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

NCT03913845 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: Retropubic Lidocaine vs Saline
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 4

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.

Conditions

Stress Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

• Number of Subjects With Urinary Retention

  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.

  This will be completed using a standardized retrograde voiding trial 1-2 hours postoperatively.

Secondary Outcomes (1)

• Postoperative Pain: VAS Scale

  Subjects will be asked to mark their pain on a VAS scale administered 2 hours and 6 hours following surgery.

Other Outcomes (1)

• Number of Subjects Reporting Satisfied or Very Satisfied

  6 weeks postoperatively

Study Arms (2)

0.5% lidocaine with epinephrine

EXPERIMENTAL

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

Normal saline with epinephrine

ACTIVE COMPARATOR

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

Interventions

lidocaine with epinephrine DRUG

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.

0.5% lidocaine with epinephrine

Normal saline with epinephrine DRUG

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.

Normal saline with epinephrine

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• West Penn Allegheny Health System: lead
• AHN Research Institute: collaborator

Study Sites (4)

AHN Bethel Park Health + Wellness Pavilion

Bethel Park, Pennsylvania, 15102, United States

Location

AHN Jefferson Hospital

Jefferson Hills, Pennsylvania, 15025, United States

Location

AHN West Penn Hospital

Pittsburgh, Pennsylvania, 15224, United States

Location

AHN Wexford Health + Wellness Pavilion

Wexford, Pennsylvania, 15090, United States

Location

Related Publications (11)

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

  BACKGROUND

• 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.

  PMID: 27682748 BACKGROUND

• 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.

  PMID: 22453319 BACKGROUND

• 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.

  PMID: 11450979 BACKGROUND

• 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.

  PMID: 15572486 BACKGROUND

• 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.

  PMID: 28694151 BACKGROUND

• 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.

  PMID: 25075308 BACKGROUND

• 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.

  PMID: 26015720 BACKGROUND

• 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.

  PMID: 2093278 BACKGROUND

• 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.

  PMID: 18259908 BACKGROUND

• 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.

  PMID: 22535232 BACKGROUND

MeSH Terms

Conditions

Urinary Incontinence, Stress

Interventions

Lidocaine; Epinephrine; Saline Solution

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Lindsay Turner
• Organization: Allegheny Health Network

lindsay.turner@ahn.org

4125781212

Study Officials

• Lindsay Turner, MD

  Department of Obstetrics and Gynecology, Allegheny Health Network

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD Female Pelvic Medicine

Study Record Dates

• First Submitted: March 20, 2019
• First Posted: April 12, 2019
• Study Start: November 25, 2019
• Primary Completion: November 14, 2024
• Study Completion: November 14, 2024
• Last Updated: April 30, 2026
• Results First Posted: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)