N/A
N=199
Patient Satisfaction Study: Clean Intermittent Self-Catheterization Teaching
Anxiety
Bottom Line
View on ClinicalTrials.gov: NCT00678444 ↗Enrolled (actual)
199
Serious AEs
0.0%
Results posted
Aug 2018
Primary outcome: Primary: State-Trait Anxiety Inventory-State Scores — 37.9; 40.7; NA; 37.7 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Educational video (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Pittsburgh
- Primary completion
- Apr 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY State-Trait Anxiety Inventory-State Scores |
37.9; 40.7; NA; 37.7; 40.6; 42.5 | — |
| SECONDARY Patient Satisfaction Scores - Visual Analogue Scores (VAS). |
36; 36; 44; 44; 7; 7 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00678444). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.