STOP: Satisfaction and Tolerability in Overactive bladder Patients (less than 65 years versus greater than or equal to 65 years)

ISRCTN	ISRCTN19242032
DOI	https://doi.org/10.1186/ISRCTN19242032
Secondary identifying numbers	018-010

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Mr Joseph Reiz
Scientific

Purdue Pharma
575 Granite Court
Pickering
L1W 3W8
Canada

Study design	Multi-centred open label trial
Primary study design	Interventional
Secondary study design	Non randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format. Please have your family physician use the contact details below to request information on the study.
Scientific title
Study acronym	STOP
Study objectives	Patients and physician satisfaction with study drug 018 will not be different in elderly and non-elderly patients.
Ethics approval(s)	Ethics approval for the lead centre was obtained from IRB Services, Aurora, Ontario (Canada) on November 23, 2006. All other participating centres obtained ethics approval before recruiting study patients.
Health condition(s) or problem(s) studied	Overactive bladder
Intervention	Oral anticholinergic-antispasmodic (018) over a four-week open label phase.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Study drug 018
Primary outcome measure	Measured after four weeks of treatment: 1. Quality of life 2. Patient and physician satisfaction
Secondary outcome measures	Measured after four weeks of treatment: 1. Tolerability 2. Cognitive status 3. Adverse events
Overall study start date	07/01/2007
Completion date	31/12/2007

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	300
Key inclusion criteria	1. Males or non-pregnant, non-nursing females greater than or equal to 18 years of age 2. Diagnosis of overactive bladder and currently experiencing incontinent episodes and frequent micturitions or urgency 3. Newly diagnosed patients or patients not currently taking medication for overactive bladder 4. Capable of completing questionnaires in English or French
Key exclusion criteria	1. Patient who will initiate treatment with any drug prescribed for the treatment of overactive bladder (except oestrogen) during the study period 2. Patient with a primary diagnosis of stress incontinence or a concurrent diagnosis of functional or overflow incontinence 3. Patients with conditions contra-indicating anticholinergic therapy or have hepatic or renal disease 4. Patients using an indwelling catheter or who had bladder electrostimulation therapy or participated in bladder training within the previous 14 days prior to study entry
Date of first enrolment	07/01/2007
Date of final enrolment	31/12/2007

Purdue Pharma

Pickering
L1W 3W8
Canada

Purdue Pharma Canada
Industry

c/o Joseph L. Reiz
575 Granite Court
Pickering
L1W 3W8
Canada

Industry

Purdue Pharma Canada

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/08/2012		Yes	No