| CTRI Number |
CTRI/2024/08/073034 [Registered on: 28/08/2024] Trial Registered Prospectively |
| Last Modified On: |
10/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluation of surgical management of bladder outlet obstruction in females. |
|
Scientific Title of Study
|
Bladder outlet obstruction in females- A comprehensive assessment of etiologies, diagnostic approach and surgical outcomes.
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Skandh Bhatia |
| Designation |
M.Ch. UROLOGY RESIDENT |
| Affiliation |
Department of Urology, Gandhi Medical College, Bhopal |
| Address |
Department of Urology, 2nd floor, H-2 Block, Hamidia Hospital, Gandhi Medical College, Bhopal-462001
Bhopal
MADHYA PRADESH
462001
India |
| Phone |
8827217235 |
| Fax |
|
| Email |
skandhbhatia4@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Saurabh Jain |
| Designation |
Professor and Head of Department |
| Affiliation |
Department of Urology, Gandhi Medical College, Bhopal |
| Address |
Department of Urology, 2nd floor, H-2 Block, Hamidia Hospital, Gandhi Medical College, Bhopal-462001
Bhopal
MADHYA PRADESH
462001
India |
| Phone |
9971902853 |
| Fax |
|
| Email |
grabsaurabh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Skandh Bhatia |
| Designation |
M.Ch. UROLOGY RESIDENT |
| Affiliation |
Department of Urology, Gandhi Medical College, Bhopal |
| Address |
Department of Urology, 2nd floor, H-2 Block, Hamidia Hospital, Gandhi Medical College, Bhopal-462001
Bhopal
MADHYA PRADESH
462001
India |
| Phone |
8827217235 |
| Fax |
|
| Email |
skandhbhatia4@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Urology, 2nd floor, H-2 Block, Hamidia Hospital, Gandhi Medical College, Bhopal-462001, Madhya Pradesh, India |
|
|
Primary Sponsor
|
| Name |
Dr Skandh Bhatia |
| Address |
Department of Urology, 2nd floor, H-2 Block, Hamidia Hospital, Gandhi Medical College, Bhopal-462001, Madhya Pradesh, India |
| Type of Sponsor |
Other [Self] |
|
|
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 Skandh Bhatia |
Hamidia Hospital, Gandhi Medical College, Bhopal |
Department of Urology, 2nd floor, H-2 Block, Hamidia Hospital, Gandhi Medical College, Bhopal-462001
Bhopal
MADHYA PRADESH |
8827217235
skandhbhatia4@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, GANDHI MEDICAL COLLEGE, BHOPAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N320||Bladder-neck obstruction, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NOT APPLICABLE |
| Comparator Agent |
NIL |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Female |
| Details |
All females presenting with obstructive lower urinary tract symptoms(LUTS) diagnosed with bladder outlet obstruction requiring intervention.
|
|
| ExclusionCriteria |
| Details |
Patients with:
Neurogenic bladder
Dysfunctional voiding
Pelvic organ prolapse
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in patient symptoms measured objectively by Uroflowmetry.
Uroflowmetry: Maximum flow rate and average flow rate in ml/sec.
|
3 weeks, 3 months, 6 months after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in patient symptoms measured subjectively by a self-administered IPSS (International Prostate Symptom Score) score. |
3 weeks, 3 months, 6 months after surgery |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
06/09/2024 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
In this single center longitudinal study, we will evaluate all females presenting to the Urology out-patient department with lower urinary tract symptoms. After a detailed history, physical examination, radiological assessment, patients diagnosed with bladder outlet obstruction will be recruited for the study and will undergo the necessary surgical procedure for the bladder outlet obstruction. Patients will be followed up at a 6-week, 3-month and 6-month interval after surgery to note the urinary flow rate by Uroflowmetry and a self-administered questionnaire to assess improvement. |