BPH (Benign Prostatic Hyperplasia)Phase 1NCT07466030
Tadalafil 5 mg on Storage Lower Urinary Tract Symptoms After Anatomical Endoscopic Enucleation of the Prostate
A Phase 1 study testing Tadalafil 5mg (Male) and Omiga 3 in people with BPH (Benign Prostatic Hyperplasia), run by Assiut University.
Trial summary
The aim of this study is to evaluate the impact of daily tadalafil 5 mg on storage lower urinary tract symptoms (LUTS) during the early postoperative period following Anatomical endoscopic enucleation of prostate in a randomized controlled clinical trial. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- BPH (Benign Prostatic Hyperplasia)
- What is being tested?
- Tadalafil 5mg (Male) and Omiga 3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2026to 1 Sep 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Must be able to swallow tablets
- Adult males undergoing elective AEEP for symptomatic benign prostatic hyperplasia (BPH) with prostate volume ≥40 ml , Moderate to severe LUTS defined by International Prostate Symptom Score (IPSS) ≥19 at baseline.
- Patient is Willing to participate and able to provide written informed consent
Who cannot join
- Contraindications to tadalafil (e.g., nitrate use, severe hepatic/renal impairment, uncontrolled hypotension) , neurogenic bladder. , Preoperative urinary catheter dependence , post-void residual urine >350 ml. ,, Cognitive impairment precluding questionnaire completion
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Impact of Daily Tadalafil 5 mg on Storage Lower Urinary Tract Symptoms After Anatomical Endoscopic Enucleation of the Prostate :A Randomized , Single Blinded ,Controlled Trial"
The aim of this study is to evaluate the impact of daily tadalafil 5 mg on storage lower urinary tract symptoms (LUTS) during the early postoperative period following Anatomical endoscopic enucleation of prostate in a randomized controlled clinical trial.
- Conditions
- BPH (Benign Prostatic Hyperplasia)
- Being tested
- Tadalafil 5mg (Male), Omiga 3
- Keywords
- Storage LUTS post AEEP
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tadalafil 5mg (Male)Drug
Tadalafil 5 mg is a phosphodiesterase type 5 (PDE-5) inhibitor taken orally, commonly prescribed as a once-daily low dose therapy. It works by relaxing smooth muscle and improving blood flow in specific tissues.
Omiga 3Drug
Giving omiga 3 for patients who are not in tadalafil group
| Study group | Role | What they receive |
|---|---|---|
| Daily tadalafil 5 mg user | Active comparator | Patients will have daily tadalafil 5 mg for 3 months post AEEP Receives: Drug: Tadalafil 5mg (Male) |
| Placebo | Placebo comparator | Omiga 3 for patient Receives: Drug: Omiga 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients achieving stress urine incontinence at 12 weeks post op, assessed by IPSS score
More Precise Academic Wording:
- Proportion of patients: The percentage (%) of the total study population.
- Stress urinary incontinence (SUI): Involuntary leakage of urine during activities that increase intra-abdominal pressure (e.g., coughing, sneezing, lifting).
- 12 weeks post-operative: Three months after surgery.
- Assessed by IPSS score: Evaluation based on patient responses to the International Prostate Symptom Score questionnaire.
Important Methodological Note:
The International Prostate Symptom Score (IPSS) is primarily designed to assess lower urinary tract symptoms (LUTS) such as:
- Frequency
- Urgency
- Weak stream
- Nocturia
Measured: 12 weeks
Secondary outcomes (1)
Change from baseline in IPSS storage subdomain score at 4 weeks , 8weeks , and 12 weeks. Time to micturate freely IPSS total .
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start1 Mar 2026 (estimated)
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BPH (Benign Prostatic Hyperplasia)Studies of the same condition, open and under way.
- More trials run by Assiut 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Adel Mansour Hageb, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07466030
- Sponsor's protocol ID
- Tadalafil 5mg post AEEP
- Status last verified
- Feb 2026
- First submitted
- 4 Mar 2026
- Last updated
- 12 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Daily Tadalafil 5 mg on Storage Lower Urinary Tract Symptoms After Anatomical Endoscopic Enucleation of the Prostate :A Randomized , Single Blinded ,Controlled Trial"
- ClinicalTrials.gov ID
- NCT07466030
- Acronym / sponsor ID
- Tadalafil 5mg post AEEP
- Conditions
- BPH (Benign Prostatic Hyperplasia)
- Keywords
- Storage LUTS post AEEP
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 12 Mar 2026 (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.
