Trial Outcomes & Findings for The Impact of Retropubic Lidocaine vs Saline on Postoperative Urinary Retention Following Midurethral Sling (NCT NCT03913845)
NCT ID: NCT03913845
Last Updated: 2026-04-30
Results Overview
To compare the number of subjects with urinary retention following retropubic midurethral sling placement in those women receiving normal saline vs lidocaine for retropubic hydrodissection.
COMPLETED
PHASE4
150 participants
This will be completed using a standardized retrograde voiding trial 1-2 hours postoperatively.
2026-04-30
Participant Flow
Participant milestones
| Measure |
0.5% Lidocaine With Epinephrine
On the day of surgery, the operating room pharmacist will prepare 20 cc of either study drug (0.5% lidocaine with epinephrine 1:200,000) or normal saline with epinephrine 1:200,000) in identical appearing 20cc syringes to be injected retropubically. Our group's routine clinical practice is to inject 20cc of 0.5% lidocaine with epinephrine 1:200,000 retropubically along the path of the midurethral sling trocars. Suburethral injection of local anesthestic will be performed at surgeon discretion. Surgical teams, anesthesia teams and patients will be blinded to allocation assignment. The investigational drug pharmacist will maintain the randomization sequence.
lidocaine with epinephrine: One of the most commonly used local anesthetic agents in surgical practice is lidocaine. Lidocaine as a local anesthetic is characterized by a rapid onset of action (typically within 2-5 minutes of injection) and intermediate duration of efficacy and thus is often favored in the outpatient setting for pre-incisional injections. Of note, however, its effects general only last up to 2 hours. Epinephrine (adrenaline) vasoconstricts arteries, delaying the resorption of lidocaine, and thus almost doubles the duration of anesthesia.
|
Normal Saline With Epinephrine
On the day of surgery, the operating room pharmacist will prepare 20 cc of either study drug (0.5% lidocaine with epinephrine 1:200,000) or normal saline with epinephrine 1:200,000) in identical appearing 20cc syringes to be injected retropubically. Our group's routine clinical practice is to inject 20cc of 0.5% lidocaine with epinephrine 1:200,000 retropubically along the path of the midurethral sling trocars. Suburethral injection of local anesthestic will be performed at surgeon discretion. Surgical teams, anesthesia teams and patients will be blinded to allocation assignment. The investigational drug pharmacist will maintain the randomization sequence.
Normal saline with epinephrine: Several mechanisms could explain the inability to void postoperatively, including nerve conduction impairment from anesthesia. Multiple studies have investigated the use of various types of anesthesia and downstream effects on postoperative urinary retention. It is postulated that denervating the regional pelvic nerves for pain control may lead to denervation of the bladder for a transient period of time, block both the afferent and efferent pathways of the voiding mechanism, affect the urethral retro-resistance pressure and impact urethral length thereby contributing to voiding dysfunction postoperatively. The use of normal saline in this setting may have a reduction in rates and duration of postoperative urinary retention following retropubic midurethral sling placement.
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|---|---|---|
|
Overall Study
STARTED
|
75
|
75
|
|
Overall Study
COMPLETED
|
69
|
69
|
|
Overall Study
NOT COMPLETED
|
6
|
6
|
Reasons for withdrawal
| Measure |
0.5% Lidocaine With Epinephrine
On the day of surgery, the operating room pharmacist will prepare 20 cc of either study drug (0.5% lidocaine with epinephrine 1:200,000) or normal saline with epinephrine 1:200,000) in identical appearing 20cc syringes to be injected retropubically. Our group's routine clinical practice is to inject 20cc of 0.5% lidocaine with epinephrine 1:200,000 retropubically along the path of the midurethral sling trocars. Suburethral injection of local anesthestic will be performed at surgeon discretion. Surgical teams, anesthesia teams and patients will be blinded to allocation assignment. The investigational drug pharmacist will maintain the randomization sequence.
lidocaine with epinephrine: One of the most commonly used local anesthetic agents in surgical practice is lidocaine. Lidocaine as a local anesthetic is characterized by a rapid onset of action (typically within 2-5 minutes of injection) and intermediate duration of efficacy and thus is often favored in the outpatient setting for pre-incisional injections. Of note, however, its effects general only last up to 2 hours. Epinephrine (adrenaline) vasoconstricts arteries, delaying the resorption of lidocaine, and thus almost doubles the duration of anesthesia.
|
Normal Saline With Epinephrine
On the day of surgery, the operating room pharmacist will prepare 20 cc of either study drug (0.5% lidocaine with epinephrine 1:200,000) or normal saline with epinephrine 1:200,000) in identical appearing 20cc syringes to be injected retropubically. Our group's routine clinical practice is to inject 20cc of 0.5% lidocaine with epinephrine 1:200,000 retropubically along the path of the midurethral sling trocars. Suburethral injection of local anesthestic will be performed at surgeon discretion. Surgical teams, anesthesia teams and patients will be blinded to allocation assignment. The investigational drug pharmacist will maintain the randomization sequence.
