Evaluation for Clinical Efficacy of Anatomical Enucleation of the Prostate for the Treatment of Benign Prostatic Hyperplasia with Underactive bladder

Not Applicable

Recruiting

• Conditions: Benign Prostatic Hyperplasia with Underactive bladder

• Registration Number: ITMCTR1900002519
• Lead Sponsor: Guangdong Provincial Hospital of Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

1. Aged 60-80 years, men;
2. Diagnosis of benign prostatic obstruction; Urodynamics suggest weak or no contraction of the detrusor(BCI<100 or Pdet@Qmax<40cmH2O)
3. With any of the following conditions:
(1) The International Prostate Symptom Score (IPSS>=12), and the quality of life score (QOL)>=4 points;
(2) The maximum urinary flow rate (Qmax) is less than 15ml/s (>=150ml);
(3) The effect of drug treatment is not good;
(4) The recurrent urinary retention (more than once);
4. Subject is classified ASA I, II, or III;
5. The patient agreed to participate in this trial, and signed informed consent.

Exclusion Criteria

1. There is operation contraindications of transurethral prostatic hyperplasia resection;
2. Subject has a life expectancy <2 yr;
3. Subject is currently enrolled in or plans to enrol in any other study;
4. Subject has a Normal detrusor contractility;
5. Subject has diagnosis of stress urinary incontinence that requires treatment or daily pad or device use;
6. Subject has history urethral stricture or bladder neck contracture within the last 6 months;
7. Subject has history of lower urinary tract surgery;
8. Subject has diagnosis of prostate cancer;
9. Combined with advanced malignant tumor or chronic wasting disease;
10. Combined with serious heart,lung disease or severe mental disorder;
11. Has an active infection;
12. Subject has a disorder of the coagulation cascade or disorders that affect platelet count or function;
13. Can not finished the follow-up for poor compliance.

Study & Design

• Study Type: Observational study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
catheterization time of bladder fistula;catheterization time of Urinary tube;IPSS;Qmax;QOL;Void efficiency;Residual urine, PVR;

Secondary Outcome Measures

Name	Time	Method
Incontinence;Serum creatinine;PSA;complications;Prostate volume;HGB;