Efficacy to recurrence was not statistically significant

Efficacy of use of Triamcinolone ointment for Clean Intermittent Self Catheterization (CISC) following Internal Urethrotomy
Sunil Regmi1, Sunil Chandra Adhikari2, Saroj Yadav2, Rabin Raj Singh2, Ravi Bastakoti2
1Department of Surgery, Morang Sahakari Hospital, 2Koshi Zonal Hospital, Biratnagar

Corresponding Author
Dr. Sunil Regmi,
Consultant Uro-surgeon
E-mail: [email protected]

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Abstract
Background
Internal urethrotomy is recommended for the treatment of urethral strictures shorter than 1.5 cm but has been associated with high recurrence rates. The aim of this study was to evaluate the efficacy of use of triamcinolone ointment for clean intermittent self catheterization (CISC) in the prevention of urethral stricture recurrence after internal urethrotomy.
Materials & Methods
Sixty patients undergoing internal urethrotomy were assigned into two groups and CISC was performed using either triamcinolone ointment or a water-based gel for lubrication of the catheter. CISC regimen was continued up to 6 month and patients were followed for 12 months. Retrograde urethrography and urethrocystoscopy were done 6 and 12 months postoperatively.
Results
The recurrence rates were compared between the two groups. There were no significant differences in patient characteristics and etiology of the stricture between the two groups. There was a 22.22% recurrence rate in the patients of the triamcinolone group against 46.42% in those of the control group after the first internal urethrotomy (P=.04). After second internal urethrotomy, the urethra was stabilized in 83.3% of the patients in the triamcinolone group and 61.5% those in the control group (P=.05). We also found a significant correlation between recurrence and stricture length (P=.02) but the time to recurrence was not statistically significant (P=.16).
Conclusion
The use of triamcinolone ointment in patients on CISC regimen after internal urethrotomy significantly decreased the stricture recurrence rate.
Keywords: Urethral stricture, Internal urethrotomy, CISC, Triamcinolone.

Introduction
Urethral stricture is one of the oldest known urologic diseases and remains a common problem with high morbidity 1. The natural history of disease usually begins with a lesion of the urethral mucosa and infection followed by a scar 2. Today most urethral strictures are the result of trauma and inflammatory strictures secondary to gonorrhea infection which were most common in the past are less common now. However, in many cases of anterior urethral stricture disease the etiology remains unknown. Three major forms of treatment exist for urethral stricture.
(1) Dilation: urethral dilation is the oldest and simplest treatment of urethral stricture disease but this method has never been regarded as curative except for patients with an epithelial stricture without spongiofibrosis 1.
(2) Open reconstruction: urethroplasty is still regarded as the gold standard for the treatment of urethral strictures but it requires surgical expertise, adequate operating room facilities and prolonged absence of patient from work 3.
(3) Internal urethrotomy: refers to any procedure that opens the stricture by incising or ablating it transurethrally to allow the scar to expand 1.

Internal urethrotomy has been recommended for urethral strictures shorter than 1.5 cm, but has been associated with high recurrence rates 4. A number of complementary procedures such as indwelling foley catheter, clean intermittent self catheterization (CISC) and urethral stents have been proposed to overcome this problem. In 1972, transurethral use of triamcinolone was proposed by Hebert 5. Corticosteroid is used to decrease collagen production, and many studies have shown the efficacy of this treatment 6. However, there are not enough clinical trials in the literature to support the use of these agents for internal urethrotomy cases. We compared the efficacy of using a corticosteroid (1% triamcinolone) for lubrication of the catheter with placebo (water-based lubricant gel) in preventing anterior urethral stricture recurrence in the patients on CISC following internal urethrotomy.

Materials and Methods
Sixty patients with urethral stricture attending the surgical outpatient department of Morang Sahakari Hospital from January 2014 to December 2016 were included in this randomized clinical trial after getting permission from the institutional ethical committee. Preoperative evaluation included a complete history and physical examination, urine culture and retrograde urethrography. We excluded those with urethral strictures longer than 1.5cms. Informed consent was obtained from all the eligible patients. The patients were scheduled for internal urethrotomy and CISC. They were assigned into 2 groups to perform CISC with lubrication by either triamcinolone 1% ointment (triamcinolone group) or a water-based lubricant gel (control group) after internal urethrotomy. Randomization was performed using a random table.

Under spinal anesthesia and using a 21 Fr Storz urethrotome, urethrotomy was performed under direct vision with a cold-knife incision of the stricture. Our technique was the same in all patients and all procedures were performed by a single surgeon. Only the scar tissue was incised, avoiding cutting too deep to cause bleeding. After performing the procedures, a 16 Fr indwelling catheter was left for 7 days in all patients. The patients were then instructed to perform CISC by a 16 Fr Nelaton catheter. One peanut size of the triamcinolone ointment was recommended to be used for lubrication of the catheter. The regimen was tapered over a 6-month period (Table I).

Table I: CISC schedule following internal urethrotomy.
Postoperative Time Catheterization
1st week Every day
2nd week Every alternate day
3rd week Twice in a week
4th week Once in a week
2nd month Once in two weeks
3rd to 6th month Once in a month

The patients had regular office visits 1, 2, 3, 6, 9 and 12 months after the procedure and all underwent urethrocystoscopic evaluation at the 6th and 12th months of follow up. If the patient complained of obstructive symptoms or any difficulty in passing the Nelaton catheter, urethrocystoscopy and internal urethrotomy (if needed) was performed.

Statistical analyses were done by the Chi square ?2 test and Students’t’ test for comparisons of the dichotomous and continuous variables between the two groups using the SPSS software v16 (SPSS Inc, Chicago, USA). A P-value of less than .05 was considered significant.

Results
Three patients in the triamcinolone group and two in the control group were lost to follow-up and therefore, were excluded. Analyses were done on the data collected from the records of 27 and 28 patients in the triamcinolone and control groups who fulfilled the 12-month follow-up period after the last internal urethrotomy. There were no significant differences in the baseline characteristics of the patients or the etiology of the stricture between the two groups (Table II).

Table II: Baseline characteristics of patients in Triamcinolone & Control groups
Characteristics Triamcinolone
(n=27) Control
(n=28) p-value*
Mean age (years) 37.2±1.6 (17-70) 36±1.7 (15-75) 0.782
Mean stricture length (cm) .93±.33( .4-1.5) 1.07±.32(.5-1.5) 0.973
Cause of stricture
1. Traumatic 12 (44.4%) 14 (50%) 0.768
2. Inflammatory 7 (25.9%) 5 (17.9%) 0.898
3. Others 8 (29.6%) 9 (32.1%) 0.767
* p-value < 0.05 was considered statistically significant

Urethral stricture recurrence was noted in 6 (22.22%) and 13 (46.42%) of the patients in the triamcinolone and control groups, respectively and needed a repeat procedure after the first attempted internal urethrotomy (P = 0.04). The urethra was stabilized in 5 of 6 patients (83.3%) in the triamcinolone group and 8 of 13 (61.5%) in the control group without any stricture recurrence during 12 months of follow-up after second internal urethrotomy (P = 0.05). There were no reported febrile urinary tract infection episodes or any other local or systemic complications specific to the use of triamcinolone ointment in our patients.

No statistically significant correlation was observed between stricture recurrence and age of the patient. However, there was a significant correlation between recurrence and stricture length. Mean stricture length was 10.8 ± 2.2 mm and 8.1 ± 1.6 mm in patients with and without stricture recurrence respectively. (P = 0.02). Although time to recurrence in the triamcinolone group was longer than control group (11.9 ± 3 months vs. 7.4 ± 4.5 months) this difference was not statistically significant (P = 0.16).

Discussion
Internal urethrotomy has been recommended for urethral strictures shorter than 1.5 cm; however, it has been associated with high recurrence rates 7 8. Urethral stricture recurrence after the first, second, and third internal urethrotomy was reported to be about 50%, 60% to 100%, and 100%, respectively 9. Ishigooka and associates mentioned that factors with no influence on recurrent stricture formation included age, etiology, site of the stricture, and duration of indwelling catheterization. On the other hand, stricture length appeared to influence the outcome (P < .001). Recurrence rate was only 4.4% in short strictures (1 cm and shorter), while it was 42.9% in longer strictures 10. Also in our study, there was a significant correlation between stricture length and recurrence (P = 0.02).

CISC following internal urethrotomy is an acceptable procedure to reduce the failure rate of the treatment 11. Transurethral injection of triamcinolone was addressed by Hebert in 1972 5. Many studies have shown clinical improvement of hypertrophic scars after treatment with intralesional corticosteroids 6. Sharpe and Finney believed that intralesional steroid might be used in many types of strictures, but it was especially useful in cases with strictures in the distal urethra or the meatus, those occurring after radical prostatectomy, and in some cases with one or more urethroplasty procedures 12.

Conclusion
Adding triamcinolone ointment to CISC regimen significantly decreased the recurrence of stricture after internal urethrotomy. Since its use is easy and with low cost, further study involving larger number of patients and longer follow-up is necessary to better elucidate the efficacy and safety of this treatment protocol in patients undergoing CISC after internal urethrotomy.

References
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