Timing of Repeat Voiding Trials After Outpatient Pelvic Floor Surgery

NCT03048682 | Completed Results

• 1 other identifier: FLA 16-123
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 2

Brief Summary

This study is a randomized controlled trial designed to assess the rate of failure of voiding trials in the early and late post-operative period within patients who underwent outpatient pelvic floor surgery that failed initial same day voiding trials.

Conditions

Pelvic Organ Prolapse; Urinary Incontinence,Stress; Surgery

Outcome Measures

Primary Outcomes (1)

• Failed Office Voiding Trials

  Determine the rates of failed voiding trials in each of the two groups

  within 8 days of surgery

Secondary Outcomes (2)

• Urinary Tract Infections

  within 6 weeks of surgery

• Rate of Bother From Urinary Catheter

  within 6 weeks of surgery

Study Arms (2)

Early Voiding Trial

EXPERIMENTAL

All subjects that are discharged home with a Foley catheter will need an in-office repeat voiding trial. Subjects in this group will have their repeat voiding trial on post-op day #2, 3, or 4

Device: Foley catheter - Early Voiding Trial

Late Voiding Trial

ACTIVE COMPARATOR

All subjects that are discharged home with a Foley catheter will need an in-office repeat voiding trial. Subjects in this group will have their repeat voiding trial on post-op day #7 or after. This is our current practice.

Device: Foley catheter - Late Voiding Trial

Interventions

Foley catheter - Early Voiding Trial DEVICE

All subjects that are discharged home with a Foley catheter will need an in-office repeat voiding trial. Subjects in the Early Voiding group will have their repeat voiding trial on post-op day #2, 3, or 4 will undergo an in-office voiding trial. The experimental group will return for an in-office voiding trial sooner than the active comparator.

Early Voiding Trial

Foley catheter - Late Voiding Trial DEVICE

All subjects that are discharged home with a Foley catheter will need an in-office repeat voiding trial. Subjects in the Late Voiding group will have their repeat voiding trial on post-op day #7 or after. This is our current practice

Late Voiding Trial

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients
• Over 18 years old
• Speak English and are capable of giving informed consent and are able to complete the English patient questionnaire
• Are willing to return to the office for all necessary visits associated with the study
• Had outpatient gynecology pelvic floor surgery for prolapse or stress urinary incontinence
• Failed the voiding trial in the recovery room
• Discharged to home on POD#0

You may not qualify if:

• Pre-operative urinary retention as defined as PVR \> 200ml
• Prior incontinence surgery
• Passed the voiding trial in the recovery room
• Require prolonged catheterization due to urethral/bladder abnormality (ie vesicovaginal fistula, urethral diverticulum) or intra-op urethral or bladder injury or for intensive post-operative monitoring
• Patients who take any post-operative antibiotics, other than prophylaxis during catheterization, for reasons other than a UTI as diagnosed and prescribed as part of the study
• Patients who take any supplements to prevent UTIs, including but not limited to D-Mannose, Hiprex, or Ellura
• Receive any post-operative vaginal estrogen during the study period
• Have any neurological conditions that may affect bladder function (ie. Multiple sclerosis, spinal cord injuries, etc.)
• Patients with pre-operative narcotic medication use due to chronic pain
• Patients who take any over-active bladder medication within one week of their surgery

Sponsors & Collaborators

• The Cleveland Clinic: lead
• Wake Forest University Health Sciences: collaborator

Study Sites (2)

Cleveland Clinic Florida

Weston, Florida, 33331, United States

Location

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (14)

• Alonzo-Sosa JE, Flores-Contreras JT, Paredes-Canul M. [Method for transurethral catheterization for 1-3 days for pelvic floor relaxation in the postoperative period]. Ginecol Obstet Mex. 1997 Nov;65:455-7. Spanish.

  PMID: 9441144 BACKGROUND

• Chong C, Kim HS, Suh DH, Jee BC. Risk factors for urinary retention after vaginal hysterectomy for pelvic organ prolapse. Obstet Gynecol Sci. 2016 Mar;59(2):137-43. doi: 10.5468/ogs.2016.59.2.137. Epub 2016 Mar 16.

  PMID: 27004205 BACKGROUND

• Ferrante KL, Kim HY, Brubaker L, Wai CY, Norton PA, Kraus SR, Shepherd J, Sirls LT, Nager CW; Urinary Incontinence Treatment Network. Repeat post-op voiding trials: an inconvenient correlate with success. Neurourol Urodyn. 2014 Nov;33(8):1225-8. doi: 10.1002/nau.22489. Epub 2013 Aug 27.

  PMID: 23983149 BACKGROUND

• Glavind K, Morup L, Madsen H, Glavind J. A prospective, randomised, controlled trial comparing 3 hour and 24 hour postoperative removal of bladder catheter and vaginal pack following vaginal prolapse surgery. Acta Obstet Gynecol Scand. 2007;86(9):1122-5. doi: 10.1080/00016340701505317.

  PMID: 17712655 BACKGROUND

• Hakvoort RA, Elberink R, Vollebregt A, Ploeg T, Emanuel MH. How long should urinary bladder catheterisation be continued after vaginal prolapse surgery? A randomised controlled trial comparing short term versus long term catheterisation after vaginal prolapse surgery. BJOG. 2004 Aug;111(8):828-30. doi: 10.1111/j.1471-0528.2004.00181.x.

  PMID: 15270931 BACKGROUND

• Kandadai P, Duenas-Garcia OF, Pilzeck AL, Saini J, Flynn MK, Leung K, Patterson D. A Randomized Controlled Trial of Patient-Controlled Valve Catheter and Indwelling Foley Catheter for Short-term Bladder Drainage. Female Pelvic Med Reconstr Surg. 2016 Mar-Apr;22(2):88-92. doi: 10.1097/SPV.0000000000000249.

  PMID: 26829348 BACKGROUND

• Kenton K, Pham T, Mueller E, Brubaker L. Patient preparedness: an important predictor of surgical outcome. Am J Obstet Gynecol. 2007 Dec;197(6):654.e1-6. doi: 10.1016/j.ajog.2007.08.059.

  PMID: 18060968 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

• Ripperda CM, Kowalski JT, Chaudhry ZQ, Mahal AS, Lanzer J, Noor N, Good MM, Hynan LS, Jeppson PC, Rahn DD. Predictors of early postoperative voiding dysfunction and other complications following a midurethral sling. Am J Obstet Gynecol. 2016 Nov;215(5):656.e1-656.e6. doi: 10.1016/j.ajog.2016.06.010. Epub 2016 Jun 16.

  PMID: 27319367 BACKGROUND

• Schiotz HA. Comparison of 1 and 3 days' transurethral Foley catheterization after retropubic incontinence surgery. Int Urogynecol J Pelvic Floor Dysfunct. 1996;7(2):98-101. doi: 10.1007/BF01902381.

  PMID: 8798095 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

• Tan GW, Chan SP, Ho CK. Is transurethral catheterisation the ideal method of bladder drainage? A survey of patient satisfaction with indwelling transurethral urinary catheters. Asian J Surg. 2010 Jan;33(1):31-6. doi: 10.1016/S1015-9584(10)60006-1.

  PMID: 20497880 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

• Wheeler TL 2nd, Richter HE, Greer WJ, Bowling CB, Redden DT, Varner RE. Predictors of success with postoperative voiding trials after a mid urethral sling procedure. J Urol. 2008 Feb;179(2):600-4. doi: 10.1016/j.juro.2007.09.080. Epub 2007 Dec 21.

  PMID: 18082219 BACKGROUND

MeSH Terms

Conditions

Pelvic Organ Prolapse; Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; 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

Results Point of Contact

• Title: Dr. Catherine Matthews
• Organization: Wake Forest Baptist Health

camatthe@wakehealth.edu

336-716-4131

Study Officials

• Jeffrey Schachar, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: January 26, 2017
• First Posted: February 9, 2017
• Study Start: January 5, 2017
• Primary Completion: November 30, 2019
• Study Completion: November 30, 2019
• Last Updated: August 21, 2024
• Results First Posted: August 21, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)