Urinary Bladder, OveractiveBOPROSTNCT07554989
Comparison of Concurrent Endoscopic Prostate Surgery With Botox-A Injection and Postoperative Medical Therapy in BPH Patients With Overactive Bladder Symptoms
An observational study of Urinary Bladder, Overactive and Prostatic Hyperplasia, Benign, run by Taksim Egitim ve Arastirma Hastanesi at 1 site in Turkey (Türkiye).
Trial summary
Intravesical OnabotulinumtoxinA (BoNT-A) injection performed concurrently with endoscopic prostate surgery provides superior clinical improvement at the 12th postoperative week compared to standard medical therapy in patients with urodynamically confirmed bladder outlet obstruction (BOO) and concomitant overactive… Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- Urinary Bladder, Overactive, Prostatic Hyperplasia, Benign, Bladder Outlet Obstruction
- Type of treatment
- Injection or infusion
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2026to 1 Apr 2027
- Phase
- Observational
- 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
Study population: "The study population consists of male patients who were treated at Taksim Egitim Ve Arastırma Hastanesi Urology Department. The cohort includes patients who underwent endoscopic prostate surgery for Benign Prostatic Hyperplasia (BPH) and had documented preoperative symptoms of Overactive Bladder (OAB). Data were retrospectively collected from the electronic medical records and patient charts of individuals treated between [2024] and [2027]."
Who may be able to join
- Male patients aged 40 years and older who were diagnosed with benign prostatic hyperplasia and underwent transurethral resection of the prostate (TURP) or a similar endoscopic prostate surgery were included in the study
Who cannot join
- Neurological Pathologies:
- Diagnosis of neurogenic bladder.
- History of Multiple Sclerosis, Parkinson's disease, or cerebrovascular accident (CVA).
- Spinal cord injury or any other conditions leading to neurogenic bladder dysfunction.
- Metabolic and Systemic Diseases:
- Diabetes Mellitus with associated neuropathy.
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- Severe renal impairment (eGFR <30 ml/min/1.73 m²).
- Severe hepatic impairment (Child-Pugh C).
- Moderate hepatic impairment (Child-Pugh B) or severe renal impairment in patients using strong CYP3A inhibitors.
- Urinary System Related Pathologies:
- Previous treatment with intravesical BoNT-A or Mirabegron.
- Active urinary tract infection (confirmed by positive urine culture).
- Presence of bladder tumor, bladder stones, or bladder diverticulum.
- History of pelvic radiotherapy.
- Urethral stricture or conditions carrying a risk of re-obstruction.
- Cardiovascular Risks (Contraindications for Mirabegron and Anticholinergics):
- Uncontrolled hypertension (≥180/110 mmHg).
- Severe cardiac arrhythmia or heart failure (NYHA Class III-IV).
- Other Exclusion Criteria:
- Patients planning to receive other overactive bladder (OAB) treatments during the study period.
- Incomplete follow-up data or missing medical records.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Taksim Egitim Ve Arastirma Hastanesi
Istanbul, 34433
About this study
Official title: A Retrospective Comparative Study of Concurrent Intraprostatic Botulinum Toxin-A Injection During Endoscopic Prostate Surgery Versus Postoperative Medical Therapy in BPH Patients With Overactive Bladder Symptoms
Intravesical OnabotulinumtoxinA (BoNT-A) injection performed concurrently with endoscopic prostate surgery provides superior clinical improvement at the 12th postoperative week compared to standard medical therapy in patients with urodynamically confirmed bladder outlet obstruction (BOO) and concomitant overactive bladder (OAB). This superiority is demonstrated through significant improvements in OABSS, OAB-V8, ICIQ-UI SF, IIQ-7, and IPSS scores.
Read the detailed description
Study Design and Patient Selection:
This prospective, randomized controlled study aims to evaluate the clinical efficacy of intravesical OnabotulinumtoxinA (BoNT-A) injection when performed concurrently with endoscopic prostate surgery (TURP or Laser Enucleation). Patients diagnosed with concomitant Bladder Outlet Obstruction (BOO) and Overactive Bladder (OAB) via preoperative urodynamic studies will be included in the study.
Intervention and Procedure:
Participants will be randomized into two groups:
- Intervention Group: Patients will receive intravesical BoNT-A injections (100 Units) into the detrusor muscle (sparing the trigone) during the same anesthesia session as the endoscopic prostate surgery.
- Control Group: Patients will undergo endoscopic prostate surgery followed by the standard postoperative medical protocol (e.g., anticholinergics or Beta-3 agonists).
Data Collection and Follow-up:
Baseline clinical data, including International Prostate Symptom Score (IPSS), Overactive Bladder Symptom Score (OABSS), OAB-V8, International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF), and Incontinence Impact Questionnaire-7 (IIQ-7), will be recorded preoperatively.
All patients will be followed for 12 weeks postoperatively. The primary objective is to compare the 12th-week clinical outcomes between the BoNT-A group and the standard medical therapy group. Statistical analysis will be performed to determine if simultaneous BoNT-A administration provides a significant advantage in alleviating OAB symptoms and improving quality of life in the early postoperative period.
