Trial Outcomes & Findings for Barbed Suture Versus Non-Barbed Suture for Posterior Colporrhaphy (NCT NCT04658784)
NCT ID: NCT04658784
Last Updated: 2023-05-06
Results Overview
To compare delayed absorbable barbed suture versus non-barbed delayed absorbable suture at the time of posterior repair on post-operative posterior compartment pain scores, as measured by the Visual Analog Scale (VAS).The VAS is a validated scale that is ranges from 0-100mm. 0mm is equivalent to "no pain" and is located on the left. 100mm is equivalent to "worst possible pain" and is located on the right. Reported as categorical variable no pain (VAS 0), low pain (VAS 1-33), moderate pain (VAS 34-66), and high pain (VAS 67-100).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
72 participants
Primary outcome timeframe
Week 6
Results posted on
2023-05-06
Participant Flow
Participant milestones
| Measure |
Intervention
Receives posterior colporrhaphy closure using standardized technique with 2-0 V-Loc 90TM, Medtronic
2-0 dioxanone, glycolide and trimethylene carbonate: delayed absorbable, monofilament barbed suture
|
Control
Receives posterior colporrhaphy closure using standardized technique with conventional 2-0 PDS® Ethicon
2-0 polydioxanone: delayed absorbable, monofilament non-barbed suture
|
|---|---|---|
|
Enrollment to 6-week Follow-up
STARTED
|
36
|
36
|
|
Enrollment to 6-week Follow-up
COMPLETED
|
36
|
36
|
|
Enrollment to 6-week Follow-up
NOT COMPLETED
|
0
|
0
|
|
6-month Follow-up
STARTED
|
36
|
36
|
|
6-month Follow-up
COMPLETED
|
34
|
31
|
|
6-month Follow-up
NOT COMPLETED
|
2
|
5
|
Reasons for withdrawal
| Measure |
Intervention
Receives posterior colporrhaphy closure using standardized technique with 2-0 V-Loc 90TM, Medtronic
2-0 dioxanone, glycolide and trimethylene carbonate: delayed absorbable, monofilament barbed suture
|
Control
Receives posterior colporrhaphy closure using standardized technique with conventional 2-0 PDS® Ethicon
2-0 polydioxanone: delayed absorbable, monofilament non-barbed suture
|
|---|---|---|
|
6-month Follow-up
Lost to Follow-up
|
2
|
5
|
Baseline Characteristics
Barbed Suture Versus Non-Barbed Suture for Posterior Colporrhaphy
Baseline characteristics by cohort
| Measure |
Intervention
n=36 Participants
Receives posterior colporrhaphy closure using standardized technique with 2-0 V-Loc 90TM, Medtronic
2-0 dioxanone, glycolide and trimethylene carbonate: delayed absorbable, monofilament barbed suture
|
Control
n=36 Participants
Receives posterior colporrhaphy closure using standardized technique with conventional 2-0 PDS® Ethicon
2-0 polydioxanone: delayed absorbable, monofilament non-barbed suture
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.6 Years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
58.2 Years
STANDARD_DEVIATION 11.0 • n=7 Participants
|
57.9 Years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
|
Sex/Gender, Customized
Female
|
36 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
34 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
BMI kg/m^2
|
27.8 kg/m^2
STANDARD_DEVIATION 3.9 • n=5 Participants
|
28.3 kg/m^2
STANDARD_DEVIATION 4.9 • n=7 Participants
|
28.0 kg/m^2
STANDARD_DEVIATION 4.4 • n=5 Participants
|
|
Tobacco use
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sexually active
|
22 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Vaginal estrogen use
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Total Pelvic Organ Prolapse Quantification (POP-Q) Stage
POP-Q Stage 0
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Total Pelvic Organ Prolapse Quantification (POP-Q) Stage
POP-Q Stage I
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Total Pelvic Organ Prolapse Quantification (POP-Q) Stage
POP-Q Stage II
|
27 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Total Pelvic Organ Prolapse Quantification (POP-Q) Stage
POP-Q Stage III
|
8 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Total Pelvic Organ Prolapse Quantification (POP-Q) Stage
POP-Q Stage IV
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Posterior Compartment Pelvic Organ Prolapse Quantification (POP-Q) Stage (0-IV)
POP-Q Stage 0
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Posterior Compartment Pelvic Organ Prolapse Quantification (POP-Q) Stage (0-IV)
POP-Q Stage I
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Posterior Compartment Pelvic Organ Prolapse Quantification (POP-Q) Stage (0-IV)
POP-Q Stage II
|
26 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Posterior Compartment Pelvic Organ Prolapse Quantification (POP-Q) Stage (0-IV)
POP-Q Stage III
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Posterior Compartment Pelvic Organ Prolapse Quantification (POP-Q) Stage (0-IV)
POP-Q Stage IV
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Prior pelvic reconstructive surgery
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 6To compare delayed absorbable barbed suture versus non-barbed delayed absorbable suture at the time of posterior repair on post-operative posterior compartment pain scores, as measured by the Visual Analog Scale (VAS).The VAS is a validated scale that is ranges from 0-100mm. 0mm is equivalent to "no pain" and is located on the left. 100mm is equivalent to "worst possible pain" and is located on the right. Reported as categorical variable no pain (VAS 0), low pain (VAS 1-33), moderate pain (VAS 34-66), and high pain (VAS 67-100).
Outcome measures
| Measure |
Intervention
n=36 Participants
Receives posterior colporrhaphy closure using standardized technique with 2-0 V-Loc 90TM, Medtronic
2-0 dioxanone, glycolide and trimethylene carbonate: delayed absorbable, monofilament barbed suture
|
Control
n=36 Participants
Receives posterior colporrhaphy closure using standardized technique with conventional 2-0 PDS® Ethicon
2-0 polydioxanone: delayed absorbable, monofilament non-barbed suture
|
|---|---|---|
|
Post-operative Posterior Compartment Pain Scores - Posterior Repair
moderate pain (VAS 34-66)
|
1 Participants
|
2 Participants
|
|
Post-operative Posterior Compartment Pain Scores - Posterior Repair
missing
|
0 Participants
|
0 Participants
|
|
Post-operative Posterior Compartment Pain Scores - Posterior Repair
no pain (VAS 0)
|
32 Participants
|
29 Participants
|
|
Post-operative Posterior Compartment Pain Scores - Posterior Repair
low pain (VAS 1-33)
|
2 Participants
|
4 Participants
|
|
Post-operative Posterior Compartment Pain Scores - Posterior Repair
high pain (VAS 67- 100)
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Month 6To compare visual analog scale (VAS) pain scores in the posterior compartment. The VAS is a validated scale that is ranges from 0-100mm. 0mm is equivalent to "no pain" and is located on the left. 100mm is equivalent to "worst possible pain" and is located on the right. Reported as categorical variable no pain, low pain, moderate pain and high pain. Reported as categorical variable no pain (VAS 0), low pain (VAS 1-33), moderate pain (VAS 34-66), and high pain (VAS 67-100).
Outcome measures
| Measure |
Intervention
n=36 Participants
Receives posterior colporrhaphy closure using standardized technique with 2-0 V-Loc 90TM, Medtronic
2-0 dioxanone, glycolide and trimethylene carbonate: delayed absorbable, monofilament barbed suture
|
Control
n=36 Participants
Receives posterior colporrhaphy closure using standardized technique with conventional 2-0 PDS® Ethicon
2-0 polydioxanone: delayed absorbable, monofilament non-barbed suture
|
|---|---|---|
|
Post-operative Posterior Compartment Pain Scores
no pain (VAS 0)
|
33 Participants
|
26 Participants
|
|
Post-operative Posterior Compartment Pain Scores
low pain (VAS 1-33)
|
1 Participants
|
1 Participants
|
|
Post-operative Posterior Compartment Pain Scores
moderate pain (VAS 34-66)
|
0 Participants
|
1 Participants
|
|
Post-operative Posterior Compartment Pain Scores
high pain (VAS 67- 100)
|
0 Participants
|
0 Participants
|
|
Post-operative Posterior Compartment Pain Scores
missing
|
2 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Time of SurgeryTo evaluate operative time for posterior repair in minutes.
