A Single-Centre, Validation Study to Evaluate the Safety and Efficacy of Autologous UrethralTransplant in Patients with Urethral Strictures more than 1 cm in length
- Conditions
- Health Condition 1: null- Male patients with urethral strictures more than 1 cm in length who have failed traditionalUrethroplasty procedure(s)
- Registration Number
- CTRI/2010/091/000656
- Lead Sponsor
- DrKNSridhar SRI RESEARCH FOR TISSUE ENGINEERING
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- Not specified
- Target Recruitment
- 25
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
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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To establish the efficacy of the procedure, Urethroplasty using Autologous Urethral Trasplant. <br/ ><br>To determine efficacy by the absence of intervention in a six month period following UrethroplastyTimepoint: Clinical outcome will be considered successful <br/ ><br>ï?· If no postoperative procedure (including self intermittent catheterization) will be needed for a <br/ ><br>period of 6 months, post re-implantation. <br/ ><br> <br/ ><br>;To establish the efficacy of the procedure, Urethroplasty using Autologous Urethral Trasplant. <br/ ><br>To determine efficacy by the absence of intervention in a six month period following UrethroplastyTimepoint: Clinical outcome will be considered successful <br/ ><br>ï?· If no postoperative procedure (including self intermittent catheterization) will be needed for a <br/ ><br>period of 6 months, post re-implantation. <br/ ><br> <br/ ><br>
- Secondary Outcome Measures
Name Time Method 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 <br/ ><br>visit IX (end of 6months) in the <br/ ><br>ï?· Urine flow rate <br/ ><br>ï?· Post void residual volume <br/ ><br>ï?· AUA score (American Urology Association Symptom score) <br/ ><br>ï?· Quality of life Questionnaire score