Trial Outcomes & Findings for Retropubic vs. Single-Incision Mid-Urethral Sling for Stress Urinary Incontinence (NCT NCT03520114)

NCT ID: NCT03520114

Last Updated: 2025-01-16

Results Overview

Dichotomous outcome (Yes/No), measured by a positive response of \> 1 to Question 17 on Pelvic Floor Distress Inventory short form-20 (PFDI-20). Response scale from 0 to 4. Symptoms Not Present = NO 0 = not present Symptoms Present = YES, scale of bother: 1 = not at all, 2 = somewhat, 3 = moderately, 4 = quite a bit

Recruitment status

COMPLETED

Study phase

Target enrollment

280 participants

Primary outcome timeframe

12 months post-operatively

Results posted on

2025-01-16

Participant Flow

Total 280 patients signed the Informed Consent. Out of enrolled 280 patients, 3 withdrawn as screen failed, 21 dropped out before randomization, and 1 did not receive the treatment as per randomization. Hence enrolled number is larger than the randomized.

Participant milestones

Participant milestones
Measure	RP Sling Group Participants assigned to the retropubic (RP) sling group will have the RP sling placement procedure. RP sling placement: A 1.5 cm incision will be made at the mid-urethra through a separate vaginal incision with lateral dissection with Metzembaum scissors. After placement of both trocars, cystoscopy with a 70-degree scope will be performed to assess for bladder and urethral injury. Surgeons will set the tension of the tension-free vaginal tape (TVT) slings so that a spacer can be placed between the sling and the urethra. Sling tensioning will be performed after anterior and apical prolapse is corrected.	SIS Group Participants assigned to the single-incision sling (SIS) group will have the SIS placement procedure. SIS placement: The sling is introduced through a single anterior vaginal incision of 1.5 cm at the mid-urethra. The sling/needle assembly is advanced behind the ischiopubic rami in a transobturator trajectory toward the obturator space bilaterally. The needle is then removed by simply sliding the fixating tip back out. The other side is then completed in an identical fashion. After the fixation of the two anchors at the 2 and 10 o'clock positions, the patient's bladder is filled with 250 mL of Sodium Chloride (NaCl). Afterward, an intraoperative crede maneuver is performed and the tension adjustment suture is pulled, when necessary, to achieve the desired continence. The mesh will lie in direct apposition to the urethra. The adjustment thread is then cut short and the vaginal incision is closed with an absorbable suture.
Overall Study STARTED	129	126
Overall Study COMPLETED	122	118
Overall Study NOT COMPLETED	7	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Retropubic vs. Single-Incision Mid-Urethral Sling for Stress Urinary Incontinence

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	RP Sling Group n=129 Participants Participants assigned to the retropubic (RP) sling group will have the RP sling placement procedure. RP sling placement: A 1.5 cm incision will be made at the mid-urethra through a separate vaginal incision with lateral dissection with Metzembaum scissors. After placement of both trocars, cystoscopy with a 70-degree scope will be performed to assess for bladder and urethral injury. Surgeons will set the tension of the tension-free vaginal tape (TVT) slings so that a spacer can be placed between the sling and the urethra. Sling tensioning will be performed after anterior and apical prolapse is corrected.	SIS Group n=126 Participants Participants assigned to the single-incision sling (SIS) group will have the SIS placement procedure. SIS placement: The sling is introduced through a single anterior vaginal incision of 1.5 cm at the mid-urethra. The sling/needle assembly is advanced behind the ischiopubic rami in a transobturator trajectory toward the obturator space bilaterally. The needle is then removed by simply sliding the fixating tip back out. The other side is then completed in an identical fashion. After the fixation of the two anchors at the 2 and 10 o'clock positions, the patient's bladder is filled with 250 mL of Sodium Chloride (NaCl). Afterward, an intraoperative crede maneuver is performed and the tension adjustment suture is pulled, when necessary, to achieve the desired continence. The mesh will lie in direct apposition to the urethra. The adjustment thread is then cut short and the vaginal incision is closed with an absorbable suture.	Total n=255 Participants Total of all reporting groups
Age, Continuous	65.5 Years STANDARD_DEVIATION 0 • n=5 Participants	67.8 Years STANDARD_DEVIATION 0 • n=7 Participants	67 Years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	129 Participants n=5 Participants	126 Participants n=7 Participants	255 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	123 Participants n=5 Participants	121 Participants n=7 Participants	244 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	13 Participants n=5 Participants	11 Participants n=7 Participants	24 Participants n=5 Participants
Race (NIH/OMB) White	112 Participants n=5 Participants	111 Participants n=7 Participants	223 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months post-operatively

Outcome measures

Outcome measures
Measure	RP Sling Group n=129 Participants Participants assigned to the retropubic (RP) sling group will have the RP sling placement procedure. RP sling placement: A 1.5 cm incision will be made at the mid-urethra through a separate vaginal incision with lateral dissection with Metzembaum scissors. After placement of both trocars, cystoscopy with a 70-degree scope will be performed to assess for bladder and urethral injury. Surgeons will set the tension of the tension-free vaginal tape (TVT) slings so that a spacer can be placed between the sling and the urethra. Sling tensioning will be performed after anterior and apical prolapse is corrected.	SIS Group n=126 Participants Participants assigned to the single-incision sling (SIS) group will have the SIS placement procedure. SIS placement: The sling is introduced through a single anterior vaginal incision of 1.5 cm at the mid-urethra. The sling/needle assembly is advanced behind the ischiopubic rami in a transobturator trajectory toward the obturator space bilaterally. The needle is then removed by simply sliding the fixating tip back out. The other side is then completed in an identical fashion. After the fixation of the two anchors at the 2 and 10 o'clock positions, the patient's bladder is filled with 250 mL of Sodium Chloride (NaCl). Afterward, an intraoperative crede maneuver is performed and the tension adjustment suture is pulled, when necessary, to achieve the desired continence. The mesh will lie in direct apposition to the urethra. The adjustment thread is then cut short and the vaginal incision is closed with an absorbable suture.
Number of Participants With Subjectively Bothersome Stress Incontinence	129 Participants	126 Participants

PRIMARY outcome

Timeframe: 12 months post-operatively

This includes pelvic floor physical therapy; incontinence pessary; urethral bulking injection; repeat incontinence surgery.

Outcome measures

Outcome measures
Measure	RP Sling Group n=122 Participants Participants assigned to the retropubic (RP) sling group will have the RP sling placement procedure. RP sling placement: A 1.5 cm incision will be made at the mid-urethra through a separate vaginal incision with lateral dissection with Metzembaum scissors. After placement of both trocars, cystoscopy with a 70-degree scope will be performed to assess for bladder and urethral injury. Surgeons will set the tension of the tension-free vaginal tape (TVT) slings so that a spacer can be placed between the sling and the urethra. Sling tensioning will be performed after anterior and apical prolapse is corrected.	SIS Group n=118 Participants Participants assigned to the single-incision sling (SIS) group will have the SIS placement procedure. SIS placement: The sling is introduced through a single anterior vaginal incision of 1.5 cm at the mid-urethra. The sling/needle assembly is advanced behind the ischiopubic rami in a transobturator trajectory toward the obturator space bilaterally. The needle is then removed by simply sliding the fixating tip back out. The other side is then completed in an identical fashion. After the fixation of the two anchors at the 2 and 10 o'clock positions, the patient's bladder is filled with 250 mL of Sodium Chloride (NaCl). Afterward, an intraoperative crede maneuver is performed and the tension adjustment suture is pulled, when necessary, to achieve the desired continence. The mesh will lie in direct apposition to the urethra. The adjustment thread is then cut short and the vaginal incision is closed with an absorbable suture.
Count of Participants Needing Retreatment for Stress Incontinence	3 Participants	5 Participants

PRIMARY outcome

Timeframe: 12 months post-operatively

Dichotomous outcome (Yes/No), measured by a worsening change in response to Question 16 on PFDI-20 with at least somewhat bothersome symptoms. Response scale from 0 to 4. Symptoms Not Present = NO 0 = not present Symptoms Present = YES, scale of bother: 1 = not at all, 2 = somewhat, 3 = moderately, 4 = quite a bit

Outcome measures

Outcome measures
Measure	RP Sling Group n=109 Participants Participants assigned to the retropubic (RP) sling group will have the RP sling placement procedure. RP sling placement: A 1.5 cm incision will be made at the mid-urethra through a separate vaginal incision with lateral dissection with Metzembaum scissors. After placement of both trocars, cystoscopy with a 70-degree scope will be performed to assess for bladder and urethral injury. Surgeons will set the tension of the tension-free vaginal tape (TVT) slings so that a spacer can be placed between the sling and the urethra. Sling tensioning will be performed after anterior and apical prolapse is corrected.	SIS Group n=103 Participants Participants assigned to the single-incision sling (SIS) group will have the SIS placement procedure. SIS placement: The sling is introduced through a single anterior vaginal incision of 1.5 cm at the mid-urethra. The sling/needle assembly is advanced behind the ischiopubic rami in a transobturator trajectory toward the obturator space bilaterally. The needle is then removed by simply sliding the fixating tip back out. The other side is then completed in an identical fashion. After the fixation of the two anchors at the 2 and 10 o'clock positions, the patient's bladder is filled with 250 mL of Sodium Chloride (NaCl). Afterward, an intraoperative crede maneuver is performed and the tension adjustment suture is pulled, when necessary, to achieve the desired continence. The mesh will lie in direct apposition to the urethra. The adjustment thread is then cut short and the vaginal incision is closed with an absorbable suture.
Count of Participants With De Novo or Worsening Urge Incontinence Symptoms	3 Participants	3 Participants

PRIMARY outcome

Timeframe: 12 Month post-operatively

Beyond 2 weeks post-operatively with PVR \> 150 ml OR \> 1/3 total voided volume up to 12 Month post-operatively..

Outcome measures

Outcome measures
Measure	RP Sling Group n=109 Participants Participants assigned to the retropubic (RP) sling group will have the RP sling placement procedure. RP sling placement: A 1.5 cm incision will be made at the mid-urethra through a separate vaginal incision with lateral dissection with Metzembaum scissors. After placement of both trocars, cystoscopy with a 70-degree scope will be performed to assess for bladder and urethral injury. Surgeons will set the tension of the tension-free vaginal tape (TVT) slings so that a spacer can be placed between the sling and the urethra. Sling tensioning will be performed after anterior and apical prolapse is corrected.	SIS Group n=103 Participants Participants assigned to the single-incision sling (SIS) group will have the SIS placement procedure. SIS placement: The sling is introduced through a single anterior vaginal incision of 1.5 cm at the mid-urethra. The sling/needle assembly is advanced behind the ischiopubic rami in a transobturator trajectory toward the obturator space bilaterally. The needle is then removed by simply sliding the fixating tip back out. The other side is then completed in an identical fashion. After the fixation of the two anchors at the 2 and 10 o'clock positions, the patient's bladder is filled with 250 mL of Sodium Chloride (NaCl). Afterward, an intraoperative crede maneuver is performed and the tension adjustment suture is pulled, when necessary, to achieve the desired continence. The mesh will lie in direct apposition to the urethra. The adjustment thread is then cut short and the vaginal incision is closed with an absorbable suture.
Count of Participants Requiring Bladder Drainage	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 12 Month post-operatively

Sling lysis or revision at any time point post-operatively up to 12 Month post-operatively.

Outcome measures

Outcome measures
Measure	RP Sling Group n=109 Participants Participants assigned to the retropubic (RP) sling group will have the RP sling placement procedure. RP sling placement: A 1.5 cm incision will be made at the mid-urethra through a separate vaginal incision with lateral dissection with Metzembaum scissors. After placement of both trocars, cystoscopy with a 70-degree scope will be performed to assess for bladder and urethral injury. Surgeons will set the tension of the tension-free vaginal tape (TVT) slings so that a spacer can be placed between the sling and the urethra. Sling tensioning will be performed after anterior and apical prolapse is corrected.	SIS Group n=103 Participants Participants assigned to the single-incision sling (SIS) group will have the SIS placement procedure. SIS placement: The sling is introduced through a single anterior vaginal incision of 1.5 cm at the mid-urethra. The sling/needle assembly is advanced behind the ischiopubic rami in a transobturator trajectory toward the obturator space bilaterally. The needle is then removed by simply sliding the fixating tip back out. The other side is then completed in an identical fashion. After the fixation of the two anchors at the 2 and 10 o'clock positions, the patient's bladder is filled with 250 mL of Sodium Chloride (NaCl). Afterward, an intraoperative crede maneuver is performed and the tension adjustment suture is pulled, when necessary, to achieve the desired continence. The mesh will lie in direct apposition to the urethra. The adjustment thread is then cut short and the vaginal incision is closed with an absorbable suture.
Count of Participants Needing Surgical Intervention for Urinary Retention	3 participants	4 participants

SECONDARY outcome

Timeframe: 12 months post-operatively

Reporting of adverse events intra- and post-operatively and include adverse events as measured by the Dindo classification system.

Outcome measures

Outcome measures
Measure	RP Sling Group n=109 Participants Participants assigned to the retropubic (RP) sling group will have the RP sling placement procedure. RP sling placement: A 1.5 cm incision will be made at the mid-urethra through a separate vaginal incision with lateral dissection with Metzembaum scissors. After placement of both trocars, cystoscopy with a 70-degree scope will be performed to assess for bladder and urethral injury. Surgeons will set the tension of the tension-free vaginal tape (TVT) slings so that a spacer can be placed between the sling and the urethra. Sling tensioning will be performed after anterior and apical prolapse is corrected.	SIS Group n=103 Participants Participants assigned to the single-incision sling (SIS) group will have the SIS placement procedure. SIS placement: The sling is introduced through a single anterior vaginal incision of 1.5 cm at the mid-urethra. The sling/needle assembly is advanced behind the ischiopubic rami in a transobturator trajectory toward the obturator space bilaterally. The needle is then removed by simply sliding the fixating tip back out. The other side is then completed in an identical fashion. After the fixation of the two anchors at the 2 and 10 o'clock positions, the patient's bladder is filled with 250 mL of Sodium Chloride (NaCl). Afterward, an intraoperative crede maneuver is performed and the tension adjustment suture is pulled, when necessary, to achieve the desired continence. The mesh will lie in direct apposition to the urethra. The adjustment thread is then cut short and the vaginal incision is closed with an absorbable suture.
Number of Participants With Adverse Events	47 Participants with Adverse Events	53 Participants with Adverse Events

SECONDARY outcome

Timeframe: post-operatively up to 12 months

Surgeon satisfaction with the sling will be assessed with a 10-point Likert Scale. The scale has a score range of 0-10, with 0=no satisfaction 10=extremely satisfied.

Outcome measures

Outcome measures
Measure	RP Sling Group n=129 Participants Participants assigned to the retropubic (RP) sling group will have the RP sling placement procedure. RP sling placement: A 1.5 cm incision will be made at the mid-urethra through a separate vaginal incision with lateral dissection with Metzembaum scissors. After placement of both trocars, cystoscopy with a 70-degree scope will be performed to assess for bladder and urethral injury. Surgeons will set the tension of the tension-free vaginal tape (TVT) slings so that a spacer can be placed between the sling and the urethra. Sling tensioning will be performed after anterior and apical prolapse is corrected.	SIS Group n=126 Participants Participants assigned to the single-incision sling (SIS) group will have the SIS placement procedure. SIS placement: The sling is introduced through a single anterior vaginal incision of 1.5 cm at the mid-urethra. The sling/needle assembly is advanced behind the ischiopubic rami in a transobturator trajectory toward the obturator space bilaterally. The needle is then removed by simply sliding the fixating tip back out. The other side is then completed in an identical fashion. After the fixation of the two anchors at the 2 and 10 o'clock positions, the patient's bladder is filled with 250 mL of Sodium Chloride (NaCl). Afterward, an intraoperative crede maneuver is performed and the tension adjustment suture is pulled, when necessary, to achieve the desired continence. The mesh will lie in direct apposition to the urethra. The adjustment thread is then cut short and the vaginal incision is closed with an absorbable suture.
Surgeon Satisfaction Scores	9 Score on a Scale Interval 8.0 to 10.0	8 Score on a Scale Interval 7.0 to 10.0

Adverse Events

RP Sling Group

Serious events: 7 serious events

Other events: 40 other events

Deaths: 0 deaths

SIS Group

Serious events: 6 serious events

Other events: 47 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	RP Sling Group n=129 participants at risk Participants assigned to the retropubic (RP) sling group will have the RP sling placement procedure. RP sling placement: A 1.5 cm incision will be made at the mid-urethra through a separate vaginal incision with lateral dissection with Metzembaum scissors. After placement of both trocars, cystoscopy with a 70-degree scope will be performed to assess for bladder and urethral injury. Surgeons will set the tension of the tension-free vaginal tape (TVT) slings so that a spacer can be placed between the sling and the urethra. Sling tensioning will be performed after anterior and apical prolapse is corrected.	SIS Group n=126 participants at risk Participants assigned to the single-incision sling (SIS) group will have the SIS placement procedure. SIS placement: The sling is introduced through a single anterior vaginal incision of 1.5 cm at the mid-urethra. The sling/needle assembly is advanced behind the ischiopubic rami in a transobturator trajectory toward the obturator space bilaterally. The needle is then removed by simply sliding the fixating tip back out. The other side is then completed in an identical fashion. After the fixation of the two anchors at the 2 and 10 o'clock positions, the patient's bladder is filled with 250 mL of Sodium Chloride (NaCl). Afterward, an intraoperative crede maneuver is performed and the tension adjustment suture is pulled, when necessary, to achieve the desired continence. The mesh will lie in direct apposition to the urethra. The adjustment thread is then cut short and the vaginal incision is closed with an absorbable suture.
Surgical and medical procedures Voiding Dysfunction	1.6% 2/129 • Number of events 2 • 1 year Protocol defined urogynecologic adverse events collected.	1.6% 2/126 • Number of events 2 • 1 year Protocol defined urogynecologic adverse events collected.
Surgical and medical procedures Urosepsis	0.78% 1/129 • Number of events 1 • 1 year Protocol defined urogynecologic adverse events collected.	0.00% 0/126 • 1 year Protocol defined urogynecologic adverse events collected.
Infections and infestations Pelvic Abscess	0.78% 1/129 • Number of events 1 • 1 year Protocol defined urogynecologic adverse events collected.	0.00% 0/126 • 1 year Protocol defined urogynecologic adverse events collected.
Blood and lymphatic system disorders Pelvic Hematoma	0.78% 1/129 • Number of events 1 • 1 year Protocol defined urogynecologic adverse events collected.	0.00% 0/126 • 1 year Protocol defined urogynecologic adverse events collected.
Congenital, familial and genetic disorders Recurrent Prolapse	0.00% 0/129 • 1 year Protocol defined urogynecologic adverse events collected.	0.79% 1/126 • Number of events 1 • 1 year Protocol defined urogynecologic adverse events collected.
Surgical and medical procedures Pelvic Pain	0.00% 0/129 • 1 year Protocol defined urogynecologic adverse events collected.	0.79% 1/126 • Number of events 1 • 1 year Protocol defined urogynecologic adverse events collected.
Surgical and medical procedures Death	0.00% 0/129 • 1 year Protocol defined urogynecologic adverse events collected.	0.00% 0/126 • 1 year Protocol defined urogynecologic adverse events collected.
Surgical and medical procedures Urinary Retention	1.6% 2/129 • Number of events 2 • 1 year Protocol defined urogynecologic adverse events collected.	1.6% 2/126 • Number of events 2 • 1 year Protocol defined urogynecologic adverse events collected.

