| CTRI Number |
CTRI/2024/01/061636 [Registered on: 19/01/2024] Trial Registered Prospectively |
| Last Modified On: |
18/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Histopathology of Female Urethral Strictures
|
|
Scientific Title of Study
|
Histologic Analysis of Female Urethral Strictures Following Dorsal On lay Buccal Mucosal Graft Urethroplasty
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prasanna Ram |
| Designation |
Senior Resident |
| Affiliation |
AIIMS Bhubaneswar |
| Address |
Department of Urology, Room no 244, Patradapa, Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
9686559576 |
| Fax |
|
| Email |
dr.praspr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prasanna Ram |
| Designation |
Senior Resident |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of urology, room o 244, All India Institute of Medical Sciences, Patradapa, Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
9686559576 |
| Fax |
|
| Email |
dr.praspr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prasanna Ram |
| Designation |
Senior Resident |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of urology, room no 244, All India Institute of Medical Sciences, Patradapa, Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
9686559576 |
| Fax |
|
| Email |
dr.praspr@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Bhubaneswar |
| NIL |
|
|
Primary Sponsor
|
| Name |
Department of Urology |
| Address |
All India Institute of Medical Sciences, Patradapa, Bhubaneswar |
| 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 |
| Dr Sambit Tripathy |
All India Institute of Medical SCiences |
Department of Urology, Room no 244, All India Institute of Medical Sciences, Patradapa, Bhubaneswar
Khordha
ORISSA |
9686559576
urol_sambit@aiimsbhubaneswar.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC AIIMS Bhubaneswar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N359||Urethral stricture, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Female |
| Details |
1. Females aged 18 years or above with urethral stricture disease confirmed by uroflowmetry and cystoscopy.
2. Females who undergo a dorsal onlay buccal mucosal graft urethroplasty.
3. Written informed consent.
|
|
| ExclusionCriteria |
| Details |
1. Patients who have undergone surgery for urethral stricture disease previously
2. Patients in whom ventral BMGU is performed.
3. Patients with STDs
4. Patients with genitourinary anomalies
5. Patients who have had surgery for hypertrophy of the bladder neck
6. Patients who have had radiation to the pelvis
7. Patients with bladder malignancies
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| a)Evaluation for epithelial hyperplasia and cell type |
10 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
a) To evaluate the presence of mucosal oedema
b) To evaluate the degree of fibroblast/inflammatory cell infiltrate
c) To evaluate the elastin fibre distribution.
|
baseline, 4 weeks |
|
|
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)
|
06/02/2024 |
| 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="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
|
There is no literature
with regard to the histopathology of female urethral stricture disease
currently. In a recent study by Ram
Pathak et al of 9 patients who underwent urethroplasty, 67 % of the patients had stratified squamous
epithelium overlying fibrosis, while 29% showed acute injury with prominent
squamous papillary hyperplasia. While many studies have looked into the pathophysiology
of Urethral Stricture Disease in males and suggested that chronic inflammation
and Lichen’s Sclerosis are the most common findings, there is a huge paucity of
data with regard to females. Here, we look to present the pathologic
analysis of female urethral stricture disease. |