ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12611000796987

Ethics application status

Not yet submitted

Date submitted

25/07/2011

Date registered

28/07/2011

Date last updated

28/07/2011

Type of registration

Prospectively registered

Titles & IDs

Public title

Effect of solifenacin and oxybutynin patch on cognitive function in elderly women with overactive bladder: An open-labelled, randomised, cross-over pilot study

Scientific title

Effect of solifenacin and oxybutynin patch on cognitive function in elderly women with overactive bladder: An open-labelled, randomised, cross-over pilot study

Secondary ID [1]

nil

Universal Trial Number (UTN)

Trial acronym

SOLOC

Linked study record

Health condition

Health condition(s) or problem(s) studied:

cognitive function

overactive bladder syndrome

Condition category

Condition code

Renal and Urogenital

Other renal and urogenital disorders

Mental Health

Studies of normal psychology, cognitive function and behaviour

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Arm 1 solifenacin oral 5 mg tablet daily will be dispensed at Royal Adelaide Hospital Pharmacy. Treatment will continue for 4 weeks followed by a washout period of 3 weeks with no active treatment. Subjects on solifenacin will crossover to receive oxybutynin patch for 4 weeks.
Arm 2 oxybutynin 3.9mg patch changed every 2 days, will be dispensed at Royal Adelaide Hospital Pharmacy. Transdermal patch will be applied to the skin, such as abdomen, buttocks or hip. Treatment will continue for 4 weeks followed by a washout period of 3 weeks with no active treatment. Subjects on oxybutynin patch will crossover to receive solifenacin for 4 weeks.

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

oxybutynin patch

Control group

Active

Outcomes

Primary outcome [1]

cognitive function. It will be assessed by written cognitive tests including symbol digit modalities test, Rey auditory verbal learning test and national adult reading test and computerised cognitive tests including Cogstate detection and identification tasks.

Timepoint [1]

at 1, 4, 7 and 11 weeks after intervention commencement

Secondary outcome [1]

mood as assessed by Depression Anxiety Stress Scales (DASS 21)

Timepoint [1]

at 1, 4, 7 and 11 weeks after intervention commencement

Secondary outcome [2]

efficacy as assessed by Overactive bladder questionnaire (OABq) short form and 3 day bladder diary

Timepoint [2]

at 1, 4, 7 and 11 weeks after intervention commencement

Secondary outcome [3]

tolerability as assessed by Benefit Willingness Satisfaction questionnaire (BWS)

Timepoint [3]

at 1, 4, 7 and 11 weeks after intervention commencement

Eligibility

Key inclusion criteria

Age 60 or above
Female
Mini Mental State Examination score greater than 24
Body mass index 22-35
Established diagnosis of overactive bladder as defined by the International Continence Society
Able to complete cognitive testing at screening visit
Able to give consent
English speaking

Minimum age

60 Years

Maximum age

No limit

Sex

Females

Can healthy volunteers participate?

Key exclusion criteria

Moderate or severe cognitive impairment (Mini Mental State Examination less than or equal to 24 at screening).
Calculated creatinine clearance of less than 30ml/min via Cockcroft-Gault equation
Clinically significant hepatic impairment in the opinion of the investigator
Subjects on treatment with a potent CYP3A4 inhibitor, e.g. ketoconazole, protease inhibitors, macrolides, moxifloxacin, ritonavir, nelfinavir, itraconazole, cyclosporin, macrolide.8
Depression as determined by the Geriatric Depression Scale (GDS) short form more than or equal to 5 at screening.
History of urinary retention, severe gastrointestinal obstruction (including paralytic ileus or intestinal atony or toxic megacolon or severe ulcerative colitis), myasthenia gravis, uncontrolled narrow angle glaucoma or shallow anterior chamber or deemed to be at risk for these conditions.
Unplanned hospitalization within the last 4 weeks prior to participation of the study
Severe pelvic organ prolapse or vaginitis.
Genitourinary surgery within the last 6 months.
Post void residual urine volume equal to or greater than 150ml (bladder ultrasound) at screening.
Severe cardiovascular disease
Bladder tumour or stone
Uncontrolled diabetes mellitus with HbA1c greater than 9%
Known hepatitis B, hepatitis C or HIV at time of screening
History of drug and / or alcohol abuse at time of screening
An average weekly alcohol intake of greater than 14 units within 3 months prior to screening
History of known or suspected hypersensitivity to solifenacin succinate, oxybutynin hydrochloride, other anti-cholinergics or lactose, to any component of the dosage form
Currently on drug therapy for overactive bladder symptoms or has history of non-drug treatment intended to treat overactive bladder symptoms within 1 month prior to screening
Currently on acetylcholinesterase inhibitor (e.g. donepezil) or tricyclic antidepressant
Unstable doses of prescribed medication within 1 month prior to screening, which in the opinion of the Investigator, will interfere with the study procedures or compromise safety
Any clinically significant abnormality following Investigator review of the physical examination or ECG
Any clinically significant abnormal heart rate or blood pressure measurements, at the screening visit (dBP greater than 100mmHg, sBP greater than 180mmHg or sBP less than 100mmHg or HR less than 40bpm or greater than 100bpm)
Any clinically significant abnormality following Investigator review of the biochemistry & haematology results which, in the opinion of the Investigator, contraindicates their participation
Participated in any clinical study within the last 30 days prior to screening
Has had full neuropsychological testing in the last 12 months
Any skin condition assessed by the Investigator which would preclude the use of a transdermal patch
Any other clinical condition or diagnosis as assessed by the Investigator would otherwise consider as a contraindication for participation in the study

