Assessment of Two Postoperative Techniques Used to Predict Voiding Efficiency After Gynecologic Surgery

NCT00392210 | Completed Results

• 1 other identifier: 15107
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

Brief Summary

After gynecologic surgery, it may be difficult to void (urinate). This problem is usually short-term with normal function returning within a few days to a few weeks. For this reason, patients may require drainage of their bladder with a catheter immediately after surgery. Currently in our office, we use two different tests to see how well you are able to urinate and how quickly the catheter can be removed. The purpose of this study is to see which voiding test is better after gynecologic surgery.

Conditions

Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Passed Bladder Trial

  Voiding trial 1 was performed according to the patient assignment to group 1 or 2. Voiding trial 2 was done immediately after completion of trial 1. A successful trial was defined as a void of greater than two-thirds of total bladder volume (voided volume + post-void residual urine).

  postoperatively after surgery on day1 or 2

Study Arms (2)

Spontaneous Fill

NO INTERVENTION

Retrograde Fill

ACTIVE COMPARATOR

Genetic: Voiding Trial

Interventions

Voiding Trial GENETIC

Post-void residual and uroflow study will be done twice

Retrograde Fill

Eligibility Criteria

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

You may qualify if:

• All women \> 18 years of age presenting to the Division of Urogynecology at the University of Rochester Medical Center/Strong Memorial Hospital and undergoing gynecologic surgery which requires postoperative placement of a transurethral catheter.
• Subjects must be competent to give informed consent.

You may not qualify if:

• Any patient less than 18 years of age.
• Patients with suprapubic catheters postoperatively.
• Patients undergoing surgery that does not require transurethral catheterization postoperatively.
• Patients not competent to give informed consent.
• Patients who are pregnant.
• Patients undergoing procedures requiring prolonged bladder decompression (i.e. fistula repair).

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Michael K. Flynn, MD
• Organization: University of Rochester

585-273-3232

Study Officials

• Michael K. Flynn, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2006
• First Posted: October 25, 2006
• Study Start: October 1, 2006
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: April 27, 2017
• Results First Posted: April 27, 2017

Record last verified: 2017-04

Locations

US (1)