Patient Satisfaction Study: Clean Intermittent Self-Catheterization Teaching

NCT ID: NCT00678444

Last Updated: 2018-08-03

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

199 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2012-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Arm 1: Non-educational video self-cath

Randomized to not watching educational video about clean intermittent self-catheterization prior to prolapse/incontinence surgery.

Group Type NO_INTERVENTION

No interventions assigned to this group

Arm 2: Educational Video Self-cath

Randomized to watch educational video about clean intermittent self-catheterization prior to prolapse/incontinence surgery.

Group Type EXPERIMENTAL

Educational video

Intervention Type OTHER

Watching an educational video about clean intermittent self-catheterization prior to prolapse/incontinence surgery.

Interventions

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Educational video

Watching an educational video about clean intermittent self-catheterization prior to prolapse/incontinence surgery.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jerry L Lowder, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

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University of Pittsburgh Medical Center - Center for Female Bladder and Pelvic Health

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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PRO07070018

Identifier Type: -

Identifier Source: org_study_id

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