A comparative study of occurrence and severity of constipation (difficulty in passing stools) with darifenacin and trospium used in the treatment of overactive bladder, a disease in which there is an increased frequency of urination, nocturnal urinations, urgency with or without urinary leakage.

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2014/09/005000
• Date of registration: 10-09-2014
• Prospective Registration: No
• Primary sponsor: Self Dr Manjunatha R
• Public title: A comparative study of occurrence and severity of constipation (difficulty in passing stools) with darifenacin and trospium used in the treatment of overactive bladder, a disease in which there is an increased frequency of urination, nocturnal urinations, urgency with or without urinary leakage.
• Scientific title: A prospective, comparative study of the incidence and severity of constipation with darifenacin and trospium in overactive bladder.
• Date of first enrolment: 28-11-2013
• Target sample size: 30
• Recruitment status: Open to Recruitment
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=9217
• Study type: Interventional
• Study design: Randomized, Parallel Group, Active Controlled Trial; Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Not Applicable Blinding and masking:Open Label
• Phase: Phase 4

Countries of recruitment

India

Contacts

• Name: Dr Manjunatha R
• Affiliation: Kempegowda Institute of Medical Sciences, Bangalore.

• Name: Dr H P Pundarikaksha
• Affiliation: Kempegowda Institute of Medical Sciences, Bangalore.

Key inclusion & exclusion criteria

Inclusion criteria: •Male and female patients aged >=18 and <80 years who were diagnosed with OAB based on their overactive bladder symptoms.

•Patients with a baseline score for urinary urgency of >=2 points, day time frequency >1 point and a total OABSS of >=3 points, with or without urgency urinary incontinence (UUI) episodes

•Patients with stable doses of alpha blockers or 5-alpha-reductase inhibitors for patients with benign prostatic hyperplasia were permitted with the limitation that a specific drug was used without a change in dosage and administration and was not replaced with another drug during the study period (observation and treatment phase).


Exclusion criteria: •Serious heart disease,

•Untreated angle-closure glaucoma,

•Myasthenia gravis,

•Gastric outlet and intestinal obstruction, paralytic ileus, gastric and intestinal atony or risk of urinary or gastric retention.

•Residual urine volume >=100 mL (determined by abdominal sonography)

•Strong possibility of prostate and bladder cancer

•Acute active urinary tract infection

•Women of childbearing age were required not to be pregnant or nursing, and to be using acceptable methods of contraception.

•Concomitant treatments known to affect urinary bladder function like anticholinergics, antispasmodics, serotonin-noradrenaline-reuptake-inhibitors, TCA, first generation antihistaminics, cholinergic agonists, cholinesterase inhibitors (e.g. bethanecol, donepezil and rivastigmine), potent inhibitors of cytochrome CYP3A4 (e.g. ketoconazole, itraconazole, ritonavir, nelfinavir, clarithromycin and nefazadone), potent P-glycoprotein inhibitors (e.g. cyclosporine and verapamil), aluminum antacids, antiparkinson and antipsychotic drugs, Calcium channel blockers, opioids, muscle relaxants, angiotensin-converting enzyme inhibitors, anticoagulants.

•Severe hepatic or renal dysfunction

•Participation in a clinical trial within 30 days before study entry.

•Patients with severe constipation ( <3 defecations a week).

•History of alcohol or drug abuse

•Currently suffering from serious disease or malignancy

•Significant psychiatric problems



Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- patients with frequency, urgency, nocturia with or without urgency urinary incontinence with normal and stable general condition

Intervention(s)

Intervention1: Darifenacin: Tab Darifenacin 7.5mg, once daily at night for 1 month
Control Intervention1: Trospium: Tab Trospium 60mg, once daily, one hour before meals with full glass of water either in the morning or at the night based on patients problems and preference.

Primary Outcome(s)

The difference in Knowles-Eccersley-Scott-Symptom (KESS) questionnaire score between two groupsTimepoint: Baseline, 2 weeks and 4 weeks.

Secondary Outcome(s)

The difference in McMillan & Williams, 1989 constipation assessment scale (CAS)and Bristol stool form scale between two groups.Timepoint: Baseline, 2 weeks, 4 weeks

Secondary ID(s)

NIL

Source(s) of Monetary Support

Self, Dr Manjunatha R

Ethics review

Status: Approved
Approval date: 07/11/2013
Contact:

KIMS-IEC