Mental CompetencyPhase 4ACENCT01922115

The Effect of Anticholinergics on Cognitive Function in the Elderly

A Phase 4 study testing Trospium Chloride in people with Mental Competency and Urinary Bladder, Overactive, run by University of North Carolina, Chapel Hill at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 50 to 99 years, women onlyHealthy volunteers can take part
Conditions the study is for: Mental Competency, Urinary Bladder, Overactive, Cognitive Function
What is being tested?: Trospium Chloride
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 59 participants
Where: 1 siteUnited States
Study dates: Jun 2013to Jun 2015
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 to 99 years
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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)

Trial locations and contacts

1 site in 1 country.

United States1 site

Unc Chapel Hill Urogynecology A2 Clinic
Chapel Hill, North Carolina, 27517

Other trials in United States

About this study

Official title: The Effect of Anticholinergics on Cognitive Function in the Elderly: a Randomized Controlled Trial

Read the detailed description

Subjects will be randomized to: 1) trospium chloride or 2) placebo.

There are three aims:

To evaluate changes in cognitive function in elderly women taking trospium versus placebo, using validated cognitive assessment tests
To develop a useful battery of cognitive screening tests for monitoring the cognitive safety of OAB management
To understand how the timing of cognitive changes relates to the timing of improvement in OAB symptoms. The investigators will recruit 60 women aged ≥ 50 with the diagnosis of OAB. Cognitive assessments will be performed at baseline and Week 1 and 4 after drug initiation using paper-based validated questionnaires. OAB improvement will be assessed with validated questionnaires.

Conditions: Mental Competency, Urinary Bladder, Overactive, Cognitive Function
Being tested: Trospium Chloride, Placebo
Keywords: COGNITIVE FUNCTION, OVERACTIVE BLADDER, [C23.888.942.343.780]
Medical subject headings: Urinary Bladder, Overactive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Trospium ChlorideDrug
Also called Sanctura XR
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.
PlaceboDrug

Study groups in NCT01922115
Study group	Role	What they receive
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). Receives: Drug: Trospium Chloride
PLACEBO	Placebo comparator	Subjects may be administered a placebo rather than the Sanctura XR (Trospium Chloride). Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: Week 4

Secondary outcomes (2)

Mini-Mental State Examination
The mini-mental state examination (MMSE) or Folstein test is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. It is commonly used in medicine and allied health to screen for dementia. The range is 0-30, with higher values indicating better outcomes.
Measured: Week 4
Overactive Bladder Questionnaire
The Overactive Bladder Questionnaire (OAB-q) was developed to assess symptom bother and the impact of overactive bladder (OAB) on health-related quality of life (HRQL). The instrument was developed and validated in both continent and incontinent OAB patients, including both men and women. Total range is 19-101 and higher values indicate worse outcomes.
Measured: Week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2013Jun 2015

First posted14 Aug 2013 (estimated)
Study startJun 2013
Primary completionJun 2015
Study completionJun 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Mental CompetencyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 59 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01922115
Sponsor's protocol ID: 13-1352
Acronym: ACE
Status last verified: Feb 2017
First submitted: 9 Aug 2013
Last updated: 22 Mar 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

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.
PubMed 37160401
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.
PubMed 28067745

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 22 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Anticholinergics on Cognitive Function in the Elderly: a Randomized Controlled Trial
ClinicalTrials.gov ID: NCT01922115
Acronym / sponsor ID: ACE / 13-1352
Conditions: Mental Competency, Urinary Bladder, Overactive, Cognitive Function
Keywords: COGNITIVE FUNCTION, OVERACTIVE BLADDER, [C23.888.942.343.780]
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 59 participants (actual)
Lead sponsor: University of North Carolina, Chapel HillUniversity, hospital or other
Collaborators: American Urogynecologic Society
Study start: Jun 2013
Primary completion: Jun 2015 (actual)
Study completion: Jun 2015 (actual)
First posted: 14 Aug 2013 (estimated)
Results: Posted 12 Jul 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Subjects will be randomized to: 1) trospium chloride or 2) placebo.

There are three aims:

To evaluate changes in cognitive function in elderly women taking trospium versus placebo, using validated cognitive assessment tests
To develop a useful battery of cognitive screening tests for monitoring the cognitive safety of OAB management
To understand how the timing of cognitive changes relates to the timing of improvement in OAB symptoms. The investigators will recruit 60 women aged ≥ 50 with the diagnosis of OAB. Cognitive assessments will be performed at baseline and Week 1 and 4 after drug initiation using paper-based validated questionnaires. OAB improvement will be assessed with validated questionnaires.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
TROSPIUM CHLORIDE	Active comparator	Drug: Trospium ChlorideThose with overactive bladder will be administered either a placebo or Sanctura XR extended release (Trospium chloride) for treatment (60 mg).
PLACEBO	Placebo comparator	Drug: PlaceboSubjects may be administered a placebo rather than the Sanctura XR (Trospium Chloride).

Who may qualify

Ages: 50 to 99 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (8 listed)

Dementia/Depression/Delirium
Current anticholinergic use (requires 2 week washout period)
Current cholinesterase
Urinary or gastric retention
Severe decreased gastrointestinal motility

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Trospium ChlorideAlso: Sanctura XRSubject 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.	Drug	TROSPIUM CHLORIDE
Placebo	Drug	PLACEBO

Primary outcome

Hopkins Verbal Learning Test - Revised
Time frame: Week 4
Assesses short term verbal learning and memory. Subscales include immediate recall (0-36) and delayed recall (0-12). Higher values indicate better outcomes.
Hopkins Verbal Learning Test - Revised
Time frame: Week 4
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.

2 secondary outcomes

Mini-Mental State Examination
Time frame: Week 4
Overactive Bladder Questionnaire
Time frame: Week 4

Results and safety

Results posted to the registry on 12 Jul 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
TROSPIUM CHLORIDE	28	21
PLACEBO	31	24

Primary outcome: Hopkins Verbal Learning Test - Revised

Time frame: Week 4. Mean (Standard Deviation). Unit: units on a scale

Measure	TROSPIUM CHLORIDE n = 21	PLACEBO n = 24
Immediate Recall	22.00 (5.51)	24.38 (5.96)
Delayed Recall	6.71 (2.80)	7.83 (3.28)

Primary outcome: Hopkins Verbal Learning Test - Revised

Time frame: Week 4. Mean (Standard Deviation). Unit: percentage of total correct

Measure	TROSPIUM CHLORIDE n = 21	PLACEBO n = 24
Value	81.68 (47.45)	83.49 (26.72)

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TROSPIUM CHLORIDE	2 of 28 (7.1%)	10 of 28 (35.7%)	Not reported
PLACEBO	0 of 31 (0%)	2 of 31 (6.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37160401Stoniute 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.
Derived from this study: PubMed 28067745Geller 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Elizabeth Geller, MD principal investigator

UNC CHAPEL HILL

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Trospium Chloride in people with Mental Competency and Urinary Bladder, Overactive, run by University of North Carolina, Chapel Hill at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Jul 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hopkins Verbal Learning Test - Revised (time frame: Week 4). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01922115, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2017.