Patient Satisfaction Study: Clean Intermittent Self-Catheterization Teaching

Overview

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.

Full Title of Study: “Patient Satisfaction Regarding Timing of Clean Intermittent Self-Catheterization Teaching After Prolapse or Incontinence Surgery”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Health Services Research
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 2011

Interventions

  • Other: Educational video
    • Watching an educational video about clean intermittent self-catheterization prior to prolapse/incontinence surgery.

Arms, Groups and Cohorts

  • No Intervention: Arm 1: Non-educational video self-cath
    • Randomized to not watching educational video about clean intermittent self-catheterization prior to prolapse/incontinence surgery.
  • Experimental: Arm 2: Educational Video Self-cath
    • Randomized to watch educational video about clean intermittent self-catheterization prior to prolapse/incontinence surgery.

Clinical Trial Outcome Measures

Primary Measures

  • State-Trait Anxiety Inventory-State Scores
    • Time Frame: Baseline, after viewing educational video, after learning self-cathterization, 6 weeks post-operatively
    • The STAI-S scale is a 20-item, Likert-type, validated measure, scored 20-80 with higher scores reflecting higher situational anxiety. STAI-S is designed to specifically assess current anxiety as opposed to baseline trait anxiety. Respondents rated their current feelings specific to bladder catheterization by answering items regarding bladder catheterization such as, “I feel at ease” or “I feel upset.” Responses ranged from 1 to 5 from “not at all” to “very much so.”

Secondary Measures

  • Patient Satisfaction Scores – Visual Analogue Scores (VAS).
    • Time Frame: Baseline, post-operatively at time of discharge from hospital, 6 weeks post-operatively
    • Secondary study measures included a study-specific visual analog scales (VAS, range 0-100 mm) to assess comfort with Clean Intermittent Self-Catheterization (CISC) and opinions on the CISC video. Higher VAS scores represent higher levels of comfort with CISC.

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 100 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Pittsburgh
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jerry L Lowder, MD, MSc, Principal Investigator, University of Pittsburgh

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