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TURP SyndromeNCT06944743

TURP Inpatient With Underactive Bladder With BOO

A study testing Transurtheral Resection of prostate ( TURP) in people with TURP Syndrome and Retention, Urinary, run by Sohag University at 1 site in Egypt.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The study is for aproved that Transurtheral Resection of prostate is good for patient with underactive bladder or not. Read more about this study

Who is it for?
Ages 40 to 70 years, men only
What is being tested?
Transurtheral Resection of prostate ( TURP)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteEgypt
Study dates
1 Apr 2025to 1 Apr 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 40 to 70 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male patients diagnosed with BOO and UAB
  • Age ≥ 40 years.

Who cannot join

  • Patient insulin dependent diabetes
  • Patient with history of cerbrovascular stroke or hemarrage.
  • History of prior prostate surgery.
  • Urethral pathology or surgery.
  • Patient with prostate or bladder cancer.
  • Spinal and pelvic trauma or surgery.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Egypt1 site, 1 recruiting
  • Emad Abdellah Ali Mostafa

    Sohag, 093

    Emad Mostafa, MD, 01092590078, emad_mostafa@med.sohag.edu.eg

    Emad Mostafa, 01092590077, emad_mostafa@med.sohag.edu.eg

    Recruiting

Other trials in Egypt

About this study

Official title: Predictors of Improvement Afetr Trasurtheral Resection of Prostate in Patients With Underactive Bladder and Bladder Outlet Obstruction

The study is for aproved that Transurtheral Resection of prostate is good for patient with underactive bladder or not.

Read the detailed description

Introduction:

Aging men frequently develop lower urinary tract symptoms (LUTS). These symptoms are commonly attributed to bladder outlet obstruction by benign prostatic hyperplasia (BPH) and the clinical condition is termed BPH. However, recent studies have implicated many factors in the pathogenesis of LUTS in addition to BPH. These include prostate inflammation and fibrosis, increased serum estrogen/testosterone ratio, diabetes, the metabolic syndrome, sleep apnea, polyuria and changes in bladder function .

Transurethral resection of prostate (TURP) is a time-tested gold standard surgical option for dealing with LUTS in men having benign prostatic enlargement (BPE) . Persistence of LUTS is reported in 5%-35% of patients undergoing TURP .

Detrusor Under activity (DUA) is defined by the International Continence Society (ICS) as "a contraction of reduced strength and/or duration, resulting in prolonged bladder emptying and/or failure to achieve complete bladder emptying within a normal time span" . Detrusor underactivity was demonstrated in 17% men presenting with LUTS after urodynamic evaluation .

Male DUA definition remains controversial and no effective treatment is consolidated. The role of prostatic surgery in male DUA is not clear. The primary endpoint was the clinical and voiding improvement based on International Prostate Symptom Score (IPSS) and the maximum flow rate in uroflowmetry (Qmax) within 12 months.

DUA is a common association for persistence of symptoms after TURP in such patients .

Projected isovolumetric pressure (PIP) was proposed by Schäfer, who used a straight line to represent the Bladder Outlet Relation (BOR) and then "projected" back to the y-axis (pdet) from the point representing pdet@Qmax to obtain the isovolumetric pressure. This projection is calculated by the formula PIP = Pdet@Qmax + KQmax where K is a fixed constant representing the steepness of the angle of the BOR to x-a axis .

K is dependent on the specific population studied and differs between men and women .In men it is usually taken as 5. The suggested groupings for PIP are as follows:

  • >150 - strong contractility
  • 100 to 150 - normal contractility
  • 50 to 100 - weak contractility
  • <50 - very weak contractility Surgical failure is more likely to occur in patients with detrusor dysfunction and lower baseline Bladder outlet obstruction index (BOOI ). It has also been found that the degree of preoperative BOO is positively associated with improvement and QoL after TURP . Therefore, a preoperative Pressure Flow Study (PFS) is recommended for optimal selection of patients who are more suitable for surgery by measuring BOOI and assessing detrusor function. BOOI (PdetQmax-2Qmax) .

Conflicting results create dilemma about the efficacy and results of TURP in patients with BPE and bladder underactivity . In this study, Investigators evaluate the Predictors of Improvement after Transurethral Resection of Prostate in Patients with Underactive Bladder and Bladder outlet obstruction.

Aim of the work:

To pick up the predictors of improvement after Transurethral Resection of Prostate in Patients with Underactive Bladder and Bladder outlet obstruction.

