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

The Impact of Retropubic Lidocaine vs Saline on Postoperative Urinary Retention Following Midurethral Sling: A Randomized Placebo Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Stress Urinary Incontinence
• Intervention / Treatment: Drug: lidocaine with epinephrine; Drug: Normal saline with epinephrine

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.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Caitlyn Copp-Millward; Phone Number: 412-578-4368; Email: Caitlyn.Copp-millward@AHN.ORG
• Study Contact Backup: Name: AHN Clinical Trials Contact; Phone Number: (412)-330-6151; Email: clinicaltrials@ahn.org

Study Locations

• United States
  • Pennsylvania
    • Bethel Park, Pennsylvania, United States, 15102
      • Recruiting
      • AHN Bethel Park Health + Wellness Pavilion
      • Principal Investigator: Lindsay Turner, MD
      • Contact: Lindsay Turner, MD; Email: lindsay.turner@ahn.org
      • Contact: AHN Clinical Trial Contact; Email: clinicaltrials@ahn.org
      • Sub-Investigator: Erin Lavelle, MD
      • Sub-Investigator: Radhika Patnam, MD
      • Sub-Investigator: Jessica Sassani, MD
    • Jefferson Hills, Pennsylvania, United States, 15025
      • Recruiting
      • AHN Jefferson Hospital
      • Principal Investigator: Lindsay Turner, MD
      • Contact: Lindsay Turner, MD; Email: lindsay.turner@ahn.org
      • Contact: AHN Clinical Trials Contact; Phone Number: 412-330-6151; Email: clinicaltrials@ahn.org
      • Sub-Investigator: Erin Lavelle, MD
      • Sub-Investigator: Radhika Patnam, MD
      • Sub-Investigator: Jessica Sassani, MD
    • Pittsburgh, Pennsylvania, United States, 15224
      • Recruiting
      • AHN West Penn Hospital
      • Principal Investigator: Lindsay Turner, MD
      • Contact: Lindsay Turner, MD; Email: lindsay.turner@ahn.org
      • Contact: AHN Clinical Trials Contact; Phone Number: 412-330-6151; Email: clinicaltrials@ahn.org
      • Sub-Investigator: Erin Lavelle, MD
      • Sub-Investigator: Radhika Patnam, MD
      • Sub-Investigator: Jessica Sassani, MD
    • Wexford, Pennsylvania, United States, 15090
      • Recruiting
      • AHN Wexford Health + Wellness Pavilion
      • Principal Investigator: Lindsay Turner, MD
      • Contact: Lindsay Turner, MD; Email: lindsay.turner@ahn.org
      • Contact: AHN Clinical Trials Contact; Phone Number: 412-330-6151; Email: clinicaltrials@ahn.org
      • Sub-Investigator: Erin Lavelle, MD
      • Sub-Investigator: Radhika Patnam, MD
      • Sub-Investigator: Jessica Sassani, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain: VAS scale	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.	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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction following surgery: Likert Scale	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.	6 weeks postoperatively

Collaborators and Investigators

• Sponsor: West Penn Allegheny Health System
• Investigators: Principal Investigator: Lindsay Turner, MD, Department of Obstetrics and Gynecology, Allegheny Health Network

Publications and helpful links

General Publications

• Nilsson CG, Kuuva N, Falconer C, Rezapour M, Ulmsten U. Long-term results of the tension-free vaginal tape (TVT) procedure for surgical treatment of female stress urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct. 2001;12 Suppl 2:S5-8. doi: 10.1007/s001920170003.
• Nicolle LE. Catheter associated urinary tract infections. Antimicrob Resist Infect Control. 2014 Jul 25;3:23. doi: 10.1186/2047-2994-3-23. eCollection 2014.
• Mazloomdoost D, Pauls RN, Hennen EN, Yeung JY, Smith BC, Kleeman SD, Crisp CC. Liposomal bupivacaine decreases pain following retropubic sling placement: a randomized placebo-controlled trial. Am J Obstet Gynecol. 2017 Nov;217(5):598.e1-598.e11. doi: 10.1016/j.ajog.2017.07.001. Epub 2017 Jul 8.
• ICOPE guidelines - World Health Organization. https://www.who.int/ageing/publications/guidelines-icope/en/
• 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.
• Bracken JN, Huffaker RK, Yandell PM, Handcock T, Higgins EW, Kuehl TJ, Shull BL. A randomized comparison of bupivacaine versus saline during placement of tension-free vaginal tape. Female Pelvic Med Reconstr Surg. 2012 Mar-Apr;18(2):93-6. doi: 10.1097/SPV.0b013e3182436655.
• Nilsson CG, Falconer C, Rezapour M. Seven-year follow-up of the tension-free vaginal tape procedure for treatment of urinary incontinence. Obstet Gynecol. 2004 Dec;104(6):1259-62. doi: 10.1097/01.AOG.0000146639.62563.e5.
• Balakrishnan K, Ebenezer V, Dakir A, Kumar S, Prakash D. Bupivacaine versus lignocaine as the choice of locall anesthetic agent for impacted third molar surgery a review. J Pharm Bioallied Sci. 2015 Apr;7(Suppl 1):S230-3. doi: 10.4103/0975-7406.155921.
• Petros PE, Ulmsten UI. An integral theory of female urinary incontinence. Experimental and clinical considerations. Acta Obstet Gynecol Scand Suppl. 1990;153:7-31. doi: 10.1111/j.1600-0412.1990.tb08027.x.
• Duckett JR, Patil A, Papanikolaou NS. Predicting early voiding dysfunction after tension-free vaginal tape. J Obstet Gynaecol. 2008 Jan;28(1):89-92. doi: 10.1080/01443610701811837.
• Choi S, Mahon P, Awad IT. Neuraxial anesthesia and bladder dysfunction in the perioperative period: a systematic review. Can J Anaesth. 2012 Jul;59(7):681-703. doi: 10.1007/s12630-012-9717-5. Epub 2012 Apr 26. Erratum In: Can J Anaesth. 2017 Dec 18;:

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2019
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: March 20, 2019
• First Submitted That Met QC Criteria: April 10, 2019
• First Posted (Actual): April 12, 2019

Study Record Updates

• Last Update Posted (Estimated): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Incontinence; Urinary Incontinence, Stress; Urinary Retention; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Adrenergic alpha-Agonists; Adrenergic Agonists; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Lidocaine; Epinephrine; Racepinephrine; Epinephryl borate
• Other Study ID Numbers: Retropubic Lidocaine vs Saline

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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