Efficacy of a Combined Surgical and Pharmacological Therapy to Treat Mixed Urinary Incontinence

Jewish General Hospital0 sites66 target enrollmentOctober 2007

ConditionsUrinary Incontinence Mixed (Stress and Urge)

InterventionsOxytrol TVT-O/Oxytrol TVT-O

DrugsOxytrol

Overview

Phase: Phase 4
Intervention: Oxytrol
Conditions: Urinary Incontinence Mixed (Stress and Urge)
Sponsor: Jewish General Hospital
Enrollment: 66
Primary Endpoint: Urinary continence (measured by weighed 24-h Pad test)
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

The purpose of this study is to determine in female patients who suffer mixed urinary incontinence (MUI) the following: 1) the proportion of patients that are cured or improved by a single modality therapy (drug or surgery alone), cured or improved by a combined therapy (drug and surgery in any order) or non-responders to any of theses therapies; 2) which of the combined therapy sequences (surgery first, then followed by oral drug therapy or oral drug therapy first, then followed by surgery) is the most effective in patients needing combined therapy.

Registry

clinicaltrials.gov

Start Date

October 2007

End Date

April 2013

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Jewish General Hospital

Responsible Party

Principal Investigator

Jacques Corcos

Professor of Urology

Jewish General Hospital

Eligibility Criteria

Inclusion Criteria

•Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the trial.
•Female outpatients older than 18 years.
•Naïve\* mixed urinary incontinence (MUI) consisting of involuntary urine leakage associated with urge incontinence and incontinence with physical exertion, coughing, sneezing, etc.
•Positive Cough Stress Test (CST):
•A positive CST is confirmed with visualization of urine leakage at the external urethral opening, concurrent with a vigorous cough and following filling of the bladder at capacity
•Positive 24-hours Pad Test (PT):
•A positive SPT is confirmed with leakage of \>8.0g/24h of urine into a pad placed over the external urethral opening. After 24 hours the pads are placed in the sealable plastic, which is weighed and the urine lost during the 24-h period is calculated
•Daytime voiding frequency equal to or greater than to 8 times per day, with night time frequency \> to 2 times per night.
•Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, the self-completion of study questionnaires and diary, and other trial procedures.
•Urgency or urge incontinence defined by a score at the overactive bladder symptom score (OABSS) \> 25 and/or urodynamic signature of the urge incontinence consisting in any uninhibited detrusor contraction during the filling phase of the CMG.

Exclusion Criteria

•Symptoms of MUI \< 6 months.
•History of uncontrolled narrow angle glaucoma.
•History of relevant neurological disease (e.g. multiple sclerosis).
•History of lower urinary tract anatomical anomaly, e.g., grades 2 to 4 urogenital prolapse (at or beyond the hymen with valsalva).
•History or evidence of urinary outlet obstruction or urinary retention, including post void residual (PVR) urine volume \> 50ml
•Chronic persistent local pathology that may cause urinary symptoms, e.g. interstitial cystitis, tumour, bladder stone.
•Subjects using any pharmacological agent or device for their urinary incontinence less than 6 weeks prior to the inclusion or having ever used Oxytrol (oxybutynin)
•Subjects with any of the following conditions:
•Indwelling urinary catheters or who perform Intermittent Self Catheterization (ISC)
•Passive urinary incontinence (e.g., vesico-vaginal fistula).