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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Total of all reporting groups

UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.

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.