An Open Prospective Clinical Study on Safety and Efficacy of Surgical Treatment of Patients With Anterior Urethral Stricture Using a Tissue-engineered Construct Based on Autologous Buccal Mucosa Cells and Matrix From Reconstituted Collagen and Reinforcing Polylactoglycolide Fibers
Overview
- Phase
- Early Phase 1
- Intervention
- Not specified
- Conditions
- Urethral Stricture
- Sponsor
- I.M. Sechenov First Moscow State Medical University
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- Serious adverse events
- Last Updated
- 6 years ago
Overview
Brief Summary
This study investigates safety and efficacy of surgical treatment of patients with anterior urethral stricture using a tissue-engineered construct based on autologous buccal mucosa cells and matrix from reconstituted collagen and reinforcing polylactoglycolide fibers. This is a single arm study with no control. Success will be assessed via objective and subjective methods; complications will be tallied in a standardized fashion. Outcomes will be measured at five years.
Detailed Description
Treatment of urethral strictures longer than 2 cm is an actual clinical challenge. In this case, the common method is replacement surgery using a buccal mucosa graft. However, the main disadvantage of this method is associated with limited donor resources and donor site morbidity. The aim of this study is to assess safety and efficacy of surgical treatment of patients with anterior urethral stricture using a tissue-engineered construct. The construct consists of autologous buccal mucosa cells and matrix from reconstituted collagen and reinforcing polylactoglycolide fibers. Patients will be followed up for 5 years within this study. The follow-up regimen includes retrograde and pericatheter urethrography, voiding cystourethrography, uroflowmetry, biopsy, and quality of life monitoring. Telephone follow-up will take place in between these assessments. The data obtained from this study will have practical implications for the urethral stricture treatment and will be based on the principles of evidence-based medicine.
Investigators
Denis Butnaru, MD
Director
I.M. Sechenov First Moscow State Medical University
Eligibility Criteria
Inclusion Criteria
- •Patient signed informed consent form
- •Diagnosed anterior urethral stricture longer than 2.0 cm and shorter than 4.0 cm
- •At least one prior internal optical urethrotomy and/or urethral bougienage
- •Non-inclusion Criteria:
- •Acute infectious diseases
- •Patient with decompensated heart and renal failure
- •Patient with non-compensated diabetes mellitus
- •Patient with malignant tumor
- •Patient with polyvalent allergy
- •Mental disorders
Exclusion Criteria
- •Patient's refusal from the further participation in trial
- •Confirmed syphilis, HIV, hepatitis B or C infections
- •Patient who cannot be regularly examined due to any circumstances
Outcomes
Primary Outcomes
Serious adverse events
Time Frame: 4 weeks after surgery
Frequency, type and severity of serious adverse events (SAE)
Serious adverse reactions
Time Frame: 4 weeks after surgery
Frequency, type and severity of serious adverse reactions (SAR)
Secondary Outcomes
- Pericatheter urethrography(4 weeks after surgery)
- Urodynamic changes via uroflowmetry - 4(5 years)
- Biopsy(4 months after surgery)
- Quality of life monitoring - 1(5 years)
- Voiding cystourethrography(5 years)
- Urodynamic changes via uroflowmetry - 2(5 years)
- Urodynamic changes via uroflowmetry - 1(5 years)
- Urodynamic changes via uroflowmetry - 3(5 years)
- Quality of life monitoring - 2(5 years)
- Retrograde urethrography(5 years)