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| ID | Type | Description | Link |
|---|---|---|---|
| IIR - DRIVE |
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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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The purpose of this study is to determine if long acting tolterodine confers more benefit than intravaginal low dose estrogen in the treatment of Overactive Bladder Syndrome at 12 weeks post-treatment initiation. The hypothesis is that low dose intra-vaginal estrogen confers greater benefit than tolterodine in the treatment of Overactive Bladder symptoms. Secondary outcomes were to assess if the addition of the other therapy to the treatment regimen conferred benefit at 24 weeks and 52 weeks.
Lower urinary tract bladder storage symptoms include urinary frequency, urinary urgency, nocturia and urge incontinence. Overactive Bladder (OAB)Syndrome is a condition in which urgency is the predominant symptom with or without urge incontinence and is usually accompanied by frequency and nocturia. The mainstay of treatment of women with OAB syndrome is treatment with anticholinergic medication as well as behavioral therapy. This method of treatment has demonstrated a 60% response rate as reported in the Cochrane Database of Systemic Reviews.
In addition to anticholinergic therapy, vaginal atrophy is often corrected as part of a pharmacologic treatment plan. Vaginal atrophy is a condition this is vastly prevalent in post-menopausal women. It is thought to affect up to 48% of post-menopausal women. Many women with this condition experience vaginal dryness, irritation, painful intercourse, as well as urinary symptoms including dysuria, urgency, frequency, nocturia, incontinence and recurrent urinary tract infections.
Comparison: Tolterodine LA compared to low dose intra-vaginal estrogen cream for the treatment of OAB symptoms
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Extended Release Tolterodine LA | Active Comparator | An anti-muscarinic drug that is used for symptomatic treatment of urinary incontinence. |
|
| Intra Vaginal Estradiol Cream | Active Comparator | For topical application to the vaginal area to treat symptoms of urgency or irritation with urination. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extended Release Tolterodine LA | Drug | Tolterodine LA 4 mg once daily for 52 weeks. At 12 Weeks, the subjects were offered the addition of the alternative therapy with follow-up at 24 and 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate Subjective Patient Change in Irritative Urinary Symptoms as Measured by the Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score | The first part of the OAB-q consists of eight questions assessing symptom bother with a possible score from 0 to 100 with a higher score indicating greater symptom bother. | From baseline through 12 Weeks of Intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate Subjective Patient Change in Irritative Urinary Symptoms as Measured by the Health Related Quality of Life (HRQL) | Assessment made using the Health Related Quality of Life (HRQL) portion of the OAB-q. The second part of the OAB-q, the HRQL consists of 25 questions that assesses HRQL which addresses coping, concern, sleep and social interaction where the scoring scale is from 0 to 100 with a higher score indicating a better quality of life. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kimberly Gerten, M.D. | Park Nicollette, St. Louis, Minnesota | Principal Investigator |
| Holly E. Richter, Ph.D., M.D. | University of Alabama at Birmingham | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26945271 | Derived | Ellington DR, Szychowski JM, Malek JM, Gerten KA, Burgio KL, Richter HE. Combined Tolterodine and Vaginal Estradiol Cream for Overactive Bladder Symptoms After Randomized Single-Therapy Treatment. Female Pelvic Med Reconstr Surg. 2016 Jul-Aug;22(4):254-60. doi: 10.1097/SPV.0000000000000256. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1: Extended Release Tolterodine | 4 mg Tolterodine po daily for 12 weeks At 12 Weeks, the subjects were offered the addition of the alternative therapy with follow-up at 24 and 52 weeks. |
| FG001 | Group 2: Intra Vaginal Estradiol Cream | 0.5 grams of Intra vaginal estradiol cream nightly for 6 weeks, then twice weekly for 6 weeks. At 12 Weeks, the subjects were offered the addition of the alternative therapy with follow-up at 24 and 52 weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment For 12 Weeks |
|
| |||||||||||||||||||||
| Treatment From 12 Weeks To 24 Weeks |
| ||||||||||||||||||||||
| Treatment From 24 Weeks to 52 Weeks |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1: Extended Release Tolterodine | 4 mg Tolterodine po daily for 12 weeks |
| BG001 | Group 2: Intra Vaginal Estradiol Cream | 0.5 grams of Intra vaginal estradiol cream nightly for 6 weeks, then twice weekly for 6 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Evaluate Subjective Patient Change in Irritative Urinary Symptoms as Measured by the Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score | The first part of the OAB-q consists of eight questions assessing symptom bother with a possible score from 0 to 100 with a higher score indicating greater symptom bother. | A baseline measure was achieved for Group 1 with 30 patients and Group 2 with 28 patients. At the 12 week measurement period, we were unable to analyze 5 patients in Group 1 (leaving 25 patients) and unable to analyze 3 patients in Group 2 (leaving 25 patients). These participants left for reasons identified in the Participant Flow. | Posted | Mean | Standard Deviation | units on a scale | From baseline through 12 Weeks of Intervention |
