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The Impact of Retropubic Lidocaine vs Saline on Postoperative Urinary Retention Following Midurethral Sling

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ClinicalTrials.gov Identifier: NCT03913845
Recruitment Status : Not yet recruiting
First Posted : April 12, 2019
Last Update Posted : April 12, 2019
Sponsor:
Information provided by (Responsible Party):
Charlie Miller, West Penn Allegheny Health System

Brief Summary:

Stress urinary incontinence affects millions of women worldwide and has a profound impact on the quality of life of older individuals, their subjective health status, levels of depression and need for care. Midurethral sling placement was introduced in 1995 and remains the current gold standard for surgical management of SUI. Although the advantages of midurethral sling surgery include its high success and minimally invasive approach, approximately 10-50% of women experience acute postoperative urinary retention and are subsequently sent home with an indwelling foley catheter or clean intermittent self catheterization. Urinary retention is anxiety provoking for most patients and adds morbidity, cost, and increased utilization of healthcare resources. Additionally, catheterization of the urinary tract results in increased risk of urinary tract infection and potential need for antibiotics.

Several recent studies have reported varying rates of postoperative voiding trial success depending on the type of local anesthetic used for hydrodissection; however the data is sparse and invites a more thorough investigation. Furthermore, to the investigators knowledge, no studies have systematically explored dosage or type of agent used intraoperatively on postoperative voiding function. Based on the preliminary data, the investigators hypothesize that patients receiving normal saline compared to a local anesthetic (e.g., lidocaine) will have a reduction in duration of postoperative urinary retention following retropubic midurethral sling placement.


Condition or disease Intervention/treatment Phase
Stress Urinary Incontinence Drug: lidocaine with epinephrine Drug: Normal saline with epinephrine Phase 4

Detailed Description:

Aim 1: to compare the incidence of urinary retention following retropubic midurethral sling placement in those women receiving normal saline vs lidocaine for retropubic hydrodissection. The investigators will compare rates of failed retrograde voiding trials between patients receiving normal saline to those receiving the same quantity of lidocaine. This will be completed using a standardized retrograde voiding trial 1-2 hours postoperatively (as outlined in "Data and Statistical Methods" below). The investigators hypothesize that patients receiving normal saline compared to a local anesthetic will have a reduction in postoperative urinary retention following retropubic midurethral sling placement.

Aim 2: to assess postoperative pain in women receiving retropubic normal saline vs lidocaine during midurethral sling placement. Postoperatively, subjects will be asked to mark their pain on a VAS scale administered 2 hours and 6 hours following surgery. The initial assessment will be performed by nursing personnel at the time of routine vital sign assessment; the subsequent assessments will be completed by patients with an at-home form through postoperative day #7. Narcotic use will be queried through the electronic medical record as well as with a pain diary administered at time of discharge until postoperative day #7.

Aim 3: to examine differences in patient satisfaction and quality of life following retropubic midurethral sling placement between women receiving retropubic normal saline vs lidocaine at time of midurethral sling placement. Differences in patient satisfaction will be compared using a Likert Scale. 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. The investigators hypothesize that women receiving normal saline for hydrodissection will have improved patient satisfaction as evidenced by higher Likert scores compared to those receiving lidocaine.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Impact of Retropubic Lidocaine vs Saline on Postoperative Urinary Retention Following Midurethral Sling: A Randomized Placebo Controlled Trial
Estimated Study Start Date : April 1, 2019
Estimated Primary Completion Date : July 1, 2022
Estimated Study Completion Date : July 1, 2022


Arm Intervention/treatment
Experimental: 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.
Drug: 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.

Active Comparator: 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.
Drug: 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.




Primary Outcome Measures :
  1. The incidence of urinary retention [ Time Frame: This will be completed using a standardized retrograde voiding trial 1-2 hours postoperatively. ]
    To compare the incidence of urinary retention following retropubic midurethral sling placement in those women receiving normal saline vs lidocaine for retropubic hydrodissection.


Secondary Outcome Measures :
  1. Postoperative pain: VAS scale [ Time Frame: Subjects will be asked to mark their pain on a VAS scale administered 2 hours and 6 hours following surgery. The subsequent assessments will be completed by patients with an at-home form through postoperative day #7. ]
    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.


Other Outcome Measures:
  1. Patient satisfaction following surgery: Likert Scale [ Time Frame: 6 weeks postoperatively ]
    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.



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 18 years or older
  • English speaking
  • Competent to give consent

Exclusion Criteria:

  • A known intolerance or allergic reaction to local anesthetics
  • Planned spinal anesthesia for the procedure
  • Planned concomitant prolapse repair other than anterior repair
  • Preoperative voiding dysfunction as evidenced by a postvoid residual (PVR) of 150 mL or greater.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03913845


Contacts
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Contact: David Parda 412-359-8084 David.Parda@ahn.org

Sponsors and Collaborators
West Penn Allegheny Health System
Investigators
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Study Director: Lindsay Turner, MD Department of Obstetrics and Gynecology, Allegheny Health Network

Publications:
ICOPE guidelines - World Health Organization. https://www.who.int/ageing/publications/guidelines-icope/en/

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Responsible Party: Charlie Miller, Resident Physician, Department of Obstetrics and Gynecology, West Penn Allegheny Health System
ClinicalTrials.gov Identifier: NCT03913845     History of Changes
Other Study ID Numbers: Retropubic Lidocaine vs Saline
First Posted: April 12, 2019    Key Record Dates
Last Update Posted: April 12, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Urinary Incontinence
Urinary Incontinence, Stress
Urinary Retention
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Lidocaine
Epinephrine
Racepinephrine
Anesthetics
Epinephryl borate
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents