Overactive Bladder
Conditions
Keywords
overactive bladder, urge leakage, nightime urination, incontinence, urinary frequency
Brief summary
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.
Detailed description
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
Interventions
DRUGExtended Release Tolterodine LA
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
DRUGIntra Vaginal Estradiol Cream
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.
Sponsors
Pfizer
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
* Irritative voiding symptoms to include sensory urgency, frequency, urge incontinence, nocturia * Postmenopausal women with a prior oophorectomy or 1 year from last menstrual period * Women age 40-90 * Women with hysterectomy with preserved ovaries must be age 55 or greater or have a documented follicle-stimulating hormone (FSH)\>40 to ensure post-menopausal status * Community dwelling * Ambulatory * Ability to participate in a 12 month study
Exclusion criteria
* Post-void residual volume\>150ml * Glaucoma without ophthalmologist clearance * Hormone replacement therapy in the past 6 months * Current anticholinergic treatment * Breast cancer * Impaired mental status * Undiagnosed vaginal bleeding in the past 12 months * Endometrial thickness on pelvic ultrasound \>5mm * History of thromboembolic event * Gynecologic cancer * Untreated urinary tract infection (would be eligible after treatment) * Stage III pelvic organ prolapse or greater * Recent diuretic medication changes (one month from change) * Neurologic condition affecting bladder function (Multiple Sclerosis, Parkinsons, spinal cord injury, spina bifida) * Congestive heart failure * Prior pelvic irradiation * Interstitial cystitis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate Subjective Patient Change in Irritative Urinary Symptoms as Measured by the Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score | From baseline through 12 Weeks of Intervention | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate Subjective Patient Change in Irritative Urinary Symptoms | From baseline through 12 Weeks of Intervention | 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. |
| Subjective Patient Change in Irritative Urinary Symptoms | From baseline through 12 Weeks of Intervention | 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. |
| Subjective Patient Change in Irritative Urinary Symptoms As Measured By the 3-Day Voiding Diary | From baseline through 12 weeks of Intervention | Number of voids and accidents/leakage per 3 day diary. A void is a voluntary and intentional event. An accident is involuntary and unintentional. |
| Evaluate Subjective Patient Change in Irritative Urinary Symptoms as Measured by the Health Related Quality of Life (HRQL) | From baseline through 12 Weeks of Intervention | 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. |
| Subjective Patient Change in Irritative Urinary Symptoms as Indicated by the Patient Satisfaction Questionnaire (PSQ) | Baseline through 24 weeks | 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. |
| Subjective Patient Change in Irritative Symptoms as Indicated by the Patient Global Impression of Improvement (PGI-I) | Baseline through 52 weeks | 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. |
| Subjective Patient Change in Irritative Urinary Symptoms as Indicated by the Patient Global Impression of Improvement (PGI-I) | Baseline through 24 weeks | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1: Extended Release Tolterodine 4 mg Tolterodine po daily for 12 weeks | 30 |
| Group 2: Intra Vaginal Estradiol Cream 0.5 grams of Intra vaginal estradiol cream nightly for 6 weeks, then twice weekly for 6 weeks | 28 |
| Total | 58 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Treatment For 12 Weeks | Family Issues | 1 | 1 |
| Treatment For 12 Weeks | Lost to Follow-up | 4 | 1 |
| Treatment For 12 Weeks | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Group 1: Extended Release Tolterodine | Group 2: Intra Vaginal Estradiol Cream | Total |
|---|---|---|---|
| Age, Continuous | 63 years STANDARD_DEVIATION 6 | 60 years STANDARD_DEVIATION 2 | 61.5 years STANDARD_DEVIATION 4 |
| Sex: Female, Male Female | 30 Participants | 28 Participants | 58 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 28 |
| other Total, other adverse events | 17 / 30 | 6 / 28 |
| serious Total, serious adverse events | 0 / 30 | 0 / 28 |
Outcome results
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.
Time frame: From baseline through 12 Weeks of Intervention
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1: Extended Release Tolterodine | Evaluate Subjective Patient Change in Irritative Urinary Symptoms as Measured by the Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score | Baseline | 65.4 units on a scale | Standard Deviation 15.3 |
| Group 1: Extended Release Tolterodine | Evaluate Subjective Patient Change in Irritative Urinary Symptoms as Measured by the Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score | 12 Weeks | 46.7 units on a scale | Standard Deviation 23.4 |
| Group 2: Intravaginal Estradiol Cream | Evaluate Subjective Patient Change in Irritative Urinary Symptoms as Measured by the Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score | Baseline | 61.6 units on a scale | Standard Deviation 20 |
| Group 2: Intravaginal Estradiol Cream | Evaluate Subjective Patient Change in Irritative Urinary Symptoms as Measured by the Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score | 12 Weeks | 45.4 units on a scale | Standard Deviation 21 |
p-value: 0.45t-test, 2 sided
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.
