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NCT04275076: enucleation
HoLEP Vs BPEP for Large Prostatic Adenoma
Phase 3 trial testing Holmium laser enucleation of the prostate versus bipolar transurethral enucleation of the prostate in management of benign prostatic hyperplasia in Prostate Hyperplasia in 100 participants. Completed in 1 February 2020.
1 February 2020
Quick facts
| Lead sponsor | Ahmed Maher Gamil Ahmed Higazy |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 100 |
| Start date | 1 February 2018 |
| Primary completion | 1 February 2020 |
| Estimated completion | 1 February 2020 |
| Sites | 1 location across Egypt |
Drugs / interventions tested
- Holmium laser enucleation of the prostate versus bipolar transurethral enucleation of the prostate in management of benign prostatic hyperplasia
Conditions studied
- Prostate Hyperplasia — all drugs for Prostate Hyperplasia →
Sponsor
Ahmed Maher Gamil Ahmed Higazy
Who can join
Eligibility, male only, with Prostate Hyperplasia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Benign prostatic hyperplasia (BPH) is one of the most common urinary disorders in elderly males. The symptoms of BPH include impaired physiological and functional well-being, which interferes with daily living. At present, transurethral resection of the prostate (TURP) is the standard surgical treatment. However, the high rate of complications associated with TURP is a major drawback of this procedure. Holmium laser enucleation of the prostate (HoLEP) was proven to be an effective surgical treatment for BPH with no prostate size limitation with adequate hemostasis, bipolar enucleation of the prostate (BPEP) has been introduced as an alternative energy source with a promising outcome with equal safety and efficacy
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04275076
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Prostate Hyperplasia
Currently open trials in the same condition.
- NCT06865430 — Management of Dysuria and Irritative Symptoms After HoLEP: a Prospective Study Evaluating the Efficacy of Alpha-Blocker · NA · recruiting
- NCT06834152 — Online Adaptive Stereotactic Body Radiotherapy for Localized Prostate Cancer (X-SMILE) · recruiting
- NCT06224218 — Prostate Single Port & Laser Enucleation Comparison Trial · NA · recruiting
- NCT05443451 — BETTY: BEnign Prostatic Hyperplasia Transperineal Targeted Microwave therapY · NA · recruiting
- NCT06116851 — Prostate Metabolism, Cancer Risk and Gut Microbiota · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04275076 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Ahmed Maher Gamil Ahmed Higazy
- Last refreshed: 16 June 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04275076.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing