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

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ClinicalTrials.gov Identifier: NCT00465894
Recruitment Status : Completed
First Posted : April 25, 2007
Results First Posted : October 23, 2012
Last Update Posted : November 1, 2018
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
David Rich Ellington, University of Alabama at Birmingham

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Overactive Bladder
Interventions Drug: Extended Release Tolterodine LA
Drug: Intra Vaginal Estradiol Cream
Enrollment 58
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Group 1: Extended Release Tolterodine Group 2: Intra Vaginal Estradiol Cream
Hide 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
Reason Not Completed
Lost to Follow-up             4             1
Family Issues             1             1
Withdrawal by Subject             0             1
Period Title: Treatment From 12 Weeks To 24 Weeks
Started 14 [1] 14 [1]
Completed 14 14
Not Completed 0 0
[1]
We included data only from participants that had complete data sets.
Period Title: Treatment From 24 Weeks to 52 Weeks
Started 11 [1] 14
Completed 11 14
Not Completed 0 0
[1]
We included data only from participants that had complete data sets.
Arm/Group Title Group 1: Extended Release Tolterodine Group 2: Intra Vaginal Estradiol Cream Total
Hide 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 Number of Baseline Participants 30 28 58
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants 28 participants 58 participants
63  (6) 60  (2) 61.5  (4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 28 participants 58 participants
Female
30
 100.0%
28
 100.0%
58
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Evaluate Subjective Patient Change in Irritative Urinary Symptoms as Measured by the Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 30 28
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 30 participants 28 participants
65.4  (15.3) 61.6  (20.0)
12 Weeks Number Analyzed 25 participants 25 participants
46.7  (23.4) 45.4  (21.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 1: Extended Release Tolterodine, Group 2: Intravaginal Estradiol Cream
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .45
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Secondary Outcome
Title Evaluate Subjective Patient Change in Irritative Urinary Symptoms as Measured by the Health Related Quality of Life (HRQL)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 30 28
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 30 participants 28 participants
53.1  (22.2) 60.9  (22.5)
12 weeks Number Analyzed 25 participants 25 participants
66.0  (26.6) 69.8  (18.2)
3.Secondary Outcome
Title Evaluate Subjective Patient Change in Irritative Urinary Symptoms
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 25 25
Measure Type: Number
Unit of Measure: participants
Very Much Better 3 0
Much Better 8 7
A Little Better 8 12
No Change 5 5
A Litlle Worse 1 0
4.Secondary Outcome
Title Subjective Patient Change in Irritative Urinary Symptoms
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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

Overall Number of Participants Analyzed 24 24
Measure Type: Number
Unit of Measure: participants
Completely Satisfied 5 3
Somewhat Satisfied 13 13
Not Satisfied 6 8
5.Secondary Outcome
Title Subjective Patient Change in Irritative Urinary Symptoms As Measured By the 3-Day Voiding Diary
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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

Overall Number of Participants Analyzed 21 25
Mean (Standard Deviation)
Unit of Measure: events
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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.)

Overall Number of Participants Analyzed 14 14
Mean (Standard Deviation)
Unit of Measure: units on a scale
-25.4  (11.6) -28.7  (20.5)
7.Secondary Outcome
Title Subjective Patient Change in Irritative Urinary Symptoms
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.)

Overall Number of Participants Analyzed 14 14
Mean (Standard Deviation)
Unit of Measure: 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)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.)

Overall Number of Participants Analyzed 14 14
Measure Type: Number
Unit of Measure: percentage of participants
77 77
9.Secondary Outcome
Title Subjective Patient Change in Irritative Urinary Symptoms as Indicated by the Patient Satisfaction Questionnaire (PSQ)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.)

Overall Number of Participants Analyzed 14 14
Measure Type: Number
Unit of Measure: percentage of participants
88 88
10.Secondary Outcome
Title Subjective Patient Change in Irritative Urinary Symptoms
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.

Overall Number of Participants Analyzed 11 14
Mean (Standard Deviation)
Unit of Measure: units on a scale
-23.4  (15.6) -31.3  (24.3)
11.Secondary Outcome
Title Subjective Patient Change in Irritative Urinary Symptoms
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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

Overall Number of Participants Analyzed 11 14
Mean (Standard Deviation)
Unit of Measure: 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)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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

Overall Number of Participants Analyzed 11 14
Measure Type: Number
Unit of Measure: percentage of participants
85 85
13.Secondary Outcome
Title Subjective Patient Change in Irritative Urinary Symptoms as Indicated by the Patient Satisfaction Questionnaire (PSQ)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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

Overall Number of Participants Analyzed 11 14
Measure Type: Number
Unit of Measure: percentage of participants
84 84
Time Frame From Baseline through 52 weeks of Intervention
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group 1: Extended Release Tolterodine Group 2: Intra Vaginal Estradiol Cream
Hide 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 (%) Affected / at Risk (%)
Total   0/30 (0.00%)      0/28 (0.00%)    
Hide 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 (0.00%)      0/28 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Group 1: Extended Release Tolterodine Group 2: Intra Vaginal Estradiol Cream
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   17/30 (56.67%)      6/28 (21.43%)    
Gastrointestinal disorders     
Constipation   10/30 (33.33%)  10 0/28 (0.00%)  0
General disorders     
xerostomia  [1]  17/30 (56.67%)  17 6/28 (21.43%)  6
Indicates events were collected by systematic assessment
[1]
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.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Holly E. Richter
Organization: University of Alabama at Birmingham
Phone: 205-934-1704
EMail: hrichter@uabmc.edu
Layout table for additonal information
Responsible Party: David Rich Ellington, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00465894    
Other Study ID Numbers: F061208008
IIR - DRIVE
First Submitted: April 23, 2007
First Posted: April 25, 2007
Results First Submitted: June 1, 2012
Results First Posted: October 23, 2012
Last Update Posted: November 1, 2018