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| ID | Type | Description | Link |
|---|---|---|---|
| IRB# 0711-0124 | Other Identifier | HMRI IRB |
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| Name | Class |
|---|---|
| Astellas Pharma US, Inc. | INDUSTRY |
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A single center, pilot trial using tamsulosin and solifenacin in 10 men with symptomatic lower urinary tract symptoms (LUTS). Subjects will be evaluated at baseline, 1, 2, and 3 months for urinary NGF, urine creatinine, NGF/CR ratio and patient reported outcomes through questionnaires.
Single center, pilot trial, single arm study using once daily dosing of tamsulosin and solifenacin in 10 men with symptomatic lower urinary tract symptoms (LUTS). Assessments occur at Baseline, 1 Month, 2 Month and 3 Month to evaluate: urinary NGF (pg/mL), urine creatinine (mg/dL), NGF/Cr ratio and patient reported questionnaire outcomes (AUA Symptom Score/IPSS, Patient Perception of Bladder Condition, Patient Perception of Urge Intensity 'PPIUS', LUTS Urinary Symptoms and Quality of Life). Each participant is assessed from baseline to Month 3 measurements. Protection of human subjects will be provided through the Houston Methodist Research Institute Institutional Review Board (see appendix 2). All men will receive morning dosing with Tamsulosin 0.4 mg (1 tab) and Solifenacin 5 mg (1 tab) orally at the same time.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| One (single arm) | Experimental | All men will receive morning dosing with Tamsulosin (Flomax) 0.4 mg (1 tab) and Solifenacin (Vesicare) 5 mg (1 tab) orally at the same time. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tamsulosin | Drug | Alpha blocker used to in the treatment of urinary difficulties related to enlarged prostate or symptomatic benign prostatic hypertrophy. All men will receive Tamsulosin (Flomax®) 0.4 mg, 1 tab, per morning with Solifenacin (Vesicare®). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Urinary Nerve Growth Factor (pg/mL) at Baseline Compared to Post Dose Exposure at Mo.3/Wk12 | Urine sample tested for urinary Nerve Growth Factor (uNGF as measured in pg/mL), a small secreted protein in the bladder that supports bladder function regulation, at baseline (pre-dose) and week 12/Month 3 post-dose, after using daily tamsulosin and solifenacin. | Change from baseline to week 12 (3 months) |
| Change From Baseline in Urinary Growth Factor to Creatinine Ratio (GF/Cr) | The urinary growth factor (GF) to creatinine ratio may be potential biomarker for overactive bladder, based on published articles. Measuring the ratio at baseline and Month 3, comparing the difference after treatment with tamsulosin and solifenacin which may provide insight into how lower urinary tract symptoms in men progresses. | change from baseline score to Month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Post Void Residual (mL) at Baseline Compared to Post Dose Exposure at Mo.1, Mo, 2, and Mo. 3/Wk12 | Urine sample tested for urinary post void residual (measured in mL) at baseline (pre-dose), Month 1 and Month 2and week 12/Month 3 post-dose, post dose w/tamsulosin and solifenacin. | Change from baseline to months 1, 2 and 3 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Timothy Boone, MD,PhD | The Methodist Hospital Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Methodist Hospital System | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | McVary KT. 2010 AUA Benign Prostatic Hyperplasia Clinical Guidelines. Panel Chair, AUA News 2010; 15 (3) 10 - 11. | ||
| 16530611 | Background | Chapple CR, Roehrborn CG. A shifted paradigm for the further understanding, evaluation, and treatment of lower urinary tract symptoms in men: focus on the bladder. Eur Urol. 2006 Apr;49(4):651-8. doi: 10.1016/j.eururo.2006.02.018. Epub 2006 Feb 17. | |
| Background | Kaplan SA. New data on Tolterodine: Do recent findings dispel questions about treating overactive bladder in men? Eur Urology 2007; Suppl 6: 10-16. | ||
| 15476515 |
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Plan to share data to be determined.
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Potential participants were approached by the PI and Study Team in an outpatient urology clinic setting between October 2011 and December 2014 for recruitment to the male lower urinary tract symptoms study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Arm (Tamsulosin and Solifenacin) | 10 Men with lower urinary tract symptoms (LUTS), consistent with BPH, were screened in our urology clinics for participation in a clinical trial. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | Men > 50 years old with urinary frequency symptoms, who entered study not taking any bladder related medications and on study took tamsulosin and solifenacin orally everyday throughout the study with follow-up assessments at Month 1/week 4, Month 2 week 8, and Month 3/week 12. |
| 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 Urinary Nerve Growth Factor (pg/mL) at Baseline Compared to Post Dose Exposure at Mo.3/Wk12 | Urine sample tested for urinary Nerve Growth Factor (uNGF as measured in pg/mL), a small secreted protein in the bladder that supports bladder function regulation, at baseline (pre-dose) and week 12/Month 3 post-dose, after using daily tamsulosin and solifenacin. | Posted | Mean | Standard Deviation | pg/ml | Change from baseline to week 12 (3 months) |
|
3 years
All reported events were assessed by the Principal Investigator and resulted in no withdrawals due to study medications.
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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 | Participant Flow | 10 Men with lower urinary tract symptoms (LUTS), consistent with BPH, were screened in our urology clinics for participation in a clinical trial. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA (10.0) | Systematic Assessment | Mild fatigue requiring no treatment (S#02) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Timothy Boone, MD, PhD, Principal Investigator | Houston Methodist Hosptial System | 713-441-6455 | tboone3@houstonmethodist.org |
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| ID | Term |
|---|---|
| D059411 | Lower Urinary Tract Symptoms |
| ID | Term |
|---|---|
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077409 | Tamsulosin |
| D000069464 | Solifenacin Succinate |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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|
| Solifenacin | Drug | Antispasmodic/anticholinergic used to treat overactive bladder. All men will receive Solifenacin (Vesicare®) 5 mg, 1 tab, per morning with Tamsulosin. |
|
|
| Change in Maximum Urinary Flow Rate (ml/s) at Baseline Compared to Post Dose Exposure at Mo.1, Mo, 2, and Mo. 3/Wk12 |
Urination flow rate (measured in milliliters per second) at baseline (pre-dose), and Month 1, Month 2, and Month 3/Week 12 pose-dosing with tamsulosin and solifenacin. An average maximum urinary flow rate in males is 21 ml/sec aged 14-45 years-old and 12 ml/sec in males aged 46-65 years-old. |
| Change from baseline to months 1, 2 and 3 |
| Change in IPSS-International Prostate Score Scale at Baseline Compared to Post Dose Survey at Month 1, 2, and Month 3/Week12. | The survey, IPSS-International Prostate Score Scale, survey responses measured 0-35, is collected at baseline compared to post dose survey response at Month 1, Month 2, and Month 3/Week12 post-dose. The lower the score is indicative of less or fewer urinary symptoms while 35 is consistent with more bothersome symptoms. | Change from baseline to months 1, 2 and 3 |
| Change in PPUS-Patient Perception of Urinary Urgency Survey Score at Baseline Compared to Post Dose Exposure at Mo.1, Mo, 2, and Mo. 3/Wk12 | The Patient Perception of Urinary Urgency self administered survey score has a maximum score 4, zero to four, for how severe a patient describes their urinary voiding frequency. Four is the most bothersome score, 0 or 1 is the least bothersome. Pre-dose / baseline score is compared at Month 1, Month 2, and Month 3, after dosing with tamsulosin and solifenacin. | Change from baseline to months 1, 2 and 3 |