Other adverse events

Additional Information

Sachin Nalin Vyas, MS,PhD

Wake Forest University

Phone: 336-713-4098

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	RP Sling Group n=129 participants at risk Participants assigned to the retropubic (RP) sling group will have the RP sling placement procedure. RP sling placement: A 1.5 cm incision will be made at the mid-urethra through a separate vaginal incision with lateral dissection with Metzembaum scissors. After placement of both trocars, cystoscopy with a 70-degree scope will be performed to assess for bladder and urethral injury. Surgeons will set the tension of the tension-free vaginal tape (TVT) slings so that a spacer can be placed between the sling and the urethra. Sling tensioning will be performed after anterior and apical prolapse is corrected.	SIS Group n=126 participants at risk Participants assigned to the single-incision sling (SIS) group will have the SIS placement procedure. SIS placement: The sling is introduced through a single anterior vaginal incision of 1.5 cm at the mid-urethra. The sling/needle assembly is advanced behind the ischiopubic rami in a transobturator trajectory toward the obturator space bilaterally. The needle is then removed by simply sliding the fixating tip back out. The other side is then completed in an identical fashion. After the fixation of the two anchors at the 2 and 10 o'clock positions, the patient's bladder is filled with 250 mL of Sodium Chloride (NaCl). Afterward, an intraoperative crede maneuver is performed and the tension adjustment suture is pulled, when necessary, to achieve the desired continence. The mesh will lie in direct apposition to the urethra. The adjustment thread is then cut short and the vaginal incision is closed with an absorbable suture.
Surgical and medical procedures Bleeding	1.6% 2/129 • Number of events 2 • 1 year Protocol defined urogynecologic adverse events collected.	4.0% 5/126 • Number of events 5 • 1 year Protocol defined urogynecologic adverse events collected.
Blood and lymphatic system disorders Hematoma	2.3% 3/129 • Number of events 3 • 1 year Protocol defined urogynecologic adverse events collected.	0.00% 0/126 • 1 year Protocol defined urogynecologic adverse events collected.
Infections and infestations Infection	3.9% 5/129 • Number of events 5 • 1 year Protocol defined urogynecologic adverse events collected.	0.79% 1/126 • Number of events 1 • 1 year Protocol defined urogynecologic adverse events collected.
Surgical and medical procedures Mesh Exposure	0.00% 0/129 • 1 year Protocol defined urogynecologic adverse events collected.	0.79% 1/126 • Number of events 1 • 1 year Protocol defined urogynecologic adverse events collected.
Congenital, familial and genetic disorders Recurrent POP	0.78% 1/129 • Number of events 1 • 1 year Protocol defined urogynecologic adverse events collected.	1.6% 2/126 • Number of events 2 • 1 year Protocol defined urogynecologic adverse events collected.
Surgical and medical procedures Readmission for Complications	1.6% 2/129 • Number of events 2 • 1 year Protocol defined urogynecologic adverse events collected.	1.6% 2/126 • Number of events 2 • 1 year Protocol defined urogynecologic adverse events collected.
Surgical and medical procedures Outpatient Surgical Intervention	2.3% 3/129 • Number of events 3 • 1 year Protocol defined urogynecologic adverse events collected.	3.2% 4/126 • Number of events 4 • 1 year Protocol defined urogynecologic adverse events collected.
Infections and infestations Urinary Tract Infection	11.6% 15/129 • Number of events 15 • 1 year Protocol defined urogynecologic adverse events collected.	19.8% 25/126 • Number of events 25 • 1 year Protocol defined urogynecologic adverse events collected.
Renal and urinary disorders Urgency "De Novo"	2.3% 3/129 • Number of events 3 • 1 year Protocol defined urogynecologic adverse events collected.	2.4% 3/126 • Number of events 3 • 1 year Protocol defined urogynecologic adverse events collected.
Renal and urinary disorders Voiding Dysfunction	3.9% 5/129 • Number of events 5 • 1 year Protocol defined urogynecologic adverse events collected.	3.2% 4/126 • Number of events 4 • 1 year Protocol defined urogynecologic adverse events collected.
Surgical and medical procedures Leg Pain	0.78% 1/129 • Number of events 1 • 1 year Protocol defined urogynecologic adverse events collected.	0.00% 0/126 • 1 year Protocol defined urogynecologic adverse events collected.
Surgical and medical procedures Bowel Injury	0.00% 0/129 • 1 year Protocol defined urogynecologic adverse events collected.	0.00% 0/126 • 1 year Protocol defined urogynecologic adverse events collected.
Surgical and medical procedures Bowel Obstruction	0.00% 0/129 • 1 year Protocol defined urogynecologic adverse events collected.	0.00% 0/126 • 1 year Protocol defined urogynecologic adverse events collected.
Surgical and medical procedures Fistula	0.00% 0/129 • 1 year Protocol defined urogynecologic adverse events collected.	0.00% 0/126 • 1 year Protocol defined urogynecologic adverse events collected.
Surgical and medical procedures Intestinal Injury	0.00% 0/129 • 1 year Protocol defined urogynecologic adverse events collected.	0.00% 0/126 • 1 year Protocol defined urogynecologic adverse events collected.
Surgical and medical procedures Mesh Erosion	0.00% 0/129 • 1 year Protocol defined urogynecologic adverse events collected.	0.00% 0/126 • 1 year Protocol defined urogynecologic adverse events collected.
Surgical and medical procedures Nerve Injury	0.00% 0/129 • 1 year Protocol defined urogynecologic adverse events collected.	0.00% 0/126 • 1 year Protocol defined urogynecologic adverse events collected.
Surgical and medical procedures Venous Thromboembolism	0.00% 0/129 • 1 year Protocol defined urogynecologic adverse events collected.	0.00% 0/126 • 1 year Protocol defined urogynecologic adverse events collected.