NCT01922115

Brief Summary

Anticholinergic medication is used to treat overactive bladder (OAB). A known side effect of this medication is cognitive dysfunction. OAB is more prevalent in the elderly population - a group that also has a higher baseline risk of cognitive dysfunction. Our objective is to evaluate the effect of an anticholinergic medication on cognitive function in elderly women.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 9, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 14, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

July 12, 2016

Completed
Last Updated

March 22, 2017

Status Verified

February 1, 2017

Enrollment Period

2 years

First QC Date

August 9, 2013

Results QC Date

March 7, 2016

Last Update Submit

February 17, 2017

Conditions

Mental CompetencyUrinary Bladder, OveractiveCognitive Function

Keywords

COGNITIVE FUNCTIONOVERACTIVE BLADDER[C23.888.942.343.780]

Outcome Measures

Primary Outcomes (2)

  • Hopkins Verbal Learning Test - Revised

    Assesses short term verbal learning and memory. Subscales include immediate recall (0-36) and delayed recall (0-12). Higher values indicate better outcomes.

    Week 4

  • Hopkins Verbal Learning Test - Revised

    Assesses short term verbal learning and memory. See below for the subscale delayed recognition (0-24). Percentages of total responses correct are reported for delayed recognition, higher values indicate better outcomes.

    Week 4

Secondary Outcomes (2)

  • Mini-Mental State Examination

    Week 4

  • Overactive Bladder Questionnaire

    Week 4

Study Arms (2)

TROSPIUM CHLORIDE

ACTIVE COMPARATOR

Those with overactive bladder will be administered either a placebo or Sanctura XR extended release (Trospium chloride) for treatment (60 mg).

Drug: Trospium Chloride

PLACEBO

PLACEBO COMPARATOR

Subjects may be administered a placebo rather than the Sanctura XR (Trospium Chloride).

Drug: Placebo

Interventions

Trospium ChlorideDRUG

Subject will be administered either placebo or 60 mg dosage of Sanctura XR for treatment of overactive bladder. Subject will take Sanctura XR once every morning. Blood will be drawn for plasma extraction at each visit.

Also known as: Sanctura XR
TROSPIUM CHLORIDE
PlaceboDRUG
PLACEBO

Eligibility Criteria

Age50 Years - 99 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female 50 or older
  • Diagnosis of OAB (ICS definition)
  • English literacy
  • Ability to swallow oral medication
  • Cognitive ability to give consent

You may not qualify if:

  • Dementia/Depression/Delirium
  • Current anticholinergic use (requires 2 week washout period)
  • Current cholinesterase
  • Urinary or gastric retention
  • Severe decreased gastrointestinal motility
  • Uncontrolled narrow-angle glaucoma
  • Myasthenia gravis
  • Diagnosis fo renal impairment (creatinine clearance \<30 mL/min)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unc Chapel Hill Urogynecology A2 Clinic

Chapel Hill, North Carolina, 27517, United States

Location

Related Publications (2)

  • Stoniute A, Madhuvrata P, Still M, Barron-Millar E, Nabi G, Omar MI. Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults. Cochrane Database Syst Rev. 2023 May 9;5(5):CD003781. doi: 10.1002/14651858.CD003781.pub3.

    PMID: 37160401DERIVED

  • Geller EJ, Dumond JB, Bowling JM, Khandelwal CM, Wu JM, Busby-Whitehead J, Kaufer DI. Effect of Trospium Chloride on Cognitive Function in Women Aged 50 and Older: A Randomized Trial. Female Pelvic Med Reconstr Surg. 2017 Mar/Apr;23(2):118-123. doi: 10.1097/SPV.0000000000000374.

    PMID: 28067745DERIVED

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

trospium chloride

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr. Elizabeth Geller
Organization
UNC Chapel Hill
elizabeth_geller@med.unc.edu
919-966-4717

Study Officials

  • Elizabeth Geller, MD

    UNC CHAPEL HILL

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2013

First Posted

August 14, 2013

Study Start

June 1, 2013

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

March 22, 2017

Results First Posted

July 12, 2016

Record last verified: 2017-02

Locations

US(1)