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NCT Number: NCT07841964

Suprapubic Cystostomy as an Adjunct to Monopolar Transurethral Enucleation of the Prostate

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).

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Key information

Conditions

Benign Prostate Hypertrophy(BPH) Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Prostatic Hyperplasia Urogenital Diseases

Age range

50 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of medicine Beni Suef University

Banī Suwayf, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Monopolar transurethral enucleation of the prostate without suprapubic cystostomy

Procedure

Monopolar transurethral enucleation of the prostate without suprapubic cystostomy

Monopolar transurethral enucleation of the prostate with suprapubic cystostomy

Procedure

Monopolar transurethral enucleation of the prostate with suprapubic cystostomy

Primary outcomes

  1. 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.

  2. 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

  1. International Prostate Symptom Score (IPSS)

    Time frame: 1, 6, and 12 months

    The total score ranges from 0 to 35, where higher scores indicate more severe urinary symptoms and worse clinical status.

  2. Maximum Urinary Flow Rate Assessed by Uroflowmetry (Qmax)

    Time frame: 1, 6, and 12 months

    Maximum urinary flow rate (Qmax) will be assessed using uroflowmetry and reported in milliliters per second (mL/s). Higher values indicate better urinary flow and improved urinary function.

  3. Hemoglobin Level Assessed by Laboratory Blood Analysis

    Time frame: Baseline and immediately after the intervention

    Hemoglobin level will be assessed using standard laboratory blood testing and reported in grams per deciliter (g/dL). Changes in hemoglobin levels will be used to evaluate perioperative blood loss.

  4. Serum Sodium Level Assessed by Laboratory Blood Analysis

    Time frame: Baseline and immediately after the intervention

    Serum sodium level will be assessed using standard laboratory blood testing and reported in milliequivalents per liter (mEq/L) or millimoles per liter (mmol/L). Changes in serum sodium levels will be used to assess fluid and electrolyte balance during the perioperative period.

  5. Catheterization Time Following Surgery

    Time frame: immediately after the intervention

    Catheterization time will be assessed as the duration of postoperative urinary catheter placement, measured in hours or days from catheter insertion to removal. Shorter catheterization times indicate faster postoperative recovery.

  6. Length of Hospital Stay Following Surgery

    Time frame: immediately after the intervention

    Length of hospital stay will be assessed as the total duration of hospitalization, measured in days from admission or surgery until discharge. Shorter hospital stays indicate improved postoperative recovery and healthcare efficiency.

  7. Perioperative Complications Assessed During the Perioperative Period

    Time frame: perioperatively

    Perioperative complications will be assessed by clinical evaluation and medical record review during and after surgery. Complications will be categorized according to their type and severity. Higher rates of complications indicate worse surgical safety outcomes.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Beni-Suef University

Other

Registry information

Official study title

Suprapubic Cystostomy as an Adjunct to Monopolar Transurethral Enucleation of the Prostate for Large Benign Prostatic Hyperplasia: A Randomized Controlled Trial

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Sep 25, 2026
Registry last updated
Sep 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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