Bladder StoneNCT07831486
Impact of Concomitant TURP on Bladder Stone Surgery Outcomes
A study testing Transurethral Cystolitholapaxy Alone and Transurethral Resection of the Prostate (TURP) in people with Bladder Stone, run by Beni-Suef University at 1 site in Egypt.
Trial summary
The management of bladder stones secondary to benign prostatic hyperplasia (BPH) remains controversial regarding whether transurethral resection of the prostate (TURP) should be performed concomitantly or selectively. Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- Bladder Stone
- What is being tested?
- Transurethral Cystolitholapaxy Alone and Transurethral Resection of the Prostate (TURP)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteEgypt
- Study dates
- Oct 2026to Jul 2028
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult men aged 40 years or older.
- Lower urinary tract symptoms (LUTS) attributed to benign prostatic hyperplasia (BPH).
- International Prostate Symptom Score (IPSS) >= 8.
- Prostate size >= 30 grams (measured by ultrasonography).
- Maximum urinary flow rate (Qmax) <= 15 mL/s.
- Presence of urinary bladder calculus/calculi confirmed by diagnostic imaging.
- Written informed consent provided prior to study enrollment.
Who cannot join
- Evidence or history of urethral stricture.
- Known or suspected prostate cancer.
- Known or suspected bladder cancer / urothelial malignancy.
- Neurogenic bladder dysfunction.
- Chronic urinary retention with overflow incontinence.
- Previous prostate or bladder neck surgery (e.g., prior TURP, TUIP, open prostatectomy).
- Active urinary tract infection (UTI) at the time of surgery (patients treated for infection preoperatively may be reassessed for eligibility).
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
Faculty of Medicine, Beni-Suef University
Banī Suwayf, Beni Suweif Governorate, 62511
doaa mahmoud khalil, assistant professor, 01152091011, drm_abdallah_88@yahoo.com
About this study
Official title: Impact of Concomitant Transurethral Resection of the Prostate on Postoperative Outcomes of Bladder Stone Surgery and Predictors of Subsequent TURP: A Prospective Comparative Study
The management of bladder stones secondary to benign prostatic hyperplasia (BPH) remains controversial regarding whether transurethral resection of the prostate (TURP) should be performed concomitantly or selectively.
The primary objective of this prospective randomized comparative study is to compare the postoperative outcomes of cystolitholapaxy alone versus cystolitholapaxy with concomitant TURP in adult male patients presenting with bladder calculi secondary to BPH. Additionally, the study aims to identify clinical and urodynamic predictors for requiring subsequent (delayed) TURP among patients initially treated with stone surgery alone.
Read the detailed description
Urinary bladder calculi represent approximately 5% of all urinary calculi, with secondary stones constituting the vast majority (>95%) of cases in adult men, predominantly secondary to bladder outlet obstruction (BOO) caused by benign prostatic hyperplasia (BPH).
While current guidelines debate the necessity of routine concomitant outlet obstruction relief at initial stone surgery, evidence remains needed regarding single-stage versus selective staged treatment.
This prospective, randomized, single-center study will be conducted at the Urology Department, Beni-Suef University. A total of 104 eligible male patients aged 40 years or older with symptomatic BPH (IPSS >= 8, prostate size >= 30g, Qmax <= 15 ml/s) and imaging-confirmed bladder calculus/calculi will be randomly allocated (1:1 allocation using computer-generated block randomization) into one of two parallel groups:
- Group 1: Managed with transurethral cystolitholapaxy alone.
- Group 2: Managed with transurethral cystolitholapaxy with concomitant TURP.
All participants undergo comprehensive preoperative evaluation including medical history, International Prostate Symptom Score (IPSS), total and free PSA, urine analysis and culture, abdominopelvic ultrasound (assessing stone dimensions, prostate volume, post-void residual urine [PVR]), and uroflowmetry (Qmax).
Follow-up evaluations are conducted at 1 month, 3 months, and 6 months postoperatively to assess the stone-free rate (SFR), stone recurrence rate, functional outcomes (IPSS, Qmax, PVR), and postoperative adverse events graded by the Clavien-Dindo classification system. Patients in Group 1 will be specifically monitored to identify independent risk factors necessitating delayed TURP during the follow-up period.
