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A prospective controlled study on the efficacy and safety of a novel green-light laser technique in ambulatory surgery for benign prostatic hyperplasia

A prospective controlled study on the efficacy and safety of a novel green-light laser technique in ambulatory surgery for benign prostatic hyperplasia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500114840
Enrollment
Unknown
Registered
2025-12-18
Start date
2022-09-29
Completion date
Unknown
Last updated
2026-01-05

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

Conditions

Benign Prostate Hyperplasia

Interventions

Trial group:Patients undergoing photoselective sharp enucleation of the prostate (PSEP) under a ambulatory-surgery model: The surgery date was scheduled via outpatient appointment, and the patient wa
Control group:Patients undergoing photoselective sharp enucleation of the prostate (PSEP) under conventional inpatient hospitalisation model: After admission, standard preoperative preparations were p

Sponsors

First Affiliated Hospital of Army Medical University, Chinese People's Liberation Army
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
45 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. Meets the diagnostic criteria for BPH in the *Chinese Guidelines for the Diagnosis and Treatment of Urological and Andrological Diseases: 2022 Edition*, confirmed by comprehensive evaluations including imaging and digital rectal examination. 2. Clear surgical indications are present (patients with moderate-to-severe LUTS who have inadequate response to or refuse medical therapy, or those with BPH-related complications: (1) recurrent urinary retention; (2) recurrent urinary tract infections; (3) bladder stones or bladder diverticula; (4) recurrent gross hematuria; (5) overflow incontinence and/or secondary upper urinary tract dilation). 3. Preoperative anesthetic assessment confirms suitability for anesthesia (ASA physical status classification I–II).

Exclusion criteria

Exclusion criteria: 1. Patients with abnormally elevated PSA levels in whom prostate cancer cannot be excluded. 2. Patients with severe urinary tract infections. 3. Patients with an acontractile bladder or neurogenic bladder dysfunction. 4. Patients with severe cardiopulmonary diseases, classified as ASA physical status grade III–IV. 5. Patients with diabetes mellitus and poor glycemic control. 6. Patients unwilling to participate in the clinical study protocol. 7. Any other conditions deemed unsuitable for participation in the study by the investigators.

Design outcomes

Primary

MeasureTime frame
Ambulatory-surgery completion rate;

Secondary

MeasureTime frame
International Prostate Symptom Score;Quality of life score;Maximum urine flow rate;residual urine volume;surgical expense;Surgical time;

Countries

China

Contacts

Public ContactShen Wenhao

First Affiliated Hospital of Army Medical University, Chinese People's Liberation Army

chongqingswh@aliyun.com+86 139 8384 2766

Outcome results

None listed

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