| Change in PBC-Patient Perception of Bladder Condition at Baseline Compared to Post Dose Exposure at Mo.1, Mo, 2, and Mo. 3/Wk12 | Change in the Perception of Bladder through a self administered survey at baseline compared to Month 1, Month 2, and Month 3, following exposure to tamsulosin and solifenacin. The survey score measures from zero to 6, with 6 being the most bothersome bladder symptoms and 0 to 1 being the least bothersome. | Change from baseline to months 1, 2 and 3 |
| Change in ICIQ-MLUTS - International Consultation on Incontinence Modular Questionnaire for Male LUTS Baseline Compared to Post Dose Exposure at Mo.1, Mo, 2, and Mo. 3/Wk12 | Measuring change in the International Consultation on Incontinence Modular Questionnaire for male lower urinary tract symptoms through a self administered survey at baseline compared to Month 1, Month 2, and Month 3, after exposure to tamsulosin and solifenacin. The survey score is a zero to 182 range with 182 being the most bothersome and zero to one being the least bothersome. | Change from baseline to months 1, 2 and 3 |
| Change in ICIQ LUTS QoL -International Consultation on Incontinence Modular Questionnaire LUTS Quality of Life for Male LUTS Baseline Compared to Post Dose Exposure at Mo.1, Mo, 2, and Mo. 3/Wk12 | Change in the International Consultation on Incontinence Modular Questionnaire on lower urinary tract symptoms quality of life survey for men, self administered, compared to Month 1, Month 2, and Month 3, after exposure to tamsulosin and solifenacin. The survey scoring is zero to 182, with 182 being the most bothersome and 0 to 1 being the least bothersome. | Change from baseline to months 1, 2 and 3 |
| Change in Urinary Nerve Growth Factor (pg/mL) at Baseline Compared to Post Dose Exposure at Mo.1/Wk4 and Mo.2/Wk8 | Urine sample tested for urinary Nerve Growth Factor (uNGF as measured in pg/mL), a small secreted protein in the bladder that supports bladder function regulation, at baseline (pre-dose) compared to Month 1/Week 4 and Month 2/Week 8, post dosing with tamsulosin and solifenacin. | Change from baseline to Mo.1/Wk4 and Mo.2/Wk8 |
| Change in Urinary Growth Factor to Creatinine Ratio (GF/Cr) From Baseline Compared to Month 1/Week4 and Month 2/Week 8. | Assessing the change from baseline to Month 1/Week 4 and Month 2/Week 8, of the urinary growth factor (GF) to creatinine ratio in men, which may be potential biomarker for overactive bladder, based on published articles. Measuring the ratio at baseline compared to Month 1 and Month 2 may provide insight into how lower urinary tract symptoms in men progresses. | change from baseline score to Mo.1/Wk4 and Mo.2/Wk8 scores |
| Background |
| Lee JY, Kim HW, Lee SJ, Koh JS, Suh HJ, Chancellor MB. Comparison of doxazosin with or without tolterodine in men with symptomatic bladder outlet obstruction and an overactive bladder. BJU Int. 2004 Oct;94(6):817-20. doi: 10.1111/j.1464-410X.2004.05039.x. |
| 17105794 | Background | Kaplan SA, Roehrborn CG, Rovner ES, Carlsson M, Bavendam T, Guan Z. Tolterodine and tamsulosin for treatment of men with lower urinary tract symptoms and overactive bladder: a randomized controlled trial. JAMA. 2006 Nov 15;296(19):2319-28. doi: 10.1001/jama.296.19.2319. |
| 18510659 | Background | Kaplan SA, Roehrborn CG, Chancellor M, Carlsson M, Bavendam T, Guan Z. Extended-release tolterodine with or without tamsulosin in men with lower urinary tract symptoms and overactive bladder: effects on urinary symptoms assessed by the International Prostate Symptom Score. BJU Int. 2008 Nov;102(9):1133-9. doi: 10.1111/j.1464-410X.2008.07761.x. Epub 2008 May 26. |
| 20001469 | Background | Kaplan SA, Goldfischer ER, Steers WD, Gittelman M, Andoh M, Forero-Schwanhaeuser S. Solifenacin treatment in men with overactive bladder: effects on symptoms and patient-reported outcomes. Aging Male. 2010 Jun;13(2):100-7. doi: 10.3109/13685530903440408. |