- Conditions
- Bladder Stone
- Being tested
- Transurethral Cystolitholapaxy Alone, Transurethral Resection of the Prostate (TURP)
- Medical subject headings
- Urinary Bladder Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transurethral Cystolitholapaxy AloneProcedure or surgery
Transurethral fragmentation and evacuation of bladder calculi using standard endourological equipment without surgical intervention for the prostate at the time of stone surgery.
Transurethral Resection of the Prostate (TURP)Procedure or surgery
Transurethral resection of the prostate to relieve bladder outlet obstruction, performed in the same operative session as cystolitholapaxy.
| Study group | Role | What they receive |
|---|---|---|
| Cystolitholapaxy Alone | Active comparator | Patients undergo transurethral cystolitholapaxy alone to clear bladder calculi, followed by conservative medical management of BPH and follow-up to evaluate the need for subsequent delayed TURP. Receives: Procedure: Transurethral Cystolitholapaxy Alone |
| Cystolitholapaxy + Concomitant TURP | Experimental | Patients undergo transurethral cystolitholapaxy combined with simultaneous transurethral resection of the prostate (TURP) in the same operative setting. Receives: Procedure: Transurethral Resection of the Prostate (TURP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stone-Free Rate (SFR)
Defined as the complete absence of residual stones evaluated using standardized imaging (urinary tract ultrasonography and plain abdominal X-ray [KUB]) for all patients.
Measured: 4 to 6 weeks postoperatively
Secondary outcomes (3)
Change in International Prostate Symptom Score (IPSS)" Unit of Measure: Units on a Scale ( Score on a Scale)
Evaluation of urinary symptoms and voiding parameters including International Prostate Symptom Score (IPSS, range 0-35),
Measured: Baseline, 1 month, 3 months, and 6 months postoperatively
"Change in Maximum Urinary Flow Rate (Qmax)" Unit of Measure: mL/s (milliliters per second)
Maximum urinary flow rate (Qmax) assessed by uroflowmetry. Unit of Measure: mL/s
Measured: Baseline, 1 month, 3 months, and 6 months postoperatively
Change in Post-Void Residual Urine Volume (PVR)
Post-void residual urine volume (PVR) assessed by ultrasonography.
Measured: Baseline, 1 month, 3 months, and 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionApr 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder StoneStudies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- 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
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Abdallah, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07831486
- Sponsor's protocol ID
- FMBSUREC/05052026/Abdel-Azeem
- Status last verified
- Sep 2026
- First submitted
- 12 Sep 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Concomitant Transurethral Resection of the Prostate on Postoperative Outcomes of Bladder Stone Surgery and Predictors of Subsequent TURP: A Prospective Comparative Study
- ClinicalTrials.gov ID
- NCT07831486
- Acronym / sponsor ID
- FMBSUREC/05052026/Abdel-Azeem
- Conditions
- Bladder Stone
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 21 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.
The management of bladder stones secondary to benign prostatic hyperplasia (BPH) remains controversial regarding whether transurethral resection of the prostate (TURP) should be performed concomitantly or selectively.
The primary objective of this prospective randomized comparative study is to compare the postoperative outcomes of cystolitholapaxy alone versus cystolitholapaxy with concomitant TURP in adult male patients presenting with bladder calculi secondary to BPH. Additionally, the study aims to identify clinical and urodynamic predictors for requiring subsequent (delayed) TURP among patients initially treated with stone surgery alone.
Detailed description
Urinary bladder calculi represent approximately 5% of all urinary calculi, with secondary stones constituting the vast majority (>95%) of cases in adult men, predominantly secondary to bladder outlet obstruction (BOO) caused by benign prostatic hyperplasia (BPH).
While current guidelines debate the necessity of routine concomitant outlet obstruction relief at initial stone surgery, evidence remains needed regarding single-stage versus selective staged treatment.