|
From Baseline through 52 weeks of Intervention
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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 | Group 1: Extended Release Tolterodine | 4 mg Tolterodine po daily for 12-weeks At 12 Weeks, the subjects were offered the addition of the alternative therapy with follow-up at 24 and 52 weeks. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| xerostomia | General disorders | Systematic Assessment | Xerostomia (also termed dry mouth as a symptom or dry mouth syndrome) is dryness in the mouth (xero- + stom- + -ia), which may be associated with a change in the composition of saliva, or reduced salivary flow, or have no identifiable cause. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Holly E. Richter | University of Alabama at Birmingham | 205-934-1704 | hrichter@uabmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 30, 2018 | Aug 1, 2018 | Prot_SAP_000.pdf |
| 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 |
|---|---|
| D000068737 | Tolterodine Tartrate |
| D004958 | Estradiol |
| ID | Term |
|---|---|
| D010665 | Phenylpropanolamine |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
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|
| Intra Vaginal Estradiol Cream | Drug | 17-B estradiol cream 0.5 grams nightly for 6 weeks then two times weekly for 46 weeks. At 12 Weeks, the subjects were offered the addition of the alternative therapy with follow-up at 24 and 52 weeks. |
|
|
| From baseline through 12 Weeks of Intervention |
| Evaluate Subjective Patient Change in Irritative Urinary Symptoms | Assessment measured using the Patient Global Impression of Improvement (PGI-I), patient perception of improvement. The PGI-I is a transition scale that is a single question asking the patient to rate their urinary tract condition now, as compared with how it was prior to before beginning treatment on a scale from 1 being very much better to 7 being very much worse. Frequencies of each response was reported. Each level achieved (movement towards 1), is considered an improvement. | From baseline through 12 Weeks of Intervention |
| Subjective Patient Change in Irritative Urinary Symptoms | This was measured using the Patient Satisfaction Questionnaire (PSQ). The PSQ consists of a single question, "How satisfied are you with your progress since your treatment" in which the 3 possible responses are "completely satisfied," "somewhat satisfied," and "not satisfied." The goal of treatment was to move all participants to "completely satisfied. | From baseline through 12 Weeks of Intervention |
| Subjective Patient Change in Irritative Urinary Symptoms As Measured By the 3-Day Voiding Diary | Number of voids and accidents/leakage per 3 day diary. A void is a voluntary and intentional event. An accident is involuntary and unintentional. | From baseline through 12 weeks of Intervention |
| Subjective Patient Change in Irritative Urinary Symptoms | The first part of the OAB-q consists of eight questions assessing symptom bother with a possible score from 0 to 100 with a higher score indicating greater symptom bother. | Baseline to 24 weeks |
| Subjective Patient Change in Irritative Urinary Symptoms | Assessment made using the Health Related Quality of Life (HRQL) portion of the OAB-q. The second part of the OAB-q, the HRQL consists of 25 questions that assesses HRQL which addresses coping, concern, sleep and social interaction where the scoring scale is from 0 to 100 with a higher score indicating a better quality of life. | Baseline to 24 weeks |
| Subjective Patient Change in Irritative Urinary Symptoms as Indicated by the Patient Global Impression of Improvement (PGI-I) | Assessment measured using the Patient Global Impression of Improvement (PGI-I), patient perception of improvement. The PGI-I is a transition scale that is a single question asking the patient to rate their urinary tract condition now, as compared with how it was prior to before beginning treatment on a scale from 1 being very much better to 7 being very much worse. Each level achieved(movement towards 1), is considered an improvement. | Baseline through 24 weeks |
| Subjective Patient Change in Irritative Urinary Symptoms as Indicated by the Patient Satisfaction Questionnaire (PSQ) | As measured by the Patient Satisfaction Questionnaire (PSQ). The PSQ consists of a single question, "How satisfied are you with your progress since your treatment" in which the 3 possible responses are "completely satisfied," "somewhat satisfied," and "not satisfied." The goal of treatment was to move all participants to "completely satisfied. | Baseline through 24 weeks |
| Subjective Patient Change in Irritative Urinary Symptoms | The first part of the OAB-q consists of eight questions assessing symptom bother with a possible score from 0 to 100 with a higher score indicating greater symptom bother. | Baseline through 52 weeks |