Time frame: From baseline through 12 Weeks of Intervention
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: Extended Release Tolterodine | Evaluate Subjective Patient Change in Irritative Urinary Symptoms | Much Better | 8 participants |
| Group 1: Extended Release Tolterodine | Evaluate Subjective Patient Change in Irritative Urinary Symptoms | No Change | 5 participants |
| Group 1: Extended Release Tolterodine | Evaluate Subjective Patient Change in Irritative Urinary Symptoms | A Little Better | 8 participants |
| Group 1: Extended Release Tolterodine | Evaluate Subjective Patient Change in Irritative Urinary Symptoms | A Litlle Worse | 1 participants |
| Group 1: Extended Release Tolterodine | Evaluate Subjective Patient Change in Irritative Urinary Symptoms | Very Much Better | 3 participants |
| Group 2: Intravaginal Estradiol Cream | Evaluate Subjective Patient Change in Irritative Urinary Symptoms | A Litlle Worse | 0 participants |
| Group 2: Intravaginal Estradiol Cream | Evaluate Subjective Patient Change in Irritative Urinary Symptoms | Very Much Better | 0 participants |
| Group 2: Intravaginal Estradiol Cream | Evaluate Subjective Patient Change in Irritative Urinary Symptoms | Much Better | 7 participants |
| Group 2: Intravaginal Estradiol Cream | Evaluate Subjective Patient Change in Irritative Urinary Symptoms | A Little Better | 12 participants |
| Group 2: Intravaginal Estradiol Cream | Evaluate Subjective Patient Change in Irritative Urinary Symptoms | No Change | 5 participants |
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.
Time frame: From baseline through 12 Weeks of Intervention
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1: Extended Release Tolterodine | Evaluate Subjective Patient Change in Irritative Urinary Symptoms as Measured by the Health Related Quality of Life (HRQL) | Baseline | 53.1 units on a scale | Standard Deviation 22.2 |
| Group 1: Extended Release Tolterodine | Evaluate Subjective Patient Change in Irritative Urinary Symptoms as Measured by the Health Related Quality of Life (HRQL) | 12 weeks | 66.0 units on a scale | Standard Deviation 26.6 |
| Group 2: Intravaginal Estradiol Cream | Evaluate Subjective Patient Change in Irritative Urinary Symptoms as Measured by the Health Related Quality of Life (HRQL) | Baseline | 60.9 units on a scale | Standard Deviation 22.5 |
| Group 2: Intravaginal Estradiol Cream | Evaluate Subjective Patient Change in Irritative Urinary Symptoms as Measured by the Health Related Quality of Life (HRQL) | 12 weeks | 69.8 units on a scale | Standard Deviation 18.2 |
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.
Time frame: Baseline through 52 weeks
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: Extended Release Tolterodine | Subjective Patient Change in Irritative Symptoms as Indicated by the Patient Global Impression of Improvement (PGI-I) | 85 percentage of participants |
| Group 2: Intravaginal Estradiol Cream | Subjective Patient Change in Irritative Symptoms as Indicated by the Patient Global Impression of Improvement (PGI-I) | 85 percentage of participants |
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.
Time frame: Baseline to 24 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1: Extended Release Tolterodine | Subjective Patient Change in Irritative Urinary Symptoms | -25.4 units on a scale | Standard Deviation 11.6 |
| Group 2: Intravaginal Estradiol Cream | Subjective Patient Change in Irritative Urinary Symptoms | -28.7 units on a scale | Standard Deviation 20.5 |
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.
Time frame: From baseline through 12 Weeks of Intervention
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: Extended Release Tolterodine | Subjective Patient Change in Irritative Urinary Symptoms | Completely Satisfied | 5 participants |
| Group 1: Extended Release Tolterodine | Subjective Patient Change in Irritative Urinary Symptoms | Somewhat Satisfied | 13 participants |
| Group 1: Extended Release Tolterodine | Subjective Patient Change in Irritative Urinary Symptoms | Not Satisfied | 6 participants |
| Group 2: Intravaginal Estradiol Cream | Subjective Patient Change in Irritative Urinary Symptoms | Completely Satisfied | 3 participants |
| Group 2: Intravaginal Estradiol Cream | Subjective Patient Change in Irritative Urinary Symptoms | Not Satisfied | 8 participants |
| Group 2: Intravaginal Estradiol Cream | Subjective Patient Change in Irritative Urinary Symptoms | Somewhat Satisfied | 13 participants |
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.
