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NCT06319898 · ClinicalTrials.gov registry record · NA
Relaxing Environment to Lower Anxiety During Onabotulinum Toxin Chemodenervation of the Bladder
A NA study, sponsored by Wake Forest University Health Sciences.
- Completed
- Registry status
- NA
- Development phase
- 113
- Enrollment target
NCT06319898 is a NA study that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 113 participants.
The verdict
NCT06319898, a NA study, has completed, sponsored by Wake Forest University Health Sciences.
- COMPLETED
- Registry status
- NA
- Development phase
- 113 participants
- Enrollment target
Study Summary
Chemodenervation of the bladder with onabotulinum toxin A is an effective treatment option for patients with refractory urgency urinary incontinence (UUI). It is often performed as an office-based procedure under local anesthesia. Alternatively, it can be performed in the operating room under general anesthesia. The ability to receive intra-detrusor chemodenervation in the office allows patients to avoid the risks associated with general anesthesia and is significantly more cost effective. The procedure, however, is painful and can be anxiety provoking for patients; especially given that patients typically return every six to nine months for repeat injections. Relaxation and distraction techniques are one way to ease patients' anxiety before an office-based procedure. While we do not know exactly how anxiety provoking office bladder chemodenervation is for patients, we do know that anxiety disorders are highly prevalent in women with overactive bladder as a population. The purpose of this study is to investigate whether women with Urge urinary incontinence (UUI) who receive office intra-detrusor chemodenervation injections performed in a relaxing environment of lavender aromatherapy, calming music, dim lighting, and modest positioning (Relaxing Environment Package) will have decreased anxiety and pain as well as increased post-procedure satisfaction compared to patients who receive chemodenervation in a typical office environment. Also investigate whether exposure to the relaxing environment impacts the well-being of staff involved in these procedures. This study design is a randomized control trial. Women scheduled for office intra-detrusor chemodenervation at Atrium Health women's Care Urogynecology \& Pelvic Surgery - Mercy clinic will be invited to participate. Participants will be randomized to the relaxing environment package or the placebo group after informed consent is obtained and immediately before undergoing intra-detrusor chemodenervation. The particip
Interventions
- BEHAVIORAL Lavender aromatherapy sticker
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 113 participants |
| Start Date | 2024-05-22 |
| Est. Completion | 2024-08-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06319898
The ClinicalTrials.gov registry entry for NCT06319898 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 113 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Wake Forest University Health Sciences, which has 1,140 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Lavender aromatherapy sticker is the first listed.
NCT06319898 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06319898 about?
NCT06319898 is a clinical study titled "Relaxing Environment to Lower Anxiety During Onabotulinum Toxin Chemodenervation of the Bladder". Chemodenervation of the bladder with onabotulinum toxin A is an effective treatment option for patients with refractory urgency urinary incontinence (UUI). It is often performed as an office-based procedure under local anesthesia. Alternatively, it can be performed in the operating room under genera...
What is the current status of trial NCT06319898?
This trial is currently completed. It is a NA study. The enrollment target is 113 participants. The study started on 2024-05-22. Estimated completion is 2024-08-12.
What interventions are being tested in trial NCT06319898?
The interventions under investigation include: Lavender aromatherapy sticker (BEHAVIORAL).
Who is sponsoring clinical trial NCT06319898?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
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