Please select the eligibility criteria that correspond to the clinical trial below.
Title: Intravesical Instillation of Liposome Encapsulated Botulinum Toxin A (Lipotoxin) in Treatment of Interstitial Cystitis - a Randomized, Double-blind, Placebo-controlled, Prospective Study
Brief Summary: To evaluate the efficacy and safety of intravesical instillation of Lipotoxin for the treatment of IC/BPS


Options:
A: Inclusion Criteria:

1. Adults with age of 20 years old or above
2. Patients with symptoms of frequency, urgency, nocturia, and/or bladder pain.
3. Proven to have glomerulations (at least grade 2) by cystoscopic hydrodistention under anesthesia in recent 1 year
4. Free of active urinary tract infection
5. Free of bladder outlet obstruction on enrollment
6. Free of overt neurogenic bladder dysfunction and limitation of ambulation
7. Patient or his/her legally acceptable representative has signed the written informed consent form

Exclusion Criteria:

1. Hunner's lesion proven by cystoscopy
2. Patients with severe cardiopulmonary disease and such as congestive heart failure, arrhythmia, poorly controlled hypertension, not able to receive regular follow-up
3. Patients with bladder outlet obstruction on enrollment
4. Patients with postvoid residual \>250ml
5. Patients with uncontrolled confirmed diagnosis of acute urinary tract infection
6. Patients have laboratory abnormalities at screening including: ALT\> 3 x upper limit of normal range, AST\> 3 x upper limit of normal range; Patients have abnormal serum creatinine level \> 2 x upper limit of normal range
7. Patients with any contraindication to be urethral catheterization during treatment
8. Female patients who is pregnant, lactating, or with child-bearing potential without contraception.
9. Myasthenia gravis, Eaton Lambert syndrome.
10. Patients with any other serious disease considered by the investigator not in the condition to enter the trial
11. Patient had received intravesical treatment for IC within recent 1 month
12. Patients participated investigational drug trial within 1 month before entering this study
B: Inclusion Criteria:

* Patients reporting non-cyclical CPP with dyspareunia and associated PFD with no palpable pelvic floor pathology, but with palpable high pelvic floor muscle (PFM) tone and tenderness will be referred for physiotherapy by the gynaecology team.
* Visceral conditions like interstitial cystitis are difficult to exclude at gynaecology review, as they mimic CPP symptoms.
* Smokers and non-smokers included.
* Nulliparous, singleton and multiparous patients.

Exclusion Criteria:

* Body mass index greater than 30, makes it difficult to dry needle as the required needle length is not available.
* Chronic back pain over 6 months duration, under pain management team.
* Orthopaedic back surgeries with implants.
* Pelvic pathologies like endometriosis, fibroids, cysts, etc.
* Pregnancy related pelvic pain.
* Pregnant during the trial.
* Pelvic organ carcinomas.
* Undergoing cancer treatment.
* Post gynaecology surgeries, less than 16 weeks.
* Cardiovascular, gastroenterology, renal or orthopaedic surgery, less than 6 month's post-operative.
* Neurological conditions like stroke, epilepsy, Parkinson's disease etc.
* Exclusion criteria for dry needling:
* Extreme needle phobia, Rheumatoid arthritis, prolonged corticosteroid treatment, warfarin treatment, heart implants and blood clotting disorders.
* Participant with no significant learning disability and should be able to understand the procedure to consent for treatment.
* Participant should not require a chaperone during treatment.
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:

* Male and female adults at least 18 years of age;
* Moderate to severe interstitial cystitis, with a mean pain intensity score above a pre-defined level.

Exclusion Criteria:

* Less than 6 months since onset of interstitial cystitis symptoms;
* History of recurrent urinary tract infections, or genitourinary cancer;
* History of hepatitis B, C or human immunodeficiency virus (HIV);
* Use of certain drugs given into the bladder up to 1 month prior to study entry.

Answer: A