Tissue-engineered Construct Based on Buccal Mucosa Cells and Matrix From Collagen and Polylactoglycolide Fibers
- Conditions
- Urethral Stricture
- Interventions
- Procedure: Urethroplasty with a tissue-engineered construct
- Registration Number
- NCT03205670
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 6
- 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
- Post traumatic urethral strictures
- Subtotal and total urethral strictures
- Sexually transmitted infections
- Hypersensitivity to any components of tissue-engineered constructs
- Any clinical state which does not ensure the safe implementation of study procedure (investigator's view)
- Other associated urethral strictures
- Laboratory markers of active urethritis
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Urethroplasty with a tissue-engineered construct Urethroplasty with a tissue-engineered construct The investigators will take a sample of the buccal mucosa to isolate epithelial cells. Autologous cells will be seeded on a hybrid matrix. Urethroplasty with this tissue-engineered construct will be performed. This is a single arm study with no control. All patients will undergo the surgical operation.
- Primary Outcome Measures
Name Time Method Serious adverse events 4 weeks after surgery Frequency, type and severity of serious adverse events (SAE)
Serious adverse reactions 4 weeks after surgery Frequency, type and severity of serious adverse reactions (SAR)
- Secondary Outcome Measures
Name Time Method Pericatheter urethrography 4 weeks after surgery Assessment of absence or presence of contrast medium leakage outside the urethra
Urodynamic changes via uroflowmetry - 4 5 years Influence of the surgery on urinary flow rate: maximum flow time
Biopsy 4 months after surgery Control of anatomical urethral structure in the intervention place
Quality of life monitoring - 1 5 years Quality of life estimated by validated questionnaires: Short Form (SF-36)
Voiding cystourethrography 5 years Full assessment of the urethral lumen after the surgery
Urodynamic changes via uroflowmetry - 2 5 years Influence of the surgery on urinary flow rate: average flow rate
Urodynamic changes via uroflowmetry - 1 5 years Influence of the surgery on urinary flow rate: maximum flow rate
Urodynamic changes via uroflowmetry - 3 5 years Influence of the surgery on urinary flow rate: total volume voided
Quality of life monitoring - 2 5 years Quality of life estimated by validated questionnaires: International Prostatic Symptom Score (IPSS)
Retrograde urethrography 5 years Influence of the surgery on the urethral lumen
Trial Locations
- Locations (1)
Sechenov University
🇷🇺Moscow, Russian Federation