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Effect of Local Anesthetic-Eluting Foley Catheter on Urethral Pain and Discomfort After Benign Prostatic Hyperplasia Surgery: A Mulitcenter Randomized Controlled Trial

Effect of Local Anesthetic-Eluting Foley Catheter (Free-Foley) on Urethral Pain and Discomfort After Benign Prostatic Hyperplasia (BPH) Surgery: A Mulitcenter Randomized Controlled Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0011090
Enrollment
108
Registered
2025-10-30
Start date
2025-06-05
Completion date
Unknown
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : ? Patients selected as study subjects are randomly assigned to either the experimental group or the control group using an alternating allocation method based on their registration or

Sponsors

Hallym University Medical Center
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: · Study subjects will be selected if they meet all of the following criteria. 1. Patients diagnosed with benign prostatic hyperplasia (BPH) and scheduled for HoLEP or Rezum™ surgery 2. Males aged 50 to 79 years 3. American Society of Anesthesiologists (ASA) physical status classification of Class I or II 4. Patients who have received adequate explanation of the study purpose and procedures and have voluntarily provided informed consent

Exclusion criteria

Exclusion criteria: · Patients meeting any of the following criteria will be excluded from the study. 1. Patients with concomitant prostate cancer or bladder cancer 2. Patients diagnosed with urethral stricture or interstitial cystitis/bladder pain syndrome accompanied by pain 3. Patients with allergy or hypersensitivity to local anesthetics (lidocaine) 4. Patients currently taking anticoagulants or antiplatelet agents who cannot discontinue them 5. Patients with a history of neurogenic bladder 6. Patients with severe liver disease or severe renal impairment (serum creatinine > 2.0 mg/dL) 7. Patients who do not consent to participate in the study or who have difficulty adhering to the study procedures 8. Individuals deemed by the investigator to be unsuitable for participation in the clinical trial

Design outcomes

Secondary

MeasureTime frame
Complications and safety assessment, additional analgesic usage, patient satisfaction assessment, urinary function assessment

Primary

MeasureTime frame
Effect on reducing pain and bladder irritation symptoms

Countries

Korea, Republic of

Contacts

Public ContactHwanik Kim

Hallym University Medical Center

misonyun007@naver.com+82-31-380-3850

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026