Please select the eligibility criteria that correspond to the clinical trial below.
Title: Comparison of Bladder Directed and Pelvic Floor Therapy in Women with Interstitial Cystitis/Bladder Pain Syndrome
Brief Summary: Women with interstitial cystitis/bladder pain syndrome (IC/BPS) have debilitating urinary frequency and urgency, and chronic pelvic or bladder pain perceived to be related to the bladder. Although many clinicians think that IC/BPS symptoms result from a bladder problem, tight pelvic floor muscles can cause similar symptoms and might be responsible for ICBPS symptoms instead of the bladder. Inadequate assessment of the problem leads to delays in treatment and often years of suffering. This clinical trial will test a bladder directed therapy (bladder instillations) compared to a course of pelvic floor physical therapy (PFPT) to assess the role of the pelvic floor as a major contributor to pelvic pain and voiding dysfunction in adult women with non-ulcerative IC/BPS. Early assessment of the pelvic floor muscles in patients with IC/BPS symptoms may prevent common delays in proper diagnosis and allow for early, more effective treatment.


Options:
A: Inclusion Criteria:

* Women 18 years and older
* Women with IC/BPS who have a score of ≥ 6 on either index (problem or symptom index) of the O'Leary-Sant questionnaire who have selected bladder instillations as part of their IC/BPS treatment
* Suitability for follow-up

Exclusion Criteria:

* Contraindications and/or allergies to the ingredients used in the bladder instillations
* Diagnosis of idiopathic thrombocytopenic purpura
* Does not desire to undergo bladder instillation therapy or unwilling to undergo bladder instillation therapy on schedule mandated by study
* Have a known alternative diagnosis explaining bladder pain symptoms that would preclude the diagnosis of IC/BPS (e.g. radiation cystitis, active urinary tract infection with bacteria or fungus treated within last 2 weeks or diagnosed at index visit, bladder injury or trauma within the last 30 days)
* Inability to speak or read English
* Bladder instillation within the past 4 weeks
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:

* Female
* Age 18 to 85 years
* History of patient self-reported of IC/BPS symptoms for at least 6 months.
* Using an approved method of birth control, or surgically sterile, or of non-child bearing age with no menstrual period for the past 12 months
* Must be willing to not start any new medication known to affect bladder or muscle function, and to ideally remain on a stable dose of all other medications through the secondary endpoint.

Exclusion Criteria:

* Active urethral or ureteral calculi, urethral diverticulum, history of pelvic radiation therapy, tuberculous cystitis, bladder cancer, carcinoma in situ (bladder), urethral cancer
* Hunner's lesions found on screening cystoscopy
* Prior investigational or therapeutic bladder instillations for IC/BPS symptoms within the past 3 months
* Lactation, pregnancy, or refusal of medically approved/reliable birth control in women of child-bearing potential.
* Pain, frequency, and/or urgency symptoms only present during menses
* Clinically confirmed urinary tract infection at time of screening
* Participant unable to tolerate insertion of one or two vaginal examining fingers (e.g. Vulvar allodynia)
* Participant had prior course of physical therapy (PT) that included internal (vaginal and/or rectal) manual therapy with connective tissue manipulation by physical therapist for the same symptoms within the past 3 months (prior treatment by therapist with biofeedback, electrical stimulation, or pelvic floor exercises is not exclusionary)
* Participant in the opinion of the investigator has a relevant neurologic disorder that affects bladder and/or neuromuscular function
* Participant has/reports any severe, debilitating or urgent concurrent, medical condition
* Participant has a potentially significant pelvic pathology or abnormality on examination or prior imaging, including prolapse beyond the hymenal ring, pelvic mass, etc., that in the investigators' judgment, could cause or contribute to the clinical symptoms, or require treatment
* Any other condition which, in the investigator's judgment, may increase risk to subject's welfare
* Participation in an investigational trial that uses a study treatment less than 6 months from the date of the screening visit

Note: For the sake of preserving scientific integrity, one or more of the eligibility criteria have been left off the list posted while the trial is ongoing. A full list of eligibility criteria will be posted upon completion of the trial.
D: Inclusion Criteria:

* Men and women over 18 years of age with moderate to severe interstitial cystitis defined by pain score.
* Women must not be pregnant or lactating, They may be post-menopausal, surgically sterilized or using an appropriate method of contraception.

Exclusion Criteria:

* History of interstitial cystitis less than 6 months
* History of current or recurrent urinary tract infections, or genitourinary cancer
* Any previous urinary diversion procedure with or without bladder removal, bladder augmentation
* Use of certain drugs given into the bladder up to 1 month prior to study entry

Answer: C