Patient Satisfaction Regarding Timing of Clean Intermittent Self-Catheterization Teaching After Prolapse or Incontinence Surgery - Full Text View

Sponsored by:	University of Pittsburgh
Information provided by:	University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00678444

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

MedlinePlus related topics: Anxiety Urinary Incontinence

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Health Services Research, Randomized, Open Label, Active Control, Parallel Assignment

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
1: No Intervention Randomized to not watching educational video about clean intermittent self-catheterization prior to prolapse/incontinence surgery.
2: Experimental 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

Responsible Party:	University of Pittsburgh School of Medicine, Department of Obstetrics, Gynecology, & Reproductive Sciences ( Jerry L. Lowder, MD, MSc )
Study ID Numbers:	PRO07070018
Study First Received:	May 10, 2008
Last Updated:	May 14, 2008
ClinicalTrials.gov Identifier:	NCT00678444
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

Study placed in the following topic categories:

Urinary Incontinence
Prolapse

ClinicalTrials.gov processed this record on January 15, 2009