The aim of this study is to evaluate the impact of daily tadalafil 5 mg on storage lower urinary tract symptoms (LUTS) during the early postoperative period following Anatomical endoscopic enucleation of prostate in a randomized controlled clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Daily tadalafil 5 mg user | Active comparator | Drug: Tadalafil 5mg (Male)Patients will have daily tadalafil 5 mg for 3 months post AEEP |
| Placebo | Placebo comparator | Drug: Omiga 3Omiga 3 for patient |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Must be able to swallow tablets
- Adult males undergoing elective AEEP for symptomatic benign prostatic hyperplasia (BPH) with prostate volume ≥40 ml , Moderate to severe LUTS defined by International Prostate Symptom Score (IPSS) ≥19 at baseline.
- Patient is Willing to participate and able to provide written informed consent
Key exclusion criteria (1 listed)
- Contraindications to tadalafil (e.g., nitrate use, severe hepatic/renal impairment, uncontrolled hypotension) , neurogenic bladder. , Preoperative urinary catheter dependence , post-void residual urine >350 ml. ,, Cognitive impairment precluding questionnaire completion
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 |
|---|---|---|
| Tadalafil 5mg (Male)Tadalafil 5 mg is a phosphodiesterase type 5 (PDE-5) inhibitor taken orally, commonly prescribed as a once-daily low dose therapy. It works by relaxing smooth muscle and improving blood flow in specific tissues. | Drug | Daily tadalafil 5 mg user |
| Omiga 3Giving omiga 3 for patients who are not in tadalafil group | Drug | Placebo |
Primary outcome
Proportion of patients achieving stress urine incontinence at 12 weeks post op, assessed by IPSS score
Time frame: 12 weeks
More Precise Academic Wording: * Proportion of patients: The percentage (%) of the total study population. * Stress urinary incontinence (SUI): Involuntary leakage of urine during activities that increase intra-abdominal pressure (e.g., coughing, sneezing, lifting). * 12 weeks post-operative: Three months after surgery. * Assessed by IPSS score: Evaluation based on patient responses to the International Prostate Symptom Score questionnaire. Important Methodological Note: The International Prostate Symptom Score (IPSS) is primarily designed to assess lower urinary tract symptoms (LUTS) such as: * Frequency * Urgency * Weak stream * Nocturia
1 secondary outcome
Change from baseline in IPSS storage subdomain score at 4 weeks , 8weeks , and 12 weeks. Time to micturate freely IPSS total .
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Pang KH, Ortner G, Yuan Y, Biyani CS, Tokas T. Complications and functional outcomes of endoscopic enucleation of the prostate: a systematic review and meta-analysis of randomized-controlled studies. Cent European J Urol \[Internet\]. 2022 \[cited 2026 JanLink provided by the sponsor.
- Vo LT, Armany D, Chalasani V, Bariol S V., Baskaranathan S, Hossack T, et al. Endoscopic enucleation of the prostate versus transurethral resection of the prostate for benign prostatic hyperplasia: a systematic review and meta-analysis. Prostate Cancer PLink provided by the sponsor.
- 4\. Kim TH, Song PH. Anatomical endoscopic enucleation of the prostate for bladder outlet obstruction: a narrative review. Journal of Yeungnam Medical Science \[Internet\]. 2021 Jan 1 \[cited 2026 Jan 3\];39(1):12-7.:Link provided by the sponsor.
- Ma J, Liu Z, Wu J, Zhou Z, Zhang X, Cui Y, et al. Role of application of tadalafil 5 mg once-daily (≥6 months) in men with erectile dysfunction from six randomized controlled trials. Transl Androl Urol \[Internet\]. 2020 Jun 1 \[cited 2026 Jan 3\];9(3):14054Link provided by the sponsor.
- Yang J, Jian ZY, Wang J, Zhang G. Phosphodiesterase type-5 inhibitors for erectile dysfunction following nerve-sparing radical prostatectomy: A network meta-analysis. Medicine \[Internet\]. 2021 Feb 26 \[cited 2026 Jan 3\];100(8):e23778.Link provided by the sponsor.
- Goh HJ, Sung JM, Lee KH, Jo JK, Kim KN. Efficacy of phosphodiesterase type 5 inhibitors in patients with erectile dysfunction after nerve-sparing radical prostatectomy: a systematic review and meta-analysis. Transl Androl Urol \[Internet\]. 2022 Feb 1 \[citLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tadalafil 5mg (Male) and Omiga 3 in people with BPH (Benign Prostatic Hyperplasia), run by Assiut University.
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 3 inclusion and 1 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: opening soon, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ali adel Mansour Hageb, GP (+201109049717 ext. +967781118703, Alihajeb42@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients achieving stress urine incontinence at 12 weeks post op, assessed by IPSS score (time frame: 12 weeks). 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 12 Mar 2026.