| CTRI Number |
CTRI/2024/01/061675 [Registered on: 19/01/2024] Trial Registered Prospectively |
| Last Modified On: |
09/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparing prostate surgery outcomes in patients with different initial symptoms |
|
Scientific Title of Study
|
A comparative study of post-TURP outcomes in patients with BPE-related
severe LUTS, Acute urinary retention, and Chronic urinary retention |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
K S Chaitanya krishna |
| Designation |
Senior Resident |
| Affiliation |
Kasturba Medical College |
| Address |
Room No. 14, First Floor, OPD Block, Kasturba Hospital, Kasturba Medical College, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9502522323 |
| Fax |
|
| Email |
chaitanyasantosh@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Padmaraj Hegde |
| Designation |
Professor and HOU |
| Affiliation |
Kasturba Medical College |
| Address |
Room No. 14, First Floor, OPD Block, Kasturba Hospital, Kasturba Medical College, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
padmaraj.hegde@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
K S Chaitanya krishna |
| Designation |
Senior Resident |
| Affiliation |
Kasturba Medical College |
| Address |
Room No. 14, First Floor, OPD Block, Kasturba Hospital, Kasturba Medical College, Manipal
KARNATAKA
576104
India |
| Phone |
9502522323 |
| Fax |
|
| Email |
chaitanyasantosh@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College |
| Address |
Room No.14, Dept of urology, First floor, OPD Block, Kasturba Hospital, Kasturba Medical college, Manipal, Udupi, Karnataka. 576104 |
| Type of Sponsor |
Private medical college |
|
|
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 K S chaitanya krishna |
Kasturba Medical College |
Department of Urology, Room no.14, First Floor, OPD Building, Kasturba Hospital, Manipal
Udupi
KARNATAKA |
9502522323
chaitanyasantosh@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
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 |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Male |
| Details |
Patients presenting with BPE with Severe LUTS and failed medical management, with Recurrent UTI, with Refractory hematuria, with acute urinary retention, with chronic urinary retention |
|
| ExclusionCriteria |
| Details |
Other causes of bladder outlet obstruction –
- urethral stricture,
- prostate cancer,
- bladder neck contracture |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Study post operative Trial with out catheterization rates, improvement in IPSS-QoL scores, Uroflowmetry parameters among patients with different initial presentations. |
Baseline, Post operative day 2, 1 month post surgery and 3 months post surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Re-catheterization rates
Re Surgery |
one and three months |
|
|
Target Sample Size
|
Total Sample Size="196"
Sample Size from India="196"
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)
|
19/01/2024 |
| 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="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
|
TURP has been the gold standard surgical mode of management for BPE-related refractory severe LUTS and Urinary retention for many years. The outcomes after TURP have not been consistent in different sets of patients with different initial presentations. So, this study aims to obtain a better understanding of the spectrum of presentation of BPO (Severe LUTS, Acute urinary retention – spontaneous or precipitated Chronic urinary retention – HPCR & LPCR) & post TURP outcomes in those patients. Many studies have indicated that patients with prolonged duration of BPE-related LUTS and urinary retention may have poorer post-TURP outcomes. So, in this study, we shall be looking to answer whether early TURP is to be preferred over prolonged medical management of BPO before AUR or CUR sets in. In this study, patients are recruited after obtaining consent and explaining about the study. They are grouped into three groups based on the initial presentation. Baseline data is collected. All patients undergo TURP and post-operative outcome measures are obtained and compared among different groups. |