Benign prostatic hyperplasia
Conditions
Interventions
Experimental group:Undergoing transurethral prostatic lift (PUL)
Control group:Undergo a single urethral dilation and cystourethroscopy
Sponsors
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
Male
Age
45 Years to 85 Years
Inclusion criteria
Inclusion criteria: Inclusion CriteriaSubjects participating in this study must meet all of the following criteria: 1. Agree to sign the informed consent form 2. Male patients aged 45 years or older (including 45) and under 85 years (including 85) 3. Meet the BPH diagnostic criteria in the 2019 Chinese "Guidelines for the Diagnosis and Treatment of Benign Prostatic Hyperplasia" 4. Poor response to medication or refusal to receive medication, IPSS score >12 5. Qmax =12 mL/s (voided volume >=150 mL) 6. Imaging examination shows prostate volume 30 mL <=PV <=80 mL
Exclusion criteria
Exclusion criteria: Exclusion CriteriaSubjects meeting any one or more of the following criteria will be excluded from the study: 1. Intravesical prostatic protrusion (IPP) >1 cm 2. PSA >4 ng/mL, unless a prostate biopsy report is negative 3. Urethral stricture or bladder neck contracture making instrument insertion difficult 4. Known bleeding disorders or taking anticoagulant or antiplatelet drugs other than aspirin (=100 mg) (unless antiplatelet drugs are discontinued at least 3 days before surgery) 5. Acute urinary tract infection 6. Lower urinary tract symptoms not caused by prostatic hyperplasia 7. History of bladder dysfunction due to neurogenic or other causes 8. History of prostate or bladder tumors 9. Urinary incontinence due to reduced sphincter function 10. Gross hematuria 11. Urinary stones within the past 3 months 12. Bacterial prostatitis within the past 6 months 13. History of lower urinary tract injury or previous prostate urethral surgery 14. History of allergy to nickel, titanium, stainless steel, or PET 15. Advanced malignant tumors 16. Language or communication barriers preventing correct understanding or answering questions 17. Cognitive disorders affecting the ability to understand, follow, or comply with the study 18. Poor compliance and inability to participate in follow-upOther conditions deemed by the investigator to be unsuitable for participation in the study 19. Other situations in which researchers believe participation in the study is not appropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in International Prostate Symptom Score (IPSS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in IPSS;Change in Quality of Life (QoL) Score;Change in maximum urine flow rate (Qmax);Change in post-void residual (PVR) volume;International Index of Erectile Function-5 (IIEF-5) Change;Male Sexual Health Questionnaire - Ejaculatory Dysfunction Score (MSHQ-EjD-SF) Change;Postoperative Recovery Quality Score (QoR-VAS);Overall Evaluation of Equipment Operational Performance: Excellent/Good Rate; | — |
Countries
China
Contacts
Public ContactCui Xingang
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Outcome results
None listed