DRIVE: Detrol Long Acting (LA) vs Estrace Vaginal Cream for the Treatment of Overactive Bladder Symptoms

• Sponsor: University of Alabama at Birmingham (Other)
• Overall Status: Completed
• CT.gov ID: NCT00465894
• Collaborator: Pfizer (Industry)
• Enrollment: 58
• Arms: 2
• Duration (Months): 56

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Overactive Bladder	Drug: Extended Release Tolterodine LA; Drug: Intra Vaginal Estradiol Cream	N/A

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 58 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Randomized Controlled Trial of Tolterodine in Combination With or Without Low-Dose Intravaginal Estradiol Cream for the Treatment of Overactive Bladder in Post-Menopausal Women
• Study Start Date: Apr 1, 2007
• Actual Primary Completion Date: Jul 1, 2010
• Actual Study Completion Date: Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Extended Release Tolterodine LA An anti-muscarinic drug that is used for symptomatic treatment of urinary incontinence.	Drug: Extended 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; Other Names: Detrol
Active Comparator: Intra Vaginal Estradiol Cream For topical application to the vaginal area to treat symptoms of urgency or irritation with urination.	Drug: Intra 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.; Other Names: Estrace Premarin vaginal cream

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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.

5. Subjective Patient Change in Irritative Urinary Symptoms [Baseline to 24 weeks]

   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.

6. Subjective Patient Change in Irritative Urinary Symptoms [Baseline to 24 weeks]

   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.

7. 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.

8. 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.

9. Subjective Patient Change in Irritative Urinary Symptoms [Baseline through 52 weeks]

   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.

10. Subjective Patient Change in Irritative Urinary Symptoms [Baseline through 52 weeks]

    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.

11. 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.

12. Subjective Patient Change in Irritative Urinary Symptoms as Indicated by the Patient Satisfaction Questionnaire (PSQ) [Baseline through 52 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 90 Years
• Sexes Eligible for Study: Female
• Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of Alabama at Birmingham
• Pfizer

Investigators

• Principal Investigator: Kimberly Gerten, M.D., Park Nicollette, St. Louis, Minnesota
• Principal Investigator: Holly E. Richter, Ph.D., M.D., University of Alabama at Birmingham

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 30, 2018

More Information

Publications

None provided.

• Responsible Party: David Rich Ellington, Principal Investigator, University of Alabama at Birmingham
• ClinicalTrials.gov Identifier: NCT00465894
• Other Study ID Numbers: F061208008; IIR - DRIVE
• First Posted: Apr 25, 2007
• Last Update Posted: Nov 1, 2018
• Last Verified: Oct 1, 2018

• Keywords provided by David Rich Ellington, Principal Investigator, University of Alabama at Birmingham: overactive bladder; urge leakage; nightime urination; incontinence; urinary frequency
• Additional relevant MeSH terms: Urinary Bladder, Overactive; Tolterodine Tartrate; Estradiol

Study Results

Participant Flow

Arm/Group Title	Group 1: Extended Release Tolterodine	Group 2: Intra Vaginal Estradiol Cream
Arm/Group Description	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.	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
Period Title: Treatment For 12 Weeks
STARTED	30	28
COMPLETED	25	25
NOT COMPLETED	5	3
Period Title: Treatment For 12 Weeks
STARTED	14	14
COMPLETED	14	14
NOT COMPLETED	0	0
Period Title: Treatment For 12 Weeks
STARTED	11	14
COMPLETED	11	14
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Group 1: Extended Release Tolterodine	Group 2: Intra Vaginal Estradiol Cream	Total
Arm/Group Description	4 mg Tolterodine po daily for 12 weeks	0.5 grams of Intra vaginal estradiol cream nightly for 6 weeks, then twice weekly for 6 weeks	Total of all reporting groups
Overall Participants	30	28	58
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	63 (6)	60 (2)	61.5 (4)
Sex: Female, Male (Count of Participants)
Female	30 100%	28 100%	58 100%
Male	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Evaluate Subjective Patient Change in Irritative Urinary Symptoms as Measured by the Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Group 1: Extended Release Tolterodine	Group 2: Intravaginal Estradiol Cream
Arm/Group Description	4 mg Tolterodine po daily for 12 weeks	0.5 grams of Intravaginal estradiol cream nightly for 6 weeks, then twice weekly for 6 weeks
Measure Participants	30	28
Baseline	65.4 (15.3)	61.6 (20.0)
12 Weeks	46.7 (23.4)	45.4 (21.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Group 1: Extended Release Tolterodine, Group 2: Intravaginal Estradiol Cream
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.45
	Comments
	Method	t-test, 2 sided
	Comments

