Urinary Incontinence Mixed (Stress and Urge)Phase 4NCT01899794
Efficacy of a Combined Surgical and Pharmacological Therapy to Treat Mixed Urinary Incontinence.
A Phase 4 study testing TVT-O/Oxytrol, TVT-O and Oxytrol in people with Urinary Incontinence Mixed (Stress and Urge), run by Jewish General Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urinary Incontinence Mixed (Stress and Urge)
- What is being tested?
- TVT-O/Oxytrol, TVT-O and Oxytrol
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- Oct 2007to Apr 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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):
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- 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.
- Naïve MUI means that the patient never received Oxytrol (oxybutynin) or surgical treatment for this condition.
Who cannot join
- 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.
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- 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).
- Not capable of independent toileting.
- Subjects with a documented and untreated UTI (temporary exclusion)
- 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.
- Subjects who are pregnant or lactating.
- Subjects with uncontrolled narrow angle glaucoma (opinion of treating ophthalmologist will be required).
- Subjects who have; on urodynamic investigation evidence of a poor bladder compliance and/or neurogenic detrusor hyperactivity.
- 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.
About this study
Official title: Efficacy of a Combined Surgical and Pharmacological Therapy to Treat Mixed Urinary Incontinence
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.
- Being tested
- TVT-O/Oxytrol, TVT-O, Oxytrol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TVT-O/OxytrolProcedure or surgery
Also called TVT-O, Oxytrol-TDS
TVT-ODevice
OxytrolDrug
| Study group | Role | What they receive |
|---|---|---|
| TVT-O | Active comparator | mid-urethral sling Receives: Procedure: TVT-O/Oxytrol; Drug: Oxytrol |
| Oxytrol | Active comparator | medication Receives: Procedure: TVT-O/Oxytrol; Device: TVT-O |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary continence (measured by weighed 24-h Pad test)
Cure is defined by a 24-h pad-test of ≤ 8 g
Measured: 12 weeks
Secondary outcomes (1)
3-day urinary diary
number of leaks per day, number of pads per day,number and volume of micturitions per day
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2013 (estimated)
- Study startOct 2007
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Incontinence Mixed (Stress and Urge)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jewish General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Centre de recherche du Centre hospitalier universitaire de Sherbrooke, Ottawa General hospital, Ottawa University, Ottawa, Ontario, Canada
- Responsible party
- Principal investigator, Jacques Corcos, Jewish General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01899794
- Sponsor's protocol ID
- 07-008
- Status last verified
- Jul 2013
- First submitted
- 8 Jul 2013
- Last updated
- 15 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Combined Surgical and Pharmacological Therapy to Treat Mixed Urinary Incontinence
- ClinicalTrials.gov ID
- NCT01899794
- Acronym / sponsor ID
- 07-008
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Jewish General HospitalUniversity, hospital or other
- Collaborators
- Centre de recherche du Centre hospitalier universitaire de Sherbrooke, Ottawa General hospital, Ottawa University, Ottawa, Ontario, Canada
- Study start
- Oct 2007
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 15 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TVT-O | Active comparator | Procedure: TVT-O/Oxytrol, Drug: Oxytrolmid-urethral sling |
| Oxytrol | Active comparator | Procedure: TVT-O/Oxytrol, Device: TVT-Omedication |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TVT-O/OxytrolAlso: TVT-O, Oxytrol-TDS | Procedure or surgery | Oxytrol, TVT-O |
| TVT-O | Device | Oxytrol |
| Oxytrol | Drug | TVT-O |
Primary outcome
Urinary continence (measured by weighed 24-h Pad test)
Time frame: 12 weeks
Cure is defined by a 24-h pad-test of ≤ 8 g
1 secondary outcome
3-day urinary diary
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing TVT-O/Oxytrol, TVT-O and Oxytrol in people with Urinary Incontinence Mixed (Stress and Urge), run by Jewish General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary continence (measured by weighed 24-h Pad test) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2013.