Timing of Repeat Voiding Trials After Outpatient Pelvic Floor Surgery

Surgery Clinical Trial

Official title:

Timing of Repeat Voiding Trials After Outpatient Pelvic Floor Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03048682
• Other study ID #: FLA 16-123
• Status: Recruiting
• Phase: N/A
• Start date: January 5, 2017
• Est. completion date: January 30, 2020

Study information

• Verified date: October 2019
• Source: The Cleveland Clinic
• Contact: Jeffrey Schachar, MD
• Phone: 954-569-5559
• Email: SchachJ[@]ccf.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This study would be powered to detect differences in UTIs and Foley catheter re-insertion rates. Assuming a 10% drop-out rate, 100 total subjects should be enrolled in the study.

All patients that meet the appropriate inclusion criteria and are scheduled for outpatient pelvic floor surgery will be considered for the study. Patients will be counseled about the study either in the office during a surgical planning office visit, over a pre-operative telephone call, or in the pre-operative area just prior to surgery. Consents will be signed in the pre-operative area.

After surgery, the patient will be given a standardized voiding trial as per the usual protocol. If the patient is un-successful in emptying her bladder she will be discharged home with an indwelling Foley catheter with antibiotics. On post-operative day (POD) #1 the patient will be re-assessed for meeting eligibility requirements and will be called and randomized to either the early voiding trial group (EVT) or the late voiding trial group (LVT). Subjects in EVT will be scheduled for a repeat VT on POD#2, POD#3, or POD#4, whereas those in LVT will be scheduled for a repeat VT on or after POD#7. Subjects that are unsuccessful in the repeat VT will have a Foley catheter re-inserted and will return for another VT in 5-7 days. Subjects who fail the third VT from either group will have the Foley catheter replaced and will return for another office VT after waiting an additional 5-7 days or will be started on clean intermittent self-catheterization.

Subjects will be monitored for a 6 week period for voiding and urinary symptoms. Urine will be tested via in-office urinalysis at each office visit, including pre-operatively, and will be sent for a urine culture per usual practice based upon abnormal urinalysis results. Urine cultures that grow out a single organism >10,000 CFU will be treated with appropriate antibiotics. In addition, patients will complete quality of life questionnaires at the time of catheter removal, the standard 2 week post-op visit and at 6weeks post-operatively.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 30, 2020
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse
• Surgery
• Urinary Incontinence
• Urinary Incontinence, Stress
• Urinary Incontinence,Stress

Intervention

Device:
• Foley catheter - Early Voiding Trial
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.
• Foley catheter - Late Voiding Trial
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

Locations

Country	Name	City	State
United States	Cleveland Clinic Florida	Weston	Florida
United States	Wake Forest Baptist Health	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
The Cleveland Clinic	Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

Glavind K, Mørup 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Schiøtz 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. — View Citation

Schiøtz 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. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2007 Dec 21. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Failed Voiding Trials	Determine the rates of failed voiding trials in each of the two groups	two years
Secondary	Urinary Tract Infections	Determine the rates of urinary tract infections in each of the two groups	two years
Secondary	Patient Satisfaction	Determine the rates of patient satisfaction in each of the two groups	two years