2. Secondary Outcome

Title	Evaluate Subjective Patient Change in Irritative Urinary Symptoms as Measured by the Health Related Quality of Life (HRQL)
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Extended Release Tolterodine	Intravaginal Estradiol Cream
Arm/Group Description	Tolterodine LA: Tolterodine LA 4 mg once daily for 52 weeks	Estrace Intravaginal Cream: 17-B estradiol cream 0.5 grams nightly for 6 weeks then two times weekly for 46 weeks
Measure Participants	30	28
Baseline	53.1 (22.2)	60.9 (22.5)
12 weeks	66.0 (26.6)	69.8 (18.2)

3. Secondary Outcome

Title	Evaluate Subjective Patient Change in Irritative Urinary Symptoms
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Group 1: Extended Release Tolterodine	Group 2: Intravaginal Estradiol Cream
Arm/Group Description	4 mg Tolterodine po daily for 12 weeks	0.5 grams of Intravaginal estradiol cream nightly for 6 weeks, then twice weekly for 6 weeks
Measure Participants	25	25
Very Much Better	3 10%	0 0%
Much Better	8 26.7%	7 25%
A Little Better	8 26.7%	12 42.9%
No Change	5 16.7%	5 17.9%
A Litlle Worse	1 3.3%	0 0%

4. Secondary Outcome

Title	Subjective Patient Change in Irritative Urinary Symptoms
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Extended Release Tolterodine LA	Intravaginal Estradiol Cream
Arm/Group Description	An anti-muscarinic drug that is used for symptomatic treatment of urinary incontinence. Extended Release Tolterodine LA: Tolterodine LA 4 mg once daily for 52 weeks	For topical application to the vaginal area to treat symptoms of urgency or irritation with urination. Intravaginal Estradiol Cream: 17-B estradiol cream 0.5 grams nightly for 6 weeks then two times weekly for 46 weeks
Measure Participants	24	24
Completely Satisfied	5 16.7%	3 10.7%
Somewhat Satisfied	13 43.3%	13 46.4%
Not Satisfied	6 20%	8 28.6%

5. Secondary Outcome

Title	Subjective Patient Change in Irritative Urinary Symptoms As Measured By the 3-Day Voiding Diary
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Group 1: Extended Release Tolterodine	Group 2: Intravaginal Estradiol Cream
Arm/Group Description	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.	0.5 grams of Intravaginal 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
Measure Participants	21	25
Number of voids	30.4 (11.6)	26.4 (10.5)
Number of voids 12 week follow-up	26.3 (9.7)	24.6 (10.2)
Number of accidents/leakage	10.8 (11.4)	11.9 (10.5)
Number of accidents/leakage at 12 weeks	7.2 (10.6)	7.7 (8.1)

6. Secondary Outcome

Title	Subjective Patient Change in Irritative Urinary Symptoms
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Group 1: Extended Release Tolterodine + Intravaginal Estradiol	Group 2: Intravaginal Estradiol Cream + Tolterodine
Arm/Group Description	After 12 weeks of therapy, participants were offered the alternative therapy in addition to their current therapy. They continued with the 4 mg Tolterodine po daily for 12 weeks and added the 0.5 grams intravaginal estradiol twice per week for 24 weeks.	0.5 grams of Intravaginal estradiol cream nightly for 6 weeks, then twice weekly for 6 weeks + 4 mg Tolterodine daily (At 12 Weeks, the subjects were offered the addition of the alternative therapy with follow-up at 24 and 52 weeks.)
Measure Participants	14	14
Mean (Standard Deviation) [units on a scale]	-25.4 (11.6)	-28.7 (20.5)

7. Secondary Outcome

Title	Subjective Patient Change in Irritative Urinary Symptoms
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Group 1: Extended Release Tolterodine + Intravaginal Estradiol	Group 2: Intravaginal Estradiol Cream + Tolterodine
Arm/Group Description	After 12 weeks of therapy, participants were offered the alternative therapy in addition to their current therapy . They continued with the 4 mg Tolterodine po daily for 12 weeks and added the 0.5 grams intravaginal estradiol twice per week for 24 weeks.	0.5 grams of Intravaginal estradiol cream nightly for 6 weeks, then twice weekly for 6 weeks + 4 mg Tolterodine daily (At 12 Weeks, the subjects were offered the addition of the alternative therapy with follow-up at 24 and 52 weeks.)
Measure Participants	14	14
Mean (Standard Deviation) [units on a scale]	19.3 (16.8)	20.9 (15.8)

8. Secondary Outcome

Title	Subjective Patient Change in Irritative Urinary Symptoms as Indicated by the Patient Global Impression of Improvement (PGI-I)
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Group 1: Extended Release Tolterodine + Intravaginal Estradiol	Group 2: Intravaginal Estradiol Cream + Tolterodine
Arm/Group Description	After 12 weeks of therapy, participants were offered the alternative therapy in addition to their current therapy. They continued with the 4 mg Tolterodine po daily for 12 weeks and added the 0.5 grams intravaginal estradiol twice per week for 24 weeks.	0.5 grams of Intravaginal estradiol cream nightly for 6 weeks, then twice weekly for 6 weeks + 4 mg Tolterodine daily (After 12 weeks of therapy, participants were offered the alternative therapy in addition to their current therapy.)
Measure Participants	14	14
Number [percentage of participants]	77 256.7%	77 275%

