Comparing Force of Stream to Retrograde Fill Voiding Trial After Vaginal Apex Suspension

NCT02753920 | Completed Results DMC

• 1 other identifier: HS16-0232
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 1

Brief Summary

Voiding difficulties are common after prolapse and incontinence surgeries. All patients after vaginal prolapse surgery must complete a voiding trial if they are to be discharged home without a catheter. Accepted protocols for voiding trials after prolapse and incontinence surgeries do not exist. The purpose of this study is to compare two different types of postoperative voiding trials to determine which leads to less postoperative issues, such as urinary retention requiring catheterization. You are being asked to participate because you are having a vaginal apex suspension surgery.

Conditions

Vaginal Apical Prolapse

Keywords

voiding trial; prolapse

Outcome Measures

Primary Outcomes (1)

• Number of Subjects Catheterized Within the Six-week Post-operative Period Following Surgical Repair of Prolapse, Among Those Discharged Without a Urinary Catheter.

  6 weeks

Secondary Outcomes (2)

• Number of Subjects Discharged With a Catheter (This is Essentially the Proportion of Patients Who Failed the Voiding Trial)

  6 weeks

• Proportion of Patients With Unexpected Visits to the Clinic, Within the Six-week Post-operative Period.

  6 weeks

Study Arms (2)

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 force of stream via visual analog scale (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.

Other: voiding trial; Device: Foley catheter

Force of Stream (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 force of stream 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 \<500cc, the patient will be discharged without a catheter; if PVR is \>/=500cc, 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; Device: Foley catheter

Interventions

voiding trial OTHER

1 of 2 tests to assess bladder function after vaginal apex suspension surgery with or without mid-urethral sling

Force of Stream (FAST) voiding trial method; Retrograde fill voiding trial method

Foley catheter DEVICE

If subject is unable to void adequately, a Foley catheter will be placed as per protocol and the subject discharged home with catheter. The subject will follow up in the office for removal of catheter.

Force of Stream (FAST) voiding trial method; Retrograde fill voiding trial method

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Women undergoing vaginal apex surgery (sacrocolpopexy, sacrospinous ligament suspension, uterosacral ligament suspension, colpocleisis) with or without mid-urethral sling, with or without anterior or posterior colporrhaphy

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 with baseline urinary retention and the inability to urinate without catheterization
• Pregnant women

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (1)

Northwell Health System Division of Urogynecology

Great Neck, New York, 11021, United States

Location

Related Publications (18)

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  PMID: 25185611 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.

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  PMID: 12114887 BACKGROUND

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  PMID: 20727543 BACKGROUND

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  PMID: 21247598 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

• 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

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  PMID: 14710061 BACKGROUND

• Sutkin G, Lowder JL, Smith KJ. Prophylactic antibiotics to prevent urinary tract infection during clean intermittent self-catheterization (CISC) for management of voiding dysfunction after prolapse and incontinence surgery: a decision analysis. Int Urogynecol J Pelvic Floor Dysfunct. 2009 Aug;20(8):933-8. doi: 10.1007/s00192-009-0885-y. Epub 2009 Apr 10.

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  PMID: 18542836 BACKGROUND

• Pilkinton ML, Williams KS, Sison CP, Shalom DF, Winkler HA. Comparing Force of Stream With a Standard Fill Voiding Trial After Surgical Repair of Apical Prolapse: A Randomized Controlled Trial. Obstet Gynecol. 2019 Apr;133(4):675-682. doi: 10.1097/AOG.0000000000003159.

  PMID: 30870290 DERIVED

MeSH Terms

Conditions

Prolapse

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Marjorie Pilkinton
• Organization: Northwell Health

mlpilk@gmail.com

5166225114

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: Co-Chief

Study Record Dates

• First Submitted: April 12, 2016
• First Posted: April 28, 2016
• Study Start: March 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: July 1, 2018
• Last Updated: November 5, 2018
• Results First Posted: November 5, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)