Urinary Retention After Total Laparoscopic Hysterectomy With Immediate Foley Catheter Removal Versus Backfill Void Trial
NCT ID: NCT03141372
Last Updated: 2018-10-11
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
84 participants
INTERVENTIONAL
2017-05-16
2018-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Postoperative Bladder Testing After Total Laparoscopic Hysterectomy
NCT03126162
Post Hysterectomy Benefits of Retained Cystoscopy Fluid
NCT03646136
Postoperative Urinary Retention and Urinary Track Infection (UTI) After Laparoscopic Assisted Vaginal Hysterectomy (LAVH) for Benign Disease
NCT00564135
The Impact of Post-operative Voiding Trial on Length of Stay Following Laparoscopic Hysterectomy: A Prospective, Randomized Control Trial
NCT04487600
Self-discontinuation of Urinary Catheters in a Rural Population
NCT07041151
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
On the surgical day, all enrolled participants will undergo standard registration and preoperative preparation by the staff pre-operative nurse, including placement of intravenous access line and administration of standard preoperative medications. Preoperative medications (unless contraindicated due to allergy or other medication interaction) include single dose prophylactic antibiotics given prior to surgical incision, Tylenol 1,000 mg PO, Dexamethasone 10 mg IV (unless the participant has diabetes), Celebrex 200 mg PO (unless patient has a sulfa allergy, is ≥ 65 years old, weighs ≥ 50 kg, or has a CCl \>50ml/min), Ondansetron 4 mg IV, and Gabapentin 600 mg PO (300 mg PO if participant is ≥ 65 years old) given in the preoperative area.11,12 Participants with a preoperative Caprini score of 5 or greater will also receive Heparin 5000 units subcutaneously for deep vein thrombosis (DVT) prophylaxis.13 The participant will be taken to the operating room. Induction, intubation, and anesthesia will be administered according to standard practice by a dedicated group of anesthesia providers. Prior to surgical incision, preoperative prophylactic antibiotics will be administered. The participant will be positioned in the dorsal lithotomy position with the lower extremities in the Allen stirrups bilaterally and the bilateral upper extremities in a tucked position. Surgical sterile preparation and draping will be performed per usual technique. Vaginal antiseptic preparation will be performed with 10% Povidone-Iodine solution. A Foley catheter will be placed prior to the start of the surgical procedure. The hysterectomy will then proceed in the usual manner. After the specimen is removed from the pelvis and the vaginal cuff is closed, a cystoscopy may be performed at the discretion of each surgeon. At this time, the randomization envelope will be opened. Participants who randomize to the backfill void trial will remain with a Foley catheter in place or will have the Foley catheter replaced, in the case that a cystoscopy is performed. Patients who randomize to the autofill void trial will be given a 500 cc bolus of crystalloid by the anesthesia team prior to leaving the operating room. All skin incisions will be closed in a subcuticular fashion and sealed with skin adhesive.
The participant will emerge from anesthesia under routine monitoring and will be transferred to the post-anesthesia care unit (PACU) when meeting appropriate criteria per anesthesia discretion. A staff PACU nurse will care for the participant in the PACU administer narcotic medications as necessary and/or per participant request. Once the participants are awake and meeting criteria for discharge, the patients in the backfill group will undergo a void trial by a PACU nurse or by a doctor if the nurse is unavailable. About 300 mL of fluid will be instilled into the bladder and the Foley will then be removed. The participant will be given up to 1 hour to urinate and the amount urinated will be recorded using a commode specimen collection measurer. The PVR will be measured using a bladder scanner. If the PVR is greater than 100 mL or if the patient is unable to void within the hour, the void trial will be considered "failed" and a Foley catheter will be replaced.
The participants in the autofill void trial group will be allowed to urinate at any time within the first 3 hours after surgery. The amount urinated will be recorded using a commode specimen collection measurer. The PVR will be measured using a bladder scanner. If the PVR is greater than 100 mL, the void trial will be considered "failed" and a Foley catheter will be replaced. We anticipate that most of these patients will void spontaneously within 2 hours of arrival to the PACU. At two hours post-operatively, any patient who cannot void or does not have the urge to void will have a bladder scan. If the patient has more than 300 cc in the bladder, she will be allowed 1 more hour to void. If she cannot, a Foley catheter will be placed and she will be considered to have failed the void trial. If the patient has less than 300 cc in the bladder, another 500 cc of crystalloid bolus will be given and we will await void for another hour. At 3 hours post-operatively, these patients will undergo another bladder scan. Those with greater than 300 cc of urine in the bladder will receive a Foley catheter. Those with less than 300 cc of urine in the bladder will have a backfill void trial by placing the remaining amount of fluid into the bladder for a total volume of 300 cc. The rest of the void trial will be completed as per normal backfill void trial protocol.
The participants who have a replaced Foley catheter will receive education regarding usage of a leg bag and will be discharged home to return to the office the following business day where a repeat void trial will be performed using the backfill method as previously outlined. If participants are unable to be discharged home, they will be admitted overnight in the hospital with documented rationale. A backfill void trial will then be performed the following day. If participants fail the 2nd void trial, a Foley catheter will be replaced and will remain in place for 1 week, at which time a backfill void trial will be repeated once again in the office. If this void trial is failed as well, participants will be educated about and asked to perform self-catheterization at home and will follow up with Urogynecology.
All participants will be discharged home with uniform medication prescriptions and instructions for usage. The medications will include Ondansetron 4mg PO every 8 hours as needed for nausea/vomiting (quantity 12), Colace 100mg PO twice daily (quantity 60), scheduled Ibuprofen 600mg PO every 6 hours (quantity 30), scheduled Acetaminophen 650mg PO every 6 hours (quantity 30), and Oxycodone 5mg PO every 4 hours as needed for breakthrough pain (quantity 30). These prescriptions are based on recent anesthesia practice guidelines.14,15
At the post-operative visit 10-14 days after the surgery, the participants will be evaluated and examined in the office. They will be asked to complete a questionnaire which includes the IIQ-7, the PPBC, and a void trial satisfaction question (see attached "post-operative participant questionnaire"). Participants will also be asked if they obtained a Foley catheter outside of the hospital at any urgent care centers, other doctors' offices, or emergency rooms. Additionally, participants will be asked if they have any urinary problems including dysuria, hematuria, frequency, hesitancy, urgency, or incomplete emptying. If any urinary complaints exist, participants will be asked to provide a urine sample for testing by urinalysis and urine culture. Participants will be treated per physician preference. After treatment, participation in the study will be considered completed.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Autofill Void Trial
Patients who randomize to the autofill void trial will be allowed to urinate at any time within the first 3 hours after surgery. The amount urinated will be recorded using a commode specimen collection measurer. The PVR will be measured. If PVR \> 100 mL, the void trial will be considered "failed" and a Foley catheter will be replaced.
Void Trial using Foley catheter
A void trial is a test to ensure that a subject does not have urinary retention after a surgical procedure. In an autofill void trial, the subject is allowed to void after surgery and the amount of resulting urine and the amount of urine still remaining in the bladder are measured. In a backfill void trial, water is instilled into the bladder, the foley is removed, and the subject is then allowed to urinate. Again, the amount of urine resulting and the amount of urine still in the bladder are measured.
Backfill Void Trial
About 300 mL of fluid will be instilled into the bladder and the Foley will then be removed. The participant will be given up to 1 hour to urinate and the amount urinated will be recorded using a commode specimen collection measurer. The PVR will be measured. If PVR \> 100 mL or if the patient is unable to void within the hour, the void trial will be considered "failed" and a Foley catheter will be replaced.
Void Trial using Foley catheter
A void trial is a test to ensure that a subject does not have urinary retention after a surgical procedure. In an autofill void trial, the subject is allowed to void after surgery and the amount of resulting urine and the amount of urine still remaining in the bladder are measured. In a backfill void trial, water is instilled into the bladder, the foley is removed, and the subject is then allowed to urinate. Again, the amount of urine resulting and the amount of urine still in the bladder are measured.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Void Trial using Foley catheter
A void trial is a test to ensure that a subject does not have urinary retention after a surgical procedure. In an autofill void trial, the subject is allowed to void after surgery and the amount of resulting urine and the amount of urine still remaining in the bladder are measured. In a backfill void trial, water is instilled into the bladder, the foley is removed, and the subject is then allowed to urinate. Again, the amount of urine resulting and the amount of urine still in the bladder are measured.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Understand and voluntarily sign an informed consent form
* English-speaking (able to read and understand English)
* Undergoing total laparoscopic hysterectomy for benign indication
Exclusion Criteria
* Undergoing robotic-assisted laparoscopy or laparotomy
* Known history of pre-operative urinary incontinence or retention
* History of prior bladder or prolapse surgery
* Neurologic or spinal cord injury affecting bladder function
* Pregnant women
* Evidence of gynecologic malignancy
* Currently taking anticholinergic medications
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sara Farag
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Sara Farag
Clinical Fellow in Minimally Invasive Gynecologic Surgery
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Michael L Sprague, MD
Role: PRINCIPAL_INVESTIGATOR
Cleveland Clinic Florida
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cleveland Clinic Florida
Weston, Florida, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Won HR, Maley P, Chetty N, Chan K, Abbott J. Bladder dysfunction after gynecologic laparoscopic surgery for benign disease. J Minim Invasive Gynecol. 2012 Jan-Feb;19(1):76-80. doi: 10.1016/j.jmig.2011.09.013. Epub 2011 Nov 25.
Alessandri F, Mistrangelo E, Lijoi D, Ferrero S, Ragni N. A prospective, randomized trial comparing immediate versus delayed catheter removal following hysterectomy. Acta Obstet Gynecol Scand. 2006;85(6):716-20. doi: 10.1080/00016340600606976.
Ghezzi F, Cromi A, Uccella S, Colombo G, Salvatore S, Tomera S, Bolis P. Immediate Foley removal after laparoscopic and vaginal hysterectomy: determinants of postoperative urinary retention. J Minim Invasive Gynecol. 2007 Nov-Dec;14(6):706-11. doi: 10.1016/j.jmig.2007.06.013.
Liang CC, Lee CL, Chang TC, Chang YL, Wang CJ, Soong YK. Postoperative urinary outcomes in catheterized and non-catheterized patients undergoing laparoscopic-assisted vaginal hysterectomy--a randomized controlled trial. Int Urogynecol J Pelvic Floor Dysfunct. 2009 Mar;20(3):295-300. doi: 10.1007/s00192-008-0769-6. Epub 2008 Nov 14.
Smorgick N, DeLancey J, Patzkowsky K, Advincula A, Song A, As-Sanie S. Risk factors for postoperative urinary retention after laparoscopic and robotic hysterectomy for benign indications. Obstet Gynecol. 2012 Sep;120(3):581-6. doi: 10.1097/AOG.0b013e3182638c3a.
Kandadai P, Saini J, Patterson D, O'Dell K, Flynn M. Urinary Retention After Hysterectomy and Postoperative Analgesic Use. Female Pelvic Med Reconstr Surg. 2015 Sep-Oct;21(5):257-62. doi: 10.1097/SPV.0000000000000151.
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.
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.
Uebersax JS, Wyman JF, Shumaker SA, McClish DK, Fantl JA. Short forms to assess life quality and symptom distress for urinary incontinence in women: the Incontinence Impact Questionnaire and the Urogenital Distress Inventory. Continence Program for Women Research Group. Neurourol Urodyn. 1995;14(2):131-9. doi: 10.1002/nau.1930140206.
Coyne KS, Matza LS, Kopp Z, Abrams P. The validation of the patient perception of bladder condition (PPBC): a single-item global measure for patients with overactive bladder. Eur Urol. 2006 Jun;49(6):1079-86. doi: 10.1016/j.eururo.2006.01.007. Epub 2006 Jan 24.
Nelson G, Altman AD, Nick A, Meyer LA, Ramirez PT, Achtari C, Antrobus J, Huang J, Scott M, Wijk L, Acheson N, Ljungqvist O, Dowdy SC. Guidelines for pre- and intra-operative care in gynecologic/oncology surgery: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations--Part I. Gynecol Oncol. 2016 Feb;140(2):313-22. doi: 10.1016/j.ygyno.2015.11.015. Epub 2015 Nov 18. No abstract available.
Modesitt SC, Sarosiek BM, Trowbridge ER, Redick DL, Shah PM, Thiele RH, Tiouririne M, Hedrick TL. Enhanced Recovery Implementation in Major Gynecologic Surgeries: Effect of Care Standardization. Obstet Gynecol. 2016 Sep;128(3):457-66. doi: 10.1097/AOG.0000000000001555.
Caprini JA. Individual risk assessment is the best strategy for thromboembolic prophylaxis. Dis Mon. 2010 Oct;56(10):552-9. doi: 10.1016/j.disamonth.2010.06.007. No abstract available.
Chou R, Gordon DB, de Leon-Casasola OA, Rosenberg JM, Bickler S, Brennan T, Carter T, Cassidy CL, Chittenden EH, Degenhardt E, Griffith S, Manworren R, McCarberg B, Montgomery R, Murphy J, Perkal MF, Suresh S, Sluka K, Strassels S, Thirlby R, Viscusi E, Walco GA, Warner L, Weisman SJ, Wu CL. Management of Postoperative Pain: A Clinical Practice Guideline From the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists' Committee on Regional Anesthesia, Executive Committee, and Administrative Council. J Pain. 2016 Feb;17(2):131-57. doi: 10.1016/j.jpain.2015.12.008.
Urbach DR, Harnish JL, McIlroy JH, Streiner DL. A measure of quality of life after abdominal surgery. Qual Life Res. 2006 Aug;15(6):1053-61. doi: 10.1007/s11136-006-0047-3.
Boccola MA, Sharma A, Taylor C, Wong LM, Travis D, Chan S. The infusion method trial of void vs standard catheter removal in the outpatient setting: a prospective randomized trial. BJU Int. 2011 Apr;107 Suppl 3:43-6. doi: 10.1111/j.1464-410X.2011.10044.x.
Du J, Marshall D, Leyland J, Shaw L, Broome KE, Mason DF. Prospective, multicentre, randomized controlled trial of bladder filling prior to trial of void on the timing of discharge. ANZ J Surg. 2013 Apr;83(4):239-42. doi: 10.1111/j.1445-2197.2012.06253.x. Epub 2012 Sep 18.
Odom BD, Ehlert M, Gupta P, Cholyway R, Boura JA, Killinger KA, Sirls LT. Clinical Comparison of 2 Trial-of-Void Methods After Outpatient Midurethral Sling Placement. Female Pelvic Med Reconstr Surg. 2016 May-Jun;22(3):172-4. doi: 10.1097/SPV.0000000000000258.
Pulvino JQ, Duecy EE, Buchsbaum GM, Flynn MK. Comparison of 2 techniques to predict voiding efficiency after inpatient urogynecologic surgery. J Urol. 2010 Oct;184(4):1408-12. doi: 10.1016/j.juro.2010.05.096. Epub 2010 Aug 19.
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.
Turner LC, Kantartzis K, Shepherd JP. Predictors of postoperative acute urinary retention in women undergoing minimally invasive sacral colpopexy. Female Pelvic Med Reconstr Surg. 2015 Jan-Feb;21(1):39-42. doi: 10.1097/SPV.0000000000000110.
Farag S, Padilla PF, Smith KA, Zimberg SE, Sprague ML. Postoperative Urinary Retention Rates after Autofill versus Backfill Void Trial following Total Laparoscopic Hysterectomy: A Randomized Controlled Trial. J Minim Invasive Gynecol. 2021 Apr;28(4):829-837. doi: 10.1016/j.jmig.2020.07.013. Epub 2020 Jul 24.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Informed Consent Form
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
FLA 17-020
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.