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Value of Urodynamic Evaluation (ValUE)

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ClinicalTrials.gov Identifier: NCT00803959
Recruitment Status : Completed
First Posted : December 8, 2008
Results First Posted : August 6, 2013
Last Update Posted : August 6, 2013
Sponsor:
Collaborators:
University of Alabama at Birmingham
University of California, San Diego
University of Maryland, College Park
University of Pittsburgh
University of Texas Southwestern Medical Center
The University of Texas Health Science Center at San Antonio
University of Utah
Beaumont Hospital
Loyola University
Information provided by (Responsible Party):
New England Research Institutes

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Urinary Incontinence
Interventions Other: Office evaluation
Other: UDS
Enrollment 630
Recruitment Details Between November 2008 and June 2010, a total of 630 women underwent randomization (315 in each group) at 11 participating US sites. Of the 53 participating surgeons, 38 were urogynecologists and 15 were urologists; more than 90% were fellowship-trained.
Pre-assignment Details 4083 women with urinary incontinence were screened for eligibility; of these 2708 did not meet inclusion criteria, 379 declined to participate and 313 were eligible but excluded for administrative reasons. This left 683 who provided written informed consent; 40 were deemed ineligible before randomization and 13 withdrew consent with 630 randomized.
Arm/Group Title Office Evaluation Only (no UDS) Urodynamic Testing (UDS Arm)
Hide Arm/Group Description UDS is not conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence. UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
Period Title: Overall Study
Started 315 315
ITT Analysis With Primary Outcome Data 266 272
Completed 259 [1] 264 [2]
Not Completed 56 51
[1]
Because it is a non-inferiority trial, the PP analysis was the main analysis (n=259).
[2]
Because it is a non-inferiority trial, the PP analysis was the main analysis (n=264).
Arm/Group Title Office Evaluation Only (no UDS) Urodynamic Testing (UDS Arm) Total
Hide Arm/Group Description UDS is not conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence. UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence. Total of all reporting groups
Overall Number of Baseline Participants 259 264 523
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 259 participants 264 participants 523 participants
51.6  (10.0) 51.9  (10.4) 51.7  (10.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 259 participants 264 participants 523 participants
Female
259
 100.0%
264
 100.0%
523
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 259 participants 264 participants 523 participants
259 264 523
1.Primary Outcome
Title Self-reported Urinary Incontinence, Irritative and Obstructive Symptoms: Reduction of 70%+ in the Urogenital Distress Inventory From Baseline to 12 Mos and "Very Much" or "Much" Better on the Patient Global Impression of Improvement Measure at 12 Mos.
Hide Description

Treatment success is defined as a reduction in the Urogenital Distress Inventory score from baseline to 12 months of 70% or more and a Patient Global Impression of Improvement response of

“very much better” or “much better” at 12 months.

Time Frame 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
There were 315 women randomized to each of the arms. In the no UDS arm (and UDS arm), 49 (43) did not have primary outcome data, leaving 266 (272) included in the ITT analysis. Of these, 259 (264) were included in the PP analysis with primary outcome data. The PP analysis was the primary analysis because the outcome was a non-inferiority endpoint.
Arm/Group Title Office Evaluation Only (no UDS) Urodynamic Testing (UDS Arm)
Hide Arm/Group Description:
UDS is not conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
Overall Number of Participants Analyzed 259 264
Measure Type: Number
Unit of Measure: percentage of participants
77.2 76.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Office Evaluation Only (no UDS), Urodynamic Testing (UDS Arm)
Comments The null hypothesis was that the no UDS group was non-inferior to those in the UDS group. Assuming a significance level of 5% and a true success rate in each group of 70% with a noninferiority margin of 11 percentage points, we needed to enroll 270 women/group to have 80% power for determining whether the results in the no UDS group were non inferior to those in the UDS group. Assuming a 10% dropout rate, a sample of 300 women per group was required.
Type of Statistical Test Non-Inferiority or Equivalence
Comments The investigators selected the 11% noninferiority margin on the basis of clinical judgement that it was a reasonable threshold for a trade-off between a decrease in the rate of successful treatment and the potential benefits of eliminating UDS studies from preoperative assessment. To minimize bias toward noninferiority, only women treated per protocol (e.g. who underwent the randomly assigned evaluation) were considered in the primary outcome analysis (ITT analysis considered secondary).
