A Phase 3 interventional study of Oxybutynin (Oxytrol, BAY839380) in Overactive Bladder, sponsored by Bayer. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-10-20.
Sponsored by Bayer · Phase 3, Interventional, and Treatment
With this study researchers want to gather information about the consumer use behavior of Oxytrol in a simulated setting in which the medicine is sold directly to a consumer without a prescription from a healthcare professional. An area of focus was on the potential benefits of an over-the-counter status for Oxytrol and on the ongoing use behavior of the consumers. Oxytrol is a thin, flexible, clear patch that is indicated for the treatment of overactive bladder a disease characterized by a collection of symptoms, including urinary frequency, urgency, and urge incontinence. The adhesive patch is placed on the skin to deliver Oxytrol through the skin into the bloodstream.
855 studies on the registry are indexed under Urinary Bladder, Overactive; 125 are open to participants now.
This study's enrollment of 855 is above the median of 72 across 652 interventional studies indexed under Urinary Bladder, Overactive.
Browse Urinary Bladder, Overactive studies →Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.
Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
Subjects decided to purchase Oxytrol.
Drug: Oxybutynin (Oxytrol, BAY839380)
Oxybutynin transdermal patch, 3.9 mg daily (Oxytrol Transdermal System)
The Percentage of Participants Who Did Not Stop Use When They Either Developed a New Symptom Referred to Anywhere in the Labeling or When Their Condition Worsened Including Abdominal and/or Pelvic Pain.
For each participant who was defined as a primary endpoint misuser (i.e., subjects who did not stop using Oxytrol when they either developed a new symptom referred to anywhere in the labeling, with the addition of abdominal and/or pelvic pain, or when their OAB condition worsened) the full case report form was reviewed in order to determine if there were factors that would mitigate the incorrect decision to continue use. For example, if the subject had consulted a physician and was told to continue use, such continuation is acceptable. This process is termed "mitigation," because it involves determining if there are mitigating factors in the decision to continue use without posing any significant medical risk. Mitigation was conducted independently post-hoc by an external panel of advisors including two urologists and an urogynecologist and one physician employed by the sponsor.
Time frame: Approximately 15 weeks from subjects' initial purchase of Oxytrol
The Percentage of Verified Users Who Did Not Stop Use When Their Condition Worsened or They Developed a New Symptom Referred to in the Labeling.
This outcome measure did not include participants who developed abdominal and/or pelvic pain and was more reflective of how consumers stopped use according to the symptoms described on the Oxytrol labeling used in the study.
Time frame: Approximately 15 weeks from subjects' initial purchase of Oxytrol
The Median Time Taken to Discontinue Oxytrol Use by Verified Users Who Did Not Experience Improvement in Their Symptoms After Two Weeks of Treatment.
This outcome measure evaluated the number of days it took for a subject to discontinue use of Oxytrol after their symptoms worsened or had stayed the same after 2 weeks of treatment. This was calculated using diary card data.
Time frame: Approximately 15 weeks from subjects' initial purchase of Oxytrol
The Percentage of Verified Users Who Did Not Stop Oxytrol Use Within Two Weeks After Experiencing no Improvement in Their Symptoms.
Factors considered in this mitigation included providing: a response to one or more open ended questions that indicated a thoughtful, informed reason for continuing use; the subject talked to a physician, and the physician advised the subject that it was acceptable to continue using product; the subject had improved by Week 7 and indicated a thoughtful, informed reason for continuing use; as well as other reasons explained in the guidelines. This outcome measure was analyzed based on pre- and post-mitigation assessments but the post-mitigation analysis includes all subject data and is a better reflection of the subject's overall behavior. This was calculated by dividing the total number of subjects by the number of subjects who used the Oxytrol patch at least once.
Time frame: Approximately 15 weeks from subjects' initial purchase of Oxytrol
Number of Participants With Medical Risk Associated With the Development of New Symptoms or When Symptoms Did Not Improve for Patients That Continued Oxytrol Treatment.
The medical risk of the newly developed symptom(s) or no sign of symptom improvement was categorized according to prospectively defined medical risk categories of 'medical risk', 'possible medical risk', and minimal/insignificant medical risk'. Mitigated data was not included in this endpoint.
Time frame: Approximately 15 weeks from subjects' initial purchase of Oxytrol
The Percentage of Verified Users Who Misused the Patch (Incorrect Duration of Use or Simultaneous Use).
Factors considered in this mitigation for incorrect duration included most of the duration of patch use being correct, subject indicated understanding of the label but perhaps forgetting for a patch or two, etc. Factors considered in mitigation for simultaneous use include obvious diary errors, a subject stating that she did not do this, or a subject's doctor telling her to wear two patches at a time.