Pre-Operative Predictors:

  1. Age.
  2. Body mass index.
  3. pre-operative urinary flow rate.
  4. International Prostate Symptom Score (IPSS).
  5. Urodynamic parameters (BCI, BOOI, PVR and bladder capacity……...etc.).
  6. Prostate size.
  7. Degree of vesicoureteral reflux (if present).
  8. Functional Bladder Capacity.

Intra-Operative Predictors:

  1. Surgical technique.
  2. Prostatic Resected weight.
  3. Intra-operative complications.
  4. Prostate type (Bilobular,trilobular,adenomatous or fibrous).
  5. TURP syndrome.

Post-Operative Predictors:

  1. Catheterization duration.
  2. post-operative urinary retention.
  3. Complications: (e.g., infections, stricture).
  4. Early post-operative voiding trials.
  5. Measure degree of vesicoureteral reflux after TURP.
  6. Functional bladder Capacity after TURP.

Urodynamic Predictors:

  1. Detrusor contractility.
  2. Bladder outlet obstruction.
  3. Functional bladder capacity.
  4. UAB severity: Mild/moderate (UAB symptoms).
  5. Maximum urinary flow rate.
  6. Compliance of bladder.

Other Predictors:

  1. Patient expectations: Realistic expectations and mental health influence.
  2. Co-morbidities.
  3. pre-operative physical therapy.
  4. Smoking cessation.

Surgical Technique:

Perioperative antibiotic coverage for surgery should be carefully considered especially for patient who has an indwelling catheter (urethral or suprapubic).

TURP is performed using spinal anesthesia. TURP involves an endoscopic approach via the patient's urethra to surgically remove the inner portion of the prostate that encircles the urethra. A bipolar electrified wire loop is used to remove the portion of the prostate between the bladder neck and the verumontanum to a depth of the surgical capsule. Before the resection is begun, the bladder should be inspected for any bladder pathology (e.g., tumor, diverticula or stones).

The bladder neck, trigone, and position of the ureteral orifices, verumontanum, and external sphincter should be noted. Three-way Foley catheter is usually placed to and traction for a short time, release of traction based on clearance of hematuria.

In the absence of significant capsular perforation or persistent bleeding, the catheter can be removed after 24 to 48 hours.

.

Being tested
Transurtheral Resection of prostate ( TURP)
Medical subject headings
Urinary Retention, Prostatic Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transurtheral Resection of prostate ( TURP)Procedure or surgery

    TURP involves an endoscopic approach via the patient's urethra to surgically remove the inner portion of the prostate that encircles the urethra. A bipolar electrified wire loop is used to remove the portion of the prostate between the bladder neck and the verumontanum to a depth of the surgical capsule. Before the resection is begun, the bladder should be inspected for any bladder pathology (e.g., tumor, diverticula or stones).

    The bladder neck, trigone, and position of the ureteral orifices, verumontanum, and external sphincter should be noted. Three-way Foley catheter is usually placed to and traction for a short time, release of traction based on clearance of hematuria.

Study groups in NCT06944743
Study groupRoleWhat they receive
Transurtheral Resection of prostate in underactive bladder with bladder outlet obstructionOtherTURP involves an endoscopic approach via the patient's urethra to surgically remove the inner portion of the prostate that encircles the urethra. A bipolar electrified wire loop is used to remove the portion of the prostate between the bladder neck and the verumontanum to a depth of the surgical capsule. Before the resection is begun, the bladder should be inspected for any bladder pathology (e.g., tumor, diverticula or stones). The bladder neck, trigone, and position of the ureteral orifices, verumontanum, and external sphincter should be noted. Three-way Foley catheter is usually placed to and traction for a short time, release of traction based on clearance of hematuria.
Receives: Procedure: Transurtheral Resection of prostate ( TURP)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in international prostate symptome score (IPSS) score.

    Outcome measure Detrusar pressure at maximum flow (Pdet-Qmax unit:CmH2O)

    Measured: 3 month .

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2025
  2. Study start1 Apr 2025
  3. Primary completion1 Apr 2026 (estimated)
  4. Study completion1 Apr 2026 (estimated)

Resources

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
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06944743
Sponsor's protocol ID
Soh-Med-25-3__IMD
Status last verified
Apr 2025
First submitted
23 Mar 2025
Last updated
25 Apr 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Transurtheral Resection of prostate ( TURP) in people with TURP Syndrome and Retention, Urinary, run by Sohag 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 2 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 25 Apr 2025. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Emad Mostafa, MD (01092590078, emad_mostafa@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in international prostate symptome score (IPSS) score. (time frame: 3 month .). 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 Apr 2025.

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