An interventional study of Preprocedure Telephone Call in Urinary Incontinence, Urinary Bladder, Overactive and Lower Urinary Tract Symptoms, sponsored by Boston Urogynecology Associates. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-01-19.
Sponsored by Boston Urogynecology Associates · Not applicable, Interventional, and Other
The purpose of this study is to determine whether an intervention (pre-procedure telephone call by the investigators) will reduce anxiety in women undergoing urodynamic testing (UDT) compared to usual care. Our hypothesis is that women who receive the intervention will report less anxiety immediately before UDT than women who receive usual care.
This is a non-blinded, randomized controlled trial. The clinical trial will investigate whether a telephone call by the investigator one week prior to urodynamic testing (UDT) will decrease patient pre-procedure anxiety, improve patient-reported preparedness and increase satisfaction compared to usual care. Patients who are scheduled for UDT will be informed about the study. If the patient agrees to participate in the study, she will be randomized to one of 2 groups based on the week of her scheduled UDT.
Group 1: Standard counseling. This group will receive the standard counseling that all Boston Urogynecology Associates (BUA) patients would receive if they are scheduled to have urodynamic testing. This counseling will include a description of the procedure and a handout about urodynamic testing. On the day of their test the participants will be asked to complete a brief survey about their experience before and after their testing. The investigators will also collect some information from their medical record, such as age and prior urogynecologic procedures.
Group 2: Standard counseling plus the intervention. The participants assigned to be in the intervention group will receive the standard counseling that all BUA patients who are scheduled for urodynamic testing receive (just like those who are assigned to group 1). This counseling includes a description of the procedure and a handout about urodynamic testing. In addition, the participants will receive a phone call from the investigators 1 week before their testing to talk about the procedure. The investigator calling the participant will document the duration of the phone call and any questions asked by the participant. On the day of their test the participants will be asked to complete the same surveys as group 1.
Surveys given to the participants on the day of their UDT appointment will include:
1,363 studies on the registry are indexed under Urinary Incontinence; 228 are open to participants now.
This study's enrollment of 130 is above the median of 66 across 1,011 interventional studies indexed under Urinary Incontinence.
Browse Urinary Incontinence studies →Boston Urogynecology Associates is the lead sponsor of 10 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
This group will receive the standard counseling that all our patients would receive if they are scheduled to have urodynamic testing. This counseling will include a description of the procedure and a handout about urodynamic testing
The participants will receive the standard counseling that all our patients who are scheduled for urodynamic testing receive (just like those who are assigned to group 1). In addition, the participants will receive intervention: a pre-procedural telephone call from the investigators 1 week before their testing to talk about the procedure.
Other: Preprocedure Telephone Call
The participants will receive a phone call from the investigators 1 week before their testing to talk about the procedure and answer any questions that patients may have . The investigator calling the participant will document the duration of the phone call and any questions asked by the participant
Overall pre-procedure anxiety as measured on a visual analog scale.
Overall pre-procedure anxiety as measured on a visual analog scale.
Time frame: Day 1
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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