Outcome measures
| Measure |
Intervention
n=36 Participants
Receives posterior colporrhaphy closure using standardized technique with 2-0 V-Loc 90TM, Medtronic
2-0 dioxanone, glycolide and trimethylene carbonate: delayed absorbable, monofilament barbed suture
|
Control
n=36 Participants
Receives posterior colporrhaphy closure using standardized technique with conventional 2-0 PDS® Ethicon
2-0 polydioxanone: delayed absorbable, monofilament non-barbed suture
|
|---|---|---|
|
Operative Time
Total procedure surgical time
|
146 Minutes
Interval 75.0 to 180.0
|
168 Minutes
Interval 114.0 to 192.0
|
|
Operative Time
Posterior repair surgical time
|
21 Minutes
Interval 15.5 to 28.5
|
20.5 Minutes
Interval 15.5 to 31.5
|
SECONDARY outcome
Timeframe: At time of surgery (Intraoperative)To evaluate amount of suture burden present at time of surgery in posterior by compartment by measuring total amount of delayed absorbable suture used for posterior colporrhaphy in centimeters.
Outcome measures
| Measure |
Intervention
n=36 Participants
Receives posterior colporrhaphy closure using standardized technique with 2-0 V-Loc 90TM, Medtronic
2-0 dioxanone, glycolide and trimethylene carbonate: delayed absorbable, monofilament barbed suture
|
Control
n=36 Participants
Receives posterior colporrhaphy closure using standardized technique with conventional 2-0 PDS® Ethicon
2-0 polydioxanone: delayed absorbable, monofilament non-barbed suture
|
|---|---|---|
|
Suture Burden
|
10.5 centimeters
Interval 7.9 to 14.4
|
26.9 centimeters
Interval 14.9 to 48.6
|
SECONDARY outcome
Timeframe: Baseline, Week 6, and month 6To evaluate change in bowel function using the Pelvic Floor Distress Inventory- 20 (PFDI-20) sub-scale Colorectal-Anal Distress Inventory-8 (CRADI-8). Total score (range 0 to 100) with the higher the score the more distress.
Outcome measures
| Measure |
Intervention
n=36 Participants
Receives posterior colporrhaphy closure using standardized technique with 2-0 V-Loc 90TM, Medtronic
2-0 dioxanone, glycolide and trimethylene carbonate: delayed absorbable, monofilament barbed suture
|
Control
n=36 Participants
Receives posterior colporrhaphy closure using standardized technique with conventional 2-0 PDS® Ethicon
2-0 polydioxanone: delayed absorbable, monofilament non-barbed suture
|
|---|---|---|
|
Change in Bowel Function Scores
baseline
|
36.4 score on a scale
Standard Deviation 20.8
|
36.6 score on a scale
Standard Deviation 19.0
|
|
Change in Bowel Function Scores
6 weeks
|
18.1 score on a scale
Standard Deviation 14.4
|
18.1 score on a scale
Standard Deviation 14.9
|
|
Change in Bowel Function Scores
Change from baseline to 6 weeks
|
-18.2 score on a scale
Standard Deviation 19.6
|
-18.6 score on a scale
Standard Deviation 22.7
|
|
Change in Bowel Function Scores
6 months
|
12.3 score on a scale
Standard Deviation 12.7
|
9.6 score on a scale
Standard Deviation 12.8
|
|
Change in Bowel Function Scores
Change from baseline to 6 months
|
-24.1 score on a scale
Standard Deviation 22.6
|
-27.9 score on a scale
Standard Deviation 19.7
|
SECONDARY outcome
Timeframe: Baseline, Week 6, and Month 6To evaluate change in pelvic organ prolapse symptoms using the Pelvic Floor Distress Inventory- 20 (PFDI-20) sub-scale the Pelvic Organ Prolapse Distress Inventory- 6 (POPDI-6). Total score (range 0 to 100) with the higher the score the more distress.
