Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2025-12-25 @ 4:03 AM
NCT ID:
NCT06803602
Eligibility Criteria:
Inclusion Criteria:
* Subjects who are male
* Post-radical prostatectomy or post HoLEP
* Experiencing urinary incontinence one-month post-RP
* Have the capacity to make their own medical decisions
* Able to complete the questionnaires and visits required.
Exclusion Criteria:
* Subjects who are not male
* Not post-radical prostatectomy or post HoLEP
* Neurologic disease
* Atonic or hypofunctional bladder (bladder contractility index (BCI) \< 100; BCI = pDetQmax+5Qmax)
* Status post pelvic radiation
* Past surgical history of other GU surgeries
* Gross hematuria
* Concomitant use of medications that cause muscle relaxation or inhibition
* Indwelling foley catheter at time of treatment
* Documented urine leak
* Not experiencing urinary incontinence
* Do not have the capacity to make their own medical decisions
* Unable to complete the questionnaires provided.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT06803602
Study Brief:
Protocol Section:
NCT06803602