Patient Satisfaction Study: Clean Intermittent Self-Catheterization Teaching

Study Overview
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Brief Summary
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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.

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

Conditions
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Anxiety

Intervention / Treatment
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* Other: Educational video


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Arm 1: Non-educational video self-cath<br>Randomized to not watching educational video about clean intermittent self-catheterization prior to prolapse/incontinence surgery. | |
| Experimental: Arm 2: Educational Video Self-cath<br>Randomized to watch educational video about clean intermittent self-catheterization prior to prolapse/incontinence surgery. | Other: Educational video<br>* Watching an educational video about clean intermittent self-catheterization prior to prolapse/incontinence surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| State-Trait Anxiety Inventory-State Scores | 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. | Baseline, after viewing educational video, after learning self-cathterization, 6 weeks post-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Satisfaction Scores - Visual Analogue Scores (VAS). | 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. | Baseline, post-operatively at time of discharge from hospital, 6 weeks post-operatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anxiety, Satisfaction, Incomplete bladder emptying, Clean Intermittent Self-catheterization, Prolapse/incontinence surgery