| CTRI Number |
CTRI/2026/03/106233 [Registered on: 13/03/2026] Trial Registered Prospectively |
| Last Modified On: |
13/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison between two endoscopic management for enlarged prostate with urinary symptoms. |
|
Scientific Title of Study
|
Comparison of Functional outcomes following Bipolar Transurethral Enucleation versus Bipolar Transurethral Resection of the Prostate in patients with lower urinary tract symptoms due to Prostatomegaly: A Randomized Controlled Trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
satish chandra |
| Designation |
senior resident |
| Affiliation |
AIIMS Patna |
| Address |
Senior resident department of Urology
AIIMS Patna Phulwarishariff
AIIMS Patna Phulwarishariff 801505
Patna
BIHAR
801505
India |
| Phone |
9621531946 |
| Fax |
|
| Email |
chandra.satish789@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Saket Singh |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Patna |
| Address |
Department of Urology
AIIMS Patna Phulwarishariff
AIIMS Patna Phulwarishariff 801505
Patna
BIHAR
801505
India |
| Phone |
9971467796 |
| Fax |
|
| Email |
docsaket89@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Saket Singh |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Patna |
| Address |
Department of Urology
AIIMS Patna Phulwarishariff
AIIMS Patna Phulwarishariff 801505
Patna
BIHAR
801505
India |
| Phone |
9971467796 |
| Fax |
|
| Email |
docsaket89@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS Patna |
| Address |
AIIMS Patna Urology department
Phulwarishariff
801505 |
| 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 |
| satish chandra |
AIIMS Patna |
Urology department AIIMS Patna
Phulwarishariff
Patna
BIHAR |
9621531946
chandra.satish789@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, AIIMS PATNA |
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 |
| Comparator Agent |
BIPOLAR ENUCLEATION OF PROSTATE |
Enucleation of prostate via urethra using bipolar working element. |
| Intervention |
BIPOLAR TURP OF PROSTATE |
Resection of prostate via urethra using bipolar working element. |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Male |
| Details |
1.Age more than 50 years and less than 80 years.
2.Patients with moderate and severe LUTS(IPSS more than 19) due to prostatomegaly.
3.Patient with BOO (Q-max less than 10 ml/s or PVR more than 100 ML or 30 percents of bladder capacity) with prostatomegaly.
4.Patients willing to provide written informed consent and comply with follow-up visits.
|
|
| ExclusionCriteria |
| Details |
1.Clinical or histological evidence of carcinoma prostate.
2.Previous prostate or urethral surgery.
3.Urethral stricture disease or neurogenic bladder.
4.Refusal to participate in the study.
5.Patients unfit for surgery.
6.Active UTI
7.Patient on anticoagulants.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the Q-max between the two groups at 3 months. |
To compare the Q-max between the two groups at 3 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• To compare the functional outcomes (IPSS and PVR) at 3 months.
• To compare quality of life parameters (QOL score/IIEF 5 scores) between both groups.
• To compare operative time.
• To compare catheterization time and hospital stay between the two procedures.
• To compare complication rates, including intraoperative and postoperative complications (as per Clavien–Dindo classification).
|
3 months |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="80"
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)
|
13/04/2026 |
| 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="1"
Months="6"
Days="20" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This research proposal from the Department of Urology at AIIMS Patna aims to compare the functional outcomes of Bipolar Transurethral Enucleation of the Prostate and Bipolar Transurethral Resection of the Prostate in patients suffering from lower urinary tract symptoms due to benign prostatic enlargement.
Although TURP is considered the gold standard surgical treatment, it is associated with complications such as bleeding, prolonged catheterization, TUR syndrome, and possible need for repeat procedures, especially in larger prostates. Enucleation techniques have emerged as promising alternatives that may reduce these complications.
This study is designed as a randomized controlled trial (RCT) to evaluate and compare functional outcomes such as maximum urinary flow rate (Q-max), International Prostate Symptom Score (IPSS), post-void residual urine (PVR), quality of life, and complication rates between the two procedures.
The study is significant because there is limited randomized evidence comparing B-TUEP and B-TURP in the Indian population. The results may help determine whether bipolar enucleation can serve as a cost-effective and efficient alternative to TURP without requiring expensive laser equipment, thereby supporting evidence-based surgical decision-making in benign prostatic enlargement |