Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Single-Blinded Randomized Multi-Center Trial to Evaluate the Efficacy and Durability of Myofascial Tissue Manipulation in Women With Interstitial Cystitis/Painful Bladder Syndrome
Brief Summary: There are many different treatments that doctors recommend for patients with IC/PBS. Only a few research studies have been done to evaluate treatments given to patients. Treatment choices can be of two types: drug therapy and non-drug therapy. The two treatments used in this study will be of the non-drug therapy type. One of the treatments being used in this study is called Myofascial Tissue Manipulation. This is a kind of physical therapy that is designed to work on specific muscles and tissue layers in a particular part of the body. In this study, this treatment will focus on the areas around the pelvis and the pelvic floor. The treatment will involve the physical therapist's use of hands and fingers to target specific muscles and tissues located within your pelvis, rectum, and/or vagina (the pelvic floor) as well as muscles and layers of tissue in your abdomen and legs. The other treatment being used in this study is Global Therapeutic Massage. This treatment involves the physical therapist's use of classic Western body massage techniques on the muscles of your arms, legs, hands, neck, shoulders, back, stomach, buttocks, and feet to create an overall feeling of well being.

The purpose of this research study is to find out if Pelvic Physical Therapy is safe and effective on treating symptoms in women with interstitial cystitis as compared to a full body therapeutic massage. This study will also measure the lasting effects of the treatment up to 3 months after your last study treatment.


Options:
A: Inclusion Criteria:

* Participant has signed and dated the appropriate Informed Consent document.
* Female participant is ≥ 18 years of age.
* Currently using an approved method of birth control, or surgically sterile, or of non-child bearing age with no menstrual period for the past year.
* Participant has a clinical diagnosis of IC/PBS in the opinion of the investigator.
* Participant with IC/PBS has reported a bladder pain/discomfort score of 3 or greater on a 0-10 Likert scale over the previous four weeks. This bladder pain/discomfort criterion must be met at each of the two baseline screening visits as reported by the participant.
* Participant with IC/PBS has reported a symptom score of abnormal urinary frequency of 3 or greater on a 0-10 Likert scale over the previous four weeks. This frequency criterion must be met at each of the two baseline screening visits, as reported by the participant.
* Participant has had symptoms of discomfort or pain in the pelvic region for at least a three (3) month period within the last six (6) months.
* Current symptoms have been present for less than 3 years. If similar symptoms were present in the past, they must have been completely resolved for at least one year prior to onset of current symptoms.
* Participant has previously undergone at least one course of therapy (other than physical therapy) for her symptoms.
* Presence of tenderness/pain to palpation found by the physician in one of the pelvic floor musculature domains during the first baseline screening visit physical examination which are confirmed by the physical therapist at screening visit 2. Presence of tenderness/pain is defined as a mild, moderate or severe finding by the physician at visit 1 and physical therapist at visit 2. The pelvic floor musculature domains are defined as: anterior or posterior levator muscles, obturator internus muscles and urogenital diaphragm (bulbospongiosus, superficial transverse perinei, ischiocavernosus, central tendon/perineal body). The assessment of tenderness/pain at Visits 1 and 2 do not need to be identical in severity or location in order for the participant to be eligible.

Exclusion Criteria:

* Participant has relevant, painful scars on lower abdominal wall that, in the opinion of the study physician or physical therapist, is unlikely to respond to physical therapy without adjuvant therapy such as injection /needling.
* A positive urine culture (defined as \>100,000 CFU/ml) is exclusionary. A negative urine culture within 1 month of study enrollment is acceptable.
* Participant is unable to tolerate insertion of one or two vaginal examining fingers (e.g. vulvar allodynia), or one rectal examining finger.
* Participant had prior course of physical therapy that included manual therapy with connective tissue manipulation by physical therapist for same symptoms. Prior treatment by therapist with biofeedback, electrical stimulation, or pelvic floor exercises is not exclusionary.
* Participant has relevant neurologic disorder that affects bladder and/or neuromuscular function in the opinion of the investigator.
* Participant has active urethral or ureteral calculi, urethral diverticulum.
* Participant has a history of pelvic radiation therapy, tuberculous cystitis, bladder cancer, carcinoma in situ, or urethral cancer.
* Participant has/reports any severe debilitating or urgent concurrent medical condition.
* Participant has a potentially significant pelvic pathology or abnormalities on examination or prior imaging, including prolapse beyond the hymenal ring, pelvic mass, etc. that could cause or contribute to the clinical symptoms or require treatment.
* Participant is unlikely to be compliant due to unmanaged medical or psychological condition, including neurological, psychological or speech /language problems that will interfere with her ability to complete the study.
* Participant has an imminent change in residence or other social factors that could compromise compliance with the protocol.
* Pregnancy or refusal of medically approved/reliable birth control in women of child-bearing potential.
* Participant has pain, frequency, urgency symptoms present only during menses.
B: 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
C: Inclusion Criteria:

1. Adults with age of 20 years old or above
2. Patients with symptoms of unpleasant sensation (pain, pressure, discomfort) perceived to be related to the urinary bladder, associated with lower urinary tract symptoms of more than six months duration, in the absence of infection or other identifiable causes
3. Patients has received cystoscopy and ruled out other bladder lesion
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. Patients had received intravesical hyaluronic acid treatment in recent 3 months, or intravesical Botox injection in recent 12 months Patients with severe cardiopulmonary disease and such as congestive heart failure, arrhythmia, poorly controlled hypertension, not able to receive regular follow-up
2. Patients with bladder outlet obstruction on enrollment
3. Patients with PVR \>100 ml
4. Patients with uncontrolled confirmed diagnosis of acute urinary tract infection
5. Patients have laboratory abnormalities at screening including: alanine aminotransferase (ALT)\> 3 x upper limit of normal range, and aspartate aminotransferase (AST) \> 3 x upper limit of normal range
6. Patients have abnormal serum creatinine level \> 2 x upper limit of normal range
7. Female patients who is pregnant, lactating, or with child-bearing potential without contraception
8. Patients with any other serious disease considered by the investigator not in the condition to enter the trial
9. Patients had received intravesical treatment for IC within recent 1 month
10. Patients had participated investigational drug trial within 1 month before entering this study
11. Patients with coagulopathy
D: 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

Answer: A