Comparison of Caffeine Reduction and Anticholinergic Medications for Treatment of Overactive Bladder

NCT00780832 | Terminated

• 1 other identifier: REB #4121
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the effects of caffeine reduction/elimination on urinary symptoms in women with overactive bladders and compare this therapeutic approach to anticholinergic therapy. We hope to show a reduction in symptoms with caffeine reduction and determine how effective caffeine reduction is compared to medication. If caffeine reduction is shown to be beneficial, women may be encouraged to use this strategy before resorting to medications.

Conditions

Overactive Bladder

Keywords

overactive bladder; dietary caffeine; anticholinergic medication; lifestyle modification; incontinence; urinary frequency

Outcome Measures

Primary Outcomes (1)

• Change in Bladder Function Questionnaire score

  30 days

Secondary Outcomes (1)

• Does the amount of caffeine consumed relate to symptom severity?

  30 days

Study Arms (2)

1

ACTIVE COMPARATOR

Caffeine reduction through diet and beverage counselling

Behavioral: Dietary Caffeine reduction

2

ACTIVE COMPARATOR

Anticholinergic medication

Drug: Anticholinergic medication

Interventions

Dietary Caffeine reduction BEHAVIORAL

Participants are counseled about reduction of dietary caffeine, given written information and a bladder control log.

Also known as: Lifestyle modification

1

Anticholinergic medication DRUG

Detrol LA 4mg. orally, once daily for 30 days

2

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Women with OAB symptoms including urgency, frequency (voids ≥8/day), and urge incontinence
• Women who consume \> one cup (250ml) caffeinated beverage per day
• Women who score $ 6 on the QUID Questionnaire for urgency symptoms

You may not qualify if:

• Women currently receiving treatment for OAB symptoms
• Women with narrow angle Glaucoma
• Women taking anticholinergics or loop diuretics
• Women with a diagnosis of painful bladder syndrome or other abnormal urinary tract lesions
• Women scoring \>4 on the QUID Questionnaire for stress symptoms
• Women with de novo symptoms following surgery
• Women with major pelvic prolapse

Sponsors & Collaborators

• IWK Health Centre: lead

Study Sites (1)

IWK Health Centre

Halifax, Nova Scotia, B3K 6R8, Canada

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Scott A Farrell, MD, FRCSC

  IWK Health Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2008
• First Posted: October 28, 2008
• Study Start: May 1, 2008
• Primary Completion: December 1, 2012
• Study Completion: April 1, 2013
• Last Updated: February 24, 2016

Record last verified: 2013-05

Locations

CA (1)