Health Condition 1: null- Male patients with urethral strictures more than 1 cm in length who have failed traditional Urethroplasty procedure(s)
Conditions
Interventions
Intervention1: Autologous Urethral Transplant: Nil
Control Intervention1: Nil: Nil
Sponsors
DrKNSridhar SRI RESEARCH FOR TISSUE ENGINEERING
Lotus Clinical Research Academy
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male patients with history of Urethral stricture > 1 cm in length at the anterior urethra 2. Undergone prior Urethroplasty or periodical dilatation and catheterization (more than 2 interventions in 1 year). The latest surgical procedure or dilatation should have taken place at least 3 weeks before study enrolment. 3. Age > 18 years 4. Willing to give Informed Consent
Exclusion criteria
Exclusion criteria: 1. Patients with urethral Strictures less than 1 cm in length 2. History of any prior surgery with autologous urethral transplant 3. Diabetes 4. Bleeding Disorders 5. Malignancy 6. Positive for HBsAg, HCV, or HIV testing 7. Use of Steroids or other immunosuppressant treatments 8. Clinical evidence of Collagen Vascular Disorder 9. Nutritional disorders like Severe Protein Deficiency (serum albumin < 3 g/dL) 10. Severe anemia (Hemoglobin < 6 g/dL)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To establish the efficacy of the procedure, Urethroplasty using Autologous Urethral Trasplant. To determine efficacy by the absence of intervention in a six month period following UrethroplastyTimepoint: Clinical outcome will be considered successful ï?· If no postoperative procedure (including self intermittent catheterization) will be needed for a period of 6 months, post re-implantation. ;To establish the efficacy of the procedure, Urethroplasty using Autologous Urethral Trasplant. To determine efficacy by the absence of intervention in a six month period following UrethroplastyTimepoint: Clinical outcome will be considered successful ï?· If no postoperative procedure (including self intermittent catheterization) will be needed for a period of 6 months, post re-implantation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety of the procedure will be evaluated during the study.Timepoint: The secondary efficacy end points will be determined by percentage change from baseline to visit IX (end of 6months) in the ï?· Urine flow rate ï?· Post void residual volume ï?· AUA score (American Urology Association Symptom score) ï?· Quality of life Questionnaire score | — |
Countries
India
Contacts
Public ContactDr.K.N.Sridhar
Outcome results
None listed