Trial Outcomes & Findings for Detrol Long Acting (LA) vs Estrace Vaginal Cream for the Treatment of Overactive Bladder Symptoms (NCT NCT00465894)
NCT ID: NCT00465894
Last Updated: 2018-11-01
Results Overview
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.
COMPLETED
NA
58 participants
From baseline through 12 Weeks of Intervention
2018-11-01
Participant Flow
Participant milestones
| Measure |
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.
|
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
|
|---|---|---|
|
Treatment For 12 Weeks
STARTED
|
30
|
28
|
|
Treatment For 12 Weeks
COMPLETED
|
25
|
25
|
|
Treatment For 12 Weeks
NOT COMPLETED
|
5
|
3
|
|
Treatment From 12 Weeks To 24 Weeks
STARTED
|
14
|
14
|
|
Treatment From 12 Weeks To 24 Weeks
COMPLETED
|
14
|
14
|
|
Treatment From 12 Weeks To 24 Weeks
NOT COMPLETED
|
0
|
0
|
|
Treatment From 24 Weeks to 52 Weeks
STARTED
|
11
|
14
|
|
Treatment From 24 Weeks to 52 Weeks
COMPLETED
|
11
|
14
|
|
Treatment From 24 Weeks to 52 Weeks
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
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.
|
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
|
|---|---|---|
|
Treatment For 12 Weeks
Lost to Follow-up
|
4
|
1
|
|
Treatment For 12 Weeks
Family Issues
|
1
|
1
|
|
Treatment For 12 Weeks
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Detrol Long Acting (LA) vs Estrace Vaginal Cream for the Treatment of Overactive Bladder Symptoms
Baseline characteristics by cohort
| Measure |
Group 1: Extended Release Tolterodine
n=30 Participants
4 mg Tolterodine po daily for 12 weeks
|
Group 2: Intra Vaginal Estradiol Cream
n=28 Participants
0.5 grams of Intra vaginal estradiol cream nightly for 6 weeks, then twice weekly for 6 weeks
|
Total
n=58 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63 years
STANDARD_DEVIATION 6 • n=39 Participants
|
60 years
STANDARD_DEVIATION 2 • n=41 Participants
|
61.5 years
STANDARD_DEVIATION 4 • n=35 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=39 Participants
|
28 Participants
n=41 Participants
|
58 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: From baseline through 12 Weeks of InterventionPopulation: 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.
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.
Outcome measures
| Measure |
Group 1: Extended Release Tolterodine
n=30 Participants
4 mg Tolterodine po daily for 12 weeks
|
Group 2: Intravaginal Estradiol Cream
n=28 Participants
0.5 grams of Intravaginal estradiol cream nightly for 6 weeks, then twice weekly for 6 weeks
|
|---|---|---|
|
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
|
61.6 units on a scale
Standard Deviation 20.0
|
|
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
|
45.4 units on a scale
Standard Deviation 21.0
|
SECONDARY outcome
Timeframe: From baseline through 12 Weeks of InterventionPopulation: 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.
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.
Outcome measures
| Measure |
Group 1: Extended Release Tolterodine
n=30 Participants
4 mg Tolterodine po daily for 12 weeks
|
Group 2: Intravaginal Estradiol Cream
n=28 Participants
0.5 grams of Intravaginal estradiol cream nightly for 6 weeks, then twice weekly for 6 weeks
|
|---|---|---|
|
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
|
60.9 units on a scale
Standard Deviation 22.5
|
|
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
|
69.8 units on a scale
Standard Deviation 18.2
|
SECONDARY outcome
Timeframe: From baseline through 12 Weeks of InterventionPopulation: 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.
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.
