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Completed

NCT Number: NCT00678444

Patient Satisfaction Study: Clean Intermittent Self-Catheterization Teaching

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.

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Key information

Conditions

Anxiety Anxiety Disorders Behavior Mental Disorders Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Personal Satisfaction Prolapse

Age range

18 year–100 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Pittsburgh, Pennsylvania, 15213, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Educational Video

Other

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

Primary outcomes

  1. State-Trait Anxiety Inventory-State Scores

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

    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."

Secondary outcomes

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

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

    Secondary study measures included a study-specific visual analog scales (VAS, range 0-100 mm) to assess comfort with Clean Intermittent Self-Catheterization (CISC) and opinions on the CISC video.

    Higher VAS scores represent higher levels of comfort with CISC.

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2011
Study completion
2012
First posted
May 15, 2008
Registry last updated
Aug 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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