| Subjective Patient Change in Irritative Urinary Symptoms | Assessment made using the Health Related Quality of Life (HRQL) portion of the OAB-q. The second part of the OAB-q, the HRQL consists of 25 questions that assesses HRQL which addresses coping, concern, sleep and social interaction where the scoring scale is from 0 to 100 with a higher score indicating a better quality of life. | Baseline through 52 weeks |
| Subjective Patient Change in Irritative Symptoms as Indicated by the Patient Global Impression of Improvement (PGI-I) | Assessment measured using the Patient Global Impression of Improvement (PGI-I), patient perception of improvement. The PGI-I is a transition scale that is a single question asking the patient to rate their urinary tract condition now, as compared with how it was prior to before beginning treatment on a scale from 1 being very much better to 7 being very much worse. Each level achieved(movement towards 1), is considered an improvement. | Baseline through 52 weeks |
| Subjective Patient Change in Irritative Urinary Symptoms as Indicated by the Patient Satisfaction Questionnaire (PSQ) | As measured by the Patient Satisfaction Questionnaire (PSQ).The PSQ consists of a single question, "How satisfied are you with your progress since your treatment" in which the 3 possible responses are "completely satisfied," "somewhat satisfied," and "not satisfied." The goal of treatment was to move all participants to "completely satisfied. | Baseline through 52 Weeks |
| Withdrawal by Subject |
|
| NOT COMPLETED |
|
| NOT COMPLETED |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Group 2: Intravaginal Estradiol Cream | 0.5 grams of Intravaginal estradiol cream nightly for 6 weeks, then twice weekly for 6 weeks |
|
|
|
| Secondary | Evaluate Subjective Patient Change in Irritative Urinary Symptoms as Measured by the Health Related Quality of Life (HRQL) | Assessment made using the Health Related Quality of Life (HRQL) portion of the OAB-q. The second part of the OAB-q, the HRQL consists of 25 questions that assesses HRQL which addresses coping, concern, sleep and social interaction where the scoring scale is from 0 to 100 with a higher score indicating a better quality of life. | In Group 1, we were unable to analyze 5 patients and in Group 2 we were unable to analyze 3 patients. These participants left for reasons identified in the Participant Flow. | Posted | Mean | Standard Deviation | units on a scale | From baseline through 12 Weeks of Intervention |
|
|
|
| Secondary | Evaluate Subjective Patient Change in Irritative Urinary Symptoms | Assessment measured using the Patient Global Impression of Improvement (PGI-I), patient perception of improvement. The PGI-I is a transition scale that is a single question asking the patient to rate their urinary tract condition now, as compared with how it was prior to before beginning treatment on a scale from 1 being very much better to 7 being very much worse. Frequencies of each response was reported. Each level achieved (movement towards 1), is considered an improvement. | In Group 1, we were unable to analyze 5 patients and in Group 2 we were unable to analyze 3 patients. These participants left for reasons identified in the Participant Flow. | Posted | Number | participants | From baseline through 12 Weeks of Intervention |
|
|
|
| Secondary | Subjective Patient Change in Irritative Urinary Symptoms | This was measured using the Patient Satisfaction Questionnaire (PSQ). The PSQ consists of a single question, "How satisfied are you with your progress since your treatment" in which the 3 possible responses are "completely satisfied," "somewhat satisfied," and "not satisfied." The goal of treatment was to move all participants to "completely satisfied. | In Group 1, we were unable to analyze 5 patients and in Group 2 we were unable to analyze 3 patients. For this outcome ONLY, 1 patient from each Group were not available to obtain the measurements from this questionnaire. Therefore the overall number of participants analyzed for this outcome is less than other outcomes. Please see Participant Flow. | Posted | Number | participants | From baseline through 12 Weeks of Intervention |
|
|
|
| Secondary | Subjective Patient Change in Irritative Urinary Symptoms As Measured By the 3-Day Voiding Diary | Number of voids and accidents/leakage per 3 day diary. A void is a voluntary and intentional event. An accident is involuntary and unintentional. | 25 patients in each group completed voiding diary at baseline. 21 patients completed the voiding diary at 12 weeks in the Tolterodine group (complete diary). 25 patients in the estradiol group completed diary at 12 weeks. Incomplete diaries were not included in our analysis. | Posted | Mean | Standard Deviation | events | From baseline through 12 weeks of Intervention |
|
|
|
| Secondary | Subjective Patient Change in Irritative Urinary Symptoms | The first part of the OAB-q consists of eight questions assessing symptom bother with a possible score from 0 to 100 with a higher score indicating greater symptom bother. | At 24 weeks, only 14 patients from Group 1 & 2 had complete data sets. Those without complete data sets were not included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | Baseline to 24 weeks |
|
|
|
