NCT00678444

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
199

participants targeted

Target at P75+ for not_applicable anxiety

Timeline
Completed

Started Apr 2008

Longer than P75 for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 10, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 15, 2008

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
6.6 years until next milestone

Results Posted

Study results publicly available

August 3, 2018

Completed
Last Updated

August 3, 2018

Status Verified

October 1, 2016

Enrollment Period

3 years

First QC Date

May 10, 2008

Results QC Date

March 2, 2016

Last Update Submit

October 31, 2017

Conditions

Anxiety

Keywords

AnxietySatisfactionIncomplete bladder emptyingClean Intermittent Self-catheterizationProlapse/incontinence surgery

Outcome Measures

Primary Outcomes (1)

  • State-Trait Anxiety Inventory-State Scores

    The STAI-S scale is a 20-item, Likert-type, validated measure, scored 20-80 with higher scores reflecting higher situational anxiety. STAI-S is designed to specifically assess current anxiety as opposed to baseline trait anxiety. Respondents rated their current feelings specific to bladder catheterization by answering items regarding bladder catheterization such as, "I feel at ease" or "I feel upset." Responses ranged from 1 to 5 from "not at all" to "very much so."

    Baseline, after viewing educational video, after learning self-cathterization, 6 weeks post-operatively

Secondary Outcomes (1)

  • Patient Satisfaction Scores - Visual Analogue Scores (VAS).

    Baseline, post-operatively at time of discharge from hospital, 6 weeks post-operatively

Study Arms (2)

Arm 1: Non-educational video self-cath

NO INTERVENTION

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

Arm 2: Educational Video Self-cath

EXPERIMENTAL

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

Other: Educational video

Interventions

Educational videoOTHER

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

Arm 2: Educational Video Self-cath

Eligibility Criteria

Age18 Years - 100 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Anxiety DisordersPersonal SatisfactionProlapse

Condition Hierarchy (Ancestors)

Mental DisordersBehaviorPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr. Jerry Lowder
Organization
UPittsburgh
lowderj@wudosis.wustl.edu
314-747-1402

Study Officials

  • Jerry L Lowder, MD, MSc

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2008

First Posted

May 15, 2008

Study Start

April 1, 2008

Primary Completion

April 1, 2011

Study Completion

January 1, 2012

Last Updated

August 3, 2018

Results First Posted

August 3, 2018

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)