Suprapubic Cystostomy as an Adjunct to Monopolar Transurethral Enucleation of the Prostate for Large Benign Prostatic Hyperplasia: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Beni-Suef University
- Enrollment
- 160
- Locations
- 1
- Primary Endpoint
- Operative time
Study Overview
Brief Summary
SPC use has previously been evaluated in monopolar transurethral enucleation and resection of the prostate (M-TUERP) compared with bipolar TURP [10]. However, to our knowledge, this is the first randomized controlled trial to compare outcomes of M-TUEP performed with versus without SPC in balanced patient groups. This study evaluates the safety and efficacy of M-TUEP with and without SPC in 160 patients with large prostatic adenomas.
To evaluate whether suprapubic cystostomy (SPC) improves the safety and operative efficiency of monopolar transurethral enucleation of the prostate (M-TUEP) in patients with large benign prostatic hyperplasia (BPH).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •age ≥50 years
- •prostate volume ≥80 cc assessed by transrectal ultrasonography
- •moderate-to-severe lower urinary tract symptoms (International Prostate Symptom Score; IPSS ≥8)
- •failure or intolerance of medical therapy.
Exclusion Criteria
- •suspected or confirmed prostate cancer
- •prior prostate surgery
- •neurogenic bladder dysfunction
- •urethral stricture disease
- •active urinary tract infection
- •bladder stones requiring open surgery
- •uncorrected coagulopathy.
Arms & Interventions
Group A: Monopolar transurethral enucleation of the prostate (M-TUEP) without suprapubic cystostom
Intervention: Monopolar transurethral enucleation of the prostate without suprapubic cystostomy (Procedure)
Group B: M-TUEP with concomitant SPC
Intervention: Monopolar transurethral enucleation of the prostate with suprapubic cystostomy (Procedure)
Outcomes
Primary Outcomes
Operative time
Time Frame: Intraoperative
Operative time will be assessed as the total duration of the surgical procedure, measured in minutes from the start of resection to completion of surgery. Shorter operative times indicate greater procedural efficiency.
Resection Efficiency Calculated From Resected Tissue Weight and Operative Time
Time Frame: Intraoperative
Resection efficiency will be assessed by dividing the weight of resected prostatic tissue (grams) by operative time (minutes), expressed as grams per minute (g/min). Higher values indicate greater surgical resection efficiency.
Secondary Outcomes
- International Prostate Symptom Score (IPSS)(1, 6, and 12 months)
- Maximum Urinary Flow Rate Assessed by Uroflowmetry (Qmax)(1, 6, and 12 months)
- Hemoglobin Level Assessed by Laboratory Blood Analysis(Baseline and immediately after the intervention)
- Serum Sodium Level Assessed by Laboratory Blood Analysis(Baseline and immediately after the intervention)
- Catheterization Time Following Surgery(immediately after the intervention)
- Length of Hospital Stay Following Surgery(immediately after the intervention)
- Perioperative Complications Assessed During the Perioperative Period(perioperatively)
Investigators
Ahmed Gamal
Associate professor
Beni-Suef University