| 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
|
|
|
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
|
|
|
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. |