Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202506591686874 Date of Approval: 20/06/2025
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of Allopurinol Alone Versus Allopurinol Plus Tadalafil on Cavernosal Uric Acid in Patients with Vasculogenic Erectile Dysfunction: A Comparative Study
Official scientific title Cavernosal uric acid level before and after allopurinol alone versus allopurinol plus daily tadalafil 5mg treatment in Vasculogenic Erectile Dysfunction Patients: A Comparative Study
Brief summary describing the background and objectives of the trial Erectile dysfunction (ED) is a common condition affecting men, often resulting from vascular and endothelial dysfunction. Emerging evidence suggests that hyperuricemia may contribute to endothelial impairment through oxidative stress and reduced nitric oxide bioavailability—mechanisms also implicated in ED. Allopurinol, a xanthine oxidase inhibitor, lowers uric acid levels and may improve endothelial function. Tadalafil, a phosphodiesterase-5 inhibitor, is a well-established treatment for ED. This study was prompted by the need to explore whether urate-lowering therapy (ULT), alone or combined with tadalafil, could improve erectile function in hyperuricemic patients. We investigated the effect of allopurinol alone versus its combination with tadalafil on cavernosal uric acid levels and erectile function scores in patients with vasculogenic ED.
Type of trial Non-Randomised
Acronym (If the trial has an acronym then please provide) ACUTE-ED
Disease(s) or condition(s) being studied Urological and Genital Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Efficacy Study
Anticipated trial start date 01/03/2023
Actual trial start date 01/04/2023
Anticipated date of last follow up 01/01/2024
Actual Last follow-up date 24/01/2024
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants) 80
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Non-randomised Allocation Sequence/Code was not concealed Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Allopurinol Allopurinol 100 mg once daily 2 months Phase 1 (Monotherapy Phase): Patients received Allopurinol 100 mg orally once daily for a duration of 2 months. Cavernosal and serum uric acid levels were measured before and after this phase, along with erectile function assessment using the International Index of Erectile Function (IIEF-5). 60
Experimental Group Allopurinol and Tadalafil Allopurinol 100 mg + Tadalafil 5 mg orally once daily 2 months Phase 2 (Combination Therapy Phase): The same 60 patients subsequently received a combination of Allopurinol 100 mg + Tadalafil 5 mg orally once daily for an additional 2 months. Cavernosal and serum uric acid levels, as well as IIEF-5 scores, were again assessed after completion. 60
Control Group Healthy control group none none A comparator arm comprising 20 age-matched healthy controls (with no erectile dysfunction or hyperuricemia) was included for baseline comparisons but did not receive any therapeutic intervention. 20 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Males aged 35–65 ED ≥ 6 months IIEF-5 score ≤ 21 Normal hormonal profile Willingness to consent Recent cardiovascular event (<6 months) Severe hepatic/renal impairment On nitrate therapy Psychiatric drugs, antihypertensives, or recent ED treatments Peyronie’s disease Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 35 Year(s) 65 Year(s) Male
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 13/12/2022 Al Azhar university Research ethics Commitee
Ethics Committee Address
Street address City Postal code Country
Al Mokhaym Al Daem, Gameat Al Azhar, Cairo 11651 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Change in cavernosal uric acid levels from baseline to 2 months and 4 months Change in IIEF-5 score baseline and at 2 months post-treatment
Secondary Outcome Penile duplex ultrasound parameters: PSV, EDV, RI Correlation between UA levels and IIEF-5 scores baseline and 2 months post treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Al Azhar University Al Mokhaym Al Daem, Gameat Al Azhar Cairo 11651 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mosaab Ragab Khalil Al Mokhaym Al Daem, Gameat Al Azhar, cairo 11651 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Al Azhar university Al Mokhaym Al Daem, Gameat Al Azhar, cairo 11651 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mosaab Khalil mosaab_ragab22@yahoo.com +20223952180 Al Mokhaym Al Daem, Gameat Al Azhar,
City Postal code Country Position/Affiliation
Cairo Egypt Resident of Dermatology
Role Name Email Phone Street address
Scientific Enquiries Mohamed Elsaie egydoc77@yahoo.com +201099501169 Al Mokhaym Al Daem, Gameat Al Azhar,
City Postal code Country Position/Affiliation
Cairo Egypt Professor of Dermatology and Venereology
Role Name Email Phone Street address
Public Enquiries Mohamed Hasan mohamed.saeed80@hotmail.com +201007212845 Al Mokhaym Al Daem, Gameat Al Azhar,
City Postal code Country Position/Affiliation
Cairo Egypt Professor of Dermatology and Venereology
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes De-identified individual participant data (including baseline, intervention, and outcome measures) will be available upon reasonable request to qualified researchers for scientific purposes after publication of the main results. Study Protocol Within 6 months after study completion. Contact corresponding author
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial description 27/05/2025 amendment requirement To assess the impact of hyperuricemia on ED and the effect of allopurinol on this population either alone or with tadalafil; a phosphodiesterase type 5 inhibitor (PDE-5I). This study evaluates the effect of allopurinol alone versus allopurinol plus daily tadalafil 5 mg on cavernosal uric acid levels and erectile function in patients with vasculogenic erectile dysfunction (VED). It aims to explore whether localized biochemical improvement correlates with clinical recovery in patients with hyperuricemia-related ED.
