Assessing patient satisfaction, outcomes, and surgical expectations following paraurethral balloons placement for male urinary incontinence.

Primary Objective

1. Specific aim 1: To assess patient satisfaction following para-urethral balloons (PUB) placement for the treatment of urinary incontinence (UI). a. Hypothesis 1: Patient satisfaction following surgery will be positively correlated to the degree of improvement in UI. We hypothesize that satisfaction might be lower in the short-term (<3-6 months) however will improve over time as UI improves. We hypothesize that the overall patient satisfaction with PUBs will be high. b. Hypothesis 2: Patient satisfaction may be impacted by post-operative complications that require surgical management or revision. 2. Specific aim 2: To assess decisional regret (DR) following PUB placement using a validated questionnaire. a. Hypothesis 3: We believe that DR will be inversely correlated to improvement in urinary incontinence following PUB placement. b. Hypothesis 4: DR may be higher in patients that experience a post-operative complication that requires surgical management. c. Hypothesis 5: DR may be higher in patients that require higher number of adjustments of their PUBs and thus an increased number of clinic visits. 3. Specific aim 3: To assess patient expectations regarding PUBs and their impact on DR. a. Hypothesis 6: Patients with higher Expectation for Treatment Scale (ETS) scores will have higher DR. 4. Specific aim 4: To characterize basic patient knowledge regarding PUBs and assess the various sources of this knowledge. a. Hypothesis 7: Baseline patient knowledge, before PUBs placement will likely impact patient expectations post-operatively, DR, and overall satisfaction.

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Type of Study





University of Colorado Hospital

Principal Investigator
Photograph of Brian Flynn,  MD

Brian Flynn, MD

Study ID

Protocol Number: 23-2500

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