Outcome measures
| Measure |
Group 1: Extended Release Tolterodine
n=25 Participants
4 mg Tolterodine po daily for 12 weeks
|
Group 2: Intravaginal Estradiol Cream
n=25 Participants
0.5 grams of Intravaginal estradiol cream nightly for 6 weeks, then twice weekly for 6 weeks
|
|---|---|---|
|
Evaluate Subjective Patient Change in Irritative Urinary Symptoms
Very Much Better
|
3 participants
|
0 participants
|
|
Evaluate Subjective Patient Change in Irritative Urinary Symptoms
Much Better
|
8 participants
|
7 participants
|
|
Evaluate Subjective Patient Change in Irritative Urinary Symptoms
A Little Better
|
8 participants
|
12 participants
|
|
Evaluate Subjective Patient Change in Irritative Urinary Symptoms
No Change
|
5 participants
|
5 participants
|
|
Evaluate Subjective Patient Change in Irritative Urinary Symptoms
A Litlle Worse
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: From baseline through 12 Weeks of InterventionPopulation: 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.
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.
Outcome measures
| Measure |
Group 1: Extended Release Tolterodine
n=24 Participants
4 mg Tolterodine po daily for 12 weeks
|
Group 2: Intravaginal Estradiol Cream
n=24 Participants
0.5 grams of Intravaginal estradiol cream nightly for 6 weeks, then twice weekly for 6 weeks
|
|---|---|---|
|
Subjective Patient Change in Irritative Urinary Symptoms
Not Satisfied
|
6 participants
|
8 participants
|
|
Subjective Patient Change in Irritative Urinary Symptoms
Completely Satisfied
|
5 participants
|
3 participants
|
|
Subjective Patient Change in Irritative Urinary Symptoms
Somewhat Satisfied
|
13 participants
|
13 participants
|
SECONDARY outcome
Timeframe: From baseline through 12 weeks of InterventionPopulation: 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.
Number of voids and accidents/leakage per 3 day diary. A void is a voluntary and intentional event. An accident is involuntary and unintentional.
Outcome measures
| Measure |
Group 1: Extended Release Tolterodine
n=21 Participants
4 mg Tolterodine po daily for 12 weeks
|
Group 2: Intravaginal Estradiol Cream
n=25 Participants
0.5 grams of Intravaginal estradiol cream nightly for 6 weeks, then twice weekly for 6 weeks
|
|---|---|---|
|
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
|
26.4 events
Standard Deviation 10.5
|
|
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
|
24.6 events
Standard Deviation 10.2
|
|
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
|
11.9 events
Standard Deviation 10.5
|
|
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
|
7.7 events
Standard Deviation 8.1
|
SECONDARY outcome
Timeframe: Baseline to 24 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Group 1: Extended Release Tolterodine
n=14 Participants
4 mg Tolterodine po daily for 12 weeks
|
Group 2: Intravaginal Estradiol Cream
n=14 Participants
0.5 grams of Intravaginal estradiol cream nightly for 6 weeks, then twice weekly for 6 weeks
|
|---|---|---|
|
Subjective Patient Change in Irritative Urinary Symptoms
|
-25.4 units on a scale
Standard Deviation 11.6
|
-28.7 units on a scale
Standard Deviation 20.5
|
SECONDARY outcome
Timeframe: Baseline to 24 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Group 1: Extended Release Tolterodine
n=14 Participants
4 mg Tolterodine po daily for 12 weeks
|
Group 2: Intravaginal Estradiol Cream
n=14 Participants
0.5 grams of Intravaginal estradiol cream nightly for 6 weeks, then twice weekly for 6 weeks
|
|---|---|---|
|
Subjective Patient Change in Irritative Urinary Symptoms
|
19.3 units on a scale
Standard Deviation 16.8
|
20.9 units on a scale
Standard Deviation 15.8
|
SECONDARY outcome
Timeframe: Baseline through 24 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Group 1: Extended Release Tolterodine
n=14 Participants
4 mg Tolterodine po daily for 12 weeks
|
Group 2: Intravaginal Estradiol Cream
n=14 Participants
