Patient Satisfaction Study: Clean Intermittent Self-Catheterization Teaching

• Sponsor: University of Pittsburgh (Other)
• Overall Status: Completed
• CT.gov ID: NCT00678444
• Collaborator: (none)
• Enrollment: 199
• Location: 1
• Arms: 2
• Duration (Months): 45
• Patients Per Site Per Month: 4.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anxiety	Other: Educational video	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 199 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Patient Satisfaction Regarding Timing of Clean Intermittent Self-Catheterization Teaching After Prolapse or Incontinence Surgery
• Study Start Date: Apr 1, 2008
• Actual Primary Completion Date: Apr 1, 2011
• Actual Study Completion Date: Jan 1, 2012

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Pittsburgh Medical Center - Center for Female Bladder and Pelvic Health	Pittsburgh	Pennsylvania	United States	15213

Sponsors and Collaborators

• University of Pittsburgh

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Pittsburgh
• ClinicalTrials.gov Identifier: NCT00678444
• Other Study ID Numbers: PRO07070018
• First Posted: May 15, 2008
• Last Update Posted: Aug 3, 2018
• Last Verified: Oct 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by University of Pittsburgh: Anxiety; Satisfaction; Incomplete bladder emptying; Clean Intermittent Self-catheterization; Prolapse/incontinence surgery

Study Results

Participant Flow

Arm/Group Title	Arm 1: Non-educational Video Self-catheterization	Arm 2: Educational Video Self-catheterization Group
Arm/Group Description	Patients in this group will not watch the educational video about clean intermittent self-catheterization prior to prolapse/incontinence surgery	Randomized to watch pre-operative educational video about clean intermittent self-catheterization prior to prolapse/incontinence surgery.
Period Title: Overall Study
STARTED	100	99
COMPLETED	100	99
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Randomized to Not Watch Educational Video	Randomized to Watch Pre-operative Educational Video About Clea	Total
Arm/Group Description	Randomized to not watch pre-operative educational video about clean intermittent self-catheterization prior to prolapse/incontinence surgery.	Randomized to watch pre-operative educational video about clean intermittent self-catheterization prior to prolapse/incontinence surgery.	Total of all reporting groups
Overall Participants	100	99	199
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	57.7 (9.8)	59.7 (11.7)	58.7 (10.8)
Sex: Female, Male (Count of Participants)
Female	100 100%	99 100%	199 100%
Male	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	1 1%	4 4%	5 2.5%
White	99 99%	95 96%	194 97.5%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	100 100%	99 100%	199 100%
Mini-Mental Status Examination (units on a scale) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [units on a scale]	30	30	30
Pelvic Floor Distress Inventory-20 (units on a scale) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [units on a scale]	84	103	94
Pelvic Floor Impact Questionnaire-7 (units on a scale) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [units on a scale]	41	59	50
Personal Health Questionnaire-9 (units on a scale) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [units on a scale]	2	2	2
State-Trait Anxiety Inventory-State scale (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	37.9 (11.6)	40.7 (11.7)	39.3 (11.7)

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm 1: Education Without Video Tutorial	Randomized to Watch Educational Video About Clean Intermittent
Arm/Group Description	Patients in this group will not watch the educational video about clean intermittent self-catheterization prior to prolapse/incontinence surgery	Randomized to watch educational video about clean intermittent self-catheterization prior to prolapse/incontinence surgery.
Measure Participants	100	99
Baseline	37.9 (11.6)	40.7 (11.7)
Post-video	NA (NA)	37.7 (12.5)
Voiding Trial Failure	40.6 (9.7)	42.5 (11.9)
Discharge	33.4 (11.7)	35.6 (13.0)
6-weeks postoperative	30.2 (10.9)	32.7 (13.4)

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm 1: Education Without Video Tutorial	Randomized to Watch Educational Video About Clean Intermittent
Arm/Group Description	Patients in this group will not watch the educational video about clean intermittent self-catheterization prior to prolapse/incontinence surgery	Randomized to watch educational video about clean intermittent self-catheterization prior to prolapse/incontinence surgery.
Measure Participants	100	99
Baseline-Comfort level	36 36%	36 36.4%
Baseline-Worry	44 44%	44 44.4%
Baseline-CISC affect Satisfaction	7 7%	7 7.1%
Baseline-Feels catheterization would be difficult	NA NaN	32 32.3%
After viewing video-Video Helpful	NA NaN	95 96%
After viewing video-Worry	NA NaN	31 31.3%
After viewing video-Relieving fear/anxiety	NA NaN	82 82.8%
After viewing video-Comfort with catheterization	NA NaN	52 52.5%
Postvideo-Feels catheterization would be difficult	NA NaN	22 22.2%

Adverse Events

Time Frame	Adverse events were reported for the 8-week period of the study starting with the pre-operative visit where participants wre randomized to the Video versus usual treatment arm.
Arm/Group Title	Arm 1: Non-educational Video Self-catheterization Group		Arm 2: Educational Video Self-catheterization Group
Arm/Group Description	Patients in this group will not watch the educational video about clean intermittent self-catheterization prior to prolapse/incontinence surgery		Randomized to watch educational video about clean intermittent self-catheterization prior to prolapse/incontinence surgery.
All Cause Mortality
	Arm 1: Non-educational Video Self-catheterization Group		Arm 2: Educational Video Self-catheterization Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Arm 1: Non-educational Video Self-catheterization Group		Arm 2: Educational Video Self-catheterization Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/100 (0%)		0/99 (0%)
Other (Not Including Serious) Adverse Events
	Arm 1: Non-educational Video Self-catheterization Group		Arm 2: Educational Video Self-catheterization Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	34/93 (36.6%)		32/91 (35.2%)
Renal and urinary disorders
Failed post-operative voiding trial	34/93 (36.6%)	34	32/91 (35.2%)	32

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.