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial description 05/06/2025 Request to provide more detailed summary by PACTR reviewers This study evaluates the effect of allopurinol alone versus allopurinol plus daily tadalafil 5 mg on cavernosal uric acid levels and erectile function in patients with vasculogenic erectile dysfunction (VED). It aims to explore whether localized biochemical improvement correlates with clinical recovery in patients with hyperuricemia-related ED. Erectile dysfunction (ED) is a common condition affecting men, often resulting from vascular and endothelial dysfunction. Emerging evidence suggests that hyperuricemia may contribute to endothelial impairment through oxidative stress and reduced nitric oxide bioavailability—mechanisms also implicated in ED. Allopurinol, a xanthine oxidase inhibitor, lowers uric acid levels and may improve endothelial function. Tadalafil, a phosphodiesterase-5 inhibitor, is a well-established treatment for ED. This study was prompted by the need to explore whether urate-lowering therapy (ULT), alone or combined with tadalafil, could improve erectile function in hyperuricemic patients. We investigated the effect of allopurinol alone versus its combination with tadalafil on cavernosal uric acid levels and erectile function scores in patients with vasculogenic ED.
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Target no of participants 27/05/2025 amendment requirement 100 80
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Target no of participants 10/06/2025 Thank you so much for your comment however let me explain the total number of participants is 80 60 patients 20 controls the same 60 received 2 arms of interventions first : allopurinol for 2 months then secondly: allpourinola + tadalafil for another 2 months therefore the total number is 80 Intervention arm (patients with vasculogenic ED + hyperuricemia): 60 These participants received: Allopurinol 100 mg daily for 2 months Then Allopurinol 100 mg + Tadalafil 5 mg daily for 2 more months (same group) Control group (healthy, no ED): 20 No intervention; served as baseline comparator 80 60
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Target no of participants 10/06/2025 Thank you so much for your comment however let me explain the total number of participants is 80 60 patients 20 controls the same 60 received 2 arms of interventions first : allopurinol for 2 months then secondly: allpourinola + tadalafil for another 2 months therefore the total number is 80 Intervention arm (patients with vasculogenic ED + hyperuricemia): 60 These participants received: Allopurinol 100 mg daily for 2 months Then Allopurinol 100 mg + Tadalafil 5 mg daily for 2 more months (same group) Control group (healthy, no ED): 20 No intervention; served as baseline comparator 60 80
Section Name Field Name Date Reason Old Value Updated Value
Study Design Intervention assignment 17/06/2025 The study used a before-and-after interventional design in a single cohort of 60 patients with vasculogenic ED and hyperuricemia. Participants received Allopurinol alone for 2 months, then the combination of Allopurinol + Tadalafil for another 2 months. A separate group of 20 healthy individuals served as a non-interventional comparator for baseline uric acid levels. Parallel: different groups receive different interventions at same time during study Single Group
Section Name Field Name Date Reason Old Value Updated Value
Study Design Intervention assignment 20/06/2025 PACTR Admin Single Group Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 27/05/2025 amendment requirement Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s) Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s), Aged: 65+ Year(s)
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 05/06/2025 Total participants: 80 Intervention arm (patients with vasculogenic ED + hyperuricemia): 60 These participants received: Allopurinol 100 mg daily for 2 months Then Allopurinol 100 mg + Tadalafil 5 mg daily for 2 more months (same group) Control group (healthy, no ED): 20 No intervention; served as baseline comparator Experimental Group, Allopurinol and Tadalafil, Allopurinol 100 mg + Tadalafil 5 mg orally once daily, 2 months, Phase 2 (Combination Therapy Phase): The same patients subsequently received a combination of Allopurinol 100 mg + Tadalafil 5 mg orally once daily for an additional 2 months. Cavernosal and serum uric acid levels, as well as IIEF-5 scores, were again assessed after completion., 30,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 17/06/2025 Thank you so much for your comment however let me explain the total number of participants is 80 60 patients 20 controls the same 60 received 2 arms of interventions first : allopurinol for 2 months then secondly: allpourinola + tadalafil for another 2 months therefore the total number is 80 Intervention arm (patients with vasculogenic ED + hyperuricemia): 60 These participants received: Allopurinol 100 mg daily for 2 months Then Allopurinol 100 mg + Tadalafil 5 mg daily for 2 more months (same group) Control group (healthy, no ED): 20 No intervention; served as baseline comparator Experimental Group, Allopurinol , Allopurinol 100 mg once daily , 2 months , Phase 1 (Monotherapy Phase): Patients received Allopurinol 100 mg orally once daily for a duration of 2 months. Cavernosal and serum uric acid levels were measured before and after this phase, along with erectile function assessment using the International Index of Erectile Function (IIEF-5). , 50,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 05/06/2025 Total participants: 80 Intervention arm (patients with vasculogenic ED + hyperuricemia): 60 These participants received: Allopurinol 100 mg daily for 2 months Then Allopurinol 100 mg + Tadalafil 5 mg daily for 2 more months (same group) Control group (healthy, no ED): 20 No intervention; served as baseline comparator Experimental Group, Allopurinol , Allopurinol 100 mg once daily , 2 months , Phase 1 (Monotherapy Phase): Patients received Allopurinol 100 mg orally once daily for a duration of 2 months. Cavernosal and serum uric acid levels were measured before and after this phase, along with erectile function assessment using the International Index of Erectile Function (IIEF-5). , 60, Experimental Group, Allopurinol , Allopurinol 100 mg once daily , 2 months , Phase 1 (Monotherapy Phase): Patients received Allopurinol 100 mg orally once daily for a duration of 2 months. Cavernosal and serum uric acid levels were measured before and after this phase, along with erectile function assessment using the International Index of Erectile Function (IIEF-5). , 30,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 05/06/2025 Total participants: 80 Intervention arm (patients with vasculogenic ED + hyperuricemia): 60 These participants received: Allopurinol 100 mg daily for 2 months Then Allopurinol 100 mg + Tadalafil 5 mg daily for 2 more months (same group) Control group (healthy, no ED): 20 No intervention; served as baseline comparator Experimental Group, Allopurinol , Allopurinol 100 mg once daily , 2 months , Phase 1 (Monotherapy Phase): Patients received Allopurinol 100 mg orally once daily for a duration of 2 months. Cavernosal and serum uric acid levels were measured before and after this phase, along with erectile function assessment using the International Index of Erectile Function (IIEF-5). , 30, Experimental Group, Allopurinol , Allopurinol 100 mg once daily , 2 months , Phase 1 (Monotherapy Phase): Patients received Allopurinol 100 mg orally once daily for a duration of 2 months. Cavernosal and serum uric acid levels were measured before and after this phase, along with erectile function assessment using the International Index of Erectile Function (IIEF-5). , 60,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 10/06/2025 Thank you so much for your comment however let me explain the total number of participants is 80 60 patients 20 controls the same 60 received 2 arms of interventions first : allopurinol for 2 months then secondly: allpourinola + tadalafil for another 2 months therefore the total number is 80 Intervention arm (patients with vasculogenic ED + hyperuricemia): 60 These participants received: Allopurinol 100 mg daily for 2 months Then Allopurinol 100 mg + Tadalafil 5 mg daily for 2 more months (same group) Control group (healthy, no ED): 20 No intervention; served as baseline comparator Experimental Group, Allopurinol , Allopurinol 100 mg once daily , 2 months , Phase 1 (Monotherapy Phase): Patients received Allopurinol 100 mg orally once daily for a duration of 2 months. Cavernosal and serum uric acid levels were measured before and after this phase, along with erectile function assessment using the International Index of Erectile Function (IIEF-5). , 60, Experimental Group, Allopurinol , Allopurinol 100 mg once daily , 2 months , Phase 1 (Monotherapy Phase): Patients received Allopurinol 100 mg orally once daily for a duration of 2 months. Cavernosal and serum uric acid levels were measured before and after this phase, along with erectile function assessment using the International