Benign prostatic hyperplasia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged between 45 and 85 years old, male. 2. Those who need to undergo surgery for the removal of benign prostatic hyperplasia (BPH) glandular tissue should have an International Prostate Symptom Score (IPSS) of 8 or above. 3. Patients with a maximum urine flow rate (Qmax) of = 125 ml) or those with urinary retention requiring indwelling catheterization; 4. The volume of the prostate is between 30 ml and 120 ml. 5. The subjects or their guardians can understand the research purpose, demonstrate sufficient compliance with the trial protocol, and sign the Informed Consent Form (ICF).
Exclusion criteria
Exclusion criteria: 1. Known to have a history of prostate cancer or bladder cancer within five years or suspected of having the above diseases. 2. Neurogenic bladder; 3. There is urethral stricture, making it impossible to insert surgical instruments. 4. Having bladder stones that cannot be treated simultaneously; 5. Post-void residual (PVR) > 300 ml (except for indwelling catheter due to urinary retention); 6. Has undergone prostate surgery in the past (biopsy excluded); 7. Those suspected of having intestinal perforation and with foreign bodies in the intestine that have not yet been removed. 8. Severe inflammation, adhesion and stenosis are present or suspected at the lesion sites of the anus, rectum and colon. 9. There are significant internal or surgical diseases that make the patient unable to tolerate the operation. 10. Those with mental or intellectual abnormalities who are unable to cooperate with treatment and evaluation. 11. Allergic to anesthetic drugs, lubricants, equipment materials, etc. used in the surgical procedure. 12. The safe withdrawal period of anticoagulant drugs and antiplatelet drugs has not reached 7 days. 13. Exclude those who have participated in other drug, biological agent or device clinical trials within the past 30 days. 14. Other situations judged by the researchers as unsuitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The success rate of remote surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| The incidence rate of surgery-related adverse events;Intraoperative time;International Prostate Symptom Score (IPSS); | — |
Countries
China
Contacts
Peking University First Hospital