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:
2025-12-24 @ 3:04 PM
Ignite Modification Date:
2025-12-24 @ 3:04 PM
NCT ID:
NCT01771159
Eligibility Criteria:
Inclusion Criteria:
* Age 18 and older that have spinal cord injury and/or chronic, irreversible neuropathic bladder dysfunction from other progressive neurological syndromes including Stroke, multiple sclerosis and Parkinsonism.
* Candidates must have a minimum duration of injury and bladder dysfunction of 2 years
* Candidates shall be those who utilize:
* an indwelling Foley catheter,
* an indwelling suprapubic catheter,
* diapers or
* external (condom) catheter drainage or intermittent self-catheterization but finds the current alternative to be socially unsatisfactory.
* Candidates need to recognize the investigational nature of the "tissue bonding cystostomy" device and must be willing to return for periodic follow-up.
* Candidates also need to recognize that a minor surgical procedure may be needed to remove the device if it proves unsatisfactory.
* Patients must be willing and capable of signing the Informed Consent Document (ICD).
* In the feasibility study detailed in this protocol only English-speaking subjects will be accepted for participation. If the protocol is expanded then a Spanish-language consent form will be developed and Spanish-speaking candidates will be accepted.
Exclusion Criteria:
* have a reversible spinal cord injury or a reversible neurological illness
* have been injured less than two years
* have acceptable forms of urological management utilizing intermittent self-catheterization, or
* spontaneous voiding with the use of an external collecting appliance.
* have no advanced neuropathic bladder dysfunction of less than 2 years duration
* have advanced neuropathic bladder dysfunction and are happy with intermittent self-catheterization or more traditional forms of tube drainage are non-candidates.
* This feasibility study will exclude females of child-bearing age. In subsequent expanded clinical trials it may be appropriate \[depending on the outcome of the feasibility study\] to include females of child-bearing age.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01771159
Study Brief:
Protocol Section:
NCT01771159