Normal saline with epinephrine: Several mechanisms could explain the inability to void postoperatively, including nerve conduction impairment from anesthesia. Multiple studies have investigated the use of various types of anesthesia and downstream effects on postoperative urinary retention. It is postulated that denervating the regional pelvic nerves for pain control may lead to denervation of the bladder for a transient period of time, block both the afferent and efferent pathways of the voiding mechanism, affect the urethral retro-resistance pressure and impact urethral length thereby contributing to voiding dysfunction postoperatively. The use of normal saline in this setting may have a reduction in rates and duration of postoperative urinary retention following retropubic midurethral sling placement.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
6
|
6
|
Baseline Characteristics
The Impact of Retropubic Lidocaine vs Saline on Postoperative Urinary Retention Following Midurethral Sling
Baseline characteristics by cohort
| Measure |
Lidocaine + Epinephrine
n=75 Participants
Subjects undergoing midurethral sling +/- anterior repair received 20cc of retropubic 0.5% lidocaine + 1:200,000 epinephrine
|
Saline + Epinephrine
n=75 Participants
Subjects undergoing midurethral sling +/- anterior repair received normal saline + 1:200,000 epinephrine
|
Total
n=150 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52 years
n=14 Participants
|
50 years
n=34 Participants
|
51.5 years
n=69 Participants
|
|
Sex: Female, Male
Female
|
75 Participants
n=14 Participants
|
75 Participants
n=34 Participants
|
150 Participants
n=69 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
|
Race/Ethnicity, Customized
race - black
|
3 Participants
n=14 Participants
|
1 Participants
n=34 Participants
|
4 Participants
n=69 Participants
|
|
Race/Ethnicity, Customized
Race- white
|
70 Participants
n=14 Participants
|
71 Participants
n=34 Participants
|
141 Participants
n=69 Participants
|
|
Race/Ethnicity, Customized
Race other
|
2 Participants
n=14 Participants
|
3 Participants
n=34 Participants
|
5 Participants
n=69 Participants
|
PRIMARY outcome
Timeframe: This will be completed using a standardized retrograde voiding trial 1-2 hours postoperatively.To compare the number of subjects with urinary retention following retropubic midurethral sling placement in those women receiving normal saline vs lidocaine for retropubic hydrodissection.
Outcome measures
| Measure |
Lidocaine + Epinephrine
n=75 Participants
Subjects undergoing midurethral sling +/- anterior repair received 20cc of retropubic 0.5% lidocaine + 1:200,000 epinephrine
|
Saline + Epinephrine
n=75 Participants
Subjects undergoing midurethral sling +/- anterior repair received normal saline + 1:200,000 epinephrine
|
|---|---|---|
|
Number of Subjects With Urinary Retention
|
15 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: Subjects will be asked to mark their pain on a VAS scale administered 2 hours and 6 hours following surgery.To assess postoperative pain in women receiving retropubic normal saline vs lidocaine during midurethral sling placement. Visual Analog Scale (VAS) pain scales are unidimensional measures of pain intensity that are easily completed and scored. Subjects place an "X" on a 10 centimeter (cm) VAS line at the point that represents their pain intensity. The score is calculated by measuring the distance in millimeters (mm) along the 10 cm line where 0 represents "no pain" and 10 represents "worst pain." Scores range from 0-100mm. They have been widely used in diverse populations to assess pain. VAS pain scores will be used as the outcome measure in this study because they are easy to complete and because they are easily compared to prior studies. The 2 hour VAS score will be completed prior to discharge. The 6 hour VAS score will be returned via mail since patients are routine discharged a few hours after sling surgery.
Outcome measures
| Measure |
Lidocaine + Epinephrine
n=75 Participants
Subjects undergoing midurethral sling +/- anterior repair received 20cc of retropubic 0.5% lidocaine + 1:200,000 epinephrine
|
Saline + Epinephrine
n=75 Participants
Subjects undergoing midurethral sling +/- anterior repair received normal saline + 1:200,000 epinephrine
|
|---|---|---|
|
Postoperative Pain: VAS Scale
2 hr postop
|
11 mm
Interval 0.0 to 28.0
|
21 mm
Interval 10.0 to 42.0
|
|
Postoperative Pain: VAS Scale
6 hr postop
|
18 mm
Interval 9.0 to 33.0
|
25 mm
Interval 13.0 to 50.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 weeks postoperativelyPopulation: Count of subjects reporting satisfied or very satisfied with the outcomes after surgery
To examine differences in patient satisfaction with surgery between women receiving retropubic normal saline vs lidocaine at time of midurethral sling placement. The Likert Scale is the most widely used approach to scaling responses in survey research and contains five tiered responses which users quantify on a visual analogue scale. The administration of such is easily comprehended, provides an effective and clinically relevant means of assessing patient satisfaction, and can readily be used in clinical practice. To determine satisfaction, patients will be asked to rate their satisfaction with surgery on a Likert scale (with 1 being the least satisfied and 5 being the most) at their 6 week postoperative follow up visit.
Outcome measures
| Measure |
Lidocaine + Epinephrine
n=75 Participants
Subjects undergoing midurethral sling +/- anterior repair received 20cc of retropubic 0.5% lidocaine + 1:200,000 epinephrine
|
Saline + Epinephrine
n=75 Participants
Subjects undergoing midurethral sling +/- anterior repair received normal saline + 1:200,000 epinephrine
|
|---|---|---|
|
Number of Subjects Reporting Satisfied or Very Satisfied
|
68 Participants
|
58 Participants
|
Adverse Events
Lidocaine + Epinephrine
Saline + Epinephrine
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Lidocaine + Epinephrine
n=75 participants at risk
Subjects undergoing midurethral sling +/- anterior repair received 20cc of retropubic 0.5% lidocaine + 1:200,000 epinephrine
|
Saline + Epinephrine
n=75 participants at risk
Subjects undergoing midurethral sling +/- anterior repair received normal saline + 1:200,000 epinephrine
|
|---|---|---|
|
Renal and urinary disorders
Urinary tract infection
|
12.0%
9/75 • within 30 days of surgery
|
9.3%
7/75 • within 30 days of surgery
|
|
General disorders
other (mesh exposure, sling obstruction, joint effusion, upper respiratory symptoms)
|
5.3%
4/75 • within 30 days of surgery
|
4.0%
3/75 • within 30 days of surgery
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place