Trial Outcomes & Findings for Value of Urodynamic Evaluation (NCT NCT00803959)

NCT ID: NCT00803959

Last Updated: 2013-08-06

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 630 participants
• Primary outcome timeframe: 12 Months
• Results posted on: 2013-08-06

Participant Flow

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.

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.

Participant milestones

Measure	Office Evaluation Only (no UDS) UDS is not conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.	Urodynamic Testing (UDS Arm) UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
Overall Study STARTED	315	315
Overall Study ITT Analysis With Primary Outcome Data	266	272
Overall Study COMPLETED	259	264
Overall Study NOT COMPLETED	56	51

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Value of Urodynamic Evaluation

Baseline characteristics by cohort

Measure	Office Evaluation Only (no UDS) n=259 Participants UDS is not conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.	Urodynamic Testing (UDS Arm) n=264 Participants UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.	Total n=523 Participants Total of all reporting groups
Age Continuous	51.6 years STANDARD_DEVIATION 10.0 • n=5 Participants	51.9 years STANDARD_DEVIATION 10.4 • n=7 Participants	51.7 years STANDARD_DEVIATION 10.2 • n=5 Participants
Sex: Female, Male Female	259 Participants n=5 Participants	264 Participants n=7 Participants	523 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	259 participants n=5 Participants	264 participants n=7 Participants	523 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 Months

Population: 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.

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.

Outcome measures

Measure	Office Evaluation Only (no UDS) n=259 Participants UDS is not conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.	Urodynamic Testing (UDS Arm) n=264 Participants UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
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.	77.2 percentage of participants	76.9 percentage of participants

SECONDARY outcome

Timeframe: Baseline, 12 mos

Population: 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.

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.

Outcome measures

Measure	Office Evaluation Only (no UDS) n=266 Participants UDS is not conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.	Urodynamic Testing (UDS Arm) n=272 Participants UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
Percentage Meeting or Exceeding 70% Decrease in UDI Score Between Baseline and 12 Months	78.9 percentage of participants	77.2 percentage of participants

SECONDARY outcome

Timeframe: 12 Months

Population: 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.

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.

Outcome measures

Measure	Office Evaluation Only (no UDS) n=262 Participants UDS is not conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.	Urodynamic Testing (UDS Arm) n=270 Participants UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
Patient Global Impression Index	90.8 percentage of participants	91.9 percentage of participants

SECONDARY outcome

Timeframe: Baseline, 12 Months

Population: 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.

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.

Outcome measures

Measure	Office Evaluation Only (no UDS) n=266 Participants UDS is not conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.	Urodynamic Testing (UDS Arm) n=272 Participants UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
Change in Bother as Measured by the UDI	-98.4 units on a scale Standard Deviation 51.4	-100.2 units on a scale Standard Deviation 50.1

SECONDARY outcome

Timeframe: Baseline & 12 Months

Population: 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.

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.

Outcome measures

Measure	Office Evaluation Only (no UDS) n=266 Participants UDS is not conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.	Urodynamic Testing (UDS Arm) n=272 Participants UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
Change in Severity as Measured by the ISI	-5.7 units on a scale Standard Deviation 3.4	-6.0 units on a scale Standard Deviation 3.3

SECONDARY outcome

Timeframe: Screen & 12 Months

Population: 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.

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.

Outcome measures

Measure	Office Evaluation Only (no UDS) n=266 Participants UDS is not conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.	Urodynamic Testing (UDS Arm) n=272 Participants UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
Change in MESA Stress Score	-60.2 units on a scale Standard Deviation 24.7	-61.5 units on a scale Standard Deviation 22.0

SECONDARY outcome

Timeframe: Screen & 12 Months

Population: 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.

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.

Outcome measures

Measure	Office Evaluation Only (no UDS) n=266 Participants UDS is not conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.	Urodynamic Testing (UDS Arm) n=272 Participants UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
Change in MESA Urge Score	-22.2 units on a scale Standard Deviation 22.4	-19.7 units on a scale Standard Deviation 21.4

SECONDARY outcome

Timeframe: Baseline, 12 Months

Population: 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.

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.

Outcome measures

Measure	Office Evaluation Only (no UDS) n=266 Participants UDS is not conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.	Urodynamic Testing (UDS Arm) n=272 Participants UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
Change in Quality of Life as Measured by the IIQ	-37.3 units on a scale Standard Deviation 23.7	-35.9 units on a scale Standard Deviation 23.2

SECONDARY outcome

Timeframe: Baseline, 12 Months

Population: 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.

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.

Outcome measures

Measure	Office Evaluation Only (no UDS) n=266 Participants UDS is not conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.	Urodynamic Testing (UDS Arm) n=272 Participants UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
Change in Quality of Life as Measured by the SF-12	7.3 units on a scale Standard Deviation 12.0	5.0 units on a scale Standard Deviation 10.8

SECONDARY outcome

Timeframe: Baseline & 12 Months

Population: 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.

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.

