AnxietyNCT00678444

Patient Satisfaction Study: Clean Intermittent Self-Catheterization Teaching

A study testing Educational video in people with Anxiety, run by University of Pittsburgh at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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… Read more about this study

Who is it for?: Ages 18 to 100 years, women only
Conditions the study is for: Anxiety
What is being tested?: Educational video
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 199 participants
Where: 1 siteUnited States
Study dates: Apr 2008to Jan 2012
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 100 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Pittsburgh Medical Center - Center for Female Bladder and Pelvic Health
Pittsburgh, Pennsylvania, 15213

Other trials in United States

About this study

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

Conditions: Anxiety
Being tested: Educational video
Keywords: Anxiety, Satisfaction, Incomplete bladder emptying, Clean Intermittent Self-catheterization, Prolapse/incontinence surgery
Medical subject headings: Anxiety Disorders, Personal Satisfaction, Prolapse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT00678444
Study group	Role	What they receive
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. Receives: Other: Educational video

What is being measured

The primary outcome is the main question the study is designed to answer.

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."
Measured: Baseline, after viewing educational video, after learning self-cathterization, 6 weeks post-operatively

Secondary outcomes (1)

Patient Satisfaction Scores - Visual Analogue Scores (VAS).
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.
Measured: Baseline, post-operatively at time of discharge from hospital, 6 weeks post-operatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2008Jan 2012

First posted15 May 2008 (estimated)
Study startApr 2008
Primary completionApr 2011
Study completionJan 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for AnxietyStudies of the same condition, open and under way.
More trials run by University of PittsburghThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 199 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00678444
Sponsor's protocol ID: PRO07070018
Status last verified: Oct 2016
First submitted: 10 May 2008
Last updated: 3 Aug 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Anxiety trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Patient Satisfaction Regarding Timing of Clean Intermittent Self-Catheterization Teaching After Prolapse or Incontinence Surgery
ClinicalTrials.gov ID: NCT00678444
Acronym / sponsor ID: PRO07070018
Conditions: Anxiety
Keywords: Anxiety, Satisfaction, Incomplete bladder emptying, Clean Intermittent Self-catheterization, Prolapse/incontinence surgery
Study type: Interventional
Recruitment status: Completed
Enrolment: 199 participants (actual)
Lead sponsor: University of PittsburghUniversity, hospital or other
Study start: Apr 2008
Primary completion: Apr 2011 (actual)
Study completion: Jan 2012 (actual)
First posted: 15 May 2008 (estimated)
Results: Posted 3 Aug 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
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	Other: Educational videoRandomized to watch educational video about clean intermittent self-catheterization prior to prolapse/incontinence surgery.

Who may qualify

Ages: 18 to 100 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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.

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Educational videoWatching an educational video about clean intermittent self-catheterization prior to prolapse/incontinence surgery.	Other	Arm 2: Educational Video Self-cath

Primary outcome

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."

1 secondary outcome

Patient Satisfaction Scores - Visual Analogue Scores (VAS).
Time frame: Baseline, post-operatively at time of discharge from hospital, 6 weeks post-operatively

Results and safety

Results posted to the registry on 3 Aug 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm 1: Non-educational Video Self-catheterization	100	100
Arm 2: Educational Video Self-catheterization Group	99	99

Primary outcome: State-Trait Anxiety Inventory-State Scores

Time frame: Baseline, after viewing educational video, after learning self-cathterization, 6 weeks post-operatively. Mean (Standard Deviation). Unit: units on a scale

Measure	Arm 1: Education Without Video Tutorial n = 100	Randomized to Watch Educational Video About Clean Intermittent n = 99
Baseline	37.9 (11.6)	40.7 (11.7)
Post-video	NA (NA)	37.7 (12.5)
Voiding Trial Failure	40.6 (9.7)	42.5 (11.9)
Discharge	33.4 (11.7)	35.6 (13.0)
6-weeks postoperative	30.2 (10.9)	32.7 (13.4)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events were reported for the 8-week period of the study starting with the pre-operative visit where participants wre randomized to the Video versus usual treatment arm.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm 1: Non-educational Video Self-catheterization Group	0 of 100 (0%)	34 of 93 (36.6%)	Not reported
Arm 2: Educational Video Self-catheterization Group	0 of 99 (0%)	32 of 91 (35.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jerry L Lowder, MD, MSc principal investigator

University of Pittsburgh

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Educational video in people with Anxiety, run by University of Pittsburgh at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

State-Trait Anxiety Inventory-State Scores (time frame: Baseline, after viewing educational video, after learning self-cathterization, 6 weeks post-operatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00678444.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2018.