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 @ 11:51 AM
Ignite Modification Date:
2025-12-24 @ 11:51 AM
NCT ID:
NCT01569061
Eligibility Criteria:
Inclusion Criteria:
* The subject is female and at least 18 years of age at screening.
* A score of \> 4 on the OAB-q short form for urgency.
* The subject has an average urinary frequency of \> 10 voids per day.
* Self-reported bladder symptoms for \> 3 months.
* Self-reported failed conservative care.
* The subject has discontinued all antimuscarinics for at least 2 weeks prior to screening.
* The subject is ambulatory and able to use the toilet independently and without difficulty.
* Negative pregnancy test in subjects of childbearing potential.
* Subject attests in writing that she has not had unprotected intercourse within 3 weeks prior to study enrollment and agrees to have no intercourse until treatments conclude.
* Subject Informed Consent obtained in writing in compliance with local regulations prior to enrollment into this study.
* The subject (and caregiver, if applicable) is willing to participate in this study for at least 7 weeks.
* The subject is otherwise in general good health with no other major medical conditions.
Exclusion Criteria:
* The subject has vaginal bleeding.
* The subject has urinary or gastric retention or a neurogenic bladder.
* The subject is not capable of completing study questionnaires or undergoing portions of the study.
* The subject has been sexually assaulted.
* The subject has an alcohol or drug addiction.
* The subject has used isotretinoin (Accutane) within 6 months prior to study enrollment.
* The subject has cancer.
* The subject has used Botox® in the bladder or pelvic floor muscles within 12 months prior to study enrollment.
* The subject currently has a urinary tract infection or vaginal infection.
* The subject is using Interstim® or Bion®.
* Current use of TENS in pelvic region, back or legs.
* The subject is pregnant or lactating, or is of childbearing potential unless she is surgically sterile or she and/or her partner are using a medically acceptable method of birth control.
* Any use of light-activated drugs (photodynamic therapy) or heat sensitive medications within 30 days of first treatment.
* The subject has used an investigational drug/device therapy or participated in any clinical investigation involving or impacting gynecologic, urinary, or renal function within 4 weeks prior to study enrollment.
* The subject is otherwise determined, based on the opinion of the Investigator, to be an unsuitable candidate for enrollment in this study.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT01569061
Study Brief:
Protocol Section:
NCT01569061