This prospective, randomized, single-center study will be conducted at the Urology Department, Beni-Suef University. A total of 104 eligible male patients aged 40 years or older with symptomatic BPH (IPSS >= 8, prostate size >= 30g, Qmax <= 15 ml/s) and imaging-confirmed bladder calculus/calculi will be randomly allocated (1:1 allocation using computer-generated block randomization) into one of two parallel groups:
- Group 1: Managed with transurethral cystolitholapaxy alone.
- Group 2: Managed with transurethral cystolitholapaxy with concomitant TURP.
All participants undergo comprehensive preoperative evaluation including medical history, International Prostate Symptom Score (IPSS), total and free PSA, urine analysis and culture, abdominopelvic ultrasound (assessing stone dimensions, prostate volume, post-void residual urine [PVR]), and uroflowmetry (Qmax).
Follow-up evaluations are conducted at 1 month, 3 months, and 6 months postoperatively to assess the stone-free rate (SFR), stone recurrence rate, functional outcomes (IPSS, Qmax, PVR), and postoperative adverse events graded by the Clavien-Dindo classification system. Patients in Group 1 will be specifically monitored to identify independent risk factors necessitating delayed TURP during the follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cystolitholapaxy Alone | Active comparator | Procedure: Transurethral Cystolitholapaxy AlonePatients undergo transurethral cystolitholapaxy alone to clear bladder calculi, followed by conservative medical management of BPH and follow-up to evaluate the need for subsequent delayed TURP. |
| Cystolitholapaxy + Concomitant TURP | Experimental | Procedure: Transurethral Resection of the Prostate (TURP)Patients undergo transurethral cystolitholapaxy combined with simultaneous transurethral resection of the prostate (TURP) in the same operative setting. |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult men aged 40 years or older.
- Lower urinary tract symptoms (LUTS) attributed to benign prostatic hyperplasia (BPH).
- International Prostate Symptom Score (IPSS) >= 8.
- Prostate size >= 30 grams (measured by ultrasonography).
- Maximum urinary flow rate (Qmax) <= 15 mL/s.
Key exclusion criteria (7 listed)
- Evidence or history of urethral stricture.
- Known or suspected prostate cancer.
- Known or suspected bladder cancer / urothelial malignancy.
- Neurogenic bladder dysfunction.
- Chronic urinary retention with overflow incontinence.
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 |
|---|---|---|
| Transurethral Cystolitholapaxy AloneTransurethral fragmentation and evacuation of bladder calculi using standard endourological equipment without surgical intervention for the prostate at the time of stone surgery. | Procedure or surgery | Cystolitholapaxy Alone |
| Transurethral Resection of the Prostate (TURP)Transurethral resection of the prostate to relieve bladder outlet obstruction, performed in the same operative session as cystolitholapaxy. | Procedure or surgery | Cystolitholapaxy + Concomitant TURP |
Primary outcome
Stone-Free Rate (SFR)
Time frame: 4 to 6 weeks postoperatively
Defined as the complete absence of residual stones evaluated using standardized imaging (urinary tract ultrasonography and plain abdominal X-ray [KUB]) for all patients.
3 secondary outcomes
Change in International Prostate Symptom Score (IPSS)" Unit of Measure: Units on a Scale ( Score on a Scale)
Time frame: Baseline, 1 month, 3 months, and 6 months postoperatively
"Change in Maximum Urinary Flow Rate (Qmax)" Unit of Measure: mL/s (milliliters per second)
Time frame: Baseline, 1 month, 3 months, and 6 months postoperatively
Change in Post-Void Residual Urine Volume (PVR)
Time frame: Baseline, 1 month, 3 months, and 6 months postoperatively
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 21 Sep 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transurethral Cystolitholapaxy Alone and Transurethral Resection of the Prostate (TURP) in people with Bladder Stone, 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 7 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: looking for participants now, as of the sponsor's last update on 21 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?
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 Mahmoud Abdallah Mahmoud, lecturer of urology (01155361979, mahmoud.abdalla@med.bsu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stone-Free Rate (SFR) (time frame: 4 to 6 weeks postoperatively). 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 21 Sep 2026.