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 range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Urinary continence (measured by weighed 24-h Pad test)
. 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)