Please select the eligibility criteria that correspond to the clinical trial below.
Title: To Investigate the Use of Trans-perineal Trigger Point Dry Needling With Manual Therapy and to Compare the Outcome With Manual Therapy Treatment for Chronic Pelvic Pain With Dyspareunia. A Randomized Clinical Trial.
Brief Summary: Chronic Pelvic Pain (CPP) are around 10% of gynaecology referrals.Non-relaxing pelvic floor dysfunction (NRPFD) is an under-appreciated cause for CPP with dyspareunia where no other pathology exists. The effectiveness of manual therapy in studies have shown statistically significant pre and post treatment differences.However no study has reviewed the efficacy of inclusion of trans- perineal trigger point dry needling used with manual therapy for NRPFD. This study will investigate the effectiveness of trans-perineal trigger point dry needling used with manual therapy techniques for CPP.


Options:
A: Inclusion Criteria:

* Participants must have a chronic urogenital pain condition

Exclusion Criteria:

* non-English speaking
* unable to read
* psychosis
* dementia
* mental impairment
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:

* Patients with IC/PBS who have failed conventional treatments for at least 6 months will be enrolled.
* A diagnosis of IC/PBS has been established based on characteristic symptoms and cystoscopic findings of glomerulations, petechia, or mucosal fissures after hydrodistention.
* All patients have been treated with at least two types of treatment modalities including non-steroid anti-inflammatory drugs, oral pentosan polysulfate sodium (PPS), intravesical instillation of heparin, hyaluronic acid, or tricyclic antidepressant for at least 6 months but the symptoms remained unchanged or relapsed.

Exclusion Criteria:

* Exclusion criteria proposed by NIDDK
* Automatic exclusions:

  1. Age \<18 years old
  2. Benign or malignant bladder tumors
  3. Radiation cystitis Tuberculous cystitis
  4. Bacterial cystitis
  5. Vaginitis
  6. Cyclophosphamide cystitis
  7. Symptomatic urethral diverticulum
  8. Uterine, cervical, vaginal, or urethral cancer
  9. Active herpes
  10. Bladder or lower ureteral calculi
  11. Waking frequency \<5 times in 12 hours
  12. