Clinical trial NCT05784181: Bipolar Versus Laser Enaculation of Prostate for >80gram Prostate .
Official title: Bipolar Versus Laser Enaculation of Prostate for >80gram Prostate .
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bipolar TURP , Laser Enucleation in Management of Enlarged Prostate
Lead sponsor: Menoufia University
Sponsor class: OTHER
First posted: 2023-03-24
Enrollment: 40
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 .

Eligibility criteria: 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 .

Primary outcomes:
measure: compare the efficacy of Bipolar versus Laser enaculation of prostate for >80gram.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Shibīn Al Kawm
country: Egypt
facility: Faculty of Medicine
state: Menoufia -
Study officials:
References: