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Year : 2011  |  Volume : 43  |  Issue : 6  |  Page : 744--745

Tolerance of bladder antispasmodics in children with urinary incontinence: An observational study from North India

Vishal Bansal1, Bikash Medhi1, Om Prakash1, Balbinder Kaur2, KL Narasimhan2,  
1 Department of Clinical Pharmacology, Postgraduate Institute of Medical Education and Research, Chandigarh - 160012, India
2 Department of Pediatric Surgery, Postgraduate Institute of Medical Education and Research, Chandigarh - 160012, India

Correspondence Address:
Bikash Medhi
Department of Clinical Pharmacology, Postgraduate Institute of Medical Education and Research, Chandigarh - 160012

How to cite this article:
Bansal V, Medhi B, Prakash O, Kaur B, Narasimhan K L. Tolerance of bladder antispasmodics in children with urinary incontinence: An observational study from North India.Indian J Pharmacol 2011;43:744-745

How to cite this URL:
Bansal V, Medhi B, Prakash O, Kaur B, Narasimhan K L. Tolerance of bladder antispasmodics in children with urinary incontinence: An observational study from North India. Indian J Pharmacol [serial online] 2011 [cited 2023 Sep 27 ];43:744-745
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Poor bladder function or urinary incontinence can adversely affect the kidney function. Anticholinergic drugs are useful in the management of hyperactive or neurogenic bladders. Five drugs are approved by US, FDA for the treatment of overactive bladder: tolterodine tartrate, oxybutynin chloride, trospium chloride, darifenacin, and solifenacin succinate. [1] The two drugs available and clinically used in India are oxybutynin and tolterodine. Tolterodine is relatively more specific for its action on urinary bladder than other drugs. [2] The main adverse effects of non specific anticholinergic drugs are dry mouth, facial flushing, drying of various body secretions, dry eyes, and raised body temperature. It is observed in our set up that many patients on anticholinergics discontinue their therapy due to these adverse effects. The present study was aimed to evaluate the tolerance to these drugs and record the reasons for discontinuation over a period of one month.

The patients included were attending the specialty clinics of pediatric surgery for urinary incontinence as decided by the pediatric surgeon based on urodynamics studies or post operative cases of posterior uretheral valves or meningocoele/ meningomyelocele. Drugs prescribed by the treating surgeon were coded and appropriate instructions were given to the attendants.

Monitoring was done by the clinical pharmacologist who was blinded to the treatment assigned. He recorded the symptoms along with baseline value of laboratory parameters, blood chemistry, ultrasound kidney, ureter and bladder (KUB), dimercaptosuccinic acid scan (DMSA), direct radionuclide cystogram (DRCG), and X-ray spine. The attendants were explained the nature of the study with common adverse symptoms that could be accompanying the drug. Informed consent was taken and all the ethical standards were followed. The attendants were instructed to report any adverse event immediately. In case nothing serious happens, they were advised to visit OPD for evaluation after 30 days. Follow-up clinical evaluation was done both by the pediatric surgeon and clinical pharmacologist, and same patients were again evaluated during humid summer to find out any variations in tolerance to drug therapy. The clinical pharmacologist remained blinded to the treatment assigned till the end of the study. The data was analyzed in blinded fashion.

A total of 41 patients were studied (24 assigned to group I received oxybutynin and 17 assigned to group II received tolterodine). The median age of patients in both the groups was 3.7 years (3-14 years). Majority of the patients were males (88 to 94% in the two groups, respectively). Main reasons for prescription were posterior urethral valves (PUV) and meningomyelocele in both the groups (71.4% and 28.6% in group I and 47% and 41.2% in group II, respectively). Less than 2% received tolterodine for other reasons of neurogenic bladder.

The attendants were instructed to note the urinary incontinence, frequency, and pain or crying on urination. The adverse reactions that the attendants were specifically informed were headache, dry eyes, blurring of vision (for children above six years of age, as young children cannot report the same) increase or decrease in thirst, fever, dry cough, altered appetite, altered bowel habits, sleep disturbances, increase or decrease in sweating, irritability, redness in the eyes, and any other symptoms. In 39 patients, there was an improvement in the symptoms of urinary incontinence within three days of therapy. There was a decrease in urinary frequency, bed wetting, day time wetting, and crying episodes. Both the drugs were well tolerated by most of the children. The total number of adverse event reported were seventeen (fever, constipation and red eyes in three each, dry mouth and increase in thirst in two each, and one each of headache, decreased sweating, dry cough, and altered appetite) in oxybutynin group (group I) and three (fever-1, constipation-1, and redness in the eyes-1) in tolterodine group (group II). Repeat study in humid summer showed intolerance to oxybutynin therapy as compared to tolterodine. Two patients were switched from oxybutynin group to tolterodine due to fever and constipation. Switching of the therapy helped these children. The two children, both of meningomyelocele (MMC), who did not have symptomatic improvement with tolterodine, were put on oxybutynin which also could not be of any help to them. These children had follow-up urodynamics and assessment of bladder volume. They needed bladder augmentation later on.

Oxybutynin and tolterodine are commonly prescribed for symptomatic improvement of urinary incontinence in pediatric and adult population. Their safety and efficacy in adult Asian patients has been proven in the treatment of overactive bladder. [3] Convincing data regarding the safety and tolerability of these drugs in the pediatric age group is lacking. We did a prospective observational study for evaluation of such patients for duration of 30 days.

There was improvement in both the groups with respect to baseline symptoms (urinary dribbling, frequency, nocturnal and day time enuresis). Two patients who switched from oxybutynin to tolterodine showed improvement. Similar improvement with tolterodine has been shown before. [4],[5]

The adverse events reported were minor in nature. They did not cause any significant problem to the health of the individual. Fever was reported at the start of the therapy by 22 patients in both the groups which presented as a transient rise in body temperature and subsided on its own without any antipyretics. Duration and severity of fever decreased with continuous use of these drugs. Anticholinergics inhibit sweating which can increase the body temperature especially in children. Therefore, in the present study, patients reported an increased intolerance to oxybutynin therapy in humid summer particularly in day time. Drying of secretions in most of the body areas can lead to the symptoms of thirst, dry cough, constipation, and irritability.

Thus, we can say that newer anticholinergic drugs that are prescribed for urinary incontinence for pediatric population are safe for at least short duration of therapy (one month) and compared to oxybutynin, tolterodine is better tolerated in humid weather. Long term, prospective comparative trials on a larger scale to assess the safety, tolerability, and efficacy of these drugs are needed.


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3Lee JG, Hong JY, Choo MS, Kwon HY, Chung DY, Lee KS, et al. Tolterodine: as effective but better tolerated than oxybutynin in Asian patients with symptoms of overactive bladder. Int J Urol 2002;9:247-52.
4Yucel S, Akkaya E, Guntekin E, Kukul E, Danisman A, Akman S, et al. Should we switch over to tolterodine in every child with non-neurogenic daytime urinary incontinence in whom oxybutynin failed? Urology 2005;65:369-73
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