| 18423678 | Background | Liu HT, Kuo HC. Urinary nerve growth factor level could be a potential biomarker for diagnosis of overactive bladder. J Urol. 2008 Jun;179(6):2270-4. doi: 10.1016/j.juro.2008.01.146. Epub 2008 Apr 18. |
| 17924444 | Background | Yokoyama T, Kumon H, Nagai A. Correlation of urinary nerve growth factor level with pathogenesis of overactive bladder. Neurourol Urodyn. 2008;27(5):417-20. doi: 10.1002/nau.20519. |
| 19220267 | Background | Liu HT, Chancellor MB, Kuo HC. Decrease of urinary nerve growth factor levels after antimuscarinic therapy in patients with overactive bladder. BJU Int. 2009 Jun;103(12):1668-72. doi: 10.1111/j.1464-410X.2009.08380.x. Epub 2009 Feb 11. |
| 20156378 | Background | Jacobs BL, Smaldone MC, Tyagi V, Philips BJ, Jackman SV, Leng WW, Tyagi P. Increased nerve growth factor in neurogenic overactive bladder and interstitial cystitis patients. Can J Urol. 2010 Feb;17(1):4989-94. |
| 18990175 | Background | Cardozo L, Hessdorfer E, Milani R, Arano P, Dewilde L, Slack M, Drogendijk T, Wright M, Bolodeoku J; SUNRISE Study Group. Solifenacin in the treatment of urgency and other symptoms of overactive bladder: results from a randomized, double-blind, placebo-controlled, rising-dose trial. BJU Int. 2008 Nov;102(9):1120-7. doi: 10.1111/j.1464-410X.2008.07939.x. Epub 2008 Oct 6. |
| 21789068 | Result | Dmochowski RR, Gomelsky A. Overactive bladder in males. Ther Adv Urol. 2009 Oct;1(4):209-21. doi: 10.1177/1756287209350383. |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Baseline Post-void residual (PVR) of urine | PVR is the measure of urine measured in milliliters (ml), by an ultrasound over the abdomen, to measure how much urine remains in the bladder after it is completely empty following urodynamic measurements. Urodynamics is the test done right before the PVR to measure how fast and how much, volume of urine is emptied from the bladder. These measurements help identify issues related to enlarged prostate or other issue. | Mean | Standard Deviation | ml |
|
| Baseline Maximum urinary flow rate | Max urinary flow rate in ml/sec measured by urodynamics at baseline. An average rate in males is 21 ml/sec (ages 14-45 years-old) and 12 ml/sec in males (ages 46-65 years-old). | Mean | Standard Deviation | ml/s |
|
| Baseline International Prostate Symptom Score (IPSS) | IPSS is a questionnaire, max of 35 points, none (0), to few symptoms to 35 (symptomatic), administered at baseline, which measures incomplete bladder emptying, frequency, urgency, straining, and nocturia. | Mean | Standard Deviation | units on a scale |
|
| Baseline Patient Perception of Urgency Score (PPUS) | PPUS is in questionnaire format with a max score of 4. Subject have a single rating, low score (none) to 4 (symptoms). | Mean | Standard Deviation | units on a scale |
|
| Baseline Perception of Bladder Condition (PBC) | Perception of bladder control measured in questionnaire format with single max rating up to 6, comparing baseline. Low score (none) to 6 (symptoms). | Mean | Standard Deviation | units on a scale |
|
| Baseline International Consultation on Incontinence Mod. Questions-Male Lower Urinary Tract Symptoms | ICIQ MLUTS (max score = 182) quality of life questionnaire to measure baseline. Low score (none to few symptoms) to 182 (very symptomatic). | Mean | Standard Deviation | units on a scale |
|
| Baseline International Consultation on Incontinence Mod. Questions Lower Urinary Tract Symptoms QoL | ICIQ LUTs Quality of Life with max score = 288 from a questionnaire taken at baseline. Low score (none to few symptoms) to 288 (very symptomatic). | Mean | Standard Deviation | units on a scale |
|
| Baseline Urinary Nerve Growth Factor (pg/ml)/Cr (mg/dl) | Urinary Nerve Growth Factor (uNGF) from a biomarker in pg/ml in a ratio over urinary creatinine (u-Cr) obtained from a lab tested urinalysis in mg/dl. | Mean | Standard Deviation | ratio |
|
