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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01091844 |
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Date of registration:
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22/03/2010 |
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Primary sponsor: |
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Public title:
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Efficacy of Retrograde Fill Vs Spontaneous Fill to Assess Voiding Function
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Scientific title:
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Efficacy of Retrograde Fill Vs Spontaneous FIll to Assess Voiding Function |
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Date of first enrolment:
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December 2009 |
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Target sample size:
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50 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01091844 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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Countries of recruitment
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United States
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Contacts
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Name:
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Kelly Hankins, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of North Carolina, Chapel Hill |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Women undergoing surgical correction of pelvic organ prolapse or urinary incontinence
Exclusion Criteria:
1. Unwillingness to participate in the investigation.
2. Inability to give informed consent.
3. Known preoperative voiding dysfunction
4. Plan for suprapubic catheter placement at time of surgery.
5. Age less than 18
6. Non-English speaking
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Surgery
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Urinary Retention
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Intervention(s)
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Procedure: Voiding Trial
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Primary Outcome(s)
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Presence of urinary retention
[Time Frame: Postoperative Day 1]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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