Pathophysiology of urge incontinence in older women

ISRCTN	ISRCTN17856439
DOI	https://doi.org/10.1186/ISRCTN17856439
Secondary identifying numbers	1999P-001891

Submission date: 09/03/2006
Registration date: 03/07/2006
Last edited: 03/07/2006

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Urological and Genital Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Neil Resnick
Scientific

Suite 500
Kaufmann Medical Building
Pittsburgh
Pennsylvania
15213
United States of America

Phone	+1 412 692 2360
Email	ResnickNM@dom.pitt.edu

Study information

Study design	Double-blind, randomized, placebo-controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study objectives	Older adults with urge incontinence respond well to generic oxybutynin when it is titrated for physiological differences in older patients. This treatment approach is efficacious even in detrusor hyperreflexia with impaired contractility (DHIC).
Ethics approval(s)	Approved by Brigham and Women's Hospital Institutional Review Board (IRB) on 26/09/1995, protocol number 94-6641-01
Health condition(s) or problem(s) studied	Urge incontinence, detrusor hyperreflexia with impaired contractility (DHIC)
Intervention	1. Immediate release oxybutynin following treatment of reversible causes, dose titrated for four weeks and maintained for further four weeks 2. Control group: placebo
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Oxybutynin
Primary outcome measure	Percentage reduction in incontinence episodes on 4-day bladder diary
Secondary outcome measures	1. Number of subjects dry at end of study 2. Subjective satisfaction
Overall study start date	01/03/1996
Completion date	31/03/2006

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	Female
Target number of participants	250
Key inclusion criteria	Cognitively intact, community-dwelling persons at least 55 years old with urge incontinence at least every two days
Key exclusion criteria	1. Significant stress incontinence 2. Outlet obstruction 3. Post-voiding residual (PVR) urine >300 ml 4. Mini mental state examination (MMSE) <24/30 5. Inability to go to the toilet independently 6. Contraindication to antimuscarinic therapy 7. Gastrointestinal obstruction 8. Megacolon 9. Severe liver or renal disease 10. Uncontrolled hyperthyroidism 11. Multiple sclerosis 12. Anteroposterior resection 13. Pelvic radiation 14. Spinal cord disease resulting in para- or quadri-plegia
Date of first enrolment	01/03/1996
Date of final enrolment	31/03/2006

Locations

Countries of recruitment

United States of America

Study participating centre

Suite 500

Pennsylvania
15213
United States of America

Sponsor information

National Institutes of Health (USA)
Government

9000 Rockville Pike
Bethesda
Maryland
20892
United States of America

"ROR"	https://ror.org/01cwqze88

Funders

Funder type

Government

National Institutes of Health (NIH) (National Institute of Diabetes and Digestive and Kidney Diseases [NIDDK])
Government organisation / National government

Alternative name(s): Institutos Nacionales de la Salud, US National Institutes of Health, NIH
Location: United States of America

Results and Publications

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