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

subjects are recruited from the Women's Health Centre outpatient at Royal Adelaide Hospital
Randomisation schedule of study drugs will be done by Pharmacy Department

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Randomisation table

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Crossover

Other design features

Phase

Phase 4

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

1/09/2011

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Department of Geriatric and Rehabilitation Medicine

Address [1]

Royal Adelaide Hospital
Department of Geriatric and Rehabilitation Medicine
Level 4 North Wing
North Terrace SA 5000

Country [1]

Australia

Funding source category [2]

Hospital

Name [2]

Department of Obstetrics and Gynaecology

Address [2]

Royal Adelaide Hospital
North Terrace SA 5000

Country [2]

Australia

Funding source category [3]

Hospital

Name [3]

Memory Trials Centre

Address [3]

Royal Adelaide Hospital
Level 7 Emergency Block
North Terrace SA 5000

Country [3]

Australia

Primary sponsor type

Individual

Name

Bianca Wong

Address

Royal Adelaide Hospital
Department of Geriatric and Rehabilitation Medicine
Level 4 North Wing
North Terrace SA 5000

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

Hospital

Name [1]

Department of Obstetrics and Gynaecology

Address [1]

Royal Adelaide Hospital
North Terrace SA 5000

Country [1]

Australia

Other collaborator category [2]

Hospital

Name [2]

Memory Trials Centre

Address [2]

Royal Adelaide Hospital
North Terrace SA 5000

Country [2]

Australia

Other collaborator category [3]

Hospital

Name [3]

Department of Pharmacy

Address [3]

Royal Adelaide Hospital
North Terrace SA 5000

Country [3]

Australia

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

Ethics committee address [1]

Ethics committee country [1]

Date submitted for ethics approval [1]

27/07/2011

Approval date [1]

Ethics approval number [1]

Summary

Brief summary

Overactive bladder (OAB) is a common problem in the elderly and undertreatment is a concern due to the perception by clinicians with regard to side-effects.  Amongst Geriatricians the cognitive side-effects are of particular concern and these drugs are relatively contraindicated in cognitive impairment. Treatment is often tailored to individual needs and comorbidities and there is no standard treatment for overactive bladder for this cohort.

Where the drug is clinically indicated, there is anecdotal evidence that Geriatricians will prescribe solifenacin rather than oxybutynin due to theoretically less impact on cognitive function.  Unfortunately trial evidence examining the cognitive impact of these drugs is lacking. 

This investigator initiated pilot study is designed to explore the cognitive effects of two different treatment licensed treatments for OAB, namely solifenacin and oxybutynin patch.  Efficacy and tolerability will be assessed as secondary outcomes.  The oxybutynin patch has been chosen over oral oxybutynin as the frequency of side-effects is recognised to be lower.  There is no placebo as such, but cognition and bladder function will be assessed following significant washout periods during the study.

A cross-over design has been chosen over a parallel group study for this pilot study as the numbers for a parallel group study would be prohibitively large and our design allows good within subject comparisons of cognition.  It is reasonable to conduct this pilot as currently there is only one cognitive study looking at single doses of solifenacin in healthy elderly people, which showed solifenacin was not associated with cognitive impairment. We speculate that solifenacin will have less effect on cognition than oxybutynin patch with repeat dosing in healthy elderly female volunteers.  

The proposed dose of solifenacin used is based on available clinical data that shows most of the dose-response is achieved at 5mg while the use of 10mg dose is more likely associated with adverse effect .  There is minimal additional clinical benefit from 10mg compared to 5mg. The use of 3.9mg transdermal patch is supported by a placebo, controlled dose escalation trial.

Subjects will be recruited from the Women’s Health Centre outpatient clinic at the RAH or through advertisement.  To participate in this trial, all subjects will meet criteria for treatment with these agents.  They will be female, age 60 or above with overactive bladder syndrome who have not been on treatment or been off treatment for one month.  There will be periods with no treatment during the initial run-in and between treatments in order to establish baseline bladder and cognitive function - this will be discussed with patients prior to commencing the clinical trial.  The subjects will have the opportunity to try two different treatment for OAB. 
 

Possible risks that can occur in subjects include the following:
Study drugs: Adverse effects listed in product information for solifenacin and oxybutynin
Blood sampling: Discomfort, bruising or infection on the venipuncture site 
Cognitive testing: Mental fatigue and potential distress

Trial website

not available

Trial related presentations / publications

nil

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Staff from Memory Trials Centre

Address

Royal Adelaide Hospital
Memory Trials Centre
Level 7 Emergency Block
North Terrace SA 5000

Country

Australia

Phone

61 8 82222798

Fax

61 8 82222799

kathy.robinson@health.sa.gov.au

Contact person for scientific queries

Name

Dr Bianca Wong

Address

Royal Adelaide Hospital
Department of Geriatric and Rehabilitation Medicine
Level 4 North Wing
North Terrace SA 5000

Country

Australia

Phone

61 8 82225215

Fax

61 8 82225725

bianca.wong@health.sa.gov.au

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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