Bipolar Resection vs Enucleation of Prostate (TURP vs BiTUEP)

South Valley University

Status: Enrolling

Conditions: Benign Prostatic Hyperplasia With Outflow Obstruction; Benign Prostatic Hyperplasia With Symptomatic Lower Urinary Tract Symptoms; Benign Prostatic Hyperplasia With Lower Urinary Tract Symptoms; Benign Prostatic Hyperplasia (BPH) Requiring Surgical Resection

Treatments: Procedure: TURP; Procedure: TUEP

Study type: Interventional

Funder types: Other

Identifiers

NCT06983444

Endoscopic surgery prostate

Details and patient eligibility

About

The aim of this study is to evaluate efficacy and safety of transurethral resection of the prostate and bipolar enucleation of the prostate.

Full description

Endoscopic management of benign prostatic hyperplasia (BPH), monopolar transurethral resection of the prostate (TURP) has been the gold standard for many years.

Despite its promising efficacy in treating BPH, TURP is associated with a risk of significant complications and clinical limitations, including life-threatening events such as transurethral resection (TUR) syndrome, as well as high cost due to long hospital stay, long catheterization time and difficulty in management of large sized prostate so alternative surgical approaches have been explored.

Minimally invasive approaches achieve equal efficiency to standard resection, but with a more favorable safety and less complications.

Anatomical enucleation of the prostate using Bipolar or Laser-based approaches such as holmium laser have been introduced with success and the efficacy and safety of these procedure has led to the integration into several international guidelines.

Early results of bipolar enucleation resemble those reported for holmium laser procedure, Bipolar transurethral enucleation of the prostate was at least equally effective, and showed less complications, good hemostatic control and both shorter catheterization time and hospital stay than old standard procedure.

A comparison between TURP and Bipolar enucleation of prostate allows us to investigate the true benefits and safety of each modality.

Enrollment: 100 estimated patients

Sex: Male

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients with lower urinary tract symptoms (LUTS) due to BPH.
2. Patients with international prostate score system (IPSS) more than 8.
3. Patients with maximal urinary flow rate (Qmax) less than 10ml/second.
4. Patients with Prostatic volume (60 - 100 gm).
5. Patient with indication for surgical intervention.
6. Patient age (50-80 years old)

Exclusion criteria

1. Prostatic cancer.
2. Bladder cancer.
3. Urethral stricture.
4. Neurogenic bladder.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

100 participants in 2 patient groups

Transurethral resection of prostate

Active Comparator group

Description:

Transurethral resection of prostate (TURP) will be performed under spinal or general anesthesia as per usual care.

Treatment:

Procedure: TURP

Transuretheral enucleation of prostate

Active Comparator group

Description:

Transurethral enucleation of prostate (TUEP) will be performed under spinal or general anesthesia as per usual care.

Treatment:

Procedure: TUEP