Benign Prostate Hypertrophy(BPH)NCT07841964
Suprapubic Cystostomy as an Adjunct to Monopolar Transurethral Enucleation of the Prostate
A study testing Monopolar transurethral enucleation of the prostate without suprapubic cystostomy and Monopolar transurethral enucleation of the prostate with suprapubic cystostomy in people with Benign Prostate Hypertrophy(BPH), run by Beni-Suef University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Benign Prostate Hypertrophy(BPH)
- What is being tested?
- Monopolar transurethral enucleation of the prostate without suprapubic cystostomy and Monopolar transurethral enucleation of the prostate with suprapubic cystostomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2022to 1 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Suprapubic Cystostomy as an Adjunct to Monopolar Transurethral Enucleation of the Prostate for Large Benign Prostatic Hyperplasia: A Randomized Controlled Trial
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).
- Conditions
- Benign Prostate Hypertrophy(BPH)
- Being tested
- Monopolar transurethral enucleation of the prostate without suprapubic cystostomy, Monopolar transurethral enucleation of the prostate with suprapubic cystostomy
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monopolar transurethral enucleation of the prostate without suprapubic cystostomyProcedure or surgery
Monopolar transurethral enucleation of the prostate without suprapubic cystostomy
Monopolar transurethral enucleation of the prostate with suprapubic cystostomyProcedure or surgery
Monopolar transurethral enucleation of the prostate with suprapubic cystostomy
| Study group | Role | What they receive |
|---|---|---|
| Group A: Monopolar transurethral enucleation of the prostate (M-TUEP) without suprapubic cystostom | Active comparator | Not described Receives: Procedure: Monopolar transurethral enucleation of the prostate without suprapubic cystostomy |
| Group B: M-TUEP with concomitant SPC | Active comparator | Not described Receives: Procedure: Monopolar transurethral enucleation of the prostate with suprapubic cystostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Intraoperative
Secondary outcomes (7)
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.
Measured: 1, 6, and 12 months
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.
Measured: 1, 6, and 12 months
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.
Measured: Baseline and immediately after the intervention
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.
Measured: Baseline and immediately after the intervention
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.
Measured: immediately after the intervention
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.
Measured: immediately after the intervention
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.
Measured: perioperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start1 Sep 2022
- Primary completion1 Oct 2023
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostate Hypertrophy(BPH)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Gamal, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07841964
- Sponsor's protocol ID
- FMBSUREC/08052022/Mohamed
- Status last verified
- Sep 2026
- First submitted
- 15 May 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suprapubic Cystostomy as an Adjunct to Monopolar Transurethral Enucleation of the Prostate for Large Benign Prostatic Hyperplasia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07841964
- Acronym / sponsor ID
- FMBSUREC/08052022/Mohamed
- Conditions
- Benign Prostate Hypertrophy(BPH)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 25 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- suspected or confirmed prostate cancer
- prior prostate surgery
- neurogenic bladder dysfunction
- urethral stricture disease
- active urinary tract infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Monopolar transurethral enucleation of the prostate without suprapubic cystostomyMonopolar transurethral enucleation of the prostate without suprapubic cystostomy | Procedure or surgery | Group A: Monopolar transurethral enucleation of the prostate (M-TUEP) without suprapubic cystostom |
| Monopolar transurethral enucleation of the prostate with suprapubic cystostomyMonopolar transurethral enucleation of the prostate with suprapubic cystostomy | Procedure or surgery | Group B: M-TUEP with concomitant SPC |
Primary outcome
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.
7 secondary outcomes
International Prostate Symptom Score (IPSS)
Time frame: 1, 6, and 12 months
Maximum Urinary Flow Rate Assessed by Uroflowmetry (Qmax)
Time frame: 1, 6, and 12 months
Hemoglobin Level Assessed by Laboratory Blood Analysis
Time frame: Baseline and immediately after the intervention
Serum Sodium Level Assessed by Laboratory Blood Analysis
Time frame: Baseline and immediately after the intervention
Catheterization Time Following Surgery
Time frame: immediately after the intervention
Length of Hospital Stay Following Surgery
Time frame: immediately after the intervention
Perioperative Complications Assessed During the Perioperative Period
Time frame: perioperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Monopolar transurethral enucleation of the prostate without suprapubic cystostomy and Monopolar transurethral enucleation of the prostate with suprapubic cystostomy in people with Benign Prostate Hypertrophy(BPH), run by Beni-Suef University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operative time (time frame: Intraoperative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.