Clinical trial NCT03913845: The Impact of Retropubic Lidocaine vs Saline on Postoperative Urinary Retention Following Midurethral Sling
Official title: The Impact of Retropubic Lidocaine vs Saline on Postoperative Urinary Retention Following Midurethral Sling: A Randomized Placebo Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Stress Urinary Incontinence
Lead sponsor: West Penn Allegheny Health System
Sponsor class: OTHER
First posted: 2019-04-12
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility 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.

Primary outcomes:
measure: The incidence of urinary retention
timeFrame: This will be completed using a standardized retrograde voiding trial 1-2 hours postoperatively.
Secondary outcomes:
measure: Postoperative pain: VAS scale
timeFrame: 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 outcomes:
measure: Patient satisfaction following surgery: Likert Scale
timeFrame: 6 weeks postoperatively
Locations:
city: Bethel Park
country: United States
facility: AHN Bethel Park Health + Wellness Pavilion
state: Pennsylvania
city: Jefferson Hills
country: United States
facility: AHN Jefferson Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: AHN West Penn Hospital
state: Pennsylvania
city: Wexford
country: United States
facility: AHN Wexford Health + Wellness Pavilion
state: Pennsylvania
Study officials:
affiliation: Department of Obstetrics and Gynecology, Allegheny Health Network
name: Lindsay Turner, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: ICOPE guidelines - World Health Organization. https://www.who.int/ageing/publications/guidelines-icope/en/
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