NCT07841964

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

May 15, 2026

Completed
4 months until next milestone

First Posted

Study publicly available on registry

September 25, 2026

Completed
Last Updated

September 25, 2026

Status Verified

September 1, 2026

Enrollment Period

1.1 years

First QC Date

May 15, 2026

Last Update Submit

September 20, 2026

Conditions

Benign Prostate Hypertrophy(BPH)

Outcome Measures

Primary Outcomes (2)

  • Operative time

    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.

    Intraoperative

  • Resection Efficiency Calculated From Resected Tissue Weight and Operative Time

    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.

    Intraoperative

Secondary Outcomes (7)

  • 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

  • +2 more secondary outcomes

Study Arms (2)

Group A: Monopolar transurethral enucleation of the prostate (M-TUEP) without suprapubic cystostom

ACTIVE COMPARATOR
Procedure: Monopolar transurethral enucleation of the prostate without suprapubic cystostomy

Group B: M-TUEP with concomitant SPC

ACTIVE COMPARATOR
Procedure: Monopolar transurethral enucleation of the prostate with suprapubic cystostomy

Interventions

Monopolar transurethral enucleation of the prostate without suprapubic cystostomyPROCEDURE

Monopolar transurethral enucleation of the prostate without suprapubic cystostomy

Group A: Monopolar transurethral enucleation of the prostate (M-TUEP) without suprapubic cystostom
Monopolar transurethral enucleation of the prostate with suprapubic cystostomyPROCEDURE

Monopolar transurethral enucleation of the prostate with suprapubic cystostomy

Group B: M-TUEP with concomitant SPC

Eligibility Criteria

Age50 Years+
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of medicine Beni Suef University

Banī Suwayf, Egypt

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Cystostomy

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

OstomySurgical Procedures, OperativeUrinary DiversionUrologic Surgical ProceduresUrogenital Surgical Procedures

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

May 15, 2026

First Posted

September 25, 2026

Study Start

September 1, 2022

Primary Completion

October 1, 2023

Study Completion

January 1, 2024

Last Updated

September 25, 2026

Record last verified: 2026-09

Locations

EG(1)