Comparison of Pasmakinetic Enucleation of the Prostate With Bipolar Transurethral Resection of the Prostate for the Treatment of Benign Prostatic Hypertrophy Patients With Large Prostate
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Fuzhou General Hospital
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- time of catheterization
Study Overview
Brief Summary
The goal of this study is to compare the perioperative and postoperative characters of plasmakinetic enucleation of the prostate(PkEP) with bipolar TURP(B-TURP) for BPH patients with large prostate.
Detailed Description
Despite the availability of numerous minimally invasive alternatives, monopolar transurethral resection of the prostate (TURP) remains the most frequently performed operation for benign prostatic hypertrophy (BPH) with small to moderate size prostates. Nevertheless, TURP for large prostates is associated with various complications and unsatisfactory long-term results. B-TURP and PkEP have both been proved to have more favorable postoperative outcomes than monopolar TURP. But whether B-TURP or PkEP is better remain controversial. We aim to compare the perioperative and postoperative characters of PkEP with B-TURP for BPH patients with large prostate. Moreover, we evaluate the long-term results of both approaches.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to 70 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Qmax < 10 mL/s, IPSS >19
- •Age between 50 and 70 years
- •Prostate volume between 70 and 200 mL, as determined by TRUS, and medical therapy failure.
Exclusion Criteria
- •Patients with neurogenic bladder
- •Urethral stricture
- •Bladder tumor
- •Prostate cancer and previous prostate bladder neck
- •Urethral surgery
- •PSA>4ng/ml, or receiving prostate biopsy within 3 months
Outcomes
Primary Outcomes
time of catheterization
At the end of both procedures, a 22F three-way Folley catheter was inserted and continuous bladder irrigation was performed. Irrigation was discontinued when the catheter drainage became clear, and the catheter was removed 6 h later.Two experienced urologists who were unaware of the surgical modality used decided bladder irrigation and catheter removal for all cases.
Secondary Outcomes
- changes in serum haemoglobin as a measure of one of the complications
- Operation time
- resected adenoma weight as a measure of treatment efficacy
- postoperative International Prostate Symptom Score as a measure of treatment efficacy and durability(5 years)
- postoperative Qmax as a masure of treatment efficacy and durability(5 years)
- re-operation rate as a measure of durability(5 years)