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Exploring the efficacy of a full pain management model for transperineal prostate aspiration biopsy: a randomized controlled clinical study

Exploring the efficacy of a full pain management model for transperineal prostate aspiration biopsy: a randomized controlled clinical study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400082494
Enrollment
Unknown
Registered
2024-03-29
Start date
2024-04-01
Completion date
Unknown
Last updated
2024-04-01

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

Conditions

prostate cancer

Interventions

Full Pain Management Group (intervention group):Compound lidocaine cream was applied to the perineal skin, mucosa of the anterior rectal wall and perianal area before biopsy
Routine Pain Management Group (control group):Placebo was applied to the perineal skin, mucosa of the anterior rectal wall and perianal area before biopsy

Sponsors

Lishui Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: ? Aged >=18 years; ? Suspicious nodules of the prostate found by digital rectal examination; ? Suspicious lesions found by transrectal ultrasound or magnetic resonance imaging; ? PSA > 10ng/ml; ? PSA 4~10ng/ml, f/t PSA0.15ng/ml.

Exclusion criteria

Exclusion criteria: ? Chronic pelvic pain syndrome; ? Chronic prostatitis; ? Previous prostate biopsy; ?Allergy to proparacaine or lidocaine; ? Coagulation disorders, should not perform prostate biopsy; ? Acute urinary tract infection or fever; ? Internal hemorrhoids, external hemorrhoids, perianal or rectal lesions; ? Withdrawal from the study; ? circumstances that require withdrawal as assessed by the investigator.

Design outcomes

Primary

MeasureTime frame
Pain visual analog scale score;

Secondary

MeasureTime frame
detection of prostate cancer;Willingness to repeat biopsy;Post-operative complications;

Countries

China

Contacts

Public ContactLi Jie

Lishui Central Hospital

lijie9783@126.com+86 159 9084 8220

Outcome results

None listed

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