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Enrolling too slowly due to insurance plans no longer covering the cost of the Percutaneous Tibial Nerve Stimulation treatment.
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The null hypothesis for this study is that the combination of solifenacin and Percutaneous Tibial Nerve Stimulation (PTNS) is not different from PTNS alone. However the investigators anticipate a 20% improvement in patients receiving combination therapy as measured by the OAB-q (Overactive Bladder questionnaire) scores.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PTNS and solifenacin | Active Comparator | PTNS bladder neuromodulation weekly for 12 treatments; solifenacin 5 mg capsule daily for 15 weeks |
|
| PTNS and placebo | Placebo Comparator | PTNS bladder neuromodulation weekly for 12 treatments; placebo 1 capsule daily for 15 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PTNS plus solifenacin | Other | 12 weekly treatments with percutaneous tibial nerve stimulation with 5 mg of solifenacin; an additional 4 weeks of solifenacin for a total of 15 weeks of study drug. |
| Measure | Description | Time Frame |
|---|---|---|
| Overactive Bladder Questionnaire, items 1-8 only | Change from Baseline in Overactive Bladder Questionnaire at 11 weeks. | |
| Overactive Bladder Questionnaire, items 1-8 only | Change from Baseline in Overactive Bladder Questionnaire at 15 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| 3-day micturition diary | To measure changes in frequency, urgency, urge incontinence episodes, nocturia and urine volume (one day of each 3-day diary) | Change in Bladder diary from Baseline to 5 weeks. |
| 3-day micturition diary |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| H. David Mitcheson, MD | Bay State Clinical Trials, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bay State Clinical Trials, Inc. | Watertown | Massachusetts | 02472 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 22, 2015 | |
| Reset | Apr 2, 2015 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 22, 2015 | Apr 2, 2015 |
| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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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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|
| Placebo | Other | 12 weekly treatments with percutaneous tibial nerve stimulation with placebo; an additional 4 weeks of placebo for a total of 15 weeks of placebo. |
|
To measure changes in frequency, urgency, urge incontinence episodes, nocturia and urine volume (one day of each 3-day diary)
| Change in Bladder diary from Baseline to 11 weeks. |
| 3-day micturition diary | To measure changes in frequency, urgency, urge incontinence episodes, nocturia and urine volume (one day of each 3-day diary) | Change in Bladder diary from Baseline to 15 weeks. |
| Urgency Perception Scale (questionnaire) | Changes in Urgency Perception from Baseline to 11 weeks. |
| Urgency Perception Scale (questionnaire) | Changes in Urgency Perception from Baseline to 15 weeks. |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007546 | Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |