Please select the eligibility criteria that correspond to the clinical trial below.
Title: Randomized Controlled Trial of PTNS Versus Sham Efficacy in Treatment of Bladder Pain Syndrome
Brief Summary: This is a prospective, single center, double-blind, randomized, controlled trial comparing the efficacy of percutaneous tibial nerve stimulation to sham in the treatment of Bladder Pain Syndrome/Interstitial Cystitis (BPS/IC) through 12 weeks of therapy.


Options:
A: Inclusion Criteria:

* Women ≥18 years old with visual analog scale \> 5
* Cessation of all analgesics or other medication for pain for at least 2 weeks prior to the PTNS intervention
* Discontinuation of any other electrical stimulation methods for 3 months prior to PTNS intervention.
* Capable of giving informed consent
* Ambulatory
* Capable and willing to follow all study-relation procedures

Exclusion Criteria:

* Patients pregnant or planning to become pregnant during the study duration
* Botox use in pelvic floor muscles within the last year
* Current urinary or vaginal infections
* Current use of Interstim device
* History of a cardiac pacemaker
* Diagnosis of neuropathy
B: Inclusion Criteria:

* Patients with interstitial cystitis/ painful bladder syndrome for more than 6 months with moderate to severe pain and a micturition frequency greater than 7 per day.
* Patients who have been on stable oral medicines for interstitial cystitis/ painful bladder syndrome for at least 3 months. Other therapies might need to be stopped.

Exclusion Criteria:

* Patients on certain recent treatments for interstitial cystitis/ painful bladder syndrome.
* Body mass index (BMI) of \>39 kg/m2.
* History of allergic or anaphylactic reaction to a therapeutic or diagnostic monoclonal antibody or IgG-fusion protein.
* Patients with peripheral neuropathy.
* Patients with Type I or type II diabetes mellitus who have an HbA1c \> 8.0%.
C: Inclusion Criteria:

* Age 18- 65 years - upper limit to reduce the risk of vaginal bleeding upon treatment with the therapeutic wand
* A diagnosis of Bladder Pain Syndrome or interstitial cystitis as per the definition of the International Society for the Study of bladder pain syndrome
* Symptoms of bladder pain, urgency and frequency in at least the last month prior to study participation
* Pain on palpation of the pelvic floor muscles, as per the European Urology Association bladder pain syndrome guidelines
* Ability to attend the department for treatment
* Ability to give informed consent
* Sufficient upper limb control to allow the participant to manipulate the therapeutic wand for self-treatment

Exclusion Criteria:

* Concurrent diagnoses which may cause pelvic pain including; chronic pelvic inflammatory disease, endometriosis, dysmenorrhoea, or irritable bowel syndrome
* Postmenopausal atrophic vaginitis due to risk of vaginal trauma and bleeding with therapeutic wand use
* Reasonable suspicion of other treatable pathologies, such as urinary tract infection
* No appropriate investigations completed such as urinalysis, urodynamic or cystoscopic assessment during diagnosis of bladder pain syndrome, as per National Institute of Health and Care Excellence (NICE) guidance
* Pregnancy or planning to conceive
* Symptoms associated only with menses
* Undergoing concurrent treatments that could affect outcome e.g. botox or analgesic injections, sacral neuromodulation or physiotherapy treatment
D: Inclusion Criteria:

* Chronic pelvic pain (\>6 months) perceived to be related to the urinary bladder and accompanied by urinary symptoms such as frequent urination during the day and/or night, and/or urgency to void
* Total score of 8 or greater on the O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI)
* The mean of the average pain intensity scores at screening phase \>=5 (on a scale of 0 to 10)
* Medically stable

Exclusion Criteria:

* Urinary culture is positive for a urinary tract infection; Recent invasive therapy to the bladder
* History or current conditions indicating that the bladder pain can be caused by diagnoses other than IC/PBS (eg, pain caused by a confirmed or suspected neoplasm)
* History of malignancy within the past 2 years, with the exception of basal cell carcinoma that has been successfully treated
* Women who are pregnant or breast-feeding
* A body mass index (BMI) of \>39 kg/m2

Answer: A