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 @ 2:10 AM
Ignite Modification Date:
2025-12-25 @ 2:10 AM
NCT ID:
NCT01470560
Eligibility Criteria:
Inclusion Criteria:
1. Females at least 18 years of age
2. Five or more urge urinary incontinence episodes on a three-day voiding diary. Urge incontinence episodes will be determined based on voiding diary and subject indication of coincident urge symptoms, allowing self-characterization of incontinence type.
3. Urge predominant (urge \>50% of total incontinent episodes) urinary incontinence based on self-reported characterization of incontinent episodes on diary.
4. Request for treatment for urge urinary incontinence.
5. Subject is able to complete all study related items and interviews.
Exclusion Criteria:
1. Any current or recent (past 4 weeks) anticholinergic medication use. Patient may discontinue medication and after 4 weeks may be eligible for study.
2. Past non-pharmacologic treatment for urge incontinence such as supervised behavioral therapy, supervised or unsupervised physical therapy, supervised biofeedback, and transvaginal electrical stimulation.
3. Current symptomatic urinary tract infection that has not resolved prior start of MBSR group.
4. Symptoms of pelvic organ prolapse screened by PFDI (Pelvic Floor Disorder Inventory question #3) "Do you have a bulge or something falling out that you can see or feel in the vaginal area?"
5. Previous or currently implanted neuromodulation (sacral or tibial).
6. Surgically altered detrusor muscle, such as augmentation cystoplasty.
7. Women with known neurologic disease believed to potentially affect urinary function (Multiple sclerosis, spinal cord injuries, myasthenia gravis, Charcot-Marie-Tooth disease).
8. In the opinion of the investigator, inability to understand diary instructions and complete 3-day voiding diary.
9. Subject has been previously diagnosed with interstitial cystitis or chronic pelvic pain syndrome.
10. Currently pregnant or within 6 months postpartum (pregnancy is not excluded for safety reasons but for quality of data)
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT01470560
Study Brief:
Protocol Section:
NCT01470560