| Baseline Urinary Nerve Growth Factor | Urine collected for urinary nerve growth factor (u-NGF with units: pg/ml) measurement at baseline. | Mean | Standard Deviation | pg/ml |
|
|
|
| Primary | Change From Baseline in Urinary Growth Factor to Creatinine Ratio (GF/Cr) | The urinary growth factor (GF) to creatinine ratio may be potential biomarker for overactive bladder, based on published articles. Measuring the ratio at baseline and Month 3, comparing the difference after treatment with tamsulosin and solifenacin which may provide insight into how lower urinary tract symptoms in men progresses. | Posted | Mean | Standard Deviation | ratio | change from baseline score to Month 3 |
|
|
|
| Secondary | Change in Post Void Residual (mL) at Baseline Compared to Post Dose Exposure at Mo.1, Mo, 2, and Mo. 3/Wk12 | Urine sample tested for urinary post void residual (measured in mL) at baseline (pre-dose), Month 1 and Month 2and week 12/Month 3 post-dose, post dose w/tamsulosin and solifenacin. | Posted | Mean | Standard Deviation | ml | Change from baseline to months 1, 2 and 3 |
|
|
|
| Secondary | Change in Maximum Urinary Flow Rate (ml/s) at Baseline Compared to Post Dose Exposure at Mo.1, Mo, 2, and Mo. 3/Wk12 | Urination flow rate (measured in milliliters per second) at baseline (pre-dose), and Month 1, Month 2, and Month 3/Week 12 pose-dosing with tamsulosin and solifenacin. An average maximum urinary flow rate in males is 21 ml/sec aged 14-45 years-old and 12 ml/sec in males aged 46-65 years-old. | Posted | Mean | Standard Deviation | ml/s | Change from baseline to months 1, 2 and 3 |
|
|
|
| Secondary | Change in IPSS-International Prostate Score Scale at Baseline Compared to Post Dose Survey at Month 1, 2, and Month 3/Week12. | The survey, IPSS-International Prostate Score Scale, survey responses measured 0-35, is collected at baseline compared to post dose survey response at Month 1, Month 2, and Month 3/Week12 post-dose. The lower the score is indicative of less or fewer urinary symptoms while 35 is consistent with more bothersome symptoms. | Posted | Mean | Standard Deviation | units on a scale | Change from baseline to months 1, 2 and 3 |
|
|
|
| Secondary | Change in PPUS-Patient Perception of Urinary Urgency Survey Score at Baseline Compared to Post Dose Exposure at Mo.1, Mo, 2, and Mo. 3/Wk12 | The Patient Perception of Urinary Urgency self administered survey score has a maximum score 4, zero to four, for how severe a patient describes their urinary voiding frequency. Four is the most bothersome score, 0 or 1 is the least bothersome. Pre-dose / baseline score is compared at Month 1, Month 2, and Month 3, after dosing with tamsulosin and solifenacin. | Posted | Mean | Standard Deviation | units on a scale | Change from baseline to months 1, 2 and 3 |
|
|
|
| Secondary | Change in PBC-Patient Perception of Bladder Condition at Baseline Compared to Post Dose Exposure at Mo.1, Mo, 2, and Mo. 3/Wk12 | Change in the Perception of Bladder through a self administered survey at baseline compared to Month 1, Month 2, and Month 3, following exposure to tamsulosin and solifenacin. The survey score measures from zero to 6, with 6 being the most bothersome bladder symptoms and 0 to 1 being the least bothersome. | Posted | Mean | Standard Deviation | units on a scale | Change from baseline to months 1, 2 and 3 |
|
|
|
| Secondary | Change in ICIQ-MLUTS - International Consultation on Incontinence Modular Questionnaire for Male LUTS Baseline Compared to Post Dose Exposure at Mo.1, Mo, 2, and Mo. 3/Wk12 | Measuring change in the International Consultation on Incontinence Modular Questionnaire for male lower urinary tract symptoms through a self administered survey at baseline compared to Month 1, Month 2, and Month 3, after exposure to tamsulosin and solifenacin. The survey score is a zero to 182 range with 182 being the most bothersome and zero to one being the least bothersome. | Posted | Mean | Standard Deviation | units on a scale | Change from baseline to months 1, 2 and 3 |
