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Comparing efficacy and safety of HoLEP against gold standard TURP in Indian population.

A Randomized control trial comparing HoLEP versus TURP in the treatment of Benign Prostatic Hyperplasia - NIL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/03/063862
Enrollment
94
Registered
2024-03-08
Start date
Unknown
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

Health Condition 1: N401- Benign prostatic hyperplasia withlower urinary tract symptoms

Interventions

Intervention1: Holmium laser enucleation of the prostate -HoLEP: HoLEP is an alternate technique for enucleation of the prostate. Frequency would be as per randomization. Duration of last intervention

Sponsors

Kushal Kumar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion criteria: 1. BPH patient with prostatic volume greater than 30cc. 2. IPSS score of 8 or more. 3. urinary peak flow Qmax 15ml/sec or low 4. BPH with refractory urinary retention 5. BPH with recurrent UTI 6. BPH leading to obstructive uropathy and relieved following per urethral catheterization 7. Serum PSA greater than >4ng/ml with normal Biopsy

Exclusion criteria

Exclusion criteria: Exclusion criteria: 1. Neurogenic bladder 2. Confirmed Carcinoma prostate 3. Those who doesn’t consent

Design outcomes

Primary

MeasureTime frame
IPSS score, Serum prostate specific antigen (PSA), pre voiding residual volume, post voiding residual Volume (PVRV) Peri-operative parameters include total operating time, resected tissue weight, drop in hemoglobin level, requirement of Blood transfusion, hospital stay, time for catheter removal.Timepoint: 0,1 & 3 moth after suegery

Secondary

MeasureTime frame
IPSS score, Serum prostate specific antigen (PSA), pre voiding residual volume, post voiding residual Volume (PVRV)Timepoint: 0,1 & 3 moth after suegery

Countries

India

Contacts

Public ContactKUSHAL KUMAR

Indira Gandhi Medical College, Shimla

drpawank19@gmail.com9418085006

Outcome results

None listed

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