Urethral Stricture
Conditions
Keywords
Mitomycin C - Visual Internal Urethrotomy - Urethral Stricture
Brief summary
To evaluate the effectiveness of administering mitomycin C through intralesional injection after performing visual internal urethrotomy (VIU) for the treatment of recurring urethral stricture.
Detailed description
Numerous studies have investigated the impact of intralesional administration of antifibrotic drugs on urethral strictures following visual internal urethrotomy (VIU). These drugs include mitomycin C, botulinum toxin A, somatostatin analog, and glucocorticoids. Mitomycin C (MMC) is known for its potent chemotherapeutic and antibiotic properties. It effectively hinders mitosis and fibroblast proliferation, playing a crucial role in tissue healing and scar formation by reducing the release of matrix proteins through the inhibition of proliferative fibroblasts. With its anti-proliferative and anti-scarring characteristics, MMC proves to be a suitable option for treating recurrent urethral strictures. thus we conduct a randomized controlled trial to evaluate the safety and efficacy of Mitomycin in decrease urethral stricture recurrence.
Interventions
DRUGMitomycin c
injection of antifibrotic drugs in urethral strictures after internal urethrotomy
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All adult male patients aged above 18 years with a single bulbar urethral stricture measuring less than ( 1.5 cm), and had failed at least one prior intervention for urethral stricture(urethral dilation & VIU) were included in our study
Exclusion criteria
* Patients with urethral strictures more than (1.5 cm), multiple urethral strictures, complex stricture, complicated by a fistula or abscess, completely occluded urethral strictures and previous urethroplasty were excluded
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Urethral stricture recurrence | 1 year | is defined as recurrence of LUTS during follow-up visits starting at 3 months till 12 months with difficulty of passing urine and confirmed by a voiding cystourethrogram. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| urinary tract infection | 1 month | post operative complication confirmed by urine culture |
| uroflowmetery | 1 year | evaluate of the urine flow during the follow up period |
Countries
Egypt
Outcome results
None listed