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.
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
- Conditions the study is for
- TURP Syndrome, Retention, Urinary, Prostate Disease
- What is being tested?
- Transurtheral Resection of prostate ( TURP)
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- 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
- 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
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:
- Age.
- Body mass index.
- pre-operative urinary flow rate.
- International Prostate Symptom Score (IPSS).
- Urodynamic parameters (BCI, BOOI, PVR and bladder capacity……...etc.).
- Prostate size.
- Degree of vesicoureteral reflux (if present).
- Functional Bladder Capacity.
Intra-Operative Predictors:
- Surgical technique.
- Prostatic Resected weight.
- Intra-operative complications.
- Prostate type (Bilobular,trilobular,adenomatous or fibrous).
- TURP syndrome.
Post-Operative Predictors:
- Catheterization duration.
- post-operative urinary retention.
- Complications: (e.g., infections, stricture).
- Early post-operative voiding trials.
- Measure degree of vesicoureteral reflux after TURP.
- Functional bladder Capacity after TURP.
Urodynamic Predictors:
- Detrusor contractility.
- Bladder outlet obstruction.
- Functional bladder capacity.
- UAB severity: Mild/moderate (UAB symptoms).
- Maximum urinary flow rate.
- Compliance of bladder.
Other Predictors:
- Patient expectations: Realistic expectations and mental health influence.
- Co-morbidities.
- pre-operative physical therapy.
- 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.
.
- Conditions
- TURP Syndrome, Retention, Urinary, Prostate Disease
- 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 group | Role | What they receive |
|---|---|---|
| Transurtheral Resection of prostate in underactive bladder with bladder outlet obstruction | Other | 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. Receives: Procedure: Transurtheral Resection of prostate ( TURP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted25 Apr 2025
- Study start1 Apr 2025
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TURP SyndromeStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emad Abdellah Ali Mostafa, Sohag University
- Investigators
- Emad Mostafa, MD, Principal investigator, Assistant lecture
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
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Improvement Afetr Trasurtheral Resection of Prostate in Patients With Underactive Bladder and Bladder Outlet Obstruction
- ClinicalTrials.gov ID
- NCT06944743
- Acronym / sponsor ID
- Soh-Med-25-3__IMD
- Conditions
- TURP Syndrome, Retention, Urinary, Prostate Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 25 Apr 2025 (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.
The study is for aproved that Transurtheral Resection of prostate is good for patient with underactive bladder or not.
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:
- Age.
- Body mass index.
- pre-operative urinary flow rate.
- International Prostate Symptom Score (IPSS).
- Urodynamic parameters (BCI, BOOI, PVR and bladder capacity……...etc.).
- Prostate size.
- Degree of vesicoureteral reflux (if present).
- Functional Bladder Capacity.
Intra-Operative Predictors:
- Surgical technique.
- Prostatic Resected weight.
- Intra-operative complications.
- Prostate type (Bilobular,trilobular,adenomatous or fibrous).
- TURP syndrome.
Post-Operative Predictors:
- Catheterization duration.
- post-operative urinary retention.
- Complications: (e.g., infections, stricture).
- Early post-operative voiding trials.
- Measure degree of vesicoureteral reflux after TURP.
- Functional bladder Capacity after TURP.
Urodynamic Predictors:
- Detrusor contractility.
- Bladder outlet obstruction.
- Functional bladder capacity.
- UAB severity: Mild/moderate (UAB symptoms).
- Maximum urinary flow rate.
- Compliance of bladder.
Other Predictors:
- Patient expectations: Realistic expectations and mental health influence.
- Co-morbidities.
- pre-operative physical therapy.
- 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.
.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transurtheral Resection of prostate in underactive bladder with bladder outlet obstruction | Other | Procedure: Transurtheral Resection of prostate ( TURP)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. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male patients diagnosed with BOO and UAB
- Age ≥ 40 years.
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| Transurtheral Resection of prostate ( TURP)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. | Procedure or surgery | Transurtheral Resection of prostate in underactive bladder with bladder outlet obstruction |
Primary outcome
Change in international prostate symptome score (IPSS) score.
Time frame: 3 month .
Outcome measure Detrusar pressure at maximum flow (Pdet-Qmax unit:CmH2O)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2025.
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Comparison of Convective Water Vapor Ablation (Convective Water Vapor Energy, WAVE™) With the Rezum™ System Versus Holmium Laser Enucleation of the Prostate (HoLEP) Versus Bipolar Transurethral Resection of the Prostate (TUR-P) in Patients With Benign Prostatic Syndrome (BPS) - A Randomized Study
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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.
Emad Mostafa, MD principal investigator
Assistant lecture
1 site in 1 country: see every site and its status.
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.