|
|
|
| Secondary | Change in ICIQ LUTS QoL -International Consultation on Incontinence Modular Questionnaire LUTS Quality of Life for Male LUTS Baseline Compared to Post Dose Exposure at Mo.1, Mo, 2, and Mo. 3/Wk12 | Change in the International Consultation on Incontinence Modular Questionnaire on lower urinary tract symptoms quality of life survey for men, self administered, compared to Month 1, Month 2, and Month 3, after exposure to tamsulosin and solifenacin. The survey scoring is zero to 182, with 182 being the most bothersome and 0 to 1 being the least bothersome. | Posted | Mean | Standard Deviation | units on a scale | Change from baseline to months 1, 2 and 3 |
|
|
|
| Secondary | Change in Urinary Nerve Growth Factor (pg/mL) at Baseline Compared to Post Dose Exposure at Mo.1/Wk4 and Mo.2/Wk8 | Urine sample tested for urinary Nerve Growth Factor (uNGF as measured in pg/mL), a small secreted protein in the bladder that supports bladder function regulation, at baseline (pre-dose) compared to Month 1/Week 4 and Month 2/Week 8, post dosing with tamsulosin and solifenacin. | Posted | Mean | Standard Deviation | pg/ml | Change from baseline to Mo.1/Wk4 and Mo.2/Wk8 |
|
|
|
| Secondary | Change in Urinary Growth Factor to Creatinine Ratio (GF/Cr) From Baseline Compared to Month 1/Week4 and Month 2/Week 8. | Assessing the change from baseline to Month 1/Week 4 and Month 2/Week 8, of the urinary growth factor (GF) to creatinine ratio in men, which may be potential biomarker for overactive bladder, based on published articles. Measuring the ratio at baseline compared to Month 1 and Month 2 may provide insight into how lower urinary tract symptoms in men progresses. | Posted | Mean | Standard Deviation | ratio | change from baseline score to Mo.1/Wk4 and Mo.2/Wk8 scores |
|
|
|
| 0 |
| 10 |
| 1 |
| 10 |
|
| malaise | General disorders | MedDRA (10.0) | Systematic Assessment | Mild malaise requiring no treatment (S#02). |
|
| bloating | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment | Mild bloating lasting two weeks and not requiring treatment (S#02). |
|
| blurred vision | Eye disorders | MedDRA (10.0) | Systematic Assessment | Mild blurred vision not requiring treatment or intervention (S#02). |
|
| decreased memory | Nervous system disorders | MedDRA (10.0) | Systematic Assessment | Mild memory decrease, not requiring treatment or intervention (S#06). |
|
| urinary frequency | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment | Mild increase in urinary frequency not requiring medication or treatment which resolved after six weeks (S#06). |
|
| constipation | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment | Moderate constipation, resolved with over-the-counter stool softener, 3 months duration (S#07) and Mild constipation resolving after 2 weeks without treatment (S#10). |
|
| tinnitus | Ear and labyrinth disorders | MedDRA (10.0) | Systematic Assessment | Mild ringing in ears, resolved after 14 days without treatment or intervention (S#07). |
|
| reduced ejaculation | Reproductive system and breast disorders | MedDRA (10.0) | Systematic Assessment | Reduced ejaculation (subjective report of moderate) but requiring no treatment or intervention while on study (S#07). |
|
| indigestion | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment | Moderately increased indigestion (baseline/pre-study condition) treated with over-the-counter antacids while on study (S#09). |
|
| dry mouth | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment | Mild dry mouth lasting three weeks requiring no treatment or intervention (S#10). |
|
Not provided
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011812 | Quinuclidines |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006571 | Heterocyclic Compounds |
| D044005 | Tetrahydroisoquinolines |
| D007546 | Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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