Comparing Voiding Trials After Midurethral Sling for Stress Incontinence

NCT02400034 | Completed DMC

• 1 other identifier: 14-667
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

Urinary incontinence is a prevalent health and quality of life concern affecting almost half of women over the age of 20. Urinary retention (abnormal holding of urine) is a concern of many surgeons who perform midurethral sling surgery. All patients after outpatient midurethral sling or vaginal prolpase surgery must complete a voiding trial if they are to be discharged without a catheter. The purpose of this study is to compare two different types of postoperative voiding trials to determine which leads to less post-operative issues, such as urinary retention requiring catheterization. You are being asked to participate because you are having midurethral sling surgery, either with or without vaginal prolapse repair.

Conditions

Stress Urinary Incontinence; Urethral Hypermobility; Cystocele

Keywords

midurethral sling; Voiding trial; stress urinary incontinence

Outcome Measures

Primary Outcomes (1)

• Rate of emergency room visits or unexpected visits to the office within 6 weeks postoperatively for voiding dysfunction or suspected infection

  Any additional visit outside the patient's scheduled postoperative visits to the emergency room, urgent care facility or doctor's office will be recorded for up to 6 six weeks postoperatively

  6 weeks

Secondary Outcomes (4)

• Number of patients sent home with a catheter

  6 weeks

• Number of patients with reported UTI

  6 weeks

• Time to discharge from hospital

  6 weeks

• Patient satisfaction with postoperative bladder function

  6 weeks

Study Arms (2)

FAST voiding trial method

ACTIVE COMPARATOR

1\) Bladder drained with indwelling foley catheter, then retrograde filled with 300cc sterile water. 2) catheter is removed; 3) Patient voids within 20 minutes (if unable to void after 20 minutes, she will be discharged home with a catheter secondary to voiding dysfunction). 4) The patient will subjectively quantify their FOS via VAS scale. 5) If VAS scale \>50 (=50%) the catheter will remain out, patient is discharged home without measuring a PVR 6) If VAS scale is from 0-49 (= 0-49%) a PVR will be checked via bladder scan. If PVR is \<500 the patient will be discharged WITHOUT a catheter; If PVR is \>500 the patient will be discharged WITH a catheter. If she is discharged with an indwelling foley catheter, she will have an in-office retrograde voiding trial in 2-5 days

Other: Voiding trial

Retrograde fill voiding trial method

ACTIVE COMPARATOR

1\) Bladder drained with indwelling foley catheter, then retrograde filled with 300cc sterile water. 2) catheter is removed; 3) Patient voids within 20 minutes (if unable to void after 20 minutes, she will be discharged home with a catheter secondary to voiding dysfunction). 4) The patient will subjectively quantify their FOS via VAS scale (however this information will only be used for research purposes). 5) If she voids \>/= 2/3 (200cc) the catheter will remain out as she will have passed her voiding trial. If she voids \< 200cc she will be discharged home with a catheter and instructed to follow-up in 2-5 days for an in-office retrograde voiding trial in 2-5 days.

Other: Voiding trial

Interventions

Voiding trial OTHER

1 of 2 tests to assess bladder function after midurethral sling surgery with and without anterior or posterior colporrhaphy

Also known as: voiding

FAST voiding trial method; Retrograde fill voiding trial method

Eligibility Criteria

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

You may qualify if:

• Postoperative patients after placement of midurethral sling (retropubic sling or transobturator) with or without anterior or posterior colporrhaphy.
• Ability to provide informed consent and complete all study requirements

You may not qualify if:

• Patients who underwent a surgery that requires long term catheterization (i.e fistula repair or urethral diverticulum)
• Patients who sustained a cystotomy during surgery as our divisional protocol is to send these patients home with a Foley catheter for 5-14 days without a voiding trial
• Patients who had an apical repair for pelvic organ prolapse (Uterosacral vaginal vault suspension, Abdominal sacral colpopexy, sacrospinous ligament fixation)

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (1)

Urogynecology, Female Pelvic Medicine and Reconstructive Surgery

Great Neck, New York, 11021, United States

Location

Related Publications (11)

• Stav K, Dwyer PL, Rosamilia A, Schierlitz L, Lim YN, Chao F, De Souza A, Thomas E, Murray C, Conway C, Lee J. Repeat synthetic mid urethral sling procedure for women with recurrent stress urinary incontinence. J Urol. 2010 Jan;183(1):241-6. doi: 10.1016/j.juro.2009.08.111.

