Urethral Stricture
Conditions
Brief summary
The field of research for this study is tissue engineering and the utilization of a bioengineered collagen implant as a substitute biomaterial for conventional buccal mucosa in substitution urethroplasty of distal urethral strictures.
Detailed description
Urethral stricture is defined as the abnormal narrowing of the urethral lumen in the area of the corpus spongiosum. A stricture is the result of ischemic spongiofibrosis manifesting as scar tissue in the corpus spongiosum. Long-term consequences are chronic fistulation through the skin, recurrent sepsis, bladder stones, obstructive uropathy, obstructive nephropathy, and finally renal failure. Current available surgical techniques for urethral stricture repair require harvesting of grafts from autologous sites resulting in additional risks of complications at the tissue harvest site and additional pain to the patient. The hypothesis of this study is that the developed bioengineered collagen implant can be used as an alternative biomaterial to buccal mucosa for substitution urethroplasty in urethral stricture patients.
Interventions
DEVICEBioengineered collagen implant
Urethral stricture repair
Sponsors
Regenosca SA
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adult males with urethral stricture less than 3 cm (anywhere from penile to bulbar urethra not including the membranous urethra) with existing lumen of at least 6 Fr suitable for augmentation urethroplasty. The stricture may be due to trauma or infection.
Exclusion criteria
* Known bovine collagen allergy * Current urinary tract infection * Chronic renal failure * Diabeted * Neurological diseases * Chronic obstructive pulmonary diseases * Sleep disturbances * Depression * Former cancer treatment * Smokers * Recurrent stricture
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Urethral patency | four weeks post-surgery | A peri-urethrogram will be performed prior to catheter removal. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Voiding symptoms | two months up-to twenty-four months post-surgery | Participants are filling out the International Prostate Symptom Score (IPSS) questionnaire. |
| Urine flow | two months up-to twenty-four months post-surgery | Participants are undergoing an uroflowmetry. This test measures the volume of urine released from the body, the speed with which it is released, and how long the release takes. |
Countries
Malaysia
Contacts
PRINCIPAL_INVESTIGATORTeng Aik Ong, Prof
University of Malaya Medical Center
Outcome results
None listed