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Chi-squared
Comments Noninferiority declared if the upper boundary of the two-sided 95% confidence interval for the difference in % success (UDS - no UDS) was < 11%.
Method of Estimation Estimation Parameter Difference in success % (UDS - no UDS)
Estimated Value -0.3
Confidence Interval (2-Sided) 95%
-7.5 to 6.9
Estimation Comments Point estimates of success percentage are calculated as 200/259= 77.2% for Office Evaluation Only and 203/264 = 76.9% for Urodynamic Testing arm.
2.Secondary Outcome
Title Percentage Meeting or Exceeding 70% Decrease in UDI Score Between Baseline and 12 Months
Hide Description The Urogenital Distress Inventory is a 20-item patient-reported measure that assesses the presence of urinary incontinence, urgency, frequency, and voiding dysfunction and the extent to which the patient is bothered by these symptoms. Scores range from 0 to 300, with higher scores indicating greater distress. The 70% cutoff value was selected on the basis of the previous experience of the study investigators and receiver-operating- characteristic curve analyses from a previous surgical trial.
Time Frame Baseline, 12 mos
Hide Outcome Measure Data
Hide Analysis Population Description
There were 315 women randomized to each arm. In the UDS arm, 43 did not have primary outcome data leaving 272 in the intention-to-treat group. In the no UDS arm, 49 did not have primary outcome data leaving 266 in the ITT group. ITT analysis was used for all outcomes with the exception of the primary non-inferiority endpoint.
Arm/Group Title Office Evaluation Only (no UDS) Urodynamic Testing (UDS Arm)
Hide Arm/Group Description:
UDS is not conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
Overall Number of Participants Analyzed 266 272
Measure Type: Number
Unit of Measure: percentage of participants
78.9 77.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Office Evaluation Only (no UDS), Urodynamic Testing (UDS Arm)
Comments Null hypothesis is that the two groups will not differ in the percent meeting 70% reduction in Urogenital Distress Inventory score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.63
Comments The p-value is not adjusted for multiple comparisons. Alpha level is considered to be 0.05.
Method Chi-squared
Comments No adjustments were made; test had 1 degree of freedom.
3.Secondary Outcome
Title Patient Global Impression Index
Hide Description

Patient Global Impression of Improvement is a patient-reported measure of perceived improvement that is obtained by asking study participants,

  • How is your urinary tract condition now, as compared with how it was before you received treatment for your urinary leakage?” Responses are on a 7-point scale from 1 meaning “very much better” to 7 meaning
  • very much worse.” Values of "very much better" (1) or "much better" (2) were considered to have "perceived improvement" according to this criteria. Values of 3 or greater were not (e.g. "a little better", "no change", "a little worse", "much worse" or "very much worse"). This instrument correlates with the frequency of incontinence episodes, pad tests, and quality of life as it relates to incontinence.
Time Frame 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
315 women were randomized to each arm. In the UDS arm, 43 did not have primary outcome data leaving 272 in the intention-to-treat group. In the no UDS arm, 49 did not have primary outcome data leaving 266 in the ITT group. Two were missing PGI-I data in the UDS arm and 4 in the no UDS arm; sample size was 262 in no UDS arm and 270 in the UDS arm.
Arm/Group Title Office Evaluation Only (no UDS) Urodynamic Testing (UDS Arm)
Hide Arm/Group Description:
UDS is not conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
Overall Number of Participants Analyzed 262 270
Measure Type: Number
Unit of Measure: percentage of participants
90.8 91.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Office Evaluation Only (no UDS), Urodynamic Testing (UDS Arm)
Comments Null hypothesis is that there is no difference in the proportion responding "very much better" or "much better" on the Patient Global Impression of Improvement at the 12 month visit.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.68
Comments P-value not adjusted for multiple comparisons; a priori threshold for statistical significance set at alpha = 0.05.
Method Chi-squared
Comments No adjustments made; 1 degree of freedom test.
4.Secondary Outcome
Title Change in Bother as Measured by the UDI
Hide Description The Urogenital Distress Inventory is a 20-item patient-reported measure that assesses the presence of urinary incontinence, urgency, frequency, and voiding dysfunction and the extent to which the patient is bothered by these symptoms. Scores range from 0 to 300, with higher scores indicating greater distress. Change was calculated as the score at 12 months minus the score at baseline. Higher scores indicate worse function, so the larger the negative value, the greater the improvement.
