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Bipolar Versus Laser Enaculation of Prostate for >80gram Prostate .

Bipolar Versus Laser Enaculation of Prostate for >80gram Prostate .

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05784181
Enrollment
40
Registered
2023-03-24
Start date
2021-10-01
Completion date
2024-12-01
Last updated
2024-01-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar TURP , Laser Enucleation in Management of Enlarged Prostate

Brief summary

Transurethral resection of the prostate (TURP ) still the gold standerad for surgical management of enlarged prostate .However , many minimally invasive procedures are now in the comparative track with Bipolar resection as Laser enaculation. Holmium laser prostatectomy was introduced since 1994 . different types of uses by laser were introduced either resection or enaculation with good outcomes and less complications . One of the most important issues related to large prostate management is the retreatment after Bipolar resection , another issue that prolonged catheter time post resection .

Detailed description

Transurethral resection of the prostate (TURP ) still the gold standerad for surgical management of enlarged prostate .However , many minimally invasive procedures are now in the comparative track with Bipolar resection as Laser enaculation. Holmium laser prostatectomy was introduced since 1994 . different types of uses by laser were introduced either resection or enaculation with good outcomes and less complications . One of the most important issues related to large prostate management is the retreatment after Bipolar resection , another issue that prolonged catheter time post resection , so , we try to analyze the effect of Laser enaculation of the prostate in comparison to Bipolar resection in prostate more than 80 gm . Aim of the work: Aim of the work is to compare the efficacy of Bipolar versus Laser enaculation of prostate for \>80gram. Patients and Methods: A randomized comparative study will be conducted at Menoufia university hospital , urology department. patients will be selected after informed consent. Inclusion criteria: similar for all patients prostatic volume more than 80 gm , peak urinary flow rate measurement (Qmax) \<15 ml/s, International Prostate Symptom Score (IPSS) of \>8 , postvoid residual (PVR) \<400 ml. Exclusion criteria: Patients with prostate size less than 80gm , urethral stricture, acute urinary tract infection, repeated treatment . Preoperatively, all the patients will undergo thorough process of history taking , clinical examination, and investigations in the form of abdominopelvic and trans rectal ultrasonography , PSA ,urine analysis, urine culture if needed and routine pre-operative lab investigations as (CBC , PT, LFTs, serum creatinine and RBS). The treatment modality chosen for an individual will be randomized . All patients with positive urine culture will be treated by proper antibiotics before the procedures. Peri-operatively , all patients will receive a single shot of pre-operative antibiotic. For the first group patients transurethral resection of prostate For the second group patients Laser enaculation by holmium: YAG laser Postoperatively, patients will undergo IPSS score , flowmetry post operative after 3months .

Interventions

DEVICEbipolar transurethral resection and Laser enaculation by holmium: YAG laser

Laser enaculation by holmium: YAG laser

Sponsors

Menoufia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
40 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

\- similar for all patients prostatic volume more than 80 gm , peak urinary flow rate measurement (Qmax) \<15 ml/s, International Prostate Symptom Score (IPSS) of \>8 , postvoid residual (PVR) \<400 ml

Exclusion criteria

* Patients with prostate size less than 80gm , urethral stricture, acute urinary tract infection, repeated treatment .

Design outcomes

Primary

MeasureTime frameDescription
compare the efficacy of Bipolar versus Laser enaculation of prostate for >80gram.1 yearcompare the efficacy of Bipolar versus Laser enaculation of prostate for \>80gram.

Countries

Egypt

Contacts

Primary Contactmohamed kamal omar, MD
kimo_81eg@yahoo.com00201066949454
Backup Contacthossam elsaid kandeel, master
hossamkandeel016@gmail.com00201097991198

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026