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
Sponsor:
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00678444
First received: May 10, 2008
Last updated: May 14, 2008
Last verified: May 2008
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on September 30, 2014