Outcome measures
| Measure |
Intervention
n=36 Participants
Receives posterior colporrhaphy closure using standardized technique with 2-0 V-Loc 90TM, Medtronic
2-0 dioxanone, glycolide and trimethylene carbonate: delayed absorbable, monofilament barbed suture
|
Control
n=36 Participants
Receives posterior colporrhaphy closure using standardized technique with conventional 2-0 PDS® Ethicon
2-0 polydioxanone: delayed absorbable, monofilament non-barbed suture
|
|---|---|---|
|
Change in Pelvic Organ Prolapse Symptoms
baseline
|
53.4 score on a scale
Standard Deviation 19.5
|
52.1 score on a scale
Standard Deviation 18.2
|
|
Change in Pelvic Organ Prolapse Symptoms
6 weeks
|
13.8 score on a scale
Standard Deviation 13.0
|
11.2 score on a scale
Standard Deviation 12.9
|
|
Change in Pelvic Organ Prolapse Symptoms
change from baseline to 6 weeks
|
-39.6 score on a scale
Standard Deviation 20.7
|
-40.9 score on a scale
Standard Deviation 23.4
|
|
Change in Pelvic Organ Prolapse Symptoms
6 months
|
7.2 score on a scale
Standard Deviation 9.6
|
8.3 score on a scale
Standard Deviation 9.0
|
|
Change in Pelvic Organ Prolapse Symptoms
Change from baseline to 6 months
|
-46.7 score on a scale
Standard Deviation 18.8
|
-43.1 score on a scale
Standard Deviation 20.9
|
SECONDARY outcome
Timeframe: Month 6Population: Different number of patients were sexually active at measured time points, baseline and 6 months.
To evaluate postoperative sexual function using the Pelvic Organ Prolapse-Urinary Incontinence Sexual Function Questionnaire (PISQ-12). Total score (range 0 to 48) with a lower score associated with poorer/worse sexual function.
Outcome measures
| Measure |
Intervention
n=27 Participants
Receives posterior colporrhaphy closure using standardized technique with 2-0 V-Loc 90TM, Medtronic
2-0 dioxanone, glycolide and trimethylene carbonate: delayed absorbable, monofilament barbed suture
|
Control
n=22 Participants
Receives posterior colporrhaphy closure using standardized technique with conventional 2-0 PDS® Ethicon
2-0 polydioxanone: delayed absorbable, monofilament non-barbed suture
|
|---|---|---|
|
Change in Postoperative Sexual Function Scores
Baseline
|
28.1 score on a scale
Standard Deviation 5.0
|
26.9 score on a scale
Standard Deviation 6.3
|
|
Change in Postoperative Sexual Function Scores
6 months
|
33.1 score on a scale
Standard Deviation 3.2
|
31.7 score on a scale
Standard Deviation 4.6
|
|
Change in Postoperative Sexual Function Scores
Change from baseline to 6 months
|
3.9 score on a scale
Standard Deviation 6.8
|
4.6 score on a scale
Standard Deviation 4.4
|
SECONDARY outcome
Timeframe: Week 6To evaluate anatomical failure of posterior compartment using a standard definition of anatomical cure will be defined as Ba or Bp at \</= 0 on POP-Q examination (i.e.at or beyond hymenal ring)
Outcome measures
| Measure |
Intervention
n=36 Participants
Receives posterior colporrhaphy closure using standardized technique with 2-0 V-Loc 90TM, Medtronic
2-0 dioxanone, glycolide and trimethylene carbonate: delayed absorbable, monofilament barbed suture
|
Control
n=36 Participants
Receives posterior colporrhaphy closure using standardized technique with conventional 2-0 PDS® Ethicon
2-0 polydioxanone: delayed absorbable, monofilament non-barbed suture
|
|---|---|---|
|
Number of Patients With Early Anatomic Recurrence
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 6 and Month 6To evaluate subjective failure of posterior compartment using a negative response on POPDI-6 portion of the PFDI-20 questionnaire to questions: "Do you usually have a sensation of bulging or protrusion from the vaginal area?" and "Do you usually have a bulge or something falling out that you can see or feel in the vaginal area?"
