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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Non-educational video self-cath | No Intervention | Randomized to not watching educational video about clean intermittent self-catheterization prior to prolapse/incontinence surgery. | |
| Arm 2: Educational Video Self-cath | Experimental | Randomized to watch educational video about clean intermittent self-catheterization prior to prolapse/incontinence surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Educational video | Other | Watching an educational video about clean intermittent self-catheterization prior to prolapse/incontinence surgery. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jerry L Lowder, MD, MSc | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh Medical Center - Center for Female Bladder and Pelvic Health | Pittsburgh | Pennsylvania | 15213 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Arm 2: Educational Video Self-catheterization Group | Randomized to watch pre-operative educational video about clean intermittent self-catheterization prior to prolapse/incontinence surgery. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Randomized to Not Watch Educational Video | Randomized to not watch pre-operative educational video about clean intermittent self-catheterization prior to prolapse/incontinence surgery. |
| BG001 | Randomized to Watch Pre-operative Educational Video About Clea |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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." | Posted | Mean | Standard Deviation | units on a scale | Baseline, after viewing educational video, after learning self-cathterization, 6 weeks post-operatively |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1: Non-educational Video Self-catheterization Group | Patients in this group will not watch the educational video about clean intermittent self-catheterization prior to prolapse/incontinence surgery |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Failed post-operative voiding trial | Renal and urinary disorders | Systematic Assessment | Failed post-operative voiding trial |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jerry Lowder | UPittsburgh | 314-747-1402 | lowderj@wudosis.wustl.edu |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D010549 | Personal Satisfaction |
| D011391 | Prolapse |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D001519 | Behavior |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Randomized to watch pre-operative educational video about clean intermittent self-catheterization prior to prolapse/incontinence surgery. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| Mini-Mental Status Examination | Range: 0-30. Higher score represents better cognitive function. | Median | Inter-Quartile Range | units on a scale |
|
| Pelvic Floor Distress Inventory-20 | Range: 0-300 (total) Higher score represents more bother from pelvic floor disorder symptoms. | Median | Inter-Quartile Range | units on a scale |
|
| Pelvic Floor Impact Questionnaire-7 | Range: 0-300 Higher score represents greater impact of pelvic floor disorders on quality of life. | Median | Inter-Quartile Range | units on a scale |
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| Personal Health Questionnaire-9 | Range: 1-27 Higher scores represent worsening degrees of depression. | Median | Inter-Quartile Range | units on a scale |
|
| State-Trait Anxiety Inventory-State scale | Range: 40-160. Higher score represents higher anxiety level/more anxiety. | Mean | Standard Deviation | units on a scale |
|
| OG001 |
| Randomized to Watch Educational Video About Clean Intermittent |
Randomized to watch educational video about clean intermittent self-catheterization prior to prolapse/incontinence surgery. |
|
|
| Secondary | 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. | Posted | Number | participants | Baseline, post-operatively at time of discharge from hospital, 6 weeks post-operatively |
|
|
|
| 0 |
| 100 |
| 34 |
| 93 |
| EG001 | Arm 2: Educational Video Self-catheterization Group | Randomized to watch educational video about clean intermittent self-catheterization prior to prolapse/incontinence surgery. | 0 | 99 | 32 | 91 |
|
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| Baseline-CISC affect Satisfaction |
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| Baseline-Feels catheterization would be difficult |
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| After viewing video-Video Helpful |
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| After viewing video-Worry |
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| After viewing video-Relieving fear/anxiety |
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| After viewing video-Comfort with catheterization |
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| Postvideo-Feels catheterization would be difficult |
|