A cohort study of anticholinergic drugs in South Asian women with detrusor overactivity

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-001210-33-GB

Enrollment

Registered

2006-05-05

Start date

2006-06-20

Completion date

Unknown

Last updated

2019-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The medical condidtion is overactive bladder . A wide range of different anticholinergic agents is available to treat overactive bladder (OAB) symptoms. Within the last 15 years, ethno-pharmacologic research has uncovered significant differences in how people in diverse ethnic groups metabolize certain drugs.

Interventions

Trade Name: Detrusitol XL Pharmaceutical Form: Capsule* Trade Name: Vesicare Pharmaceutical Form: Tablet

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria • Eligible patients will be from South Asian women or Caucasian women aged 18 or over with urodynamically proven detrusor overactivity (DOA). • No anticholinergic medication over the previous two months • No contraindications to the use of anticholinergic agents. • Ability to provide fully informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Women who have a contraindication to the use of anticholinergic drugs. Women with coexisting bladder neck weakness (stress incontinence). Women who have been treated with anticholinergic medication in the previous three months.

Design outcomes

Primary

Measure	Time frame
Main Objective: To carry out a pilot study to assess the effects of different anti cholinergic medications in our South Asian female population with a diagnosis of detrusor over activity, and to compare them to a matched group of Caucasian women.;Secondary Objective: ;Primary end point(s): Primary outcome measure • Change in frequency and urge associated leakage episode /24 hours from baseline. Secondary outcome measures Diary review • Change in urge associated leakage episode/24 hours from baseline. • Change in bladder capacity (indirectly measured from the voided volumes). • Change in leakage severity reported at each follow up • Change in urge episodes (urgency without leakage) Questionnaire Measures • Change in the International Consultation on Incontinence Questionnaire score (ICIQ-SF) • Change in Patient Global Impression of Severity and Improvement Scores	—

Measure

Time frame

Main Objective: To carry out a pilot study to assess the effects of different anti cholinergic medications in our South Asian female population with a diagnosis of detrusor over activity, and to compare them to a matched group of Caucasian women.;Secondary Objective: ;Primary end point(s): Primary outcome measure • Change in frequency and urge associated leakage episode /24 hours from baseline. Secondary outcome measures Diary review • Change in urge associated leakage episode/24 hours from baseline. • Change in bladder capacity (indirectly measured from the voided volumes). • Change in leakage severity reported at each follow up • Change in urge episodes (urgency without leakage) Questionnaire Measures • Change in the International Consultation on Incontinence Questionnaire score (ICIQ-SF) • Change in Patient Global Impression of Severity and Improvement Scores

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026