Patient Satisfaction and Pain with Ambulatory Bulkamid Injection

J
Jennifer Hamner

Primary Investigator

Enrolling By Invitation
18 years - 100 years
Female
Phase N/A
50 participants needed
4 Locations

Brief description of study

What is the purpose of this study?

This research will employ a prospective study design to investigate patient satisfaction and pain with ambulatory Bulkamid injection.  Patients who are scheduled for ambulatory Bulkamid injections will be eligible for the study.

THIS STUDY IS ENROLLING BY INVITATION ONLY - All patients will be recruited from urogynecologic clinics directly by study staff within the Indiana University Health and Eskenazi Health systems. Subjects will be identified via the electronic medical record by study personnel. The schedule for participating sites will be reviewed.  Patients who are scheduled for ambulatory Bulkamid injections will be recruited and consented in the urogynecology clinic prior to injection.  Patient will be identified at their preoperative visit and sign consent form at that time. If they do not have an in-person visit, then they will be verbally consented over the phone by study personnel prior to procedure.

Detailed description of study

What will happen during the study?

This study will compare anticipated and experienced pain with ambulatory Bulkamid injection to assess patient satisfaction with ambulatory Bulkamid injection.  Patients will fill out a VAS form with their anticipated pain experience for the procedure.
- Then they will undergo the procedure as planned.
- Within 1 hour after completion of the procedure, they will complete an identical VAS documenting their experienced pain during the procedure. 
- On post-procedure day 1, they will receive a phone call to check on them. They will be asked if they would undergo ambulatory procedure again if needed10
- Chart review will be performed to collect patient background information and procedural
data.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Stress urinary incontinence, SUI
  • Age: 18 years - 100 years
  • Gender: Female

Inclusion criteria:

  • Women aged 18 and older who undergo cystoscopy with intraurethral Bulkamid injection within the Indiana University Health and Eskenazi Health systems.
  • Must be English-speaking
  • Must be neurologically intact without prior urethral trauma
     

Exclusion criteria:

  • Have concomitant procedures performed (bladder biopsies, etc), history of spinal cord injury with loss of sensation, have
    chronic narcotic use, have had previous Bulkamid injections, or are undergoing active cancer treatment.

Updated on 24 Feb 2025. Study ID: OBGYN-IIR-BULKAMID-INJECTIONS, 25154
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