Trial Outcomes & Findings for Patient Satisfaction Study: Clean Intermittent Self-Catheterization Teaching (NCT NCT00678444)
NCT ID: NCT00678444
Last Updated: 2018-08-03
Results Overview
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."
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
199 participants
Primary outcome timeframe
Baseline, after viewing educational video, after learning self-cathterization, 6 weeks post-operatively
Results posted on
2018-08-03
Participant Flow
Participant milestones
| Measure |
Arm 1: Non-educational Video Self-catheterization
Patients in this group will not watch the educational video about clean intermittent self-catheterization prior to prolapse/incontinence surgery
|
Arm 2: Educational Video Self-catheterization Group
Randomized to watch pre-operative educational video about clean intermittent self-catheterization prior to prolapse/incontinence surgery.
|
|---|---|---|
|
Overall Study
STARTED
|
100
|
99
|
|
Overall Study
COMPLETED
|
100
|
99
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Patient Satisfaction Study: Clean Intermittent Self-Catheterization Teaching
Baseline characteristics by cohort
| Measure |
Randomized to Not Watch Educational Video
n=100 Participants
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 Clea
n=99 Participants
Randomized to watch pre-operative educational video about clean intermittent self-catheterization prior to prolapse/incontinence surgery.
|
Total
n=199 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.7 years
STANDARD_DEVIATION 9.8 • n=99 Participants
|
59.7 years
STANDARD_DEVIATION 11.7 • n=107 Participants
|
58.7 years
STANDARD_DEVIATION 10.8 • n=206 Participants
|
|
Sex: Female, Male
Female
|
100 Participants
n=99 Participants
|
99 Participants
n=107 Participants
|
199 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
99 Participants
n=99 Participants
|
95 Participants
n=107 Participants
|
194 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
100 participants
n=99 Participants
|
99 participants
n=107 Participants
|
199 participants
n=206 Participants
|
|
Mini-Mental Status Examination
|
30 units on a scale
n=99 Participants
|
30 units on a scale
n=107 Participants
|
30 units on a scale
n=206 Participants
|
|
Pelvic Floor Distress Inventory-20
|
84 units on a scale
n=99 Participants
|
103 units on a scale
n=107 Participants
|
94 units on a scale
n=206 Participants
|
|
Pelvic Floor Impact Questionnaire-7
|
41 units on a scale
n=99 Participants
|
59 units on a scale
n=107 Participants
|
50 units on a scale
n=206 Participants
|
|
Personal Health Questionnaire-9
|
2 units on a scale
n=99 Participants
|
2 units on a scale
n=107 Participants
|
2 units on a scale
n=206 Participants
|
|
State-Trait Anxiety Inventory-State scale
|
37.9 units on a scale
STANDARD_DEVIATION 11.6 • n=99 Participants
|
40.7 units on a scale
STANDARD_DEVIATION 11.7 • n=107 Participants
|
39.3 units on a scale
STANDARD_DEVIATION 11.7 • n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline, after viewing educational video, after learning self-cathterization, 6 weeks post-operativelyThe 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."
Outcome measures
| Measure |
Arm 1: Education Without Video Tutorial
n=100 Participants
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
n=99 Participants
Randomized to watch educational video about clean intermittent self-catheterization prior to prolapse/incontinence surgery.
|
|---|---|---|
|
State-Trait Anxiety Inventory-State Scores
Post-video
|
NA units on a scale
Standard Deviation NA
Not measured as this group did not view video at this time point.
|
37.7 units on a scale
Standard Deviation 12.5
|
|
State-Trait Anxiety Inventory-State Scores
Baseline
|
37.9 units on a scale
Standard Deviation 11.6
|
40.7 units on a scale
Standard Deviation 11.7
|
|
State-Trait Anxiety Inventory-State Scores
Voiding Trial Failure
|
40.6 units on a scale
Standard Deviation 9.7
|
42.5 units on a scale
Standard Deviation 11.9
|
|
State-Trait Anxiety Inventory-State Scores
Discharge
|
33.4 units on a scale
Standard Deviation 11.7
|
35.6 units on a scale
Standard Deviation 13.0
|
|
State-Trait Anxiety Inventory-State Scores
6-weeks postoperative
|
30.2 units on a scale
Standard Deviation 10.9
|
32.7 units on a scale
Standard Deviation 13.4
|
SECONDARY outcome
Timeframe: Baseline, post-operatively at time of discharge from hospital, 6 weeks post-operativelySecondary 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.
Outcome measures
| Measure |
Arm 1: Education Without Video Tutorial
n=100 Participants
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
n=99 Participants
Randomized to watch educational video about clean intermittent self-catheterization prior to prolapse/incontinence surgery.
|
|---|---|---|
|
Patient Satisfaction Scores - Visual Analogue Scores (VAS).
Baseline-Comfort level
|
36 participants
|
36 participants
|
|
Patient Satisfaction Scores - Visual Analogue Scores (VAS).
Baseline-Worry
|
44 participants
|
44 participants
|
|
Patient Satisfaction Scores - Visual Analogue Scores (VAS).
After viewing video-Worry
|
NA participants
Routine care group did not view video.
|
31 participants
|
|
Patient Satisfaction Scores - Visual Analogue Scores (VAS).
After viewing video-Comfort with catheterization
|
NA participants
Routine care group did not view video.
|
52 participants
|
|
Patient Satisfaction Scores - Visual Analogue Scores (VAS).
Baseline-CISC affect Satisfaction
|
7 participants
|
7 participants
|
|
Patient Satisfaction Scores - Visual Analogue Scores (VAS).
Baseline-Feels catheterization would be difficult
|
NA participants
Routine care group did not view video.
|
32 participants
|
|
Patient Satisfaction Scores - Visual Analogue Scores (VAS).
After viewing video-Video Helpful
|
NA participants
Routine care group did not view video.
|
95 participants
|
|
Patient Satisfaction Scores - Visual Analogue Scores (VAS).
After viewing video-Relieving fear/anxiety
|
NA participants
Routine care group did not view video.
|
82 participants
|
|
Patient Satisfaction Scores - Visual Analogue Scores (VAS).
Postvideo-Feels catheterization would be difficult
|
NA participants
Routine care group did not view video.
|
22 participants
|
Adverse Events
Arm 1: Non-educational Video Self-catheterization Group
Serious events: 0 serious events
Other events: 34 other events
Deaths: 0 deaths
Arm 2: Educational Video Self-catheterization Group
Serious events: 0 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm 1: Non-educational Video Self-catheterization Group
n=93 participants at risk；n=100 participants at risk
Patients in this group will not watch the educational video about clean intermittent self-catheterization prior to prolapse/incontinence surgery
|
Arm 2: Educational Video Self-catheterization Group
n=91 participants at risk；n=99 participants at risk
Randomized to watch educational video about clean intermittent self-catheterization prior to prolapse/incontinence surgery.
|
|---|---|---|
|
Renal and urinary disorders
Failed post-operative voiding trial
|
36.6%
34/93 • Number of events 34 • 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.
|
35.2%
32/91 • Number of events 32 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place