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A multi-center, single-blind, non-inferiority randomized controlled trial of dual-wavelength laser enucleation of the prostate and red laser enucleation of the prostate in the treatment of benign prostatic hyperplasia

A multi-center, single-blind, non-inferiority randomized controlled trial of dual-wavelength laser enucleation of the prostate and red laser enucleation of the prostate in the treatment of benign prostatic hyperplasia

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200061292
Enrollment
Unknown
Registered
2022-06-19
Start date
2022-06-06
Completion date
Unknown
Last updated
2023-03-26

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

Conditions

Benign prostatic hyperplasia

Interventions

Group 1 :Dual wavelength laser enucleation of the prostate
Group 2:Red laser prostate enucleation

Sponsors

The First Affiliated Hospital of Anhui Medical University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
50 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Male aged 50-85 years; 2. BPH patients who have surgical indications and plan to undergo transurethral laser enucleation surgery; 3. The volume of the prostate is 25 ml-125 ml (calculation standard: multiplied by the three diameters of the prostate detected by rectal ultrasound x 0.52); 4. Patients with any of the following conditions: (1) International Prostate Symptom Score (IPSS) >= 8 points, and quality of life score (QOL) >= 4 points; (2) Maximum urine flow rate (Qmax) <= 15 mL/s; (3) Urodynamic examination indicates bladder outlet obstruction; 5. Patients who can complete the relevant scale scores independently and with the assistance of their family members; 6. Patients who voluntarily participate in this experimental research, sign informed consent and are willing to accept follow-up.

Exclusion criteria

Exclusion criteria: 1. Patients with neurogenic cystitis, urethral stricture and cystoscope sheath cannot pass through urethral dilation; 2. Diagnosed or suspected prostate cancer and bladder cancer patients; 3. Patients with severe cardiovascular and cerebrovascular diseases, severe respiratory diseases and severe liver and kidney dysfunction; 4. Participants in other clinical trials within three months before enrollment; 5. Other conditions that the researchers think are not suitable for inclusion.

Design outcomes

Primary

MeasureTime frame
International Prostate Symptom Score, IPSS;Maximum urine flow rate;—

Secondary

MeasureTime frame
operative time;Decrease in hemoglobin;Serum electrolyte changes;bladder irrigation time;catheterization time;hospital stay days postoperatively;Quality of life score;International Index of Erectile Function;prostate volume;Prostate-specific antigen, PSA;—

Countries

China

Contacts

Public ContactChaozhao Liang

The First Affiliated Hospital of Anhui Medical University

liang_chaozhao@163.com+86 18010883001

Outcome results

None listed

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