Efficacy of a Combined Surgical and Pharmacological Therapy to Treat Mixed Urinary Incontinence. (NCT01899794) | Clinical Trial Compass
CompletedPhase 4
Efficacy of a Combined Surgical and Pharmacological Therapy to Treat Mixed Urinary Incontinence.
66 participantsStarted 2007-10
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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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):
✓. Positive 24-hours Pad Test (PT):
✓. 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).
What they're measuring
1
Urinary continence (measured by weighed 24-h Pad test)
. 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)