Stress Urinary Incontinence
Conditions
Keywords
mid-urethral sling, pubovaginal sling, postoperative pain, visual analog scale, suprapubic approach, SPARC sling
Brief summary
There are many ways to perform a suprapubic approach pubovaginal sling. Some surgeons inject local pain medical into the retropubic space before placing the sling, others do not. This study is to determine if injection of local pain medication into the retropubic space before placing a mid-urethral sling for urinary stress incontinence results in lower postoperative pain scores, lower use of postoperative narcotic medication and lower rates of urinary retention.
Detailed description
To evaluate if an injection in the retropubic space with a local acting anesthetic, Marcaine, (bupivacaine) at the time of mid-urethral sling placement will improve patients' reported post operative pain and decrease the use of narcotic pain medication. This study will include all female patients age 18 and older who will undergo a mid-urethral sling with or without anterior repair for the treatment of urinary stress incontinence by a member of the Division of Urogynecology and Reconstructive Pelvic Surgery who consent to be in the study. Once patients have consented to participate in the study they will be randomized into two groups. One group will have the mid-urethral sling placed in the usual fashion with no injection of local anesthetic. The other group will have the mid-urethral sling placed after the retropubic space has been infiltrated with local anesthetic as previously described in the literature. Pain will be assessed with the use of a Visual Analog Scale during the hospitalization and the use of narcotic pain medication will be assessed during recovery and overnight in the hospital. Patients will be asked to record how often and what type of pain medication they use. Patients will also be asked to keep a log of their urination if they are discharged home with self catheterization. They will be asked to mail in their pain medication log and voiding diary (if needed) at a two-week post-operative. Outcomes will then be compared.
Interventions
DRUG0.125% Marcaine
Patients randomized to the intervention arm will receive 60 cc of 0.125% Marcaine injected into the retropubic space along the tract that the suprapubic mid-urethral trocar will follow (one on each side) for a total of 120 cc of 0.125% Marcaine, prior to the placement of the mid-urethral sling via the suprapubic approach.
Sponsors
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Any female patient, age 18 or older, who elects to have a mid-urethral sling with or without an anterior or posterior repair at the University of North Carolina Hospitals by a member of the Division of Urogynecology.
Exclusion criteria
* Any patient with a chronic pain syndrome, a contraindication to nonsteroidal anti-inflammatory drugs (NSAIDs) such as liver disease, abnormal coagulation, esophageal disorders or peptic ulcers or where pain evaluation is unreliable because of neurological disease and those on treatment with steroids/NSAIDs/opioids prior to surgery. * Also excluded will be any patient who is having any other reconstructive pelvic surgery concomitantly or would require the placement of a suprapubic catheter. * Patients electing to have their surgery with regional anesthesia, such as an epidural or spinal will be excluded. * All minors, decisional impaired people, nursing mothers and non-English speaking people will be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in Postoperative Pain Using a Visual Analog Scale at 2 Hours. | 2 hours postoperative from mid-urethral sling placement | At approximately two hours postoperatively patients completed a visual analog scale (VAS), which was a 10-cm numeric scale on which 0 represented no pain and 10 represented the worst pain ever. |
| Difference in Postoperative Pain Using a Visual Analog Scale at 6 Hours. | 6 hours postoperative from mid-urethral sling placement | At approximately six hours postoperatively patients completed a visual analog scale (VAS), which was a 10-cm numeric scale on which 0 represented no pain and 10 represented the worst pain ever. |
| Difference in Postoperative Pain Using a Visual Analog Scale at 24 Hours. | 24 hours postoperative from mid-urethral sling placement | At approximately twenty-four hours postoperatively patients completed a visual analog scale (VAS), which was a 10-cm numeric scale on which 0 represented no pain and 10 represented the worst pain ever. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| In-hospital Medication Amounts | From surgery until discharge, average | Secondary outcome included differences in amount of pain medication used in the hospital. This was assessed by comparing the number of pills of oral narcotics the patient took while hospitalized. |
| Difference in Successful Voiding Trial Prior to Discharge Following Placement of Mid-urethral Sling Via the Suprapubic Approach. | From after surgery to discharge from hospital. | Prior to discharge, patients underwent voiding trials. At our institution, in order to pass the voiding trial, they must void at least 200 cc spontaneously and have less than 100 cc as a post void residual two times in a row. |
Countries
United States
Participant flow
Recruitment details
From January 2008 to September of 2009, all female patients planning to undergo a sling with or without an anterior or posterior repair at the University of North Carolina (UNC) Hospital were approached for participation.
Participants by arm
| Arm | Count |
|---|---|
| Intervention Group - Received Marcaine Patients randomized to this arm will receive 60 cc of 0.125% Marcaine injected into the retropubic space along the tract that the suprapubic mid-urethral trocar will follow (one on each side) for a total of 120 cc of 0.125% Marcaine, prior to the placement of the mid-urethral sling via the suprapubic approach. | 21 |
| Control Group - No Marcaine Patients assigned to this arm will have the mid-urethral sling placed via the suprapubic approach in the standard fashion with no injection of Marcaine into the retropubic space. | 21 |
| Total | 42 |
Baseline characteristics
| Characteristic | Total | Intervention Group - Received Marcaine | Control Group - No Marcaine |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 3 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 37 Participants | 18 Participants | 19 Participants |
| Age Continuous | 52 years STANDARD_DEVIATION 12 | 49.4 years STANDARD_DEVIATION 13.5 | 52.6 years STANDARD_DEVIATION 10.7 |
| Region of Enrollment United States | 42 participants | 21 participants | 21 participants |
| Sex: Female, Male Female | 42 Participants | 21 Participants | 21 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 21 | 1 / 21 |
| serious Total, serious adverse events | 0 / 21 | 0 / 21 |
Outcome results
Primary
Difference in Postoperative Pain Using a Visual Analog Scale at 24 Hours.
At approximately twenty-four hours postoperatively patients completed a visual analog scale (VAS), which was a 10-cm numeric scale on which 0 represented no pain and 10 represented the worst pain ever.
Time frame: 24 hours postoperative from mid-urethral sling placement
Population: Analysis was intention to treat. One patient in the control group was discharged before her 24 hour VAS was collected.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group - Received Marcaine | Difference in Postoperative Pain Using a Visual Analog Scale at 24 Hours. | 2.0 cm | Standard Deviation 2.37 |
| Control Group - No Marcaine | Difference in Postoperative Pain Using a Visual Analog Scale at 24 Hours. | 2.3 cm | Standard Deviation 2.22 |
Comparison: A t-test was used in comparing the intervention and control groups, if continuous variables were approximately normal. If data were not approximately normal, a Mann-Whitney Wilcoxon test was used in comparing the two groups. Normality of continuous variables was assessed using the Shapiro-Wilk test. For categorical data, Fisher's exact test was used to evaluate the data. A Bonferroni correction was used when evaluating the VAS results to adjust for multiple comparisons.p-value: 0.435Wilcoxon (Mann-Whitney)
Primary
Difference in Postoperative Pain Using a Visual Analog Scale at 2 Hours.
At approximately two hours postoperatively patients completed a visual analog scale (VAS), which was a 10-cm numeric scale on which 0 represented no pain and 10 represented the worst pain ever.
Time frame: 2 hours postoperative from mid-urethral sling placement
Population: Analysis was intention to treat. One patient in the intervention did not have a 2 hour VAS collected.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group - Received Marcaine | Difference in Postoperative Pain Using a Visual Analog Scale at 2 Hours. | 1.9 cm | Standard Deviation 2.38 |
| Control Group - No Marcaine | Difference in Postoperative Pain Using a Visual Analog Scale at 2 Hours. | 2.6 cm | Standard Deviation 1.78 |
Comparison: A 2.0 cm difference on a 10.0 cm VAS scale was clinically significant. Assuming a power of 80% to detect a 2.0 difference on scores between groups, standard deviation of 2.2, an α of 0.05, then, 21 patients would be needed in each group for a total of 42 subjects. A t-test was used in comparing the intervention and control groups, if continuous variables were approximately normal. If data were not approximately normal, a Mann-Whitney Wilcoxon test was used in comparing the two groups.p-value: 0.0251Wilcoxon (Mann-Whitney)
Primary
Difference in Postoperative Pain Using a Visual Analog Scale at 6 Hours.
At approximately six hours postoperatively patients completed a visual analog scale (VAS), which was a 10-cm numeric scale on which 0 represented no pain and 10 represented the worst pain ever.
Time frame: 6 hours postoperative from mid-urethral sling placement
Population: Intention to treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group - Received Marcaine | Difference in Postoperative Pain Using a Visual Analog Scale at 6 Hours. | 2.1 cm | Standard Deviation 2.46 |
| Control Group - No Marcaine | Difference in Postoperative Pain Using a Visual Analog Scale at 6 Hours. | 2.3 cm | Standard Deviation 2 |
Comparison: A t-test was used in comparing the intervention and control groups, if continuous variables were approximately normal. If data were not approximately normal, a Mann-Whitney Wilcoxon test was used in comparing the two groups. Normality of continuous variables was assessed using the Shapiro-Wilk test. For categorical data, Fisher's exact test was used to evaluate the data. A Bonferroni correction was used when evaluating the VAS results to adjust for multiple comparisons.p-value: 0.258Wilcoxon (Mann-Whitney)
Secondary
Difference in Successful Voiding Trial Prior to Discharge Following Placement of Mid-urethral Sling Via the Suprapubic Approach.
Prior to discharge, patients underwent voiding trials. At our institution, in order to pass the voiding trial, they must void at least 200 cc spontaneously and have less than 100 cc as a post void residual two times in a row.
Time frame: From after surgery to discharge from hospital.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention Group - Received Marcaine | Difference in Successful Voiding Trial Prior to Discharge Following Placement of Mid-urethral Sling Via the Suprapubic Approach. | 4 participants w/sucessful voiding trial |
| Control Group - No Marcaine | Difference in Successful Voiding Trial Prior to Discharge Following Placement of Mid-urethral Sling Via the Suprapubic Approach. | 7 participants w/sucessful voiding trial |
Comparison: Chi square was performed to compared the two groups and the patient's ability to pass their voiding trial prior to dischargep-value: 0.4756Chi-squared
Secondary
In-hospital Medication Amounts
Secondary outcome included differences in amount of pain medication used in the hospital. This was assessed by comparing the number of pills of oral narcotics the patient took while hospitalized.
Time frame: From surgery until discharge, average
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group - Received Marcaine | In-hospital Medication Amounts | 4 number of pills | Standard Deviation 3.83 |
| Control Group - No Marcaine | In-hospital Medication Amounts | 6 number of pills | Standard Deviation 4.32 |
Comparison: A t-test was used in comparing the intervention and control groups, if continuous variables were approximately normal. If data were not approximately normal, a Mann-Whitney Wilcoxon test was used in comparing the two groups.p-value: 0.0923Wilcoxon (Mann-Whitney)