- Conditions
- Urinary Bladder, Overactive, Prostatic Hyperplasia, Benign, Bladder Outlet Obstruction, Botulinium Toxin-A
- Keywords
- BPH, OAB, BONT-A, TUR-P, LUTS
- Medical subject headings
- Urinary Bladder, Overactive, Prostatic Hyperplasia, Urinary Bladder Neck Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| BoNT-A Group | Patients who received intravesical OnabotulinumtoxinA injection (100 Units) concurrently with endoscopic prostate surgery | |
| Control Group (Medical Therapy Group) | Patients who underwent endoscopic prostate surgery and received standard postoperative medical therapy (anticholinergics or Beta-3 agonists) without BoNT-A injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Overactive Bladder Symptom Score (OABSS)
A validated questionnaire used to quantify overactive bladder symptoms. Total score ranges from 0 to 15, where higher scores indicate more severe symptoms
Measured: Baseline (Preoperative) and Postoperative 12th Week
Secondary outcomes (1)
IPSS Score Change
International Prostate Symptom Score (0-35 points). Higher scores indicate more severe LUTS
Measured: Baseline and 12th Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2026
- Study start1 Apr 2026
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Bladder, OveractiveStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taksim Egitim ve Arastirma Hastanesi
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07554989
- Sponsor's protocol ID
- 145
- Acronym
- BOPROST
- Status last verified
- Apr 2026
- First submitted
- 21 Apr 2026
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared to protect patient privacy and maintain confidentiality in accordance with the institutional ethics committee regulations.
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Comparative Study of Concurrent Intraprostatic Botulinum Toxin-A Injection During Endoscopic Prostate Surgery Versus Postoperative Medical Therapy in BPH Patients With Overactive Bladder Symptoms
- ClinicalTrials.gov ID
- NCT07554989
- Acronym / sponsor ID
- BOPROST / 145
- Conditions
- Urinary Bladder, Overactive, Prostatic Hyperplasia, Benign, Bladder Outlet Obstruction, Botulinium Toxin-A
- Keywords
- BPH, OAB, BONT-A, TUR-P, LUTS
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Taksim Egitim ve Arastirma HastanesiOther government
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 28 Apr 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.
Intravesical OnabotulinumtoxinA (BoNT-A) injection performed concurrently with endoscopic prostate surgery provides superior clinical improvement at the 12th postoperative week compared to standard medical therapy in patients with urodynamically confirmed bladder outlet obstruction (BOO) and concomitant overactive bladder (OAB). This superiority is demonstrated through significant improvements in OABSS, OAB-V8, ICIQ-UI SF, IIQ-7, and IPSS scores.
Detailed description
Study Design and Patient Selection:
This prospective, randomized controlled study aims to evaluate the clinical efficacy of intravesical OnabotulinumtoxinA (BoNT-A) injection when performed concurrently with endoscopic prostate surgery (TURP or Laser Enucleation). Patients diagnosed with concomitant Bladder Outlet Obstruction (BOO) and Overactive Bladder (OAB) via preoperative urodynamic studies will be included in the study.
Intervention and Procedure:
Participants will be randomized into two groups:
- Intervention Group: Patients will receive intravesical BoNT-A injections (100 Units) into the detrusor muscle (sparing the trigone) during the same anesthesia session as the endoscopic prostate surgery.
- Control Group: Patients will undergo endoscopic prostate surgery followed by the standard postoperative medical protocol (e.g., anticholinergics or Beta-3 agonists).
Data Collection and Follow-up:
Baseline clinical data, including International Prostate Symptom Score (IPSS), Overactive Bladder Symptom Score (OABSS), OAB-V8, International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF), and Incontinence Impact Questionnaire-7 (IIQ-7), will be recorded preoperatively.
All patients will be followed for 12 weeks postoperatively. The primary objective is to compare the 12th-week clinical outcomes between the BoNT-A group and the standard medical therapy group. Statistical analysis will be performed to determine if simultaneous BoNT-A administration provides a significant advantage in alleviating OAB symptoms and improving quality of life in the early postoperative period.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BoNT-A Group | – | –Patients who received intravesical OnabotulinumtoxinA injection (100 Units) concurrently with endoscopic prostate surgery |
| Control Group (Medical Therapy Group) | – | –Patients who underwent endoscopic prostate surgery and received standard postoperative medical therapy (anticholinergics or Beta-3 agonists) without BoNT-A injection |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- "The study population consists of male patients who were treated at Taksim Egitim Ve Arastırma Hastanesi Urology Department. The cohort includes patients who underwent endoscopic prostate surgery for Benign Prostatic Hyperplasia (BPH) and had documented preoperative symptoms of Overactive Bladder (OAB). Data were retrospectively collected from the electronic medical records and patient charts of individuals treated between [2024] and [2027]."
Key inclusion criteria (1 listed)
- Male patients aged 40 years and older who were diagnosed with benign prostatic hyperplasia and underwent transurethral resection of the prostate (TURP) or a similar endoscopic prostate surgery were included in the study
Key exclusion criteria (21 listed)
- Neurological Pathologies:
- Diabetes Mellitus with associated neuropathy.
- Severe renal impairment (eGFR <30 ml/min/1.73 m²).
- Severe hepatic impairment (Child-Pugh C).
- Moderate hepatic impairment (Child-Pugh B) or severe renal impairment in patients using strong CYP3A inhibitors.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Overactive Bladder Symptom Score (OABSS)
Time frame: Baseline (Preoperative) and Postoperative 12th Week
A validated questionnaire used to quantify overactive bladder symptoms. Total score ranges from 0 to 15, where higher scores indicate more severe symptoms
1 secondary outcome
IPSS Score Change
Time frame: Baseline and 12th Week
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 28 Apr 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared to protect patient privacy and maintain confidentiality in accordance with the institutional ethics committee regulations.
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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?
An observational study of Urinary Bladder, Overactive and Prostatic Hyperplasia, Benign, run by Taksim Egitim ve Arastirma Hastanesi at 1 site in Turkey (Türkiye).
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 1 inclusion and 21 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: under way, not looking for participants, as of the sponsor's last update on 28 Apr 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 Turkey (Türkiye). 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?
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?
Change in Overactive Bladder Symptom Score (OABSS) (time frame: Baseline (Preoperative) and Postoperative 12th Week). 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 28 Apr 2026.