Index of Erectile Function (IIEF-5). , 40,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 10/06/2025 Thank you so much for your comment however let me explain the total number of participants is 80 60 patients 20 controls the same 60 received 2 arms of interventions first : allopurinol for 2 months then secondly: allpourinola + tadalafil for another 2 months therefore the total number is 80 Intervention arm (patients with vasculogenic ED + hyperuricemia): 60 These participants received: Allopurinol 100 mg daily for 2 months Then Allopurinol 100 mg + Tadalafil 5 mg daily for 2 more months (same group) Control group (healthy, no ED): 20 No intervention; served as baseline comparator Experimental Group, Allopurinol , Allopurinol 100 mg once daily , 2 months , Phase 1 (Monotherapy Phase): Patients received Allopurinol 100 mg orally once daily for a duration of 2 months. Cavernosal and serum uric acid levels were measured before and after this phase, along with erectile function assessment using the International Index of Erectile Function (IIEF-5). , 40, Experimental Group, Allopurinol , Allopurinol 100 mg once daily , 2 months , Phase 1 (Monotherapy Phase): Patients received Allopurinol 100 mg orally once daily for a duration of 2 months. Cavernosal and serum uric acid levels were measured before and after this phase, along with erectile function assessment using the International Index of Erectile Function (IIEF-5). , 60,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 17/06/2025 Thank you so much for your comment however let me explain the total number of participants is 80 60 patients 20 controls the same 60 received 2 arms of interventions first : allopurinol for 2 months then secondly: allpourinola + tadalafil for another 2 months therefore the total number is 80 Intervention arm (patients with vasculogenic ED + hyperuricemia): 60 These participants received: Allopurinol 100 mg daily for 2 months Then Allopurinol 100 mg + Tadalafil 5 mg daily for 2 more months (same group) Control group (healthy, no ED): 20 No intervention; served as baseline comparator Experimental Group, Allopurinol , Allopurinol 100 mg once daily , 2 months , Phase 1 (Monotherapy Phase): Patients received Allopurinol 100 mg orally once daily for a duration of 2 months. Cavernosal and serum uric acid levels were measured before and after this phase, along with erectile function assessment using the International Index of Erectile Function (IIEF-5). , 50, Experimental Group, Allopurinol , Allopurinol 100 mg once daily , 2 months , Phase 1 (Monotherapy Phase): Patients received Allopurinol 100 mg orally once daily for a duration of 2 months. Cavernosal and serum uric acid levels were measured before and after this phase, along with erectile function assessment using the International Index of Erectile Function (IIEF-5). , 60,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 05/06/2025 Total participants: 80 Intervention arm (patients with vasculogenic ED + hyperuricemia): 60 These participants received: Allopurinol 100 mg daily for 2 months Then Allopurinol 100 mg + Tadalafil 5 mg daily for 2 more months (same group) Control group (healthy, no ED): 20 No intervention; served as baseline comparator Experimental Group, Allopurinol and Tadalafil, Allopurinol 100 mg + Tadalafil 5 mg orally once daily, 2 months, Phase 2 (Combination Therapy Phase): The same patients subsequently received a combination of Allopurinol 100 mg + Tadalafil 5 mg orally once daily for an additional 2 months. Cavernosal and serum uric acid levels, as well as IIEF-5 scores, were again assessed after completion., 30, Experimental Group, Allopurinol and Tadalafil, Allopurinol 100 mg + Tadalafil 5 mg orally once daily, 2 months, Phase 2 (Combination Therapy Phase): The same patients subsequently received a combination of Allopurinol 100 mg + Tadalafil 5 mg orally once daily for an additional 2 months. Cavernosal and serum uric acid levels, as well as IIEF-5 scores, were again assessed after completion., 60,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 10/06/2025 Total participants: 80 Intervention arm (patients with vasculogenic ED + hyperuricemia): 60 These participants received: Allopurinol 100 mg daily for 2 months Then Allopurinol 100 mg + Tadalafil 5 mg daily for 2 more months (same group) Control group (healthy, no ED): 20 No intervention; served as baseline comparator Experimental Group, Allopurinol and Tadalafil, Allopurinol 100 mg + Tadalafil 5 mg orally once daily, 2 months, Phase 2 (Combination Therapy Phase): The same patients subsequently received