Condition category
Urological and Genital Diseases
Date applied
09/03/2006
Date assigned
03/07/2006
Last edited
03/07/2006
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Neil Resnick

ORCID ID

Contact details

Suite 500
Kaufmann Medical Building
Pittsburgh
Pennsylvania
15213
United States of America
+1 412 692 2360
ResnickNM@dom.pitt.edu

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1999P-001891

Study information

Scientific title

Acronym

Study hypothesis

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

Approved by Brigham and Women's Hospital Institutional Review Board (IRB) on 26/09/1995, protocol number 94-6641-01

Study design

Double-blind, randomized, placebo-controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Oxybutynin

Primary outcome measures

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 trial start date

01/03/1996

Overall trial end date

31/03/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Cognitively intact, community-dwelling persons at least 55 years old with urge incontinence at least every two days

Participant type

Patient

Age group

Senior

Gender

Female

Target number of participants

250

Participant 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

Recruitment start date

01/03/1996

Recruitment end date

31/03/2006

Locations

Countries of recruitment

United States of America

Trial participating centre

Suite 500
Pennsylvania
15213
United States of America

Sponsor information

Organisation

National Institutes of Health (USA)

Sponsor details

9000 Rockville Pike
Bethesda
Maryland
20892
United States of America

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

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

Alternative name(s)

NIH

Funding Body Type

government organisation

Funding Body Subtype

federal/national government

Location

United States of America

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes