Efficacy of a Combined Surgical and Pharmacological Therapy to Treat Mixed Urinary Incontinence.
Information source: Jewish General Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Urinary Incontinence Mixed (Stress and Urge)
Intervention: TVT-O/Oxytrol (Procedure); TVT-O (Device); Oxytrol (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Jewish General Hospital
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.
Clinical Details
Official title: Efficacy of a Combined Surgical and Pharmacological Therapy to Treat Mixed Urinary Incontinence
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Urinary continence (measured by weighed 24-h Pad test)
Secondary outcome: 3-day urinary diary
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
Inclusion Criteria:
1. 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.
2. Female outpatients older than 18 years.
3. Naïve* mixed urinary incontinence (MUI) consisting of involuntary urine leakage
associated with urge incontinence and incontinence with physical exertion, coughing,
sneezing, etc.
4. 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
5. 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
6. Daytime voiding frequency equal to or greater than to 8 times per day, with night
time frequency > to 2 times per night.
7. 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.
8. 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.
- Naïve MUI means that the patient never received Oxytrol (oxybutynin) or surgical
treatment for this condition.
Exclusion Criteria:
1. Symptoms of MUI < 6 months.
2. History of uncontrolled narrow angle glaucoma.
3. History of relevant neurological disease (e. g. multiple sclerosis).
4. History of lower urinary tract anatomical anomaly, e. g., grades 2 to 4 urogenital
prolapse (at or beyond the hymen with valsalva).
5. History or evidence of urinary outlet obstruction or urinary retention, including
post void residual (PVR) urine volume > 50ml
6. Chronic persistent local pathology that may cause urinary symptoms, e. g. interstitial
cystitis, tumour, bladder stone.
7. 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)
8. Subjects with any of the following conditions:
1. Indwelling urinary catheters or who perform Intermittent Self Catheterization
(ISC)
2. Passive urinary incontinence (e. g., vesico-vaginal fistula).
3. Not capable of independent toileting.
9. Subjects with a documented and untreated UTI (temporary exclusion)
10. Subjects who require Hormone Replacement Therapy (HRT) must have been taking this at
a stable dose for at least 3 months prior to study entry. Any change in dose or type
of HRT taken during the study will be considered a protocol violation.
11. Subjects who are pregnant or lactating.
12. Subjects with uncontrolled narrow angle glaucoma (opinion of treating ophthalmologist
will be required).
13. Subjects who have; on urodynamic investigation evidence of a poor bladder compliance
and/or neurogenic detrusor hyperactivity.
14. Subjects who in the opinion of the investigator or that of the trial Clinician, are
unable and/or unlikely to comprehend the nature, scope and possible consequences of
the study and to follow the study procedures and instructions and complete all study
related measurements. This includes poor compliance with the trial medication, and
subjects who demonstrate uncooperative behaviour.
Locations and Contacts
Additional Information
Starting date: October 2007
Last updated: July 11, 2013
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