| CTRI Number |
CTRI/2025/07/091030 [Registered on: 16/07/2025] Trial Registered Prospectively |
| Last Modified On: |
02/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Other (Specify) [Academic Study] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A novel treatment using hashed buccal mucosa for the treatment of short segment urethral stricture disease |
|
Scientific Title of Study
|
BHES-HAUS-Buccal epithelium Hashed and Encapsulated in Scaffold-Hybrid Approach to Urethral Stricture (BHES-HAUS) procedure |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BHES-HAUS |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vaddi Surya Prakash |
| Designation |
Principal Investigator |
| Affiliation |
Kamineni Academy of Medical Sciences and Research Centre (KAMS&RC) |
| Address |
Department of Urology,
Kamineni Academy of Medical Sciences and Research Centre (KAMS&RC),
L.B Nagar.
Hyderabad
TELANGANA
500068
India |
| Phone |
9490166130 |
| Fax |
|
| Email |
suryaprakashuro@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vaddi Surya Prakash |
| Designation |
Principal Investigator |
| Affiliation |
Kamineni Academy of Medical Sciences and Research Centre (KAMS&RC) |
| Address |
Department of Urology,
Kamineni Academy of Medical Sciences and Research Centre (KAMS&RC),
L.B Nagar.
TELANGANA
500068
India |
| Phone |
9490166130 |
| Fax |
|
| Email |
suryaprakashuro@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vaddi Surya Prakash |
| Designation |
Principal Investigator |
| Affiliation |
Kamineni Academy of Medical Sciences and Research Centre (KAMS&RC) |
| Address |
Department of Urology,
Kamineni Academy of Medical Sciences and Research Centre (KAMS&RC),
L.B Nagar.
TELANGANA
500068
India |
| Phone |
9490166130 |
| Fax |
|
| Email |
suryaprakashuro@gmail.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Dr. Vaddi Surya Prakash
Department of Urology, Kamineni Academy of Medical Sciences and Research Centre (KAMS&RC), L.B Nagar. Hyderabad
TELANGANA - 500068
India |
|
|
Primary Sponsor
|
| Name |
Dr Vaddi Surya Prakash |
| Address |
Kamineni Academy of Medical Sciences and Research Centre (KAMS&RC)
L.B Nagar, Hyderabad,
Telangana, India-500068. |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pavani |
Kamineni Academy of Medical Sciences and Research Centre |
Department of Pathology
Kamineni Academy of Medical Sciences and Research Centre (KAMS&RC),
L.B Nagar
Hyderabad
TELANGANA |
9652105709
pavanipeter@gmail.com |
| Dr Sandeep Kumar Reddy D |
Kamineni Academy of Medical Sciences and Research Centre |
OP No 4. Department of Urology,
Kamineni Academy of Medical Sciences and Research Centre (KAMS&RC),
L.B Nagar
Hyderabad
TELANGANA |
9100680309
sandyreddy19@gmail.com |
| Dr Vaddi Surya Prakash |
Kamineni Academy of Medical Sciences and Research Centre |
OP No 4. Department of Urology,
Kamineni Academy of Medical Sciences and Research Centre (KAMS&RC),
L.B Nagar
Hyderabad
TELANGANA |
9490166130
suryaprakashuro@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Kamineni Academy of Medical Sciences and Research Centre |
Approved |
| Institutional Ethics Committee, Kamineni Academy of Medical Sciences and Research Centre |
Approved |
| Institutional Ethics Committee, Kamineni Academy of Medical Sciences and Research Centre |
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 |
BHES-HAUS (Buccal epithelium Hashed and Encapsulated in Scaffold-Hybrid Approach to Urethral Stricture) |
This is a novel surgical treatment intended to treat and possibly prevent recurrence of urethral stricture.
Surgery is to be performed on patients with anterior urethral strictures and followed up for a period of 12 months from the date of surgery. |
| Comparator Agent |
None. Non comparative study. |
None. Non comparative study. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. All patients aged above 18 years with less than 2 cm stricture of anterior urethra. |
|
| ExclusionCriteria |
| Details |
1. Multiple strictures
2. Long Segment stricture
3. Radiation induced stricture
4. Penile or posterior urethral stricture
5. Donor site unavailability (tobacco chewers, submucosal fibrosis, previous oral surgery)
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of this novel treatment for urethral stricture disease. |
1. International Prostate Symptom Score (Pre Surgery, Post Surgery - 3 weeks, 3 months, 6 months, 12 months)
2. Uroflowmetry (Pre Surgery, Post Surgery - 3 weeks, 3 months, 6 months, 12 months)
3. Ultrasound KUB with PVR (Pre Surgery, Post Surgery - 6 months)
4. Retrograde Urethrogram (12 Months)
5. Cystoscopy (12 Months)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the stricture recurrence following BHES-HAUS. |
Follow up of 1 year |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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)
|
28/07/2025 |
| 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="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
|
Study Design : An Open Label, Prospective, Non-Randomised, Non-Comparative, Single Arm Study. Indication : Urethral Stricture Disease Investigational Treatment Modality : BHES-HAUS Surgical Procedure Comparator : None. Non comparative study. Follow Up Duration : 1 year following surgery. Subject Population : 15 subjects with anterior urethral stricture Assessments
1. International Prostate Symptom Score
2. Complete Urine Examination
3. Urine Culture
4. Uroflowmetry
5. Ultrasound
6. Retrograde Urethrogram
Background of the study: Direct
vision internal urethrotomy (DVIU) and Urethroplasty are the two most common
treatment options for anterior urethral strictures. While DVIU is the preferred
treatment option for short segment strictures less than 2 cm, its long-term
success rate is dismal and varies from 9% to 30% among the various series.
Substitution Urethroplasty using oral mucosal graft is known to have higher
success rates than DVIU. However, due to its steep learning curve, longer
operative times, donor site morbidity, bleeding, the risk for erectile or
ejaculatory dysfunction, wound infection, it is typically reserved for long,
recurrent, or complex urethral strictures. Various techniques have been
described to deliver the cellular graft to the stricture site endourethrally.
Kulkarni et al. used the “live-cultured buccal epithelial cell,” and Vaddi et
al. used the “buccal epithelium expanded and encapsulated in scaffold-hybrid
approach.” In the first report of liquid buccal mucosal graft endourethral
urethroplasty (LBMGU) technique by Nikolavsky et al., a minced buccal graft was
suspended in a liquid aliquot and delivered under vision with an endoscope over
a urinary catheter after DVIU in an animal model. Successful grafting through
an endoscopic approach would eliminate the morbidity of open surgery and reduce
the failure rates of DVIU.
Rationale : The Buccal epithelium Hashed
and Encapsulated in Scaffold-Hybrid Approach to Urethral Stricture (BHES-HAUS)
is a tissue engineering-based cell therapy procedure that is completely
endoscopic and is a much less morbid procedure. In this procedure, autologous
buccal epithelial cells obtained by hashing the buccal tissue and encapsulated
in TGP scaffold are implanted at the stricture site after a wide endoscopic urethrotomy
to form an epithelial layer. This procedure is a one-day procedure wherein no
culture of the cells is involved. It takes place completely in the operation
theatre.
|