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 @ 12:05 PM
Ignite Modification Date:
2025-12-24 @ 12:05 PM
NCT ID:
NCT02983461
Eligibility Criteria:
Inclusion Criteria:
* Postmenopausal females, 50-80 years of age, at the time of consent
* Have stress or mixed urinary incontinence, with at least 3 episodes/week
* Willing and able to comply with study procedures
* Willing and able to provide written informed consent
Exclusion Criteria:
* Significant heart, liver, kidney, pulmonary, blood, autoimmune or peripheral vascular disease (history of Hashimoto's thyroiditis is not exclusionary if stable and thyroid replacement is being administered. Thyroid testing will be performed at screening and as needed during study visits. )
* Systolic blood pressure \<100 or \>150, diastolic blood pressure \<60 or \>90 after repeated evaluation with proper cuff. This range is smaller than the acceptable range stated in the prescribing information for sildenafil (\>90/50 and \<170/110)
* Diabetes mellitus or other untreated endocrine disease
* Active cancer
* Currently using and planning to continue use of urinary incontinence medications during study period
* BMI \> 40
* HIV, Hepatitis B, or Hepatitis C
* Use of systemic nitrates, anabolic steroids or corticosteroids in the past 6 months
* Use of alpha blockers
* Any medical condition that, in the opinion of the investigator, would place the subject at increased risk for participation.
* Known allergic reaction to any agent under investigation or required by the protocol.
* History of prior non-compliance or the presence or history of psychiatric condition (including drug or alcohol addiction) that would, in the opinion of the investigator, make it difficult for the subject to comply with the study procedures or follow the investigators instructions.
* Females who are pregnant or lactating.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
50 Years
Maximum Age:
80 Years
Study:
NCT02983461
Study Brief:
Protocol Section:
NCT02983461