Reducing Postoperative Catheterization

NCT03009968 | Completed

• 1 other identifier: 16-2888
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

After reconstructive pelvic surgery urinary retention occurs in up to 60% of patients requiring an indwelling catheter or self-catheterization (1-5). Up to 35% of women with acute retention experience urinary tract infections in the postoperative period (6, 7). Many women consider being discharged with a Foley catheter to be a surgical complication and describe catheter use as the worst aspect of their surgery(8). At this time there is no consensus within the field of Female Pelvic Medicine and Reconstructive Surgery (FPMRS) on how to best assess voiding function postoperatively. FPMRS providers both within the United States and around the world utilize a variety of void trial methods and varying criteria to determine adequacy of post-operative voiding efficiency (5). The traditional backfill assisted void trial method involves the assessment of a postvoid residual (PVR) volume obtained either via catheterization or bladder scan (3). Recently, there have been efforts to determine ways to avoid the assessment of a PVR as it is time-consuming and potentially exposes the patient to additional catheterizations (9, 10). Many FPMRS providers utilize the backfill assisted method without assessing a PVR and instead utilize a certain voided volume threshold to determine adequate voiding. However, to date, no one has directly studied this approach or compared the traditional backfill assisted void trial to a PVR-free backfill assisted void trial. By decreasing catheterization and creating a more efficient void trial method, the investigators hope improve patients' postoperative experience and reduce catheterization and risk of urinary tract infection (UTI). This study aims to compare two void trial methodologies in order to help standardize post-operative care in the urogynecology population. This study also has potential to lead to an overall change in our field and improve the postoperative course for women across the country and abroad.

Conditions

Urinary Retention; Urinary Incontinence; Pelvic Organ Prolapse; Urinary Tract Infections

Outcome Measures

Primary Outcomes (1)

• Rate of postoperative catheterization

  Rate of postoperative catheterization which is defined as failing the postoperative voiding trial requiring the patients to be discharged to home with a Foley catheter or using clean intermittent self-catheterization (CISC).

  At the time of hospital discharge (0-1 days)

Secondary Outcomes (5)

• Duration of catheterization

  From the day of surgery to 6 weeks post op

• Treatment of clinical-suspected or culture proven urinary tract infection

  From the day of surgery to 6 weeks post op

• Time spent in the Post Anesthesia Care Unit (PACU).

  0-24 hours

• Short term catheter burden

  1 week

• Number of post-operative patient calls and subsequent clinic visits.

  From the day of surgery to 6 weeks post op

Study Arms (2)

Traditional backfill assisted voiding trial

NO INTERVENTION

Backfill the bladder with up to 300 ml as tolerated of normal saline or sterile water through an indwelling Foley catheter. The catheter is removed and the patient is given 15 minutes to void and the voided volume is measured. A post void residual (PVR) is measured after voiding (or attempt to void) using either an in and out catheter or a bladder scanner. The participant is considered to have passed the void trial if they have a PVR of less than 100 mL or less than half the voided volume if voided volume is greater than 200 mL.

Post-void residual free voiding trial

EXPERIMENTAL

The post-void residual free voiding trial (intervention): Backfill the bladder with up to 300 ml as tolerated of normal saline or sterile water through an indwelling Foley catheter. The catheter is removed and the patient is given 15 minutes to void and the voided volume is measured. The participant is considered to have passed the void trial if they void more than 1/2 the instilled volume. A PVR will not be performed.

Other: Post-void residual free voiding trial

Interventions

Post-void residual free voiding trial OTHER

Will proceed with voiding trial and assess bladder emptying based on voided amount without checking a post-void residual.

Post-void residual free voiding trial

Eligibility Criteria

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

You may qualify if:

• The study will include women scheduled for pelvic organ prolapse surgery and/or stress urinary incontinence surgery requiring a post-operative voiding trial.
• years or older
• English speaking
• Documented PVR of less than 100mL prior to surgery obtained either during a previous clinic visit or at the time of their preoperative urodynamics evaluation.

You may not qualify if:

• Pregnancy
• Dependent on catheterization to void preoperatively
• Patient's undergoing fistula repair, sacral neuromodulation, urethral diverticulum/vaginal mass excision or mesh revision surgery
• Inability to give informed consent

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• North Carolina Translational and Clinical Sciences Institute: collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599-7570, United States

Location

Related Publications (12)

• Geller EJ, Hankins KJ, Parnell BA, Robinson BL, Dunivan GC. Diagnostic accuracy of retrograde and spontaneous voiding trials for postoperative voiding dysfunction: a randomized controlled trial. Obstet Gynecol. 2011 Sep;118(3):637-642. doi: 10.1097/AOG.0b013e318229e8dd.

  PMID: 21860294 BACKGROUND

• Schiotz HA, Tanbo TG. Postoperative voiding, bacteriuria and urinary tract infection with Foley catheterization after gynecological surgery. Acta Obstet Gynecol Scand. 2006;85(4):476-81. doi: 10.1080/00016340500409877.

  PMID: 16612711 BACKGROUND

• Foster RT Sr, Borawski KM, South MM, Weidner AC, Webster GD, Amundsen CL. A randomized, controlled trial evaluating 2 techniques of postoperative bladder testing after transvaginal surgery. Am J Obstet Gynecol. 2007 Dec;197(6):627.e1-4. doi: 10.1016/j.ajog.2007.08.017.

  PMID: 18060956 BACKGROUND

• Hakvoort RA, Thijs SD, Bouwmeester FW, Broekman AM, Ruhe IM, Vernooij MM, Burger MP, Emanuel MH, Roovers JP. Comparing clean intermittent catheterisation and transurethral indwelling catheterisation for incomplete voiding after vaginal prolapse surgery: a multicentre randomised trial. BJOG. 2011 Aug;118(9):1055-60. doi: 10.1111/j.1471-0528.2011.02935.x. Epub 2011 Apr 11.

  PMID: 21481147 BACKGROUND

• Hakvoort RA, Burger MP, Emanuel MH, Roovers JP. A nationwide survey to measure practice variation of catheterisation management in patients undergoing vaginal prolapse surgery. Int Urogynecol J Pelvic Floor Dysfunct. 2009 Jul;20(7):813-8. doi: 10.1007/s00192-009-0847-4. Epub 2009 Mar 10.

  PMID: 19495543 BACKGROUND

• Sutkin G, Alperin M, Meyn L, Wiesenfeld HC, Ellison R, Zyczynski HM. Symptomatic urinary tract infections after surgery for prolapse and/or incontinence. Int Urogynecol J. 2010 Aug;21(8):955-61. doi: 10.1007/s00192-010-1137-x. Epub 2010 Mar 31.

  PMID: 20354678 BACKGROUND

• Dieter AA, Amundsen CL, Edenfield AL, Kawasaki A, Levin PJ, Visco AG, Siddiqui NY. Oral antibiotics to prevent postoperative urinary tract infection: a randomized controlled trial. Obstet Gynecol. 2014 Jan;123(1):96-103. doi: 10.1097/AOG.0000000000000024.

  PMID: 24463669 BACKGROUND

• Elkadry EA, Kenton KS, FitzGerald MP, Shott S, Brubaker L. Patient-selected goals: a new perspective on surgical outcome. Am J Obstet Gynecol. 2003 Dec;189(6):1551-7; discussion 1557-8. doi: 10.1016/s0002-9378(03)00932-3.

  PMID: 14710061 BACKGROUND

• Ingber MS, Vasavada SP, Moore CK, Rackley RR, Firoozi F, Goldman HB. Force of stream after sling therapy: safety and efficacy of rapid discharge care pathway based on subjective patient report. J Urol. 2011 Mar;185(3):993-7. doi: 10.1016/j.juro.2010.10.050. Epub 2011 Jan 19.

  PMID: 21247598 BACKGROUND

• Tunitsky-Bitton E, Murphy A, Barber MD, Goldman HB, Vasavada S, Jelovsek JE. Assessment of voiding after sling: a randomized trial of 2 methods of postoperative catheter management after midurethral sling surgery for stress urinary incontinence in women. Am J Obstet Gynecol. 2015 May;212(5):597.e1-9. doi: 10.1016/j.ajog.2014.11.033. Epub 2014 Nov 27.

  PMID: 25434837 BACKGROUND

• Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials. Obstet Gynecol. 2010 May;115(5):1063-1070. doi: 10.1097/AOG.0b013e3181d9d421. No abstract available.

  PMID: 20410783 BACKGROUND

• Willis-Gray MG, Wu JM, Field C, Pulliam S, Husk KE, Brueseke TJ, Geller EJ, Connolly A, Dieter AA. Is a Postvoid Residual Necessary? A Randomized Trial of Two Postoperative Voiding Protocols. Female Pelvic Med Reconstr Surg. 2021 Feb 1;27(2):e256-e260. doi: 10.1097/SPV.0000000000000743.

  PMID: 31157716 DERIVED

MeSH Terms

Conditions

Urinary Retention; Urinary Incontinence; Pelvic Organ Prolapse; Urinary Tract Infections

Condition Hierarchy (Ancestors)

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; Prolapse; Pathological Conditions, Anatomical; Infections

Study Officials

• Marcella G Willis-Gray, MD

  UNC at Chapel Hill, Division of Female Pelvic Medicine and Reconstructive Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2017
• First Posted: January 4, 2017
• Study Start: March 17, 2017
• Primary Completion: January 1, 2018
• Study Completion: February 1, 2018
• Last Updated: March 19, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)