Value of Urodynamic Evaluation

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

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.

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

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.

Time frame: 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.

Time frame: 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.

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

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.

Time frame: 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.

Time frame: 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.

Time frame: 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 (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

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.

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

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.

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

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.

Time frame: 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.

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

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.