0.5 grams of Intravaginal estradiol cream nightly for 6 weeks, then twice weekly for 6 weeks
|
|---|---|---|
|
Subjective Patient Change in Irritative Urinary Symptoms as Indicated by the Patient Global Impression of Improvement (PGI-I)
|
77 percentage of participants
|
77 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline through 24 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Group 1: Extended Release Tolterodine
n=14 Participants
4 mg Tolterodine po daily for 12 weeks
|
Group 2: Intravaginal Estradiol Cream
n=14 Participants
0.5 grams of Intravaginal estradiol cream nightly for 6 weeks, then twice weekly for 6 weeks
|
|---|---|---|
|
Subjective Patient Change in Irritative Urinary Symptoms as Indicated by the Patient Satisfaction Questionnaire (PSQ)
|
88 percentage of participants
|
88 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline through 52 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Group 1: Extended Release Tolterodine
n=11 Participants
4 mg Tolterodine po daily for 12 weeks
|
Group 2: Intravaginal Estradiol Cream
n=14 Participants
0.5 grams of Intravaginal estradiol cream nightly for 6 weeks, then twice weekly for 6 weeks
|
|---|---|---|
|
Subjective Patient Change in Irritative Urinary Symptoms
|
-23.4 units on a scale
Standard Deviation 15.6
|
-31.3 units on a scale
Standard Deviation 24.3
|
SECONDARY outcome
Timeframe: Baseline through 52 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Group 1: Extended Release Tolterodine
n=11 Participants
4 mg Tolterodine po daily for 12 weeks
|
Group 2: Intravaginal Estradiol Cream
n=14 Participants
0.5 grams of Intravaginal estradiol cream nightly for 6 weeks, then twice weekly for 6 weeks
|
|---|---|---|
|
Subjective Patient Change in Irritative Urinary Symptoms
|
26.8 units on a scale
Standard Deviation 20.5
|
19.7 units on a scale
Standard Deviation 25.1
|
SECONDARY outcome
Timeframe: Baseline through 52 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Group 1: Extended Release Tolterodine
n=11 Participants
4 mg Tolterodine po daily for 12 weeks
|
Group 2: Intravaginal Estradiol Cream
n=14 Participants
0.5 grams of Intravaginal estradiol cream nightly for 6 weeks, then twice weekly for 6 weeks
|
|---|---|---|
|
Subjective Patient Change in Irritative Symptoms as Indicated by the Patient Global Impression of Improvement (PGI-I)
|
85 percentage of participants
|
85 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline through 52 WeeksPopulation: 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.
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.
Outcome measures
| Measure |
Group 1: Extended Release Tolterodine
n=11 Participants
4 mg Tolterodine po daily for 12 weeks
|
Group 2: Intravaginal Estradiol Cream
n=14 Participants
0.5 grams of Intravaginal estradiol cream nightly for 6 weeks, then twice weekly for 6 weeks
|
|---|---|---|
|
Subjective Patient Change in Irritative Urinary Symptoms as Indicated by the Patient Satisfaction Questionnaire (PSQ)
|
84 percentage of participants
|
84 percentage of participants
|
Adverse Events
Group 1: Extended Release Tolterodine
Group 2: Intra Vaginal Estradiol Cream
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group 1: Extended Release Tolterodine
n=30 participants at risk
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.
|
Group 2: Intra Vaginal Estradiol Cream
n=28 participants at risk
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.
|
|---|---|---|
|
General disorders
xerostomia
|
56.7%
17/30 • Number of events 17 • From Baseline through 52 weeks of Intervention
|
21.4%
6/28 • Number of events 6 • From Baseline through 52 weeks of Intervention
|
|
Gastrointestinal disorders
Constipation
|
33.3%
10/30 • Number of events 10 • From Baseline through 52 weeks of Intervention
|
0.00%
0/28 • From Baseline through 52 weeks of Intervention
|
Additional Information
Dr. Holly E. Richter
University of Alabama at Birmingham
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place