| CTRI Number |
CTRI/2024/02/063056 [Registered on: 22/02/2024] Trial Registered Prospectively |
| Last Modified On: |
21/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
To look for the causes of persistence of symptoms even after surgery in patients with enlarged prostate |
|
Scientific Title of Study
|
Predictors of persistent lower urinary tract symptoms post TURP: a prospective study |
| 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. Ankit Agarwal |
| Designation |
Registrar, Department of Urology, KMC, Manipal |
| Affiliation |
Kasturba Medical college, Manipal |
| Address |
Opd no. 14, Department of urology and Renal Transplant, KMC, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
7983162244 |
| Fax |
|
| Email |
ankitag421@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Arun Chawla |
| Designation |
Professor, Department of Urology |
| Affiliation |
Kasturba Medical college, Manipal |
| Address |
Opd no. 14, Department of Urology and Renal Transplant, KMC, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9008002440 |
| Fax |
|
| Email |
arun.chawla@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
ANKIT AGARWAL |
| Designation |
Registrar, Department of Urology, KMC, Manipal |
| Affiliation |
Kasturba Medical college, Manipal |
| Address |
Opd no. 14, Department of Urology and Renal Transplant, KMC, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
7983162244 |
| Fax |
|
| Email |
ankitag421@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College, Manipal |
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College Manipal |
| Address |
Opd no 14, Department of Urology and Renal Transplant, KMC, Manipal |
| 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 Ankit Agarwal |
Kasturba Medical College, Manipal |
Opd no. 14, Department of Urology and Renal Transplant, Manipal
Udupi
KARNATAKA |
7983162244
ankitag421@gmail.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 |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Male |
| Details |
Patients undergoing TURP
1.Severe LUTS with failed medical management
2.AUR which is refractory or recurrent
3.CUR which is either LPCR, HPCR
4.Vesical calculi, recurrent UTIs, recurrent hematuria which are BPE related complications
|
|
| ExclusionCriteria |
| Details |
1.Previous prostate surgery
2.Urethral stricture
3.Prostate cancer
4.TCC Bladder
5.Persistent LUTS due to TURP complications like bladder neck contracture, urethral stricture, inadequate resection
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Following clinical and urodynamic variables will be compared between the patients of two groups – Persistent LUTS or No LUTS, to preoperatively predict persistence of LUTS.
1.Mean age and comorbidity
2.Pre and post-operative IPSS (including sub score IPSS-S, IPSS-V), QoL
3.Prostatic volume and IVPP
4.Uroflowmetry – Qmax, PVR
5.UDS (wherever indicated)
|
Baseline and 3 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To look what modality of treatment is offered to the patients which presented with persistent LUTS post TURP |
3 months |
|
|
Target Sample Size
|
Total Sample Size="114"
Sample Size from India="114"
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)
|
01/03/2024 |
| 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 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
|
· The present study will include 114 patients presenting to Kasturba Hospital, Manipal with Bothersome LUTS and undergoing TURP after meeting the inclusion and exclusion criteria. Informed consent will be obtained for collection of data in patient’s own vernacular language. Detailed history and clinical examination will be done. · Patient’s predominant symptom, age, BMI, any comorbidity, DRE findings will be noted. Further preoperative workup will be done – including IPSS (including sub score IPSS-S, IPSS-V) and QoL, USG KUB to look for prostate size and IVPP, Uroflowmetry with PVR, UDS (if indicated). · Patient will undergo TURP. Intraoperative findings and HPE will be noted. · Patient will be followed up at 3rd month. · At follow up patient will be divided into two groups – Patients with persistent bothersome LUTS or patient with No LUTS · Patients having persistent bothersome LUTS post TURP will be evaluated with thorough history and physical examination including IPSS (including sub score IPSS-S, IPSS-V), QoL, Urine culture. Noninvasive uroflowmetry with post-void residual, and subsequent urodynamic study or cystoscopy will be utilized as needed. · Patients having persistent LUTS related to TURP complications will be excluded from study. · Statistical analysis will be done between the two groups to find the predictors of persistence LUTS post TURP. |