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

Phase 4

• Conditions: cognitive function; overactive bladder syndrome; Renal and Urogenital - Other renal and urogenital disorders; Mental Health - Studies of normal psychology, cognitive function and behaviour

• Registration Number: ACTRN12611000796987
• Lead Sponsor: Bianca Wong

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-07-28
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Female
• Target Recruitment: 16

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

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

• Study Type: Interventional
• Study Design: Not specified