Outcome measures
| Measure |
Intervention
n=36 Participants
Receives posterior colporrhaphy closure using standardized technique with 2-0 V-Loc 90TM, Medtronic
2-0 dioxanone, glycolide and trimethylene carbonate: delayed absorbable, monofilament barbed suture
|
Control
n=36 Participants
Receives posterior colporrhaphy closure using standardized technique with conventional 2-0 PDS® Ethicon
2-0 polydioxanone: delayed absorbable, monofilament non-barbed suture
|
|---|---|---|
|
Number of Patients With Subjective Failure
6 weeks
|
0 Participants
|
0 Participants
|
|
Number of Patients With Subjective Failure
6 months
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: Comparison of 30 day ACS NSQIP complications in intervention and control groups.
To evaluate differences in adverse outcomes, using number of adverse events (AEs) as defined by the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) 30-day postoperative complications criteria. These criteria were reviewed at the week 6 data collection time interval.
Outcome measures
| Measure |
Intervention
n=36 Participants
Receives posterior colporrhaphy closure using standardized technique with 2-0 V-Loc 90TM, Medtronic
2-0 dioxanone, glycolide and trimethylene carbonate: delayed absorbable, monofilament barbed suture
|
Control
n=36 Participants
Receives posterior colporrhaphy closure using standardized technique with conventional 2-0 PDS® Ethicon
2-0 polydioxanone: delayed absorbable, monofilament non-barbed suture
|
|---|---|---|
|
American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) 30-day Postoperative Complications.
Urinary tract infection (UTI)
|
5 Adverse events
|
3 Adverse events
|
|
American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) 30-day Postoperative Complications.
Surgical site infection (SSI)
|
0 Adverse events
|
1 Adverse events
|
|
American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) 30-day Postoperative Complications.
Readmission
|
1 Adverse events
|
0 Adverse events
|
|
American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) 30-day Postoperative Complications.
Return to the operating room (OR)
|
1 Adverse events
|
0 Adverse events
|
|
American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) 30-day Postoperative Complications.
Unplanned reintubation
|
0 Adverse events
|
1 Adverse events
|
SECONDARY outcome
Timeframe: month 6Population: Analysis of surgery specific adverse events in intervention and control groups.
To evaluate differences in adverse outcomes, using number of surgery specific adverse events.
Outcome measures
| Measure |
Intervention
n=34 Participants
Receives posterior colporrhaphy closure using standardized technique with 2-0 V-Loc 90TM, Medtronic
2-0 dioxanone, glycolide and trimethylene carbonate: delayed absorbable, monofilament barbed suture
|
Control
n=31 Participants
Receives posterior colporrhaphy closure using standardized technique with conventional 2-0 PDS® Ethicon
2-0 polydioxanone: delayed absorbable, monofilament non-barbed suture
|
|---|---|---|
|
Surgery Specific Adverse Events (AEs) Measured at 6-months.
de novo dyspareunia
|
4 Adverse events
|
5 Adverse events
|
|
Surgery Specific Adverse Events (AEs) Measured at 6-months.
new or worsening pelvic pain >3months
|
1 Adverse events
|
4 Adverse events
|
|
Surgery Specific Adverse Events (AEs) Measured at 6-months.
New or worsening constipation > 3 months
|
2 Adverse events
|
1 Adverse events
|
|
Surgery Specific Adverse Events (AEs) Measured at 6-months.
New fecal incontinence
|
1 Adverse events
|
1 Adverse events
|
|
Surgery Specific Adverse Events (AEs) Measured at 6-months.
Nerve injury
|
1 Adverse events
|
0 Adverse events
|
|
Surgery Specific Adverse Events (AEs) Measured at 6-months.
Other
|
1 Adverse events
|
0 Adverse events
|
|
Surgery Specific Adverse Events (AEs) Measured at 6-months.
Classified as Severe Adverse Event (SAE)
|
1 Adverse events
|
1 Adverse events
|
Adverse Events
Intervention
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
Control
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Intervention
n=36 participants at risk
Receives posterior colporrhaphy closure using standardized technique with 2-0 V-Loc 90TM, Medtronic
2-0 dioxanone, glycolide and trimethylene carbonate: delayed absorbable, monofilament barbed suture
|
Control
n=36 participants at risk
Receives posterior colporrhaphy closure using standardized technique with conventional 2-0 PDS® Ethicon
2-0 polydioxanone: delayed absorbable, monofilament non-barbed suture
|
|---|---|---|
|
Nervous system disorders
Nerve entrapment
|
2.8%
1/36 • Number of events 1 • Adverse event data was collected at 6 weeks, 6 months and 12 months time points.
