Patient Satisfaction Study: Clean Intermittent Self-Catheterization Teaching

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

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.

Study Overview

• Status: Completed
• Conditions: Anxiety
• Intervention / Treatment: Other: Educational video

• Study Type: Interventional
• Enrollment (Actual): 199
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center - Center for Female Bladder and Pelvic Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: Educational video; Watching an educational video about clean intermittent self-catheterization prior to prolapse/incontinence surgery.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Investigators: Principal Investigator: Jerry L Lowder, MD, MSc, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Actual): April 1, 2011
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: May 10, 2008
• First Submitted That Met QC Criteria: May 14, 2008
• First Posted (Estimate): May 15, 2008

Study Record Updates

• Last Update Posted (Actual): August 3, 2018
• Last Update Submitted That Met QC Criteria: October 31, 2017
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Anxiety; Satisfaction; Incomplete bladder emptying; Clean Intermittent Self-catheterization; Prolapse/incontinence surgery
• Other Study ID Numbers: PRO07070018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO