Comparison of outcome of augmentation urethroplasty versus incision urethrotomy in females with urethral stricture disease – A randomized controlled trial
Overview
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- AIIMS PATNA
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Evaluate and compare the outcomes of augmentation urethroplasty and incision urethrotomy in resolving urethral stricture in females. This includes assessing improvement in urinary symptoms (AUA symptom score betterment), restoration of normal urinary flow (Qmax more than 15 ml/sec) and reduction in PVR (to less than 100ml)
Overview
Brief Summary
My thesis is to compare outcomes of augmentation urethroplasty with incision urethrotomy in females with urethral stricture. I will be including female patients in the age group of 18 years to 75 years, who were diagnosed with urethral strictutre clinically and radiologically. Patients will be randomely allotted into two groups by block randomization method, one group will undergo augmentation urethroplasty and other will undergo incision urethrotomy. I will be comparing the outcomes of both above mentioned procedures at 3 months and 6 months like symptomatic improvement and recurrence of stricture.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 75.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •Those who belong to above mentioned age group and having urethral stricture proven either by clinical or radiological evidence, who are ready to give consent.
Exclusion Criteria
- •Age not belonging to inclusion criteria, those who are not giving consent for surgery, patients with neurogenic bladder, genital prolapse and previous surgeries for urethral stricture will be excluded.
Outcomes
Primary Outcomes
Evaluate and compare the outcomes of augmentation urethroplasty and incision urethrotomy in resolving urethral stricture in females. This includes assessing improvement in urinary symptoms (AUA symptom score betterment), restoration of normal urinary flow (Qmax more than 15 ml/sec) and reduction in PVR (to less than 100ml)
Time Frame: At 3 months and 6 months postoperatively
Secondary Outcomes
- To compare short term recurrence (6 months) of urethral stricture after augmentation urethroplasty and incision urethrotomy(6 months)
Investigators
Dr Bibin Sunny
AIIMS Patna