Urethral stricture MedDRA version: 26.0 Level: LLT Classification code 10046466 Term: Urethral stricture System Organ Class: 10038359 - Renal and urinary disorders
Conditions
Interventions
Trade Name: MukoCell®
Product Name: MukoCell®
Pharmaceutical Form: Implant
Sponsors
MukoCell GmbH
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Signed declaration of consent and data protection declaration obtained prior to any trial-specific procedures 2. Male patient aged =18 and =75 years 3. Urethral stricture fulfilling the following criteria: - Medical need for urethroplasty - Located pre-dominantly bulbar - No more than 3 previous urethrotomies Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 120 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 80
Exclusion criteria
Exclusion criteria: 1. Any urethroplasty in the past 2. Presence of solely penile stricture 3. Penile /urethral abnormality (e.g. hypospadia, penile curvature, etc.) interfering with study related assessments 4. Lichen sclerosis 5 Previous radiation therapy or laser treatment of the urethral region 6. Acute or chronic urethritis, presence of balanitis 7. Acute or chronic infections in the oral cavity 8. Presence of urologic disease(s) interfering with urination 9. Concomitant therapy with medications that may lead to urinary retention (e.g. anticholinergics etc.) 10. Severe liver or kidney disease 11. Severe somatopathic, neurological and /or psychiatric disease(s) 12. Malignant growth (concurrent or previous cancer with a relapse-free and treatment-free interval of less than 5 years before the Screening visit)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare tissue-engineered oral mucosa graft (MukoCell®) urethroplasty vs. native oral mucosa graft urethroplasty with respect to the 12-month recurrence rate (treatment failure rate) and long-term complication rate at the donor site;Secondary Objective: •To demonstrate the superiority of oral mucosal cell harvesting for TEOMG (MukoCell®) urethroplasty vs. native OMG urethroplasty with respect to short-term and mid-term complications at the donor site •To compare TEOMG (MukoCell®) urethroplasty vs. native OMG urethroplasty with respect to the 24-month recurrence rate (treatment failure rate) und long-term complication rate at the donor site •To evaluate safety and tolerability of TEOMG (MukoCell®) urethroplasty vs. native OMG urethroplasty. ;Primary end point(s): Recurrence rate (treatment failure rate) up to Visit 8 (12 months [±2 weeks] after urethroplasty): The primary endpoint of the clinical trial is the recurrence rate (treatment failure rate) up to Visit 8, defined as the percentage of patients with a need for an intervention due to a medically relevant restenosis of urethra at the operated site diagnosed up to 12 months [±2 weeks] after urethroplasty. An intervention is defined as another urethroplasty or urethrotomy in the area of the initial urethroplasty conducted at the beginning of this clinical trial. Note: An intervention due to an anastomosis stricture is not counted as an intervention for the primary endpoint. ;Timepoint(s) of evaluation of this end point: 12 months after urethroplasty | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Ad 1: 4 days after harvesting of oral mucosal cells / native OMG Ad 2: 30 days after harvesting of oral mucosal cells / native OMG Ad 3: 24 months after harvesting of oral mucosal cells / native OMG Ad 4: 24 months after urethroplasty Ad 5: 1 month after urethroplasty Ad 6: 1, 6, 12 and 24 months after urethroplasty Ad 7: 1, 6, 12 and 24 months after urethroplasty;Secondary end point(s): 1. Short-term donor site complication rate The calculation includes all patients with at least one solicited adverse reaction (reaction to harvesting of oral mucosa) at the donor site of moderate or severe intensity (rating scores 2 or 3) (i.e. donor site complications with onset =4 days after harvesting of oral mucosal cells /native OMG). 2. Mid-term donor site complication rate The calculation includes all patients with at least one solicited adverse reaction (reaction to harvesting of oral mucosa) at the donor site of moderate or severe intensity (rating scores 2 or 3) newly reported or ongoing defined as donor site complications occurring >4 days to <30 days after harvesting of oral mucosal cells /native OMG. 3. Long-term donor site complication rate The calculation includes all patients with at least one solicited adverse reaction (reaction to harvesting of oral mucosa) at the donor site of moderate or severe intensity (rating scores 2 or 3) newly reported or ongoing defined as donor site complications occurring =30 days to =24 months [±2 weeks depending on Visit 10] after harvesting of oral mucosal cells /native OMG). 4. Recurrence rate (treatment failure rate) up to Visit 10 (24 months [±2 weeks] after urethroplasty) 5. Change in mean uroflowmetry peak flow rates from baseline to 1 month after urethroplasty (Visit 1 vs. Visit 6) 6. Change in mean QoL-US score from baseline to 1, 6, 12, and 24 month(s) after urethroplasty (Visit 1 vs. Visits 6, 7, 8, and 10, respectively) 7. Change in mean QoL-DSS score from basel | — |
Countries
Germany, Switzerland
Contacts
Public ContactBioMedizinzentrum Dortmund
MukoCell GmbH
Outcome results
None listed