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The purpose of this study is to determine if there is a difference in post-operative voiding function between subjects receiving local anesthetic and those receiving placebo at the time of mid-urethral sling placement. The secondary objective is to evaluate pain after the procedure in the two groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bupivacaine + epinephrine | Active Comparator |
| |
| Saline + epinephrine | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine | Drug | 10ml 0.5% bupivacaine |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Who Passed the Voiding Trial After a Midurethral Sling | Study team assessment of whether the use of local anesthetic has any affect on the percentage of patients who pass their post-operative bladder challenge. This is determined by their voided volume and post-void residual. | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative Pain Scores at 2-3 Hours Post op | Visual analog score at 2 hours post op will be compared in the two groups. The scale ranges from 0 (no pain) to a maximum of 10 (unbearable pain) | 2-3 hours |
| Post-operative Pain Scale at 6-7 Hours Post op |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Flynn, MD | University of Massachusetts, Worcester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Massachusetts | Worcester | Massachusetts | 01655 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27682748 | Derived | Duenas-Garcia OF, Patterson D, De la Luz Nieto M, Leung K, Flynn MK. Voiding Function After Midurethral Slings With and Without Local Anesthetic: Randomized Controlled Trial. Female Pelvic Med Reconstr Surg. 2017 Jan/Feb;23(1):56-60. doi: 10.1097/SPV.0000000000000343. |
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10 participants did not receive allocated intervention--patient-initiated cancellation of surgery. (Saline + Epinephrine n=6, Bupivavane + Epinephrine n=4). Midway through study, indigo carmine became unavailable and surgical team opted for phenazopyridine. Failed to obtain 6-7 hour pain score in 24 out of 80 subjects.
Subjects with stress incontinence or stress-predominant mixed urinary incontinence who were scheduled to undergo a retropubic midurethral sling with no concomitant procedures at UMass Memorial Healthcare, Inc.
Enrollment occurred from March 2012 to June 2015 with study presented and consent sought at time of preoperative appointment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Marcaine + Epinephrine | Bupivicaine + epinephrine: 10ml 0.5% bupivicaine plus 1:200,000 epinephrine |
| FG001 | Saline + Epinephrine | Sodium chloride + epinephrine: 10ml 0.9% sodium chloride plus 1:200,000 epinephrine |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Marcaine + Epinephrine | Bupivicaine + epinephrine: 10ml 0.5% bupivicaine plus 1:200,000 epinephrine |
| BG001 | Saline + Epinephrine | Sodium chloride + epinephrine: 10ml 0.9% sodium chloride plus 1:200,000 epinephrine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | all subjects were included in the baseline assessments the final numbers in the results section differ due to subject withdrawal or drop out |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Subjects Who Passed the Voiding Trial After a Midurethral Sling | Study team assessment of whether the use of local anesthetic has any affect on the percentage of patients who pass their post-operative bladder challenge. This is determined by their voided volume and post-void residual. | Passed void trial | Posted | Count of Participants | Participants | 2 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Marcaine + Epinephrine | Bupivicaine + epinephrine: 10ml 0.5% bupivicaine plus 1:200,000 epinephrine |
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Failure to obtain 6-7 hour pain score for 24/80 participants. Impact of large preponderance of slings placed by a subrapublic approach. Study not designed to examine the effect of phenazopyridine in study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Flynn, MD | UMass Worcester | 508-334-9840 | michael.flynn@umassmemorial.org |
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| ID | Term |
|---|---|
| D014550 | Urinary Incontinence, Stress |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D012965 | Sodium Chloride |
| D004837 | Epinephrine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Saline | Drug | 10ml 0.9% sodium chloride |
|
|
| Epinephrine | Drug | 1:200,000 epinephrine |
|
Visual analog score at 6 hours post op will be compared in the two groups. The scale ranges from 0 (no pain) to a maximum of 10 (unbearable pain) |
| 6-7 hours |
| Visual Analog Scale for Pain: Pre-operative. | Participants asked to report on pre-operative level of pain using a Visual Analog Scale. The scale is participant reported and ranges from 0 representing no pain to 10 representing unbearable pain. | At enrollment |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | 45 randomized to each, number analyzed differs due to participant withdrawal | Count of Participants | Participants |
|
| Visual Analog Scale for Pain: Preoperative | Participants were asked to report on pre-operative level of pain using a Visual Analog Scale, The scale is participant reported and ranged form 0 representing no pain to 10 representing unbearable pain. | Mean | Standard Deviation | Units on a Scale |
|
|
|
| Secondary | Post-operative Pain Scores at 2-3 Hours Post op | Visual analog score at 2 hours post op will be compared in the two groups. The scale ranges from 0 (no pain) to a maximum of 10 (unbearable pain) | Please notice that the number of subjects is different because we only analyzed the pain scores from the subjects who were randomized and had the surgery. We also had some missing pain scores | Posted | Mean | Standard Deviation | units on a scale | 2-3 hours |
|
|
|
|
| Secondary | Post-operative Pain Scale at 6-7 Hours Post op | Visual analog score at 6 hours post op will be compared in the two groups. The scale ranges from 0 (no pain) to a maximum of 10 (unbearable pain) | Study team failed to obtain 6-7 hour pain score for 24 out of the 80 participants. The overall number of participants analyzed reflects this occurence. | Posted | Mean | Standard Deviation | units on a scale | 6-7 hours |
|
|
|
| Secondary | Visual Analog Scale for Pain: Pre-operative. | Participants asked to report on pre-operative level of pain using a Visual Analog Scale. The scale is participant reported and ranges from 0 representing no pain to 10 representing unbearable pain. | Please noticed that there is a discrepancy with the number of subjects. We include the data from all subjects who were randomized and had the intervention. | Posted | Mean | Standard Deviation | Reported Pain Level score on VAS | At enrollment |
|
|
|
| 0 |
| 45 |
| 0 |
| 45 |
| 0 |
| 45 |
| EG001 | Saline + Epinephrine | Sodium chloride + epinephrine: 10ml 0.9% sodium chloride plus 1:200,000 epinephrine | 0 | 45 | 0 | 45 | 0 | 45 |
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000588 |
| Amines |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |