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CTRI Number  CTRI/2025/12/099812 [Registered on: 24/12/2025] Trial Registered Prospectively
Last Modified On: 03/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Comparative observational prospective study 
Study Design  Other 
Public Title of Study   comparison of 2 prostate intervention by surgery:- TURP and HOLEP.to see main outcome and perioperative complications 
Scientific Title of Study   A comparative observational prospective study to assess outcome in monopolar transurethral resection of the prostate (turp) vs holmium laser enucleation of the prostate (holep) in benign prostatic hyperplasia 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Harshad Kavad 
Designation  DrNB Urology Resident  
Affiliation  Bhaktivedanta Hospital and Research Institute 
Address  opd-9 , first floor,department of urology bhaktivedanta hospital and research institute , bhaktivedant marg, mira road , thane

Thane
MAHARASHTRA
401107
India 
Phone  8238862486  
Fax    
Email  kavadharshad@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vikash Kumar  
Designation  Mch Urology 
Affiliation  Bhaktivedanta Hospital and Research Institute 
Address  Opd-9 , first floor,department of urology bhaktivedanta hospital and research institute , bhaktivedant marg, mira road , thane

Thane
MAHARASHTRA
401107
India 
Phone  9820163302  
Fax    
Email  drvikash.k@bhaktivedantahospital.com  
 
Details of Contact Person
Public Query
 
Name  Dr Harshad Kavad 
Designation  DrNB Urology Resident  
Affiliation  Bhaktivedanta Hospital and Research Institute 
Address  opd-9 , first floor,department of urology bhaktivedanta hospital and research institute , bhaktivedant marg, mira road , thane

Thane
MAHARASHTRA
401107
India 
Phone  8238862486  
Fax    
Email  kavadharshad@gmail.com  
 
Source of Monetary or Material Support  
Bhaktivedanta Hospital and Research Institute,Bhaktivedant marg, Mira road, Thane, 401107 
 
Primary Sponsor  
Name  Bhaktivedanta Hospital and Research Institute 
Address  Bhaktivedanta Hospital and Research Institute,Bhaktivedant marg, Mira road, Thane, 401107 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NA  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Harshad Kavad  Bhaktivedanta Hospital and Research Institute  OPD-9,1st floor, Department of Urology,Bhaktivedanta Hospital and Research Institute,Bhaktivedant marg, Mira road, Thane, 401107
Thane
MAHARASHTRA 
8238862486

kavadharshad@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Bhaktivedanta Hospital Ethics Committee for Biomedical and Health Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N401||Benign prostatic hyperplasia withlower urinary tract symptoms,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  99.00 Year(s)
Gender  Male 
Details  1. Male patients age more than 50 years
2. Diagnosed with symptomatic BPH with moderate to severe lower urinary tract symptoms (International Prostate Symptom Score [IPSS] more than or equal to 8).
3. Patient of BPH with recurrent UTI and recurrent Hematuria.
4. Prostate size between 40 mL and 100 mL as assessed by prostate ultrasound done by Senior Radiologist at our hospital (Voluson).
5. Patients consenting to undergo surgical treatment and participate in the study.
 
 
ExclusionCriteria 
Details  1. Patients with prostate cancer confirmed by biopsy.
2. Patients with neurogenic bladder or other neurological conditions affecting voiding.
3. Previous prostate surgery.
4. Presence of active urinary tract infection.
• Patients unfit for anaesthesia or surgery.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
• Prostate weight in gm
• Hemoglobin drop(g/dL) postoperatively.
• Catheterization time (hours).
• Length of hospital stay (days).
• Perioperative complications (INCONTINENCE, RETENTION).
• S.PSA drop postoperatively
• Prostate weight in gm
• Operative time (minutes).

 
1 , 3 , 6 and 12 months  
 
Secondary Outcome  
Outcome  TimePoints 
• Improvement in International Prostate Symptom Score (IPSS) at 1, 3,6 and 12 months.
• Improvement in maximum urinary flow rate (Qmax) at 1, 3,6 and 12 months.

 
1 , 3 , 6 and 12 months  
 
Target Sample Size   Total Sample Size="68"
Sample Size from India="68" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   12/01/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Benign prostatic hyperplasia (BPH) is most common causes of lower urinary tract symptoms (LUTS) in ageing male, with significant impact on quality of life. Surgical management is indicated in patients with severe symptoms, complications, and failure of medical management. Monopolar transurethral resection of the prostate (mTURP) has long been considered the gold standard surgical treatment, offering proven efficacy in relieving LUTS in BPH. However, mTURP is associated with some limitations such as perioperative bleeding, risk of TUR syndrome, and reduced efficiency in very large prostates.

Holmium laser enucleation of the prostate (HoLEP) is a novel, minimally invasive technique that uses the Holmium:YAG laser to enucleate the adenoma, followed by intravesical morcellation. HoLEP can be applied to all sizes prostates, uses saline irrigation (avoiding TUR syndrome), and is associated with reduced blood loss, shorter catheterisation time, and shorter hospital stay. Despite these advantages, its adoption is limited by high equipment costs, a steep learning curve, and limited availability. There is limited study on moderate size prostate glands which is most seen in BPH.  

This prospective comparative study aims to evaluate and compare perioperative parameters, functional outcomes, complication rates, and patient satisfaction between mTURP and HoLEP in patients with BPH. Eligible patients will be allocated to either surgical group and followed up for 1 year. Data will be analysed to determine differences in symptom improvement, flow rate changes, hospitalisation duration, and postoperative complications. The findings of this study are expected to provide evidence-based insights into the relative merits of these two surgical modalities, helping guide clinical decision-making and optimising patient care in the context of both traditional and evolving urological practice.

 
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