a combination of Allopurinol 100 mg + Tadalafil 5 mg orally once daily for an additional 2 months. Cavernosal and serum uric acid levels, as well as IIEF-5 scores, were again assessed after completion., 60, Experimental Group, Allopurinol and Tadalafil, Allopurinol 100 mg + Tadalafil 5 mg orally once daily, 2 months, Phase 2 (Combination Therapy Phase): The same 60 patients subsequently received a combination of Allopurinol 100 mg + Tadalafil 5 mg orally once daily for an additional 2 months. Cavernosal and serum uric acid levels, as well as IIEF-5 scores, were again assessed after completion., 40,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 10/06/2025 Thank you so much for your comment however let me explain the total number of participants is 80 60 patients 20 controls the same 60 received 2 arms of interventions first : allopurinol for 2 months then secondly: allpourinola + tadalafil for another 2 months therefore the total number is 80 Intervention arm (patients with vasculogenic ED + hyperuricemia): 60 These participants received: Allopurinol 100 mg daily for 2 months Then Allopurinol 100 mg + Tadalafil 5 mg daily for 2 more months (same group) Control group (healthy, no ED): 20 No intervention; served as baseline comparator Experimental Group, Allopurinol and Tadalafil, Allopurinol 100 mg + Tadalafil 5 mg orally once daily, 2 months, Phase 2 (Combination Therapy Phase): The same 60 patients subsequently received a combination of Allopurinol 100 mg + Tadalafil 5 mg orally once daily for an additional 2 months. Cavernosal and serum uric acid levels, as well as IIEF-5 scores, were again assessed after completion., 40, Experimental Group, Allopurinol and Tadalafil, Allopurinol 100 mg + Tadalafil 5 mg orally once daily, 2 months, Phase 2 (Combination Therapy Phase): The same 60 patients subsequently received a combination of Allopurinol 100 mg + Tadalafil 5 mg orally once daily for an additional 2 months. Cavernosal and serum uric acid levels, as well as IIEF-5 scores, were again assessed after completion., 60,
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 27/05/2025 amendment requirement Primary Outcome, Change in cavernosal uric acid levels from baseline to 2 months and 4 months Change in IIEF-5 score, 2 months Primary Outcome, Change in cavernosal uric acid levels from baseline to 2 months and 4 months Change in IIEF-5 score, baseline and at 2 months post-treatment
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 27/05/2025 amendment requirement Secondary Outcome, Penile duplex ultrasound parameters: PSV, EDV, RI Correlation between UA levels and IIEF-5 scores, 2 months Secondary Outcome, Penile duplex ultrasound parameters: PSV, EDV, RI Correlation between UA levels and IIEF-5 scores, baseline and 2 months post treatment
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 27/05/2025 its usually approved with no date stamping for all university protocols however that was the date TRUE, Al Azhar university Research ethics Commitee, Al Mokhaym Al Daem, Gameat Al Azhar,, Cairo, 11651, Egypt, , 13 Dec 2022, +201007212845, info@azhar.edu.eg, 34762_31910_4737.pdf TRUE, Al Azhar university Research ethics Commitee, Al Mokhaym Al Daem, Gameat Al Azhar,, Cairo, 11651, Egypt, , 13 Dec 2022, +201007212845, info@azhar.edu.eg, 34762_31910_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 05/06/2025 PACTR reviewer request TRUE, Al Azhar university Research ethics Commitee, Al Mokhaym Al Daem, Gameat Al Azhar,, Cairo, 11651, Egypt, , 13 Dec 2022, +201007212845, info@azhar.edu.eg, 34762_31910_4737.pdf TRUE, Al Azhar university Research ethics Commitee, Al Mokhaym Al Daem, Gameat Al Azhar,, Cairo, 11651, Egypt, , 13 Dec 2022, +201007212845, info@azhar.edu.eg, 34762_31910_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 27/05/2025 amendment required none, Al Mokhaym Al Daem, Gameat Al Azhar, , cairo, 11651, Egypt, Self Funded, Mosaab Ragab Khalil , Al Mokhaym Al Daem, Gameat Al Azhar, , cairo, 11651, Egypt, Self Funded,
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 27/05/2025 amendment requirement Cavernosal and serum uric acid levels, IIEF-5 scores, penile duplex findings De-identified individual participant data (including baseline, intervention, and outcome measures) will be available upon reasonable request to qualified researchers for scientific purposes after publication of the main results.
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD-Sharing time frame 27/05/2025 amendment requirement Available upon reasonable request after publication Within 6 months after study completion.