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Patient Satisfaction Regarding Timing of Clean Intermittent Self-Catheterization Teaching After Prolapse or Incontinence Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by University of Pittsburgh.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00678444
First received: May 10, 2008
Last updated: May 14, 2008
Last verified: May 2008
History of Changes

May 10, 2008
May 14, 2008
April 2008
April 2010   (final data collection date for primary outcome measure)
Anxiety scores [ Time Frame: Baseline, after viewing educational video, after learning self-cathterization, 6 weeks post-operatively ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00678444 on ClinicalTrials.gov Archive Site
Patient satisfaction scores. [ Time Frame: Baseline, post-operatively at time of discharge from hopsital, 6 weeks post-operatively ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Patient Satisfaction Regarding Timing of Clean Intermittent Self-Catheterization Teaching After Prolapse or Incontinence Surgery
Not Provided

To compare patient satisfaction and anxiety scores between female subjects undergoing urinary incontinence and/or pelvic reconstructive surgery who are instructed preoperatively in the technique of clean intermittent self-catheterization (CISC) by means of an instructional video and those who do not receive specific preoperative instruction in CISC, other than basic informed consent regarding risks of postoperative urinary retention.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Anxiety
Other: Educational video
Watching an educational video about clean intermittent self-catheterization prior to prolapse/incontinence surgery.
  • No Intervention: 1
    Randomized to not watching educational video about clean intermittent self-catheterization prior to prolapse/incontinence surgery.
  • Experimental: 2
    Randomized to watch educational video about clean intermittent self-catheterization prior to prolapse/incontinence surgery.
    Intervention: Other: Educational video
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
Not Provided
April 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Enrollment will be offered to all women undergoing pelvic reconstructive and/or urinary incontinence surgery by the DIvision of Urogynecology, Department of Obstetrics and Gynecology at Magee Womens Hospital.

Exclusion Criteria:

  • Subjects who have performed CISC in the past will be excluded.
  • Subjects whose score on the MMSE reflects dementia (<24) will be excluded.
  • Subjects anticipated to have placement of a suprapubic catheter placement at the time of surgery will be excluded.
  • Subjects deemed by the enrolling physician to be incapable of physically performing self-catheterization will be excluded.
Female
18 Years and older
No
Contact: Jerry L Lowder, MD, MSc 412-641-4474 jlowder@mail.magee.edu
Contact: Judy Gruss, RN 412-641-5388 jgruss@mail.magee.edu
United States
 
NCT00678444
PRO07070018
Yes
Jerry L. Lowder, MD, MSc, University of Pittsburgh School of Medicine, Department of Obstetrics, Gynecology, & Reproductive Sciences
University of Pittsburgh
Not Provided
Not Provided
University of Pittsburgh
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP