INTRODUCTION:
Over active bladder [OAB] is becoming an internationally “hot topic”. The tremendous number of patients with this problem is just now becoming recognized, and the potential economic impact is staggering. World wide, OAB is known to affect 50-100 million people. The condition is probably under reported and under treated, since patients have not become totally aware that they are suffering from OAB. More over the patients do not recognize that their condition is not normal and needs treatment.
In the United States alone, there are an estimated 32 or 33 million people affected by OAB. It costs an estimated $26 billion a year in the United States to manage loss of bladder control. With continued ageing of the populations in all developed countries, the problems associated with bladder control will certainly continue to increase.
OBJECTIVES:
1. To compare the efficacy of solifenacin (5 mg once daily) and tolterodine (2 mg twice daily) in reducing the number of micturitions per day (24hours), number of incontinence episodes, urgency episodes in patients with over active bladder (OAB).
2. To compare the efficacy of solifenacin and tolterodine on volume voided per void in patients with OAB.
3. To evaluate the tolerability of solifenacin and tolterodine in OAB.
MATERIALS AND METHODS:
Study Center:
Department of Urology, Government General Hospital and
Department of Urology, Kasturba Gandhi Government Hospital for Women & Children, Madras Medical College, Chennai.
Study Design:
Open label, comparative, randomized, parallel group, prospective study.
Study duration:
4 weeks.
Study period:
01-05-05 to 15-06-2006.
Study sample:
30 patients.
Inclusion Criteria:
1. Age between 18 to 75 years.
2. Sex: both males & female.
3. Urine culture should be negative for microorganisms.
4. Patients with overactive bladder must have experienced frequency of micturition on an average of >8 times per 24hours and > 3 episodes of urgency or incontinency during the 3 days, immediately prior to randomization.
Exclusion criteria:
1. Patients with
❖ History of hypersensitivity to the study drugs solifenacin & tolterodine and other anticholinergic drugs.
❖ History of stress incontinence, urinary outflow obstruction recurrent or symptomatic urinary tract infection, interstitial cystitis, uninvestigated haematuria or haematuria due to malignant disease.
❖ Presence of neurological cause for detrusor muscle over activity.
❖ Any condition in which the use of anti muscarinic therapy is contraindicated. such as patients with urinary retention, gastric retention or uncontrolled narrow- angle glaucoma.
❖ An indwelling catheter or use of intermittent catheterization.
❖ QT interval prolongation in ECG.
❖ Significant hepatic, cardiac, renal, hematological, neurological, psychiatric or endocrinological disorder.
❖ History of Diabetes mellitus, hypertension and tuberculosis.
2. Patients who have
❖ Received previous pelvic irradiation or currently have malignant diseases of the pelvic organ.
❖ Received treatment with any anti muscarinic drug or any drug for urinary incontinence or any non- pharmacological treatment for over active bladder including electro- stimulation or bladder training within two weeks before the study.
❖ Taken part in any other investigational study in the last one-month prior to enrollment.
3. Urine culture positive growth for microorganisms.
4. Pregnant or breast-feeding woman or woman of child bearing potential not using a reliable method of contraception.
CONCLUSION:
From our study we conclude that solifenacin 5mg once daily is effective and well tolerated than tolterodine 2mg twice a day in the management of over active bladder by
❖ Reducing the number of micturitions per day (24 hours), number of incontinence episodes, urgency episodes.
❖ More effective in increasing the volume voided per void.
❖ Better tolerance