9. Secondary Outcome

Title	Subjective Patient Change in Irritative Urinary Symptoms as Indicated by the Patient Satisfaction Questionnaire (PSQ)
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Group 1: Extended Release Tolterodine + Intravaginal Estradiol	Group 2: Intravaginal Estradiol Cream + Tolterodine
Arm/Group Description	After 12 weeks of therapy, participants were offered the alternative therapy in addition to their current therapy. They continued with the 4 mg Tolterodine po daily for 12 weeks and added the 0.5 grams intravaginal estradiol twice per week for 24 weeks	0.5 grams of Intravaginal estradiol cream nightly for 6 weeks, then twice weekly for 6 weeks+ 4 mg Tolterodine daily (After 12 weeks of therapy, participants were offered the alternative therapy in addition to their current therapy.)
Measure Participants	14	14
Number [percentage of participants]	88 293.3%	88 314.3%

10. Secondary Outcome

Title	Subjective Patient Change in Irritative Urinary Symptoms
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Group 1: Extended Release Tolterodine + Intravaginal Estradiol	Intravaginal Estradiol Cream + Tolterodine
Arm/Group Description	After 12 weeks of therapy, participants were offered the alternative therapy in addition to their current therapy. They continued with the 4 mg Tolterodine po daily for 12 weeks and added the 0.5 grams intravaginal estradiol twice per week for 52 weeks	Intravaginal estradiol Cream: 17-B estradiol cream 0.5 grams nightly for 6 weeks then two times weekly for 46 weeks+ 4 mg Tolterodine daily At 12 Weeks, the subjects were offered the addition of the alternative therapy with follow-up at 24 and 52 weeks.
Measure Participants	11	14
Mean (Standard Deviation) [units on a scale]	-23.4 (15.6)	-31.3 (24.3)

11. Secondary Outcome

Title	Subjective Patient Change in Irritative Urinary Symptoms
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Group 1: Extended Release Tolterodine + Intravaginal Estradiol	Group 2: Intravaginal Estradiol Cream
Arm/Group Description	After 12 weeks of therapy, participants were offered the alternative therapy in addition to their current therapy. They continued with the 4 mg Tolterodine po daily for 12 weeks and added the 0.5 grams intravaginal estradiol twice per week for 52 weeks.	0.5 grams of Intravaginal 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
Measure Participants	11	14
Mean (Standard Deviation) [units on a scale]	26.8 (20.5)	19.7 (25.1)

12. Secondary Outcome

Title	Subjective Patient Change in Irritative Symptoms as Indicated by the Patient Global Impression of Improvement (PGI-I)
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Group 1: Extended Release Tolterodine + Intravaginal Estradiol	Group 2: Intravaginal Estradiol Cream
Arm/Group Description	After 12 weeks of therapy, participants were offered the alternative therapy in addition to their current therapy. They continued with the 4 mg Tolterodine po daily for 12 weeks and added the 0.5 grams intravaginal estradiol twice per week for 52 weeks	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
Measure Participants	11	14
Number [percentage of participants]	85 283.3%	85 303.6%

13. Secondary Outcome

Title	Subjective Patient Change in Irritative Urinary Symptoms as Indicated by the Patient Satisfaction Questionnaire (PSQ)
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Group 1: Extended Release Tolterodine + Intravaginal Estradiol	Group 2: Intravaginal Estradiol Cream
Arm/Group Description	After 12 weeks of therapy, participants were offered the alternative therapy in addition to their current therapy. They continued with the 4 mg Tolterodine po daily for 12 weeks and added the 0.5 grams intravaginal estradiol twice per week for 52 weeks.	0.5 grams of Intravaginal 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
Measure Participants	11	14
Number [percentage of participants]	84 280%	84 300%

Adverse Events

Time Frame	From Baseline through 52 weeks of Intervention
Arm/Group Title	Group 1: Extended Release Tolterodine		Group 2: Intra Vaginal Estradiol Cream
Arm/Group Description	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.		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.
All Cause Mortality
	Group 1: Extended Release Tolterodine		Group 2: Intra Vaginal Estradiol Cream
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/28 (0%)
Serious Adverse Events
	Group 1: Extended Release Tolterodine		Group 2: Intra Vaginal Estradiol Cream
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/28 (0%)
Other (Not Including Serious) Adverse Events
	Group 1: Extended Release Tolterodine		Group 2: Intra Vaginal Estradiol Cream
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	17/30 (56.7%)		6/28 (21.4%)
Gastrointestinal disorders
Constipation	10/30 (33.3%)	10	0/28 (0%)	0
General disorders
xerostomia	17/30 (56.7%)	17	6/28 (21.4%)	6

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.