Time Frame Baseline, 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
There were 315 women randomized to each arm. In the UDS arm, 43 did not have primary outcome data leaving 272 in the intention-to-treat group. In the no UDS arm, 49 did not have primary outcome data leaving 266 in the ITT group. ITT analysis was used for all outcomes with the exception of the primary non-inferiority endpoint.
Arm/Group Title Office Evaluation Only (no UDS) Urodynamic Testing (UDS Arm)
Hide Arm/Group Description:
UDS is not conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
Overall Number of Participants Analyzed 266 272
Mean (Standard Deviation)
Unit of Measure: units on a scale
-98.4  (51.4) -100.2  (50.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Office Evaluation Only (no UDS), Urodynamic Testing (UDS Arm)
Comments Null hypothesis is that the two arms do not differ according to change in UDI score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.68
Comments P-value is not adjusted for multiple comparisons; a priori threshold for statistical significance was set at alpha = 0.05.
Method t-test, 2 sided
Comments One df t test assumed equal variance; no evidence was found to the contrary.
5.Secondary Outcome
Title Change in Severity as Measured by the ISI
Hide Description Incontinence Severity Index has scores ranging from 1 to 12 and higher scores indicating greater severity. Change was calculated as the score at 12 months minus the score at baseline. Higher scores indicate worse function, so the larger the negative value, the greater the improvement.
Time Frame Baseline & 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
There were 315 women randomized to each arm. In the UDS arm, 43 did not have primary outcome data leaving 272 in the intention-to-treat group. In the no UDS arm, 49 did not have primary outcome data leaving 266 in the ITT group. ITT analysis was used for all outcomes with the exception of the primary non-inferiority endpoint.
Arm/Group Title Office Evaluation Only (no UDS) Urodynamic Testing (UDS Arm)
Hide Arm/Group Description:
UDS is not conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
Overall Number of Participants Analyzed 266 272
Mean (Standard Deviation)
Unit of Measure: units on a scale
-5.7  (3.4) -6.0  (3.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Office Evaluation Only (no UDS), Urodynamic Testing (UDS Arm)
Comments Null hypothesis is that the 2 arms do not differ according to change in ISI score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.40
Comments P-value was not adjusted for multiple comparisons; a priori threshold for statistical significance set at alpha = 0.05.
Method t-test, 2 sided
Comments Test was 1 df t-test assuming equal variances; no evidence to the contrary was found.
6.Secondary Outcome
Title Change in MESA Stress Score
Hide Description The Medical, Epidemiological, and Social Aspects of Aging (MESA) stress score was measured at baseline and the 12 month visit with a possible range from 0 to 100 with higher scores indicating worse function. The outcome measures is change from baseline to 12 mo visit in MESA stress score. Change was calculated as the score at 12 months minus the score at baseline and could range from -100 to 100. Higher raw scores indicate worse function, so the larger the negative change score value, the greater the improvement.
Time Frame Screen & 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
There were 315 women randomized to each arm. In the UDS arm, 43 did not have primary outcome data leaving 272 in the intention-to-treat group. In the no UDS arm, 49 did not have primary outcome data leaving 266 in the ITT group. ITT analysis was used for all outcomes with the exception of the primary non-inferiority endpoint.
Arm/Group Title Office Evaluation Only (no UDS) Urodynamic Testing (UDS Arm)
Hide Arm/Group Description:
UDS is not conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
Overall Number of Participants Analyzed 266 272
Mean (Standard Deviation)
Unit of Measure: units on a scale
-60.2  (24.7) -61.5  (22.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Office Evaluation Only (no UDS), Urodynamic Testing (UDS Arm)
Comments Null hypothesis is that the 2 arms do not differ in change in MESA stress score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.50
Comments P-value not adjusted for multiple comparisons; a priori threshold was alpha = 0.05.
Method t-test, 2 sided
Comments The t test had 1 df assuming equal variances; no evidence of unequal variances was found.
7.Secondary Outcome
Title Change in MESA Urge Score
Hide Description The Medical, Epidemiological, and Social Aspects of Aging (MESA) urge score was measured at baseline and the 12 month visit with a possible range from 0 to 100 with higher scores indicating worse function. The outcome measures is change from baseline to 12 mo visit in MESA urge score. Change was calculated as the score at 12 months minus the score at baseline and could range from -100 to 100. Higher raw scores indicate worse function, so the larger the negative change score value, the greater the improvement.
Time Frame Screen & 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
There were 315 women randomized to each arm. In the UDS arm, 43 did not have primary outcome data leaving 272 in the intention-to-treat group. In the no UDS arm, 49 did not have primary outcome data leaving 266 in the ITT group. ITT analysis was used for all outcomes with the exception of the primary non-inferiority endpoint.
Arm/Group Title Office Evaluation Only (no UDS) Urodynamic Testing (UDS Arm)
Hide Arm/Group Description:
UDS is not conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
Overall Number of Participants Analyzed 266 272
Mean (Standard Deviation)
Unit of Measure: units on a scale
-22.2  (22.4) -19.7  (21.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Office Evaluation Only (no UDS), Urodynamic Testing (UDS Arm)
Comments Null hypothesis is that the two arms do not differ according to change in MESA urgency score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.19
Comments P-value not adjusted for multiple comparisons and a priori threshold for statistical significance set at alpha = 0.05.
Method t-test, 2 sided
Comments The t test had 1 df and assumed equal variances; no evidence of different variances was found.
8.Secondary Outcome
Title Change in Quality of Life as Measured by the IIQ
Hide Description Incontinence Impact Questionnaire has scores ranging from 0 to 400 and higher scores indicating a more negative effect on quality of life. Change was calculated as the score at 12 months minus the score at baseline and scores could range from -400 to 400. Higher scores indicate worse function, so the larger the negative value, the greater the improvement.
Time Frame Baseline, 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
There were 315 women randomized to each arm. In the UDS arm, 43 did not have primary outcome data leaving 272 in the intention-to-treat group. In the no UDS arm, 49 did not have primary outcome data leaving 266 in the ITT group. ITT analysis was used for all outcomes with the exception of the primary non-inferiority endpoint.
Arm/Group Title Office Evaluation Only (no UDS) Urodynamic Testing (UDS Arm)
Hide Arm/Group Description:
UDS is not conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
Overall Number of Participants Analyzed 266 272
Mean (Standard Deviation)
Unit of Measure: units on a scale
-37.3  (23.7) -35.9  (23.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Office Evaluation Only (no UDS), Urodynamic Testing (UDS Arm)
Comments Null hypothesis is that the 2 arms do not differ according to mean change in IIQ score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.49
Comments P-value not adjusted for multiple comparisons and a priori threshold for statistical significance set at alpha = 0.05
Method t-test, 2 sided
Comments T test had 1 df and assumed equal variance; no evidence of different variances was found.
9.Secondary Outcome
Title Change in Quality of Life as Measured by the SF-12
Hide Description The Medical Outcomes Study 12-Item Short Form Health Survey has scores ranging from 0 to 200 and higher scores indicating better health. Change was calculated as the score at 12 months minus the score at baseline and could range from -200 to 200. The larger the positive value, the greater the improvement.
Time Frame Baseline, 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
There were 315 women randomized to each arm. In the UDS arm, 43 did not have primary outcome data leaving 272 in the intention-to-treat group. In the no UDS arm, 49 did not have primary outcome data leaving 266 in the ITT group. ITT analysis was used for all outcomes with the exception of the primary non-inferiority endpoint.
Arm/Group Title Office Evaluation Only (no UDS) Urodynamic Testing (UDS Arm)
Hide Arm/Group Description:
UDS is not conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
Overall Number of Participants Analyzed 266 272
Mean (Standard Deviation)
Unit of Measure: units on a scale
7.3  (12.0) 5.0  (10.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Office Evaluation Only (no UDS), Urodynamic Testing (UDS Arm)
Comments Null hypothesis is that the 2 arms do not differ according to mean change in SF-12 scores.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments P-value not adjusted for multiple comparisons and a priori threshold for statistical significance set at alpha = 0.05.
Method t-test, 2 sided
Comments T test had 1 df assuming equal variances; no evidence of unequal variances was found.
10.Secondary Outcome
Title Change in Severity as Measured by the PGI-S
Hide Description The Patient Global Impression of Severity has scores ranging from 1 [normal] to 4 [severe]. Change was calculated as the score at 12 months minus the score at baseline and could range from -3 to 3. Higher scores indicate worse function, so the larger the negative value, the greater the improvement.
Time Frame Baseline & 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
There were 315 women randomized to each arm. In the UDS arm, 43 did not have primary outcome data leaving 272 in the intention-to-treat group. In the no UDS arm, 49 did not have primary outcome data leaving 266 in the ITT group. ITT analysis was used for all outcomes with the exception of the primary non-inferiority endpoint.
Arm/Group Title Office Evaluation Only (no UDS) Urodynamic Testing (UDS Arm)
Hide Arm/Group Description:
UDS is not conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
Overall Number of Participants Analyzed 266 272
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.8  (0.9) -1.8  (0.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Office Evaluation Only (no UDS), Urodynamic Testing (UDS Arm)
Comments Null hypothesis is that the 2 arms do not differ according to mean change in PGI-S score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.51
Comments [Not Specified]
Method t-test, 2 sided
Comments The t test had 1 df and assumed equal variance; no evidence of different variances was found.
11.Secondary Outcome
Title Moderate or Severe Severity as Measured by the PGI-S
Hide Description The Patient Global Impression of Severity (PGI-S) has scores ranging from 1 [normal] to 4 [severe]. This measure is the percentage of participants responding to the PGI-S with a "3" corresponding to the "moderate" category or a "4" corresponding to the "severe" category at the 12 month visit.
Time Frame 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
There were 315 women randomized to each arm. In the UDS arm, 43 did not have primary outcome data leaving 272 in the intention-to-treat group. In the no UDS arm, 49 did not have primary outcome data leaving 266 in the ITT group. One woman was missing PGI-S data in the UDS arm and was excluded leaving n=271 in the UDS arm.
Arm/Group Title Office Evaluation Only (no UDS) Urodynamic Testing (UDS Arm)
Hide Arm/Group Description:
UDS is not conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
Overall Number of Participants Analyzed 266 271
Measure Type: Number
Unit of Measure: percentage of participants
5.6 7.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Office Evaluation Only (no UDS), Urodynamic Testing (UDS Arm)
Comments Null hypothesis is that the 2 arms do not differ in the proportion of women who score moderate or severe on the PGI-S at 12 months
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.51
Comments [Not Specified]
Method Chi-squared
Comments Chi-squared test had 1 df and no adjustments.
12.Secondary Outcome
Title Patient Satisfaction With Treatment Outcome
Hide Description A summary score for patient satisfaction was based on responses to questions developed for this study with scores ranging from 0 to 100 and higher scores indicating better satisfaction.
Time Frame 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
There were 315 women randomized to each arm. In the UDS arm, 43 did not have primary outcome data leaving 272 in the intention-to-treat group. In the no UDS arm, 49 did not have primary outcome data leaving 266 in the ITT group. ITT analysis was used for all outcomes with the exception of the primary non-inferiority endpoint.
Arm/Group Title Office Evaluation Only (no UDS) Urodynamic Testing (UDS Arm)
Hide Arm/Group Description:
UDS is not conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
Overall Number of Participants Analyzed 266 272
Mean (Standard Deviation)
Unit of Measure: units on a scale
82.2  (28.6) 79.5  (30.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Office Evaluation Only (no UDS), Urodynamic Testing (UDS Arm)
Comments Null hypothesis is that the 2 arms do not differ according to mean overall patient satisfaction score at 12 months.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.28
Comments P-value was not adjusted for multiple comparisons and the a priori threshold for statistical significance was alpha = 0.05.
Method t-test, 2 sided
Comments T test had 1 df and assumed equal variances; no evidence of unequal variances was found.
13.Secondary Outcome
Title Stress Test at 12 Mos
Hide Description A provocative stress test at a bladder volume of 300 ml was performed for direct observation of urine leakage. Observed urine loss from the urethra coincidental with the Valsalva maneuver or cough was considered a positive test. The stress test was not performed by the study surgeon but rather by an outcome assessor who was unaware of the study assignments.
Time Frame Screen and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
There were 315 women randomized to each arm. In the UDS arm, 43 did not have primary outcome data leaving 272 in the intention-to-treat group. In the no UDS arm, 49 did not have primary outcome data leaving 266 in the ITT group. Of these, only 225 in the UDS arm and 222 in the no UDS had stress test data at 12 months.