Outcome measures

Measure	Office Evaluation Only (no UDS) n=266 Participants UDS is not conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.	Urodynamic Testing (UDS Arm) n=272 Participants UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
Change in Severity as Measured by the PGI-S	-1.8 units on a scale Standard Deviation 0.9	-1.8 units on a scale Standard Deviation 0.9

SECONDARY outcome

Timeframe: 12 Months

Population: 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.

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.

Outcome measures

Measure	Office Evaluation Only (no UDS) n=266 Participants UDS is not conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.	Urodynamic Testing (UDS Arm) n=271 Participants UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
Moderate or Severe Severity as Measured by the PGI-S	5.6 percentage of participants	7.0 percentage of participants

SECONDARY outcome

Timeframe: 12 Months

Population: 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.

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.

Outcome measures

Measure	Office Evaluation Only (no UDS) n=266 Participants UDS is not conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.	Urodynamic Testing (UDS Arm) n=272 Participants UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
Patient Satisfaction With Treatment Outcome	82.2 units on a scale Standard Deviation 28.6	79.5 units on a scale Standard Deviation 30.4

SECONDARY outcome

Timeframe: Screen and 12 months

Population: 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.

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.

Outcome measures

Measure	Office Evaluation Only (no UDS) n=222 Participants UDS is not conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.	Urodynamic Testing (UDS Arm) n=225 Participants UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
Stress Test at 12 Mos	11.7 percentage of participants	16.0 percentage of participants

Adverse Events

Office Evaluation Only (no UDS)

Serious events: 30 serious events

Other events: 39 other events

Deaths: 0 deaths

Urodynamic Testing (UDS Arm)

Serious events: 21 serious events

Other events: 49 other events

Deaths: 0 deaths

Serious adverse events

Measure	Office Evaluation Only (no UDS) n=315 participants at risk UDS is not conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.	Urodynamic Testing (UDS Arm) n=315 participants at risk UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
Surgical and medical procedures Bladder Perforation	5.7% 18/315 • Number of events 18	3.8% 12/315 • Number of events 12
Surgical and medical procedures Intraoperative Bleeding	0.00% 0/315	0.32% 1/315 • Number of events 1
Surgical and medical procedures Mesh complication: erosion	0.32% 1/315 • Number of events 1	0.00% 0/315
Surgical and medical procedures Mesh complication: exposure	0.95% 3/315 • Number of events 3	0.63% 2/315 • Number of events 2
Infections and infestations Recurrent UTI	0.95% 3/315 • Number of events 3	0.32% 1/315 • Number of events 1
Surgical and medical procedures Granulation Tissue	0.00% 0/315	0.32% 1/315 • Number of events 1
Renal and urinary disorders Voiding dysfunction	1.6% 5/315 • Number of events 5	0.95% 3/315 • Number of events 3
Surgical and medical procedures Other: Fascial Wound Dehiscence	0.32% 1/315 • Number of events 1	0.00% 0/315
Surgical and medical procedures Other: Vaginal Perforation with sling	0.00% 0/315	0.32% 1/315 • Number of events 1
Cardiac disorders Other: episode of postoperative bradycardia	0.00% 0/315	0.32% 1/315 • Number of events 1

Other adverse events

Measure	Office Evaluation Only (no UDS) n=315 participants at risk UDS is not conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.	Urodynamic Testing (UDS Arm) n=315 participants at risk UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
Surgical and medical procedures Anesthetic Complication	0.00% 0/315	0.95% 3/315 • Number of events 3
Surgical and medical procedures Intraoperative Bleeding	0.32% 1/315 • Number of events 1	0.63% 2/315 • Number of events 2
Surgical and medical procedures Postoperative bleeding	0.32% 1/315 • Number of events 1	0.63% 2/315 • Number of events 2
Surgical and medical procedures Mesh complication: erosion	0.32% 1/315 • Number of events 1	0.32% 1/315 • Number of events 1
Surgical and medical procedures Mesh complication: exposure	1.3% 4/315 • Number of events 5	0.63% 2/315 • Number of events 2
Surgical and medical procedures Surgical site infection: superficial incisional	0.32% 1/315 • Number of events 1	0.32% 1/315 • Number of events 1
Surgical and medical procedures Surgical site infection: deep incisional	0.32% 1/315 • Number of events 1	0.00% 0/315
Surgical and medical procedures Surgical site infection: organ/space	0.00% 0/315	0.32% 1/315 • Number of events 1
Infections and infestations Culture proven UTI	4.1% 13/315 • Number of events 14	4.8% 15/315 • Number of events 15
Infections and infestations Empiric UTI	3.8% 12/315 • Number of events 12	3.5% 11/315 • Number of events 11
Infections and infestations Recurrent UTI	0.00% 0/315	0.95% 3/315 • Number of events 3
Surgical and medical procedures Granulation tissue	0.63% 2/315 • Number of events 2	0.63% 2/315 • Number of events 2
Renal and urinary disorders Voiding dysfunction	0.32% 1/315 • Number of events 1	0.95% 3/315 • Number of events 3
General disorders Other	2.9% 9/315 • Number of events 9	3.8% 12/315 • Number of events 12

Additional Information

Heather Litman, PhD

New England Research Institutes

Phone: 617 972 3297

Email: hlitman@neriscience.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place