Characterize procedure time from first incision to closing.

Describe the type of anesthesia used.

Number of participants requiring the use of a foley catheter intra-operatively.

Number of participants requiring the use of a foley catheter who were able to void prior to discharge.

Number of participants requiring the use of a foley catheter post-discharge following Bladder Management instructions.

Characterize procedural parameters including the use of tack sutures.

Characterize procedural parameters, including muscle dissection across all participants.

Characterize procedural parameters, including the movement of urethral bulb while tensioning in all participants.

Summarize device success as defined as a successful placement of the device in a desired position, peri-operatively, in participants.

Summarize subject satisfaction of 1-hour pad weight for participants.

Last observation carried forward (LOCF) and worst case scenario (WCS) data are derived from data from the 24 month visit

Summarize subject satisfaction with 24-hour pad weight across participants.

LOCF and WCS data are derived from data from the 24 month visit

Summarize the percent of subjects that have a decrease of pad weight of 25%, 50%, or 75% at follow-up (1-hour pad weight test used).

Summarize the percent of subjects that have a decrease of pad weight of 25%, 50%, or 75% at follow-up (24-hour pad weight test used).

Summarize the subject satisfaction using pads per day use collected in follow-up in participants.

LOCF and WCS data are derived from data from the 24 month visit

The Incontinence Quality of Life (I-QOL) questionnaire contains 22 items, each with a 5-point Likert-type response scale, evaluating a subject's quality of life with respect to his urinary problems or incontinence. A possible total score can be 0-100, with a higher score meaning less problems.

Number of subjects that did not have test performed at follow-up visit.

The ICIQ-SF questionnaire evaluates the impact of urinary incontinence on quality of life through four questions that evaluate the frequency, severity and impact of urinary incontinence. A set of eight self-diagnosis items related to the causes or situations of urinary incontinence experienced by the subject are also assessed. Scores may range from 0 to 21. Improvement in the subject's quality of life from baseline to follow-up is indicated by a decrease in the ICIQ-SF score.

Number of subjects that did not have test performed at follow-up visit.

Baseline uroflow measurements including peak flow rates, average flow rates, voided volume, and post-void residual were compared to follow-up results at 3, 6, 12, and 24 months.

Number of subjects that did not have test performed at follow-up visit.

Baseline uroflow measurements including peak flow rates, average flow rates, voided volume, and post-void residual were compared to follow-up results at 3, 6, 12, and 24 months.

Number of subjects that did not have test performed at follow-up visit.

Baseline uroflow measurements including peak flow rates, average flow rates, voided volume, and post-void residual were compared to follow-up results at 3, 6, 12, and 24 months.

Number of subjects that did not have test performed at follow-up visit.

Baseline uroflow measurements including peak flow rates, average flow rates, voided volume, and post-void residual were compared to follow-up results at 3, 6, 12, and 24 months.

Number of subjects that did not have test performed at follow-up visit.

Baseline urodynamic measurements including bladder capacity, maximum detrusor pressure, detrusor pressure at maximum flow, and detrusor instability were measured at baseline and at 6-month follow-up.

Number of subjects that did not have test performed at follow-up visit.

Baseline urodynamic measurements including bladder capacity, maximum detrusor pressure, detrusor pressure at maximum flow, and detrusor instability were measured at baseline and at 6-month follow-up.

Maximum detrusor pressure is measured during a urodynamic study when tension is applied to the bladder wall (detrusor muscles) by filling the bladder to capacity with saline water and observing the detrusor muscle during filling of the bladder and voiding of the saline water.

Number of subjects that did not have test performed at follow-up visit.

Baseline urodynamic measurements including bladder capacity, maximum detrusor pressure, detrusor pressure at maximum flow, and detrusor instability were measured at baseline and at 6-month follow-up.

Maximum detrusor pressure is measured during a urodynamic study when tension is applied to the bladder wall (detrusor muscles) by filling the bladder to capacity with saline water and observing the detrusor muscle during filling of the bladder and voiding of the saline water. Pdet at Qmax is the detrusor pressure at maximal flow rate when the bladder is full and the patient begins voiding.

Number of subjects that did not have test performed at follow-up visit.

Baseline urodynamic measurements including bladder capacity, maximum detrusor pressure, detrusor pressure at maximum flow, and detrusor instability were measured at baseline and at 6-month follow-up.

Detrusor instability occurs when the detrusor muscle is unstable and spontaneously contracts the bladder.

The measure data table shows the mean volume at the start of the urodynamic measurement study for patients with detrusor instability.

Number of subjects that did not have test performed at follow-up visit.

Baseline urodynamic measurements including bladder capacity, maximum detrusor pressure, detrusor pressure at maximum flow, and detrusor instability were measured at baseline and at 6-month follow-up.

Maximum detrusor pressure is measured during a urodynamic study when tension is applied to the bladder wall (detrusor muscles) by filling the bladder to capacity with saline water and observing the detrusor muscle during filling of the bladder and voiding of the saline water. Pdet at Qmax is the detrusor pressure at maximal flow rate when the bladder is full and the patient begins voiding.

Detrusor instability occurs when the detrusor muscle is unstable and spontaneously contracts the bladder.

The outcome measure data table shows the Pdet for patients with detrusor instability.

Number of subjects that did not have test performed at follow-up visit.

Baseline urodynamic measurements including bladder capacity, maximum detrusor pressure, detrusor pressure at maximum flow, and detrusor instability were measured at baseline and at 6-month follow-up.

Abnormal graphical representation of bladder pressure during urodynamics testing which is when the bladder is filled with saline water.

Number of subjects that did not have test performed at follow-up visit.

Abdominal leak point pressure (ALPP) is one indicator of improvement in continence symptoms. Abdominal leak point pressure was collected at baseline and 6-month follow-up as part of the urodynamic assessment.

18 participants did not have 6-month follow-up data

Improvement in the subject's quality of life from baseline to follow-up is indicated by an increase in the UCLA/RAND urinary function score. Scores may range from 0 to 100.

Number of subjects that did not have test performed at follow-up visit.

Physician evaluation of subject's incontinence status at 6 weeks and subsequent follow-up evaluations

Percentage of participants with serious and non-serious adverse events.