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| Name | Class |
|---|---|
| Astellas Pharma Inc | INDUSTRY |
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Urinary urgency is a key symptom of overactive bladder syndrome (OAB) and may be more bothersome to a patient than the symptom of urinary frequency. Unfortunately, controversy continues to surround the term 'urgency' and there is no good tool to evaluate the severity of urgency. This fact has constrained the performance of clinical research in this field. The cause of urinary urgency is not fully understood and may vary from patient to patient.
Although clinicians regularly obtain measures of bladder sensation during cystometry, little attention has been paid to the patient experience of urinary urgency. In this study, the researchers will use a non-significant risk device (i.e., an Urgeometer) to measure urinary urgency in women with overactive bladder.
At baseline, a small catheter is placed inside the participant's bladder. The bladder is filled with sterile water through the catheter. As the bladder is filled, the participant is asked to rate their urinary urgency using the Urgeometer. The Urgeometer lever marks a continuous scale from 0 'no urge at all' to 100 'maximum urge which you can tolerate'. The testing is stopped once the bladder is filled. To minimize the chance of infection, participants receive one dose of oral antibiotics prior to the bladder testing.
Following completion of the bladder test, participants will take 10mg solifenacin succinate (VesicareR) daily for 30 days. Afterward, participants repeat the bladder test. The change in participants' maximal tolerated cystometric capacity (MCC) will be measured in milliliters and used to evaluate the effectiveness of the drug.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Solifenacin Succinate | Experimental | The intervention for this study is 10mg daily solifenacin. Patients with overactive bladder syndrome will take this study drug for 30 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Solifenacin Succinate | Drug | Participants take 10mg daily solifenacin succinate for 30 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Maximal Cystometric Capacity (mL) | At baseline, a small catheter is placed inside the participant's bladder. The bladder is filled with sterile water through the catheter and participants' maximal tolerated cystometric capacity (MCC) is measured in milliliters. Following completion of the bladder test, participants take 10mg solifenacin succinate (VesicareR) daily for 30 days. After 30 days of treatment, participants repeat the bladder test. Change in the MCC is used to evaluate the effectiveness of the drug. | 30 Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mary P FitzGerald, MD | Loyola University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loyola University Medical Center | Maywood | Illinois | 60153 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16086677 | Background | Craggs MD. Objective measurement of bladder sensation: use of a new patient-activated device and response to neuromodulation. BJU Int. 2005 Sep;96 Suppl 1:29-36. doi: 10.1111/j.1464-410X.2005.05649.x. | |
| 12478595 | Background | Oliver S, Fowler C, Mundy A, Craggs M. Measuring the sensations of urge and bladder filling during cystometry in urge incontinence and the effects of neuromodulation. Neurourol Urodyn. 2003;22(1):7-16. doi: 10.1002/nau.10082. |
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Due to restrictions on the availability of individual participant data (IPD), IPD are not publicly available
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Following informed consent, nine women were negative for OAB and did not receive solifenacin succinate
Fifty-one individuals were consented and 42 women with overactive bladder (OAB) received study drug between January 2007 and February 2009. Participants were recruited using physician solicitation.
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| ID | Title | Description |
|---|---|---|
| FG000 | Detrusor Overactivity Incontinence (DOI) | Patients in this cohort were diagnosed with detrusor overactivity incontinence (DOI). |
| FG001 | Urodynamic Stress Incontinence (USI) | Patients in this cohort were diagnosed with urodynamic stress incontinence (USI) |
| FG002 | Mixed Incontinence (DOI-USI) | Patients in this cohort were diagnosed with both detrusor overactivity incontinence (DOI) and urodynamic stress incontinence (USI) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The baseline analysis population comprises all women who signed informed consent and have a valid diagnosis of OAB
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| ID | Title | Description |
|---|---|---|
| BG000 | Detrusor Overactivity Incontinence (DOI) | Patients in this cohort were diagnosed with detrusor overactivity incontinence (DOI) |
| BG001 | Urodynamic Stress Incontinence (USI) | Patients in this cohort were diagnosed with urodynamic stress incontinence (USI) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Maximal Cystometric Capacity (mL) | At baseline, a small catheter is placed inside the participant's bladder. The bladder is filled with sterile water through the catheter and participants' maximal tolerated cystometric capacity (MCC) is measured in milliliters. Following completion of the bladder test, participants take 10mg solifenacin succinate (VesicareR) daily for 30 days. After 30 days of treatment, participants repeat the bladder test. Change in the MCC is used to evaluate the effectiveness of the drug. | The primary outcome analysis population comprises only women with two valid MCC recordings (i.e., one baseline recording and one recording following 30 days of treatment with daily 10mg solifenacin succinate. The groups DOI and USI were combined for this repeated measures analysis. | Posted | Median | Inter-Quartile Range | milliliters (mL) | 30 Days |
|
Adverse event data were collected during the 30 day trial
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Detrusor Overactivity Incontinence (DOI) | Patients in this cohort were diagnosed with detrusor overactivity incontinence (DOI) |
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The trial experienced significant attrition. Otherwise, there are no limitations or caveats to report.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mary P FitzGerald | Loyola University Chicago | 708-216-2170 | mfitzg8@lumc.edu |
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| ID | Term |
|---|---|
| D000069464 | Solifenacin Succinate |
| ID | Term |
|---|---|
| D011812 | Quinuclidines |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006571 | Heterocyclic Compounds |
| D044005 | Tetrahydroisoquinolines |
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| 12559262 | Background | Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, Van Kerrebroeck P, Victor A, Wein A; Standardisation Sub-Committee of the International Continence Society. The standardisation of terminology in lower urinary tract function: report from the standardisation sub-committee of the International Continence Society. Urology. 2003 Jan;61(1):37-49. doi: 10.1016/s0090-4295(02)02243-4. No abstract available. |
| 11744914 | Background | Barber MD, Kuchibhatla MN, Pieper CF, Bump RC. Psychometric evaluation of 2 comprehensive condition-specific quality of life instruments for women with pelvic floor disorders. Am J Obstet Gynecol. 2001 Dec;185(6):1388-95. doi: 10.1067/mob.2001.118659. |
| 2514773 | Background | Herzog AR, Diokno AC, Fultz NH. Urinary incontinence: medical and psychosocial aspects. Annu Rev Gerontol Geriatr. 1989;9:74-119. doi: 10.1007/978-3-662-40455-3_3. |
| BG002 | Mixed Incontinence (DOI-USI) | Patients in this cohort were diagnosed with both detrusor overactivity incontinence (DOI) and urodynamic stress incontinence (USI) |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
All patients with DOI or USI had their baseline maximal cystometric capacity recorded
| OG001 | One Month Maximal Cystometric Capacity | All patients with DOI or USI had their maximal cystometric capacity recorded following 30 days of treatment with daily 10mg solifenacin succinate. |
|
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| 0 |
| 18 |
| 0 |
| 18 |
| 0 |
| 18 |
| EG001 | Urodynamic Stress Incontinence (USI) | Patients in this cohort were diagnosed with urodynamic stress incontinence (USI) | 0 | 15 | 0 | 15 | 0 | 15 |
| EG002 | Mixed Incontinence (DOI-USI) | Patients in this cohort were diagnosed with both detrusor overactivity incontinence (DOI) and urodynamic stress incontinence (USI) | 0 | 9 | 0 | 9 | 0 | 9 |
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| D007546 | Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |