Urinary Retention After Total Laparoscopic Hysterectomy With Immediate Foley Catheter Removal Versus Backfill Void Trial
Study Details
Study Description
Brief Summary
Acute urinary retention is a complication of hysterectomies that can result in bladder over-distension and long term bladder dysfunction. The incidence of acute urinary retention after total laparoscopic hysterectomy (TLH) has been reported to be anywhere between 4% and 34%. Studies have varied in the method of post-operative bladder challenge and the modality of hysterectomy included. Moreover, most of the published studies are retrospective chart reviews or prospective observational studies, with a lack of randomized controlled trials. Risk factors for urinary retention include type of anesthesia used, how the hysterectomy is performed, use of post-operative narcotics, pre-operative urinary retention, and possibly aggressive bladder dissection. With the increased trend towards same-day discharge following TLH, urinary retention may cause unnecessary patient distress and a worsened post-operative course. Standardization of post-hysterectomy bladder challenge and identification of risk factors for urinary retention may aid in preventing urinary retention or acute bladder dysfunction. The primary objective is to compare the rate of void trial failure after TLH with the backfill technique versus the autofill technique.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
This will be a randomized control trial. Patients undergoing total laparoscopic hysterectomy (TLH) for benign conditions will be invited and consented to participate in the study prior to the day of their surgery. Each patient will be contacted by one of the study investigators and presented with the study including the risks, benefits, and follow up requirements. She will be given the option to participate and if agrees, she will sign a consent form. All enrolled participants will have a post-void residual (PVR) checked and recorded in the clinic using the bladder scanner that is available to us. The enrolled participants will also be asked to complete the Patient Perception of Bladder Condition (PPBC) and the Incontinence Impact Questionnaire-Short Form (IIQ-7) and the completed forms will be collected by the research team (see attached "Preoperative participant questionnaire").9,10 Each consented participant will be randomized to receive a post-operative backfill void trial or an autofill void trial on the day of her surgery. The participant will not be told of her randomization group pre-operatively; however, the surgical team will be aware of the randomization.
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: 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. |
Device: 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 Names:
|
| Active Comparator: 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. |
Device: 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 Names:
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Void Trial Failure Rate [post-operative day, about 4 hours post-surgery]
The primary endpoint of this study will be to determine if the rate of void trial failure after total laparoscopic hysterectomy is different after the autofill method versus the backfill method.
Secondary Outcome Measures
- Time to Discharge [post-operative day, about 4 hours post-surgery]
The time to discharge will be measured for each participant. This will be determined by calculating the time between arrival to the post-anesthesia care unit and the time of discharge using documentation from Epic and from the case report forms.
- Number of Patients With Urinary Retention [10-14 days post-surgery]
After discharge, participants will be monitored for any encounters for urinary retention (in our hospital system) and will be asked at their 10-14 day post-operative visit if they had a Foley catheter placed outside the hospital. Additionally, any participant who fails their 2nd void trial will be noted. The incidence of urinary retention post-discharge will be determined using this data.
- Number of Participants With Post-Operative Urinary Tract Infection [up to 14 days post-surgery]
Any participant diagnosed with a culture-proven urinary tract infection will be noted.
- Quality of Bladder Function Using the Incontinence Impact Questionnaire [pre-surgery and 14 days post-surgery]
The Incontinence Impact Questionnaire-7 will be used to determine if there are any changes to the participants' short term quality of life before and after surgery. The questionnaire includes 7 questions asking how the participant's bladder function has affected her: Ability to do household chores. Physical recreation Entertainment activities Ability to travel by car or bus more than 30 minutes from home Participation in social activities outside the home Emotional health Feeling frustrated The patient scores each of the questions using the following scale: 0 - Not at all - Slightly - Moderately - Greatly The scores were added and divided by 7 to obtain an average score for each participant. Hence the range of scores is 0 to 3 with 0 being the best and 3 being the worst.
- Patient Perception of Bladder Condition Score [presurgery and at 10-14 days post-surgery]
The Patient Perception of Bladder Condition will be used to determine if there are any changes to the participants' perception of bladder function before and after surgery. In this questionnaire, the participant answers one question as follows: My bladder condition: 0 - Does not cause me any problems at all - Causes me very minor problems - Causes me some minor problems - Causes me (some) moderate problems - Causes me severe problems - Causes me many severe problems The score was recorded for each patient. The range of possible scores were 0 to 5 with 0 being the best and 5 being the worst scores.
- Number of Participants Satisfied or Very Satisfied With Void Trial Using 5 Point Lickert Scale [at 10-14 days post-surgery]
Participant satisfaction level with the method of void trial will be collected at the 10-14 day post-operative visit and compared between the two methods of void trial.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Females at least 18 years of age
-
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 concomitant procedures in addition to hysterectomy which may cause urinary dysfunction
-
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cleveland Clinic Florida | Weston | Florida | United States | 33331 |
Sponsors and Collaborators
- Sara Farag
Investigators
- Principal Investigator: Michael L Sprague, MD, Cleveland Clinic Florida
Study Documents (Full-Text)
More Information
Publications
- 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.
- 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.
- 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.
- 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. Erratum in: J Pain. 2016 Apr;17(4):508-10. Dosage error in article text.
- 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. Epub 2006 Jan 24.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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®) Society recommendations--Part I. Gynecol Oncol. 2016 Feb;140(2):313-22. doi: 10.1016/j.ygyno.2015.11.015. Epub 2015 Nov 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- FLA 17-020
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Autofill Void Trial | Backfill Void Trial |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Period Title: Overall Study | ||
| STARTED | 42 | 42 |
| COMPLETED | 42 | 40 |
| NOT COMPLETED | 0 | 2 |
Baseline Characteristics
| Arm/Group Title | Autofill Void Trial | Backfill Void Trial | Total |
|---|---|---|---|
| Arm/Group Description | 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. | 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. | Total of all reporting groups |
| Overall Participants | 42 | 40 | 82 |
| Age (years) [Median (Inter-Quartile Range) ] | |||
| Median (Inter-Quartile Range) [years] |
46
|
46
|
46
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
42
100%
|
40
100%
|
82
100%
|
| Male |
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
1
2.5%
|
1
1.2%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
19
45.2%
|
16
40%
|
35
42.7%
|
| White |
23
54.8%
|
23
57.5%
|
46
56.1%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| BMI (kg/m^2) [Median (Inter-Quartile Range) ] | |||
| Median (Inter-Quartile Range) [kg/m^2] |
32.4
|
28.8
|
30.2
|
Outcome Measures
| Title | Number of Participants With Void Trial Failure Rate |
|---|---|
| Description | The primary endpoint of this study will be to determine if the rate of void trial failure after total laparoscopic hysterectomy is different after the autofill method versus the backfill method. |
| Time Frame | post-operative day, about 4 hours post-surgery |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Autofill Void Trial | Backfill Void Trial |
|---|---|---|
| Arm/Group Description | 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 postvoid residual will be measured. If postvoid residual greater than 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. | 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 postvoid residual will be measured. If postvoid residual 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. 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. |
| Measure Participants | 42 | 40 |
| Count of Participants [Participants] |
7
16.7%
|
11
27.5%
|
| Title | Time to Discharge |
|---|---|
| Description | The time to discharge will be measured for each participant. This will be determined by calculating the time between arrival to the post-anesthesia care unit and the time of discharge using documentation from Epic and from the case report forms. |
| Time Frame | post-operative day, about 4 hours post-surgery |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Autofill Void Trial | Backfill Void Trial |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 42 | 40 |
| Median (Inter-Quartile Range) [minutes] |
176
|
218
|
| Title | Number of Patients With Urinary Retention |
|---|---|
| Description | After discharge, participants will be monitored for any encounters for urinary retention (in our hospital system) and will be asked at their 10-14 day post-operative visit if they had a Foley catheter placed outside the hospital. Additionally, any participant who fails their 2nd void trial will be noted. The incidence of urinary retention post-discharge will be determined using this data. |
| Time Frame | 10-14 days post-surgery |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Autofill Void Trial | Backfill Void Trial |
|---|---|---|
| Arm/Group Description | 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 postvoid residual will be measured. If postvoid residual greater than 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. | 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 postvoid residual will be measured. If postvoid residual 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. 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. |
| Measure Participants | 42 | 40 |
| Count of Participants [Participants] |
1
2.4%
|
1
2.5%
|
| Title | Number of Participants With Post-Operative Urinary Tract Infection |
|---|---|
| Description | Any participant diagnosed with a culture-proven urinary tract infection will be noted. |
| Time Frame | up to 14 days post-surgery |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Autofill Void Trial | Backfill Void Trial |
|---|---|---|
| Arm/Group Description | 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 postvoid residual will be measured. If postvoid residual greater than 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. | 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 postvoid residual will be measured. If postvoid residual 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. 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. |
| Measure Participants | 42 | 40 |
| Count of Participants [Participants] |
2
4.8%
|
1
2.5%
|
| Title | Quality of Bladder Function Using the Incontinence Impact Questionnaire |
|---|---|
| Description | The Incontinence Impact Questionnaire-7 will be used to determine if there are any changes to the participants' short term quality of life before and after surgery. The questionnaire includes 7 questions asking how the participant's bladder function has affected her: Ability to do household chores. Physical recreation Entertainment activities Ability to travel by car or bus more than 30 minutes from home Participation in social activities outside the home Emotional health Feeling frustrated The patient scores each of the questions using the following scale: 0 - Not at all - Slightly - Moderately - Greatly The scores were added and divided by 7 to obtain an average score for each participant. Hence the range of scores is 0 to 3 with 0 being the best and 3 being the worst. |
| Time Frame | pre-surgery and 14 days post-surgery |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Autofill Void Trial | Backfill Void Trial |
|---|---|---|
| Arm/Group Description | 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 postvoid residual will be measured. If postvoid residual greater than 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. | 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 postvoid residual will be measured. If postvoid residual 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. 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. |
| Measure Participants | 42 | 40 |
| Median (Inter-Quartile Range) [scores on a scale] |
0
|
0
|
| Title | Patient Perception of Bladder Condition Score |
|---|---|
| Description | The Patient Perception of Bladder Condition will be used to determine if there are any changes to the participants' perception of bladder function before and after surgery. In this questionnaire, the participant answers one question as follows: My bladder condition: 0 - Does not cause me any problems at all - Causes me very minor problems - Causes me some minor problems - Causes me (some) moderate problems - Causes me severe problems - Causes me many severe problems The score was recorded for each patient. The range of possible scores were 0 to 5 with 0 being the best and 5 being the worst scores. |
| Time Frame | presurgery and at 10-14 days post-surgery |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Autofill Void Trial | Backfill Void Trial |
|---|---|---|
| Arm/Group Description | 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 postvoid residual will be measured. If postvoid residual greater than 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. | 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 postvoid residual will be measured. If postvoid residual 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. 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. |
| Measure Participants | 42 | 40 |
| Median (Inter-Quartile Range) [score on a scale] |
0
|
0
|
| Title | Number of Participants Satisfied or Very Satisfied With Void Trial Using 5 Point Lickert Scale |
|---|---|
| Description | Participant satisfaction level with the method of void trial will be collected at the 10-14 day post-operative visit and compared between the two methods of void trial. |
| Time Frame | at 10-14 days post-surgery |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Autofill Void Trial | Backfill Void Trial |
|---|---|---|
| Arm/Group Description | 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 postvoid residual will be measured. If postvoid residual greater than 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. | 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 postvoid residual will be measured. If postvoid residual 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. 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. |
| Measure Participants | 42 | 40 |
| Count of Participants [Participants] |
39
92.9%
|
30
75%
|
Adverse Events
| Time Frame | 1 month | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Autofill Void Trial | Backfill Void Trial | ||
| Arm/Group Description | 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. | 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. | ||
All Cause Mortality |
||||
| Autofill Void Trial | Backfill Void Trial | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/42 (0%) | 0/40 (0%) | ||
Serious Adverse Events |
||||
| Autofill Void Trial | Backfill Void Trial | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/42 (0%) | 0/40 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Autofill Void Trial | Backfill Void Trial | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/42 (0%) | 0/40 (0%) | ||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Sara Farag, Fellow in Minimally Invasive Gynecologic Surgery |
|---|---|
| Organization | Cleveland Clinic Florida |
| Phone | 8147691904 |
| faragsara@gmail.com |
- FLA 17-020