Comparison of Concurrent Endoscopic Prostate Surgery With Botox-A Injection and Postoperative Medical Therapy in BPH Patients With Overactive Bladder Symptoms (BOPROST)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Urinary Bladder, Overactive; Bladder Outlet Obstruction; Prostatic Hyperplasia, Benign; Botulinium Toxin-A

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:

1. 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.
2. 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 Type: Observational
• Enrollment (Estimated): 70

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Istanbul, Turkey (Türkiye), 34433
    • Taksim Egitim ve Arastirma Hastanesi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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]."

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.
• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline (Preoperative) and Postoperative 12th Week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IPSS Score Change	International Prostate Symptom Score (0-35 points). Higher scores indicate more severe LUTS	Baseline and 12th Week

Collaborators and Investigators

• Sponsor: Taksim Egitim ve Arastirma Hastanesi

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: April 21, 2026
• First Submitted That Met QC Criteria: April 21, 2026
• First Posted (Actual): April 28, 2026

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: LUTS; OAB; BPH; TUR-P; BONT-A
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder Diseases; Urethral Diseases; Urethral Obstruction; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Prostatic Hyperplasia; Urinary Bladder, Overactive; Urinary Bladder Neck Obstruction
• Other Study ID Numbers: 145

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared to protect patient privacy and maintain confidentiality in accordance with the institutional ethics committee regulations.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No