  PMID: 19913831 BACKGROUND

• Kleeman S, Goldwasser S, Vassallo B, Karram M. Predicting postoperative voiding efficiency after operation for incontinence and prolapse. Am J Obstet Gynecol. 2002 Jul;187(1):49-52. doi: 10.1067/mob.2002.124841.

  PMID: 12114887 BACKGROUND

• 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.

  PMID: 20727543 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

• Barron KI, Savageau JA, Young SB, Labin LC, Morse AN. Prediction of successful voiding immediately after outpatient mid-urethral sling. Int Urogynecol J Pelvic Floor Dysfunct. 2006 Nov;17(6):570-5. doi: 10.1007/s00192-005-0064-8. Epub 2006 Apr 1.

  PMID: 16583182 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

• Peleg AY, Hooper DC. Hospital-acquired infections due to gram-negative bacteria. N Engl J Med. 2010 May 13;362(19):1804-13. doi: 10.1056/NEJMra0904124. No abstract available.

  PMID: 20463340 BACKGROUND

• El-Barky E, El-Shazly A, El-Wahab OA, Kehinde EO, Al-Hunayan A, Al-Awadi KA. Tension free vaginal tape versus Burch colposuspension for treatment of female stress urinary incontinence. Int Urol Nephrol. 2005;37(2):277-81. doi: 10.1007/s11255-004-6101-6.

  PMID: 16142556 BACKGROUND

• Barber MD, Kleeman S, Karram MM, Paraiso MF, Walters MD, Vasavada S, Ellerkmann M. Transobturator tape compared with tension-free vaginal tape for the treatment of stress urinary incontinence: a randomized controlled trial. Obstet Gynecol. 2008 Mar;111(3):611-21. doi: 10.1097/AOG.0b013e318162f22e.

  PMID: 18310363 BACKGROUND

• Ward KL, Hilton P; UK and Ireland TVT Trial Group. Tension-free vaginal tape versus colposuspension for primary urodynamic stress incontinence: 5-year follow up. BJOG. 2008 Jan;115(2):226-33. doi: 10.1111/j.1471-0528.2007.01548.x. Epub 2007 Oct 25.

  PMID: 17970791 BACKGROUND

• Liapis A, Bakas P, Creatsas G. Long-term efficacy of tension-free vaginal tape in the management of stress urinary incontinence in women: efficacy at 5- and 7-year follow-up. Int Urogynecol J Pelvic Floor Dysfunct. 2008 Nov;19(11):1509-12. doi: 10.1007/s00192-008-0664-1. Epub 2008 Jun 10.

  PMID: 18542836 BACKGROUND

MeSH Terms

Conditions

Urinary Incontinence, Stress; Cystocele

Interventions

Urination

Condition Hierarchy (Ancestors)

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; Pathological Conditions, Signs and Symptoms; Urinary Bladder Diseases; Pelvic Organ Prolapse; Prolapse; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Urinary Tract Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Officials

• Harvey A Winkler, MD

  North Shore LIJ Divsion of Female Pelvic Medicine and Reconstructive Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: FPMRS Fellowship Director, Co-Chair Division of Urogynecology

Study Record Dates

• First Submitted: March 23, 2015
• First Posted: March 26, 2015
• Study Start: March 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: October 21, 2016

Record last verified: 2016-10

Locations

US (1)