No difference in definitions or collection.
|
2.8%
1/36 • Number of events 1 • Adverse event data was collected at 6 weeks, 6 months and 12 months time points.
No difference in definitions or collection.
|
|
Nervous system disorders
Pelvic pain
|
2.8%
1/36 • Number of events 1 • Adverse event data was collected at 6 weeks, 6 months and 12 months time points.
No difference in definitions or collection.
|
2.8%
1/36 • Number of events 1 • Adverse event data was collected at 6 weeks, 6 months and 12 months time points.
No difference in definitions or collection.
|
Other adverse events
| Measure |
Intervention
n=36 participants at risk
Receives posterior colporrhaphy closure using standardized technique with 2-0 V-Loc 90TM, Medtronic
2-0 dioxanone, glycolide and trimethylene carbonate: delayed absorbable, monofilament barbed suture
|
Control
n=36 participants at risk
Receives posterior colporrhaphy closure using standardized technique with conventional 2-0 PDS® Ethicon
2-0 polydioxanone: delayed absorbable, monofilament non-barbed suture
|
|---|---|---|
|
Infections and infestations
Surgical site infection
|
2.8%
1/36 • Number of events 1 • Adverse event data was collected at 6 weeks, 6 months and 12 months time points.
No difference in definitions or collection.
|
2.8%
1/36 • Number of events 1 • Adverse event data was collected at 6 weeks, 6 months and 12 months time points.
No difference in definitions or collection.
|
|
Infections and infestations
Urinary tract infection (UTI)
|
13.9%
5/36 • Number of events 5 • Adverse event data was collected at 6 weeks, 6 months and 12 months time points.
No difference in definitions or collection.
|
8.3%
3/36 • Number of events 3 • Adverse event data was collected at 6 weeks, 6 months and 12 months time points.
No difference in definitions or collection.
|
|
Nervous system disorders
New or worsening pelvic pain > 3months
|
2.8%
1/36 • Number of events 1 • Adverse event data was collected at 6 weeks, 6 months and 12 months time points.
No difference in definitions or collection.
|
11.1%
4/36 • Number of events 4 • Adverse event data was collected at 6 weeks, 6 months and 12 months time points.
No difference in definitions or collection.
|
|
Reproductive system and breast disorders
De novo dyspareunia
|
11.1%
4/36 • Number of events 4 • Adverse event data was collected at 6 weeks, 6 months and 12 months time points.
No difference in definitions or collection.
|
13.9%
5/36 • Number of events 5 • Adverse event data was collected at 6 weeks, 6 months and 12 months time points.
No difference in definitions or collection.
|
|
Gastrointestinal disorders
New fecal incontinence
|
2.8%
1/36 • Number of events 1 • Adverse event data was collected at 6 weeks, 6 months and 12 months time points.
No difference in definitions or collection.
|
2.8%
1/36 • Number of events 1 • Adverse event data was collected at 6 weeks, 6 months and 12 months time points.
No difference in definitions or collection.
|
|
Gastrointestinal disorders
New or worsening constipation
|
5.6%
2/36 • Number of events 2 • Adverse event data was collected at 6 weeks, 6 months and 12 months time points.
No difference in definitions or collection.
|
2.8%
1/36 • Number of events 1 • Adverse event data was collected at 6 weeks, 6 months and 12 months time points.
No difference in definitions or collection.
|
|
Blood and lymphatic system disorders
Other
|
2.8%
1/36 • Number of events 1 • Adverse event data was collected at 6 weeks, 6 months and 12 months time points.
No difference in definitions or collection.
|
0.00%
0/36 • Adverse event data was collected at 6 weeks, 6 months and 12 months time points.
No difference in definitions or collection.
|
Additional Information
Dr. Amanda Merriman
Ascension Saint Thomas Medical Group
Phone: 615-397-6919
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place