Patient Satisfaction Regarding Timing of Clean Intermittent Self-Catheterization Teaching After Prolapse or Incontinence Surgery
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by University of Pittsburgh.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
University of Pittsburgh
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00678444
First received: May 10, 2008
Last updated: May 14, 2008
Last verified: May 2008
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Purpose
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 | Intervention |
|---|---|
|
Anxiety |
Other: Educational video |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Health Services Research |
Resource links provided by NLM:
Further study details as provided by University of Pittsburgh:
Primary Outcome Measures:
- Anxiety scores [ Time Frame: Baseline, after viewing educational video, after learning self-cathterization, 6 weeks post-operatively ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Patient satisfaction scores. [ Time Frame: Baseline, post-operatively at time of discharge from hopsital, 6 weeks post-operatively ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 200 |
| Study Start Date: | April 2008 |
| Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: 1
Randomized to not watching educational video about clean intermittent self-catheterization prior to prolapse/incontinence surgery.
|
|
|
Experimental: 2
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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00678444
Contacts
| Contact: Jerry L Lowder, MD, MSc | 412-641-4474 | jlowder@mail.magee.edu |
| Contact: Judy Gruss, RN | 412-641-5388 | jgruss@mail.magee.edu |
Locations
| United States, Pennsylvania | |
| University of Pittsburgh Medical Center - Center for Female Bladder and Pelvic Health | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Contact: Jerry Lowder, MD, MSc 412-641-4474 jlowder@mail.magee.edu | |
| Contact: Judy Gruss, RN 412-641-5388 jgruss@mail.magee.edu | |
| Principal Investigator: Jerry Lowder, MD, MSc | |
| Principal Investigator: Sallie Oliphant, MD | |
| Sub-Investigator: Halina Zyczynski, MD | |
| Sub-Investigator: Pamela Moalli, MD, PhD | |
| Sub-Investigator: Chiara Ghetti, MD | |
| Sub-Investigator: Gary Sutkin, MD | |
| Sub-Investigator: Judy Gruss, RN | |
| Sub-Investigator: Rennique Ellison, BS | |
Sponsors and Collaborators
University of Pittsburgh
More Information
No publications provided
| Responsible Party: | Jerry L. Lowder, MD, MSc, University of Pittsburgh School of Medicine, Department of Obstetrics, Gynecology, & Reproductive Sciences |
| ClinicalTrials.gov Identifier: | NCT00678444 History of Changes |
| Other Study ID Numbers: | PRO07070018 |
| Study First Received: | May 10, 2008 |
| Last Updated: | May 14, 2008 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Pittsburgh:
|
Anxiety Satisfaction Incomplete bladder emptying Clean Intermittent Self-catheterization Prolapse/incontinence surgery |
Additional relevant MeSH terms:
|
Anxiety Disorders Mental Disorders |
ClinicalTrials.gov processed this record on June 18, 2013