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CompletedNCT07841964Updated Sep 25, 2026

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

An interventional study of Monopolar transurethral enucleation of the prostate without suprapubic cystostomy and Monopolar transurethral enucleation of the prostate with suprapubic cystostomy in Benign Prostate Hypertrophy(BPH), sponsored by Beni-Suef University. Completed at 1 site in Egypt. Open to male participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-09-25.

Sponsored by Beni-Suef University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years 8 months after the study started (first participant enrolled Sep 2022, registered May 2026).
Updated Sep 25, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
160
Allocation
Randomized
Ages
50 Years and older
Sex
Male
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 11 studies in Prostatic Hyperplasia by Beni-Suef University — 5 open to participants now, 5 under way, none of them phase 3. Prostatic Hyperplasia · Beni-Suef University.

Enrollment
4th of 11
160 · median 120
Started
2022
the only one that year
No phase
6 of 11
3 open now
Registered
5th of 11
by date

Among the 11 studies in Prostatic Hyperplasia by Beni-Suef University, this one is the 4th largest by enrollment, is the only one that started in 2022, is one of 6 with no phase, and was the 5th registered.

Prostatic Hyperplasia

828 studies on the registry are indexed under Prostatic Hyperplasia; 179 are open to participants now.

Browse Prostatic Hyperplasia studies →

Open to participants now

5 of the 11 studies in Prostatic Hyperplasia by Beni-Suef University are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 5 open studies →

Where they have run

Who these studies take

Of the 102 Prostatic Hyperplasia studies recruiting now, 70 (69%) set no upper age limit and 4 (4%) stop at 75 or younger; 7 take children under 18; 7 take healthy volunteers.

This study: 50 Years and older · male · no healthy volunteers.

The full table on the hub →

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02

Study 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).

03

Conditions studied

  • Benign Prostate Hypertrophy(BPH)

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04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
160 participants (actual)

Study arms

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

    Procedure: Monopolar transurethral enucleation of the prostate without suprapubic cystostomy

  • Active comparator
    Group B: M-TUEP with concomitant SPC

    Procedure: Monopolar transurethral enucleation of the prostate with suprapubic cystostomy

Interventions

  • ProcedureMonopolar transurethral enucleation of the prostate without suprapubic cystostomy

    Monopolar transurethral enucleation of the prostate without suprapubic cystostomy

  • ProcedureMonopolar transurethral enucleation of the prostate with suprapubic cystostomy

    Monopolar transurethral enucleation of the prostate with suprapubic cystostomy

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Intraoperative

  2. 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.

    Time frame: Intraoperative

Secondary outcomes

  1. International Prostate Symptom Score (IPSS)

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

    Time frame: 1, 6, and 12 months

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

    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.

    Time frame: 1, 6, and 12 months

  3. Hemoglobin Level Assessed by Laboratory Blood Analysis

    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.

    Time frame: Baseline and immediately after the intervention

  4. Serum Sodium Level Assessed by Laboratory Blood Analysis

    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.

    Time frame: Baseline and immediately after the intervention

  5. Catheterization Time Following Surgery

    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.

    Time frame: immediately after the intervention

  6. Length of Hospital Stay Following Surgery

    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.

    Time frame: immediately after the intervention

  7. Perioperative Complications Assessed During the Perioperative Period

    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.

    Time frame: perioperatively

07

Study locations

1 site
  • Faculty of medicine Beni Suef University
    Banī Suwayf, Egypt
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Undecided

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2022 to primary completion in Oct 2023, 13 months.

Of 153 non-industry interventional studies with no phase under Prostatic Hyperplasia, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 48. This study's 13 months is below that.

Counting every sponsor, half of 205 studies reached it within 26 months; a quarter within 15 and three quarters within 48.

How these figures are worked out, and which studies are left out of them.

Registered
May 15, 2026
First posted
Sep 25, 2026
StartActual
Sep 1, 2022
Primary completionActual
Oct 1, 2023
CompletionActual
Jan 1, 2024
Last update
Sep 25, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Sep 25, 2026
Show all 1 update
  1. Sep 25, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07841964
Responsible party
Ahmed Gamal (Associate professor, Beni-Suef University) — Principal investigator
First posted
Sep 25, 2026
Start date
Sep 1, 2022
Primary completion
Oct 1, 2023
Completion
Jan 1, 2024
Last update
Sep 25, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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