Use of intra-urethral steroid clobetasol cream to prevent the recurrence of urethral stricture after optical urethrotomy: Randomized clinical trial Mediscope

Background: One of the most frequently used treatments of urethral strictures is the optical internal urethrotomy (OIU). About 20%-60% of urethral stricture patients develop recurrent stricture after Urethrotomy. Glucocorticoids have proved anti-proliferative effect and thereby used to reduce the formation of scar tissue. In urethral stricture, the main pathology is scar tissue formation. Objective: The aim of this study is to see the influence the local application of steroid clobetasol cream after Urethrotomy. Method: Between January to December 2016, all Bulbar urethral stricture patients attended to the hospital and private clinics, were included in this study. They were placed in two groups alternatively. They underwent standard OIU. First group (35 patients) offered clean intermittent self-catheterization (CISC) postoperatively without any steroid cream in urethra. The second group (35 patients) practiced CISC in the same way but used clobetasol cream with catheter. Both groups used topical anaesthesic Lidocain HCL for lubrica-tion of urethra. Result: No patient developed recurrence with clobetasol cream after 3 months, but two patients developed recurrence without steroid. At 6 months, this result is 6 (17.14%) and 10 (28.57%) accordingly. Conclusion: Topical steroid clobetasol cream reduces urethral stricture recurrence.

ing countries. 4 Iatrogenic injuries, such as oversized resectoscope at the time of transurethral surgery and traumatic placement of indwelling urinary catheters, account for 45 percent of all cases. 5 Urethral stricture is one of the most difficult urological problems to heal adequately and many surgical and non surgical techniques have been described to its management. 6 The use of various antifibrotic substances during the endoscopic procedure have also been describe by many authors -corticosteroids, botulinum toxin, hyaluronic acid, captopril gel and mitomycin C among others. 7 Urethral stricture disease has always been a challenge for urologists. Different treatment modalities that are used for treatment of urethral stricture disease are dilatation, urethrotomy, stent placement, and urethroplasty. Steenkamp et al. have found no significant difference in efficacy between dilation and internal urethrotomy as initial treatment of strictures. 8 The male anterior urethra stricture (US) is characterized by a fibrotic process which achieves varying degrees of peri-urethral spongiosum tissue fibrosis (spongiofibrosis) associated with a decrease in urethral caliber and consequently in the urine flow. Endoscopic treatment is based on the deep incision of the fibrotic area and subsequently local reepithelization process to the maintenance of the urethral patency. 9 Management of US is a challenge for Urologists. Different modalities of treatment -used for Urethral Stricture disease are Dilatation, Urethrotomy (OIU) and Urethroplasty. Recurrent Urethral Stricture is most common late post-operative complication. Low success rate and high recurrence rate encouraged the urologists to use different adjuvant agents. The agents used to reduce US recurrence are intralesional steroid injection (triamcinolone acetate), Hyaluronidase and Mitomycin C. Although, intralesional steroid injection has been shown to provide good results after Urethrotomy, but it is difficult to inject steroid intralesionally. It needs help of doctor every time. But clean intermittent self catheterization (CISC) is common practice after Urethrotomy and performed by the patient himself. Few study has evaluated the efficacy of tropical steroid clobetasol cream after urethrotomy (OIU).

Methods:
The study conducted at Khulna Medical College Hospital and some private hospitals of Khulna and Dhaka.

Study Design: Randomized clinical trial.
Study period: January 2016 to December 2016 (total 12 months).
Study population includes urethral stricture (US) which is less than 2 cm in length. The stricture length was measured by both preoperative retrograde-urethrogram and endoscopic evaluation.
Exclusion criteria: >2 cm stricture, post-TURP US, neurogenic bladder with US, associated Balanitis Xerotica Obliterance (BXO), previous OIU or dilatation and patients with previous corticosteroid therapy were excluded from this study.
Pre-operative Evaluation: All patients were evaluated by details history, physical examination, Retrograde urethrogram (RGU) and urethroscopy. Pre-operative antibiotic Ceftriaxazone 1gm daily injected half an hour before OIU. A glide wire (0.035") passed through the narrow lumen under spinal anaesthesia. Using cold knife -incision was made only at 12�clock position of stricture site to avoid spongio-cavernous fistula. Only fibrous tissue was cut, normal healthy urethra remained intact. 16fr Foly Bardia catheter kept in situ for 7days. After removal of catheter patients were followed up after 1 month, 3 months and 6 months.
Patients were placed in two groups. Every Odds (Group-A) selected for tropical clobetasol cream (Clovate.05% cream, ACI pharmaceuticals) with 14fr Nelaton catheter during clean intermittent self-catheterization (CISC) and Lidocaine HCL jelly in the urethra. Every even numbers (Group-B), in which patients have not given clobetasol cream to lubricate the catheter, but used tropical anaestia Lidocain HCL jelly in urethra to lubricate. The schedule of CISC was twice a week for six months with 14fr Nelaton Catheter. Patients were followed with history, physical examination, urinalysis and Uroflowmetry at 1 month, 3 month and 6 month. Uroflow pattern assured for improvement of flow pattern after OIU. Flow rate <10ml/sec with bothersome symptoms should suspect for recurrence and confirmed with Retrograde Urethrogram (RGU) and Urethroscopy. Recurrence was defined as a need for repeat of surgical intervention during the follow-up period.

Result:
Number of patients underwent OIU =81. Of them 11 patients lost from follow-up. Each group has 35 patients.

Q-max) of the patients
Mean pre-operative maximum flow rate was found 6.1±1.1 ml/sec in group A and 6.3±1.0 ml/sec in group B. The difference was not statistically significant (p>0.05) between two groups.  At 1 month, mean post-operative maximum flow rate was found 24.0±11.1 ml/sec in group A and 23.4±10.9 ml/sec in group B. At 3 month, mean post-operative maximum flow rate was found 22.0±9.1 ml/sec in group A and 18.2±9.0 ml/sec in group B. At 6 month, mean post-operative maximum flow rate was found 17.4±9.2 ml/sec in group A and 14.0±8.8 ml/sec in group B. The difference were not statistically significant (p>0.05) between two groups.

Conclusion:
Use of tropical clobetasol cream may reduce urethral stricture recurrence after optical internal urethrotomy.

Limitations & Recommendations:
Small group of study population and short followup. Proper randomization not followed. Large