Arm/Group Title Office Evaluation Only (no UDS) Urodynamic Testing (UDS Arm)
Hide Arm/Group Description:
UDS is not conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
Overall Number of Participants Analyzed 222 225
Measure Type: Number
Unit of Measure: percentage of participants
11.7 16.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Office Evaluation Only (no UDS), Urodynamic Testing (UDS Arm)
Comments Null hypothesis is that the proportion having a positive provocative stress test at 12 months was the same in both treatment arms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.19
Comments P-values was not adjusted for multiple comparisons and the a priori threshold for statistical significance was set at alpha = 0.05.
Method Chi-squared
Comments Chi-squared test had 1 df and no adjustments.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Office Evaluation Only (no UDS) Urodynamic Testing (UDS Arm)
Hide Arm/Group Description UDS is not conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence. UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
All-Cause Mortality
Office Evaluation Only (no UDS) Urodynamic Testing (UDS Arm)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Office Evaluation Only (no UDS) Urodynamic Testing (UDS Arm)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   30/315 (9.52%)      21/315 (6.67%)    
Cardiac disorders     
Other: episode of postoperative bradycardia   0/315 (0.00%)  0 1/315 (0.32%)  1
Infections and infestations     
Recurrent UTI  [1]  3/315 (0.95%)  3 1/315 (0.32%)  1
Renal and urinary disorders     
Voiding dysfunction   5/315 (1.59%)  5 3/315 (0.95%)  3
Surgical and medical procedures     
Bladder Perforation   18/315 (5.71%)  18 12/315 (3.81%)  12
Intraoperative Bleeding   0/315 (0.00%)  0 1/315 (0.32%)  1
Mesh complication: erosion   1/315 (0.32%)  1 0/315 (0.00%)  0
Mesh complication: exposure   3/315 (0.95%)  3 2/315 (0.63%)  2
Granulation Tissue   0/315 (0.00%)  0 1/315 (0.32%)  1
Other: Fascial Wound Dehiscence   1/315 (0.32%)  1 0/315 (0.00%)  0
Other: Vaginal Perforation with sling   0/315 (0.00%)  0 1/315 (0.32%)  1
Indicates events were collected by systematic assessment
[1]
Recurrent UTI is defined as presumed UTI with treatment, 3 or more in one year after 6 weeks post surgery with no time limit for reporting.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Office Evaluation Only (no UDS) Urodynamic Testing (UDS Arm)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   39/315 (12.38%)      49/315 (15.56%)    
General disorders     
Other   9/315 (2.86%)  9 12/315 (3.81%)  12
Infections and infestations     
Culture proven UTI   13/315 (4.13%)  14 15/315 (4.76%)  15
Empiric UTI   12/315 (3.81%)  12 11/315 (3.49%)  11
Recurrent UTI   0/315 (0.00%)  0 3/315 (0.95%)  3
Renal and urinary disorders     
Voiding dysfunction   1/315 (0.32%)  1 3/315 (0.95%)  3
Surgical and medical procedures     
Anesthetic Complication   0/315 (0.00%)  0 3/315 (0.95%)  3
Intraoperative Bleeding   1/315 (0.32%)  1 2/315 (0.63%)  2
Postoperative bleeding   1/315 (0.32%)  1 2/315 (0.63%)  2
Mesh complication: erosion   1/315 (0.32%)  1 1/315 (0.32%)  1
Mesh complication: exposure   4/315 (1.27%)  5 2/315 (0.63%)  2
Surgical site infection: superficial incisional   1/315 (0.32%)  1 1/315 (0.32%)  1
Surgical site infection: deep incisional   1/315 (0.32%)  1 0/315 (0.00%)  0
Surgical site infection: organ/space   0/315 (0.00%)  0 1/315 (0.32%)  1
Granulation tissue   2/315 (0.63%)  2 2/315 (0.63%)  2
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Heather Litman, PhD
Organization: New England Research Institutes
Phone: 617 972 3297
EMail: hlitman@neriscience.com
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Responsible Party: New England Research Institutes
ClinicalTrials.gov Identifier: NCT00803959     History of Changes
Other Study ID Numbers: ValUE (completed)
First Submitted: December 5, 2008
First Posted: December 8, 2008
Results First Submitted: May 7, 2013
Results First Posted: August 6, 2013
Last Update Posted: August 6, 2013