Patient Satisfaction Study: Clean Intermittent Self-Catheterization Teaching

Not Applicable

Completed

• Conditions: Anxiety
• Interventions: Other: Educational video

• Registration Number: NCT00678444
• Lead Sponsor: University of Pittsburgh

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-05-10
• Study First Submitted QC: 2008-05-14
• Study First Posted: 2008-05-15
• Primary Completion: 2011-04
• Study Completion: 2012-01
• Results First Submitted: 2016-03-02
• Status Verified: 2016-10
• Results First Submitted QC: 2017-10-31
• Last Update Submitted: 2017-10-31
• Results First Posted: 2018-08-03
• Last Update Posted: 2018-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 199

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2: Educational Video Self-cath	Educational video	Randomized to watch educational video about clean intermittent self-catheterization prior to prolapse/incontinence surgery.

Primary Outcome Measures

Name	Time	Method
State-Trait Anxiety Inventory-State Scores	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 Outcome Measures

Name	Time	Method
Patient Satisfaction Scores - Visual Analogue Scores (VAS).	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.

Trial Locations

Locations (1)

University of Pittsburgh Medical Center - Center for Female Bladder and Pelvic Health; 🇺🇸 Pittsburgh, Pennsylvania, United States