Time frame: Approximately 15 weeks from subjects' initial purchase of Oxytrol
Study was conducted in US-sites and pharmacies from 25May2010 (first patient first visit) to 22Jun2011 (last patient last visit).
| Milestone | Oxybutynin (Oxytrol, BAY839380) |
|---|---|
| Started | 855 |
| Treated | 727 |
| Completed | 703 |
| Not completed | 152 |
| Withdrew: Not completed end-of-study interview | 24 |
| Withdrew: Non-users | 70 |
| Withdrew: Non-verifiable users | 58 |
For each participant who was defined as a primary endpoint misuser (i.e., subjects who did not stop using Oxytrol when they either developed a new symptom referred to anywhere in the labeling, with the addition of abdominal and/or pelvic pain, or when their OAB condition worsened) the full case report form was reviewed in order to determine if there were factors that would mitigate the incorrect decision to continue use. For example, if the subject had consulted a physician and was told to continue use, such continuation is acceptable. This process is termed "mitigation," because it involves determining if there are mitigating factors in the decision to continue use without posing any significant medical risk. Mitigation was conducted independently post-hoc by an external panel of advisors including two urologists and an urogynecologist and one physician employed by the sponsor.
| Percentage of participants | Oxybutynin (Oxytrol, BAY839380) |
|---|---|
| Pre-mitigation | 14.4 (12.0 to 17.2) |
| Post-mitigation | 3.4 (2.2 to 5.0) |
This outcome measure did not include participants who developed abdominal and/or pelvic pain and was more reflective of how consumers stopped use according to the symptoms described on the Oxytrol labeling used in the study.
| Percentage of participants | Oxybutynin (Oxytrol, BAY839380) |
|---|---|
| Pre-Mitigation | 13.1 (10.7 to 15.7) |
| Post-Mitigation | 3.2 (2.0 to 4.7) |
This outcome measure evaluated the number of days it took for a subject to discontinue use of Oxytrol after their symptoms worsened or had stayed the same after 2 weeks of treatment. This was calculated using diary card data.
| Days | Oxybutynin (Oxytrol, BAY839380) |
|---|---|
| The Median Time Taken to Discontinue Oxytrol Use by Verified Users Who Did Not Experience Improvement in Their Symptoms After Two Weeks of Treatment. | 35 (26 to 46) |
Factors considered in this mitigation included providing: a response to one or more open ended questions that indicated a thoughtful, informed reason for continuing use; the subject talked to a physician, and the physician advised the subject that it was acceptable to continue using product; the subject had improved by Week 7 and indicated a thoughtful, informed reason for continuing use; as well as other reasons explained in the guidelines. This outcome measure was analyzed based on pre- and post-mitigation assessments but the post-mitigation analysis includes all subject data and is a better reflection of the subject's overall behavior. This was calculated by dividing the total number of subjects by the number of subjects who used the Oxytrol patch at least once.
| Percentage of participants | Oxybutynin (Oxytrol, BAY839380) |
|---|---|
| All Subjects Pre-Mitigation | 22.6 (19.4 to 26.0) |
| All Subjects Post-Mitigation | 11.0 (8.7 to 13.7) |
The medical risk of the newly developed symptom(s) or no sign of symptom improvement was categorized according to prospectively defined medical risk categories of 'medical risk', 'possible medical risk', and minimal/insignificant medical risk'. Mitigated data was not included in this endpoint.
| Participants | Oxybutynin (Oxytrol, BAY839380) |
|---|---|
| Medical risk (subjects) | 16 |
| Possible medical risk (subjects) | 24 |
| Minimal/insignificant medical risk (subjects) | 284 |
Factors considered in this mitigation for incorrect duration included most of the duration of patch use being correct, subject indicated understanding of the label but perhaps forgetting for a patch or two, etc. Factors considered in mitigation for simultaneous use include obvious diary errors, a subject stating that she did not do this, or a subject's doctor telling her to wear two patches at a time.
| Percentage of participants | Oxybutynin (Oxytrol, BAY839380) |
|---|---|
| Total Subjects Pre-Mitigation | 51.7 (47.9 to 55.4) |
| Total Subjects Post-Mitigation | 21.2 (18.3 to 24.4) |
Collected over 15 weeks. Non-serious events are listed at a 0.3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Oxybutynin (Oxytrol, BAY839380) | — | 35/785 (4.5%) | 509/785 (64.8%) |
| Event | Oxybutynin (Oxytrol, BAY839380) |
|---|---|
| Urinary tract infectionInfections and infestations | 3/785 |
| Chest painGeneral disorders | 2/785 |
| CholecystitisHepatobiliary disorders | 2/785 |
| ArrhythmiaCardiac disorders | 1/785 |
| Cardiac disorderCardiac disorders | 1/785 |
| Diarrhoea haemorrhagicGastrointestinal disorders | 1/785 |
| Hepatic failureHepatobiliary disorders | 1/785 |
| HypersensitivityImmune system disorders | 1/785 |
| BronchitisInfections and infestations | 1/785 |
| CellulitisInfections and infestations | 1/785 |
| Event | Oxybutynin (Oxytrol, BAY839380) |
|---|---|
| Application site irritationGeneral disorders | 142/785 |
| Urinary tract infectionInfections and infestations | 47/785 |
| NasopharyngitisInfections and infestations | 46/785 |
| Dry mouthGastrointestinal disorders | 32/785 |
| Urge incontinenceRenal and urinary disorders | 24/785 |
| SinusitisInfections and infestations | 21/785 |
| ConstipationGastrointestinal disorders | 20/785 |
| HeadacheNervous system disorders | 20/785 |
| InfluenzaInfections and infestations | 18/785 |
| Back painMusculoskeletal and connective tissue disorders | 17/785 |
| Age, Continuous(Years) | Oxybutynin (Oxytrol, BAY839380) |
|---|---|
| Mean | 58.4 ± 15.0 |
| Sex: Female, Male(Participants) | Oxybutynin (Oxytrol, BAY839380) |
|---|---|
| Female | 727 |
| Male | 0 |
| Race/Ethnicity, Customized(Participants) | Oxybutynin (Oxytrol, BAY839380) |
|---|---|
| White | 561 |
| Black or African American | 66 |
| Hispanic or Latino | 64 |
| Asian | 12 |
| Other | 24 |
This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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