Time frame: Baseline to 24 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1: Extended Release Tolterodine | Subjective Patient Change in Irritative Urinary Symptoms | 19.3 units on a scale | Standard Deviation 16.8 |
| Group 2: Intravaginal Estradiol Cream | Subjective Patient Change in Irritative Urinary Symptoms | 20.9 units on a scale | Standard Deviation 15.8 |
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.
Time frame: Baseline through 52 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1: Extended Release Tolterodine | Subjective Patient Change in Irritative Urinary Symptoms | -23.4 units on a scale | Standard Deviation 15.6 |
| Group 2: Intravaginal Estradiol Cream | Subjective Patient Change in Irritative Urinary Symptoms | -31.3 units on a scale | Standard Deviation 24.3 |
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.
Time frame: Baseline through 52 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1: Extended Release Tolterodine | Subjective Patient Change in Irritative Urinary Symptoms | 26.8 units on a scale | Standard Deviation 20.5 |
| Group 2: Intravaginal Estradiol Cream | Subjective Patient Change in Irritative Urinary Symptoms | 19.7 units on a scale | Standard Deviation 25.1 |
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.
Time frame: Baseline through 24 weeks
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: Extended Release Tolterodine | Subjective Patient Change in Irritative Urinary Symptoms as Indicated by the Patient Global Impression of Improvement (PGI-I) | 77 percentage of participants |
| Group 2: Intravaginal Estradiol Cream | Subjective Patient Change in Irritative Urinary Symptoms as Indicated by the Patient Global Impression of Improvement (PGI-I) | 77 percentage of participants |
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.
Time frame: Baseline through 52 Weeks
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: Extended Release Tolterodine | Subjective Patient Change in Irritative Urinary Symptoms as Indicated by the Patient Satisfaction Questionnaire (PSQ) | 84 percentage of participants |
| Group 2: Intravaginal Estradiol Cream | Subjective Patient Change in Irritative Urinary Symptoms as Indicated by the Patient Satisfaction Questionnaire (PSQ) | 84 percentage of participants |
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.
Time frame: Baseline through 24 weeks
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: Extended Release Tolterodine | Subjective Patient Change in Irritative Urinary Symptoms as Indicated by the Patient Satisfaction Questionnaire (PSQ) | 88 percentage of participants |
| Group 2: Intravaginal Estradiol Cream | Subjective Patient Change in Irritative Urinary Symptoms as Indicated by the Patient Satisfaction Questionnaire (PSQ) | 88 percentage of participants |
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.
Time frame: From baseline through 12 weeks of Intervention
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1: Extended Release Tolterodine | Subjective Patient Change in Irritative Urinary Symptoms As Measured By the 3-Day Voiding Diary | Number of voids | 30.4 events | Standard Deviation 11.6 |
| Group 1: Extended Release Tolterodine | Subjective Patient Change in Irritative Urinary Symptoms As Measured By the 3-Day Voiding Diary | Number of voids 12 week follow-up | 26.3 events | Standard Deviation 9.7 |
| Group 1: Extended Release Tolterodine | Subjective Patient Change in Irritative Urinary Symptoms As Measured By the 3-Day Voiding Diary | Number of accidents/leakage | 10.8 events | Standard Deviation 11.4 |
| Group 1: Extended Release Tolterodine | Subjective Patient Change in Irritative Urinary Symptoms As Measured By the 3-Day Voiding Diary | Number of accidents/leakage at 12 weeks | 7.2 events | Standard Deviation 10.6 |
| Group 2: Intravaginal Estradiol Cream | Subjective Patient Change in Irritative Urinary Symptoms As Measured By the 3-Day Voiding Diary | Number of accidents/leakage at 12 weeks | 7.7 events | Standard Deviation 8.1 |
| Group 2: Intravaginal Estradiol Cream | Subjective Patient Change in Irritative Urinary Symptoms As Measured By the 3-Day Voiding Diary | Number of voids | 26.4 events | Standard Deviation 10.5 |
| Group 2: Intravaginal Estradiol Cream | Subjective Patient Change in Irritative Urinary Symptoms As Measured By the 3-Day Voiding Diary | Number of accidents/leakage | 11.9 events | Standard Deviation 10.5 |
| Group 2: Intravaginal Estradiol Cream | Subjective Patient Change in Irritative Urinary Symptoms As Measured By the 3-Day Voiding Diary | Number of voids 12 week follow-up | 24.6 events | Standard Deviation 10.2 |