Benign Prostatic Hyperplasia (BPH) Requiring Surgical Resection, Benign Prostatic Hyperplasia With Outflow Obstruction, Benign Prostatic Hyperplasia With Symptomatic Lower Urinary Tract Symptoms, Benign Prostatic Hyperplasia With Lower Urinary Tract Symptoms
Conditions
Keywords
TURP, TUEP, BPH
Brief summary
The aim of this study is to evaluate efficacy and safety of transurethral resection of the prostate and bipolar enucleation of the prostate.
Detailed 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.
Interventions
PROCEDURETURP
Using bipolar loop diathermy via cystoscopy, excess prostate tissue is resected piecemeal to remove obstruction to the prostatic urethra due to BPH.
PROCEDURETUEP
Using bipolar enucleation loop diathermy via cystoscopy, to anatomically enucleate prostate.
Sponsors
South Valley University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
A comparison between TURP and Bipolar enucleation of prostate allows us to investigate the true benefits and safety of each modality.
Eligibility
Sex/Gender
MALE
Age
50 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Catheter and lower urinary tract symptoms free after Bipolar Transurethral resection of prostate (TURP) versus Bipolar Transurethral enucleation of prostate (TUEP) in patient with BPH with lower urinary tract symptoms | at least 6 months up to one year | To determine number of patients in each group that will be Catheter and lower urinary tract symptoms free with changes in IPPS \< 20 score after intervention and follow up at 1 month, 3 months and 6 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Compare complication rate of TURP versus TUEP | at least 6 months up to one year | To determine the percentage and severity of complications after each intervention (according to the Clavien-Dindo classification). * Minimum score is class I: No intervention needed * Maximum score is class V: Death of a patient |
| Cost effectiveness of TURP versus TUEP in achieving catheter-free rates in BPH patients with urinary retention | at least 6 months up to one year | To determine the cost required to achieve catheter free patients for each intervention (including hospitalization, anesthetic costs, equipment, consumables, etc) |
| Compare patient reported symptom measures by IPSS questionnaire after TURP versus TUEP | at least 6 months up to one year | sing International prostate symptom score (IPSS) questionnaire to determine patient reported symptom measure after each intervention minimal score: 0, maximum score is 35 higher score means worse outcome |
| Operative time in minutes in each group of intervention | 60 - 90 minutes for each group of intervention | To determine operative time in minutes in each group of intervention |
| Compare patient reported symptom measures by IIEF-5 questionnaire after TURP versus TUEP | at least 6 months up to one year | Using the International index of erectile function- 5 items (IIEF-5) questionnaire to determine patient reported symptom measure after each intervention minimum score: 1, maximum score: 25 higher score means better outcome |
| Compare patient reported quality of life by SF-12 questionnaire after TURP versus TUEP | at least 6 months up to one year | sing the Short Form 12 (SF-12) questionnaire to determine patient reported quality of life measures after each intervention minimum score: 0, maximum score: 100 higher score means better outcome |
| Compare patient reported symptom measures by Michigan Incontinence Symptom Index (M-ISI) questionnaire after TURP versus TUEP | at least 6 months up to one year | Using the Michigan Incontinence Symptom Index (M-ISI) questionnaire to determine patient reported symptom measure after each intervention * Minimum score: 1 * Maximum score: 12 * The higher the score means worse outcome |
Countries
Egypt
Contacts
Primary ContactAHMED A.FATAH HAMED, Master's
Backup ContactMostafa A.Razik Ahmed, Doctorate
Outcome results
None listed