| Secondary | Subjective Patient Change in Irritative Urinary Symptoms | Assessment made using the Health Related Quality of Life (HRQL) portion of the OAB-q. The second part of the OAB-q, the HRQL consists of 25 questions that assesses HRQL which addresses coping, concern, sleep and social interaction where the scoring scale is from 0 to 100 with a higher score indicating a better quality of life. | At 24 weeks, only 14 patients from Group 1 & 2 had complete data sets. Those without complete data sets were not included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | Baseline to 24 weeks |
|
|
|
| Secondary | Subjective Patient Change in Irritative Urinary Symptoms as Indicated by the Patient Global Impression of Improvement (PGI-I) | Assessment measured using the Patient Global Impression of Improvement (PGI-I), patient perception of improvement. The PGI-I is a transition scale that is a single question asking the patient to rate their urinary tract condition now, as compared with how it was prior to before beginning treatment on a scale from 1 being very much better to 7 being very much worse. Each level achieved(movement towards 1), is considered an improvement. | At 24 weeks, only 14 patients from Group 1 & 2 had complete data sets. Those without complete data sets were not included in the analysis. | Posted | Number | percentage of participants | Baseline through 24 weeks |
|
|
|
| Secondary | Subjective Patient Change in Irritative Urinary Symptoms as Indicated by the Patient Satisfaction Questionnaire (PSQ) | As measured by the Patient Satisfaction Questionnaire (PSQ). The PSQ consists of a single question, "How satisfied are you with your progress since your treatment" in which the 3 possible responses are "completely satisfied," "somewhat satisfied," and "not satisfied." The goal of treatment was to move all participants to "completely satisfied. | At 24 weeks, only 14 patients from Group 1 & 2 had complete data sets. Those without complete data sets were not included in the analysis. | Posted | Number | percentage of participants | Baseline through 24 weeks |
|
|
|
| Secondary | Subjective Patient Change in Irritative Urinary Symptoms | The first part of the OAB-q consists of eight questions assessing symptom bother with a possible score from 0 to 100 with a higher score indicating greater symptom bother. | At 52 weeks, only 11 patients in Group 1 and 14 patients from Group 2 had complete data sets. Those without complete data sets were not included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | Baseline through 52 weeks |
|
|
|
| Secondary | Subjective Patient Change in Irritative Urinary Symptoms | Assessment made using the Health Related Quality of Life (HRQL) portion of the OAB-q. The second part of the OAB-q, the HRQL consists of 25 questions that assesses HRQL which addresses coping, concern, sleep and social interaction where the scoring scale is from 0 to 100 with a higher score indicating a better quality of life. | At 52 weeks, only 11 patients in Group 1 and 14 patients from Group 2 had complete data sets. Those without complete data sets were not included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | Baseline through 52 weeks |
|
|
|
| Secondary | Subjective Patient Change in Irritative Symptoms as Indicated by the Patient Global Impression of Improvement (PGI-I) | Assessment measured using the Patient Global Impression of Improvement (PGI-I), patient perception of improvement. The PGI-I is a transition scale that is a single question asking the patient to rate their urinary tract condition now, as compared with how it was prior to before beginning treatment on a scale from 1 being very much better to 7 being very much worse. Each level achieved(movement towards 1), is considered an improvement. | At 52 weeks, only 11 patients in Group 1 and 14 patients from Group 2 had complete data sets. Those without complete data sets were not included in the analysis. | Posted | Number | percentage of participants | Baseline through 52 weeks |
|
|
|
| Secondary | Subjective Patient Change in Irritative Urinary Symptoms as Indicated by the Patient Satisfaction Questionnaire (PSQ) | As measured by the Patient Satisfaction Questionnaire (PSQ).The PSQ consists of a single question, "How satisfied are you with your progress since your treatment" in which the 3 possible responses are "completely satisfied," "somewhat satisfied," and "not satisfied." The goal of treatment was to move all participants to "completely satisfied. | At 52 weeks, only 11 patients in Group 1 and 14 patients from Group 2 had complete data sets. Those without complete data sets were not included in the analysis. | Posted | Number | percentage of participants | Baseline through 52 Weeks |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 17 |
| 30 |
| EG001 | Group 2: Intra Vaginal Estradiol Cream | 0.5 grams of Intra vaginal estradiol cream nightly for 6 weeks, then twice weekly for 6 weeks At 12 Weeks, the subjects were offered the addition of the alternative therapy with follow-up at 24 and 52 weeks. | 0 | 28 | 0 | 28 | 6 | 28 |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
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| 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 |
| D009930 |
| Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D003408 | Cresols |
| D010636 | Phenols |
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| 12 weeks |
|
|
| A Little Better |
|
| No Change |
|
| A Litlle Worse |
|
| Not Satisfied |
|
| Number of accidents/leakage |
|
| Number of accidents/leakage at 12 weeks |
|