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A randomized controlled study on the efficacy and safety of single port robot assisted laparoscopic prostatectomy (SP-RASP) and transurethral holmium laser enucleation of the prostate (HoLEP) in the treatment of large volume benign prostatic hyperplasia

A randomized controlled study on the efficacy and safety of single port robot assisted laparoscopic prostatectomy (SP-RASP) and transurethral holmium laser enucleation of the prostate (HoLEP) in the treatment of large volume benign prostatic hyperplasia

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400082278
Enrollment
Unknown
Registered
2024-03-26
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

benign prostatic hyperplasia

Interventions

SP-PASP group:SP-PASP surgery
HoLEP group:HoLEP surgery

Sponsors

Ninth People’s Hospital, School of Medicine, Shanghai Jiaotong University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
50 Years to 90 Years

Inclusion criteria

Inclusion criteria: (1) There are indications for benign prostatic hyperplasia surgery: repeated urinary retention, hematuria or poor drug treatment effect seriously affect the quality of life; (2) Prostate volume>80ml; (3) Having normal sexual activity.

Exclusion criteria

Exclusion criteria: (1) Qmax>20ml/s; (2) Neurogenic bladder dysfunction or sexual dysfunction; (3) History of lower urinary tract injury or previous experience with prostate or urethral surgery; (4) Previous history of prostate cancer; (5) Urethral stenosis or bladder neck contracture;

Design outcomes

Primary

MeasureTime frame
Changes in the International Prostate Symptom Score compared to baseline;post-void residual urine volume, PVR;

Secondary

MeasureTime frame
urethral stricture rate;Retrograde ejaculation rate;Qmax;

Countries

China

Contacts

Public ContactBin Xu

Ninth People’s Hospital, School of Medicine Shanghai Jiaotong University

chxb2004@126.com+86 13 386 277 1601

Outcome results

None listed

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