Please select the eligibility criteria that correspond to the clinical trial below.
Title: Overactive Bladder Innovative Therapy Trial
Brief Summary: The purpose of this study is to compare percutaneous tibial nerve stimulation (PTNS) to drug therapy for the treatment of symptoms of overactive bladder (OAB).


Options:
A: Inclusion Criteria:

* Female.
* Over 18 years of age.
* Clinically diagnosed of idiopathic OAB according to the definition by the International Continence Society (Haylen et al, 2012) given above.
* Good response to PTNS. For the purpose of this study, responders will be considered those subjects who have achieved a reduction in the number of micturitions per 24 hours by \> 30%.
* Able and willing to give informed consent.

Exclusion Criteria:

* Patients who do not comprehend the physiotherapist's instructions or who are unable to co-operate.
* Pregnancy, or plans of becoming pregnant during the course of the study. The main acupuncture point that will be used (SP6) has been reported to induce uterine activity (Hecker et al, 2001).
* Presence of a relevant neurological condition (causing neurogenic detrusor overactivity or peripheral neuropathy).
* Previous history of continence surgery.
* Women with a pace-maker fitted.
* Women with uncorrectable coagulopathies or on anticoagulant medication.
* Presence of dermatological lesions (e.g. dermatitis, eczema...) in the medial aspect of lower leg and/or feet.
* No anticholinergic medication will be allowed during the study period with minimum wash-out period of 15 days before randomization.
B: Inclusion Criteria:

* Women and men \>18 years of age
* A score of \> 4 on the OAB-q short form for urgency (question 1)
* Average urinary frequency \> 10 times in one 24 hour day based on a 3-day voiding diary
* Self-reported bladder symptoms present \> 3 months
* Self-reported failed conservative care (i.e., dietary restriction, fluid restriction, bladder training, behavioral modification, pelvic muscle training, biofeedback, etc.)
* Off all antimuscarinics for at least 2 weeks prior to enrollment
* Capable of giving informed consent
* Ambulatory and able to use a toilet independently, without difficulty
* Capable and willing to follow all study-related procedures

Exclusion Criteria:

* Pregnant as confirmed by urine pregnancy test, or plans to become pregnant during the study period
* Neurogenic bladder
* Botox use in bladder or pelvic floor muscles in the past year
* Pacemakers or implantable defibrillators
* Primary complaint of stress urinary incontinence
* Current urinary tract infection (UTI)
* Current vaginal infection
* Current use of InterStim
* Current use of Bion
* Current use of TENS in the pelvic region, back or legs
* Previously been treated with PTNS
* Use of investigational drug/device therapy within the past 4 weeks
* Participating or have participated within the past 4 weeks in any clinical investigation involving or impacting gynecologic, urinary or renal function
* Deemed unsuitable for enrollment in study by the investigators based on subjects' history or physical examination (including bleeding disorders or anticoagulant medications, and peripheral neuropathy)
* Subjects with nerve damage that would impact either percutaneous tibial nerve or pelvic floor function
C: Inclusion Criteria:

* Is at least 18 years of age
* Experiences OAB with a voiding frequency of at least 8 times per day
* Is ambulatory and able to use a toilet independently and without difficulty

Exclusion Criteria:

* On OAB pharmacotherapy within the previous month
* Primary complaint is stress urinary incontinence
* Has pacemaker or implantable defibrillator
* Has history of heart problems
* Has nerve damage or neuropathy
* Has gastric or urinary retention
* Has uncontrolled narrow-angle glaucoma
* Has known sensitivity to drug ingredients
* Is pregnant or planning to become pregnant during the trial
D: Inclusion Criteria:

* Subjects who signed the informed consent and were eligible to participate in the original SUmiT Trial
* Subjects who were randomized and treated with the active PTNS therapy during their participation in the original SUmiT Trial
* Subject must be a positive responder from initial 12 weekly treatments as prescribed in original SUmiT Trial - 13 week GRA questionnaire must indicate "moderately" or "markedly improved" on question #1 of GRA
* Subjects must not have started any antimuscarinics treatment since completion of original SUmiT Trial
* Subjects must not have started any urologic Botox treatment since completion of original SUmiT Trial
* Subjects must remain off all antimuscarinics throughout participation in trial
* Subjects must initiate PTNS maintenance therapy within 2 weeks of their last PTNS treatment as part of SUmiT protocol UPC082008
* Capable of giving informed consent
* Capable and willing to follow all study-related procedures for up to 33 months for a total participation of 3 years

Exclusion Criteria:

* Pregnant as confirmed by urine pregnancy test, or plans to become pregnant during the study period
* Subjects who were not able or willing to follow original SUmiT Trial study schedule

Answer: C