BEMER Int.AG, Liechtenstein product). in people with Erectile Dysfunction Due to Diseases Classified Elsewhere and Multiple Sclerosis, Relapsing-Remitting, run by Imam Abdulrahman Bin Faisal University at 2 sites in Saudi Arabia.
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 4 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 9 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Saudi Arabia. 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 Abdulaziz A Alzahrani, PhDcandidate (+966500324592, 2210700007@iau.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Index of Erectile Function - Erectile Function (IIEF-EF) (time frame: Change from Baseline Erectile Function at 3 weeks). 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 NCT05615454, which also lists 32 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 9 Mar 2023.