CTRI

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CTRI Number

CTRI/2025/10/095630 [Registered on: 06/10/2025] Trial Registered Prospectively

Last Modified On:

03/10/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Screening

Study Design

Single Arm Study

Public Title of Study

Role of urine stream testing after surgery for abnormal urinary opening.

Scientific Title of Study

Role of uroflowmetry in hypospadias children and correlation with post op complication.

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 Shilpa V
Designation	Senior resident
Affiliation	BANGLORE MEDICALCOLLEGE AND RESE
Address	Department of Pediatric surgery, Bangalore medical college and Research Institute, K R road, Bangalore 560002 Department of Pediatric surgery, Bangalore medical college and Research Institute, K R road, Bangalore 560002 Bangalore KARNATAKA 560002 India
Phone	9739613174
Fax
Email	shilpashivaranjini95@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Raghu S R
Designation	Professor and Head of the Department
Affiliation	BANGLORE MEDICALCOLLEGE AND RESE
Address	Department of Pediatric surgery, Bangalore medical college and Research Institute, K R road, Bangalore 560002 Department of Pediatric surgery, Bangalore medical college and Research Institute, K R road, Bangalore 560002 Bangalore KARNATAKA 560002 India
Phone	9481101223
Fax
Email	drsrraghu@gmail.com

Details of Contact Person
Public Query

Name	Dr Shilpa V
Designation	Senior resident
Affiliation	BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE
Address	Department of Pediatric surgery, Bangalore medical college and Research Institute, K R road, Bangalore Department of Pediatric surgery, Bangalore medical college and Research Institute, K R road, Bangalore 560002 Bangalore KARNATAKA 560002 India
Phone	9739613174
Fax
Email	shilpashivaranjini95@gmail.com

Source of Monetary or Material Support

NIL

Primary Sponsor

Name	Dr Shilpa V
Address	Department of Pediatric surgery, Bangalore medical college and Research Institute, K R road, Bangalore 560002
Type of Sponsor	Other [self]

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Shilpa V	Bangalore medical college and Research Institute	Pediatric surgery OPD, 3rd Floor, PMSSY Block, 560002 Bangalore KARNATAKA	9739613174 shilpashivaranjini95@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Bangalore medical college and Research Institute Ethics committee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: Q54\|\|Hypospadias,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	NIL	NIL
Intervention	Uroflowmetry	Child is asked to drink water and after feeling urgency, should void in chamber, both pre and post operative period and parameters are assessed using UDS software to identify complications early like stricture urethra

Inclusion Criteria

Age From	2.00 Year(s)
Age To	18.00 Year(s)
Gender	Male
Details	1.Patients who are undergoing hypospadias repair in Pediatric Surgery department. 2.Age more than 2 and half year and are able to void on command.

ExclusionCriteria

Details

• Patients who are undergoing hypospadias repair in Pediatric Surgery department.
• Age more than 2 and half year and are able to void on command.

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
To compare the pre and post operative uroflowmetry and to identify urethral stricture and plan for early intervention	Baseline, 2 weeks, 1 month, 3 months, 6 months.

Secondary Outcome

Outcome	TimePoints
nil	nil

Target Sample Size

Total Sample Size="36"
Sample Size from India="36"
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)

20/10/2025

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

Hypospadias is one of the most common congenital abnormalities of the male genital tract. The word hypospadias is derived from the words ‘hypo’ (down) and ‘spadon’ (split, hole) in Latin. The urethra opens to a region more proximal to the end portion of the glans penis than normal in these cases. The incidence is˜1 in 300 liveborn boys [1–3].

Uroflowmetry is a simple and non invasive investigation

used in the evaluation of urinary stream and urethral

and bladder function.[4] A normal uroflow curve mostly

excludes anatomical urethral obstruction as well as functional voiding disturbances.[5] Considering that most patients with hypospadias have normal bladder contractility, we believe that any abnormalities in urinary flow rates, as well as the shape of the flow curve in these patients, would reflect abnormal urethral function.[6] Previous studies have showed that post hypospadias repair, obstructive pattern in uroflowmetry is demonstrated in varying number of cases (7-67%) [7] Reasons for this could be meatal stenosis, urethral stricture, lack of muscle covering the neourethra or scar tissue preventing distensibility of neo urethra.