FindTrial
Sign In

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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ITMCTR
Registry ID
ITMCTR1900002519
Enrollment
Unknown
Registered
2019-08-12
Start date
2019-08-15
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

Benign Prostatic Hyperplasia with Underactive bladder

Interventions

Operation group:Anatomical Enucleation of the Prostate

Sponsors

Guangdong Provincial Hospital of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
60 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged 60-80 years, men; 2. Diagnosis of benign prostatic obstruction; Urodynamics suggest weak or no contraction of the detrusor(BCI=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

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.

Design outcomes

Primary

MeasureTime frame
catheterization time of bladder fistula;catheterization time of Urinary tube;IPSS;Qmax;QOL;Void efficiency;Residual urine, PVR;—

Secondary

MeasureTime frame
Incontinence;Serum creatinine;PSA;complications;Prostate volume;HGB;—

Countries

China

Contacts

Public ContactSongtao Xiang

Department of Urology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, Guangdong, People's Republic of China

tonyxst@163.com+86 020-81399499-8331

Outcome results

None listed

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