Assessment of Voiding After Sling

NCT ID: NCT01343784

Last Updated: 2014-02-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2013-12-31

Brief Summary

The purpose of this study is to compare the incidence of catheterization from discharge to 6 weeks postoperatively when using two methods of post-operative voiding evaluation after a mid-urethral sling procedure. The investigators' results may lead to a decreased use of indwelling catheters and their associated morbidity after outpatient sling surgery.

Detailed Description

Minimally invasive slings have demonstrated similar efficacy to earlier abdominal anti-incontinence procedures, but offer the benefit of shorter operating times, less voiding dysfunction, lower morbidity and are usually done as an outpatient procedure. Despite the advantages, about 35% of patients are discharged home with indwelling catheters. Indwelling catheters are bothersome for patients, costly to the healthcare system and are a source of significant morbidity. The challenge for pelvic surgeons performing anti-incontinence procedures is avoiding postoperative urinary retention while minimizing the use of catheters and their associated risks. A commonly described backfill-assisted voiding trial is used as a means of evaluating bladder function postoperatively. This method uses a low post-void residual as a specific criterion for discharge without a catheter. However, the validity of this method has never been critically evaluated. Our recent observational study suggests that patients may be safely discharged without a catheter after a midurethral sling procedure based on their subjective assessment of the force of stream. Our proposed study expands on this pilot data using a randomized trial to evaluate two methods of post-operative voiding evaluation. The results may lead to a decreased use of indwelling catheters and their associated morbidity after outpatient sling surgery.

Conditions

Post-operative Voiding

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: TRIPLE

Study Groups

Standard Voiding Trial

Subjects in this group will undergo backfill-assisted voiding trial that involves infusing 300ml of fluid in the bladder, removing the catheter and allowing the patient to void. All subjects will be asked to use visual analog scale (VAS) to assess their force of stream (FOS) and the voided amount as well as post-void residual (PVR) (measured by the bladder ultrasound) will be measured and recorded. Subjects will be discharged without a catheter if the voided amount is more than 200ml, or 2/3rds of the infused volume (300ml).

Group Type: ACTIVE_COMPARATOR

Urinary voiding assessment after midurethral sling

Intervention Type: OTHER

Both groups will undergo voiding trial in the similar manner. The decision to discharge based on an objective measure (voided amount) versus based on the subjective measure (force of stream self assessment).

Force of Stream Voiding Trial

Subjects in this group will undergo backfill-assisted voiding trial that involves infusing 300ml of fluid in the bladder, removing the catheter and allowing the patient to void. All subjects will be asked to use visual analog scale (VAS) to assess their force of stream (FOS) and the voided amount as well as post-void residual (PVR) (measured by the bladder ultrasound) will be measured and recorded. Subjects in the FOS group will be discharged home without a catheter if they are able to void any amount and report an FOS of at least 50% their typical FOS based on a visual analog scale

Group Type: EXPERIMENTAL

Urinary voiding assessment after midurethral sling

Intervention Type: OTHER

Both groups will undergo voiding trial in the similar manner. The decision to discharge based on an objective measure (voided amount) versus based on the subjective measure (force of stream self assessment).

Interventions

Urinary voiding assessment after midurethral sling

Both groups will undergo voiding trial in the similar manner. The decision to discharge based on an objective measure (voided amount) versus based on the subjective measure (force of stream self assessment).

Intervention Type: OTHER

Eligibility Criteria

Exclusion Criteria

1. Women undergoing concomitant urinary tract or pelvic reconstructive procedures

2. Women with pelvic organ prolapse beyond the hymen

3. Women who have undergone a different or same procedure for urinary incontinence in the past

4. Women with neurological conditions, such as multiple sclerosis, spinal cord injury/pathology

5. Cases complicated by a cystotomy or other complication necessitating postoperative catheterization

6. Non-English speakers

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 81 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John Eric Jelovsek, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Matthew Barber, MD, MHS

Role: STUDY_DIRECTOR

The Cleveland Clinic

Locations

Cleveland Clinic Beachwood

Beachwood, Ohio, United States

Cleveland Clinic Hillcrest Hospital

Mayfield Heights, Ohio, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 25434837 (View on PubMed)

Other Identifiers

IRB 11-082

Identifier Type: -

Identifier Source: org_study_id