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

NCT07554989 | Active Not Recruiting

• 1 other identifier: 145
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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 bladder (OAB). This superiority is demonstrated through significant improvements in OABSS, OAB-V8, ICIQ-UI SF, IIQ-7, and IPSS scores.

Conditions

Urinary Bladder, Overactive; Prostatic Hyperplasia, Benign; Bladder Outlet Obstruction; Botulinium Toxin-A

Keywords

BPH; OAB; BONT-A; TUR-P; LUTS

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• IPSS Score Change

  Baseline and 12th Week

Study Arms (2)

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

Eligibility Criteria

• Age: 40 Years+
• Gender Eligibility Details: The study involves prostate surgery, which is only performed on male patients
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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 \[2027\]."

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taksim Egitim ve Arastirma Hastanesi: lead

Study Sites (1)

Taksim Egitim Ve Arastirma Hastanesi

Istanbul, 34433, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive; Prostatic Hyperplasia; Urinary Bladder Neck Obstruction

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urethral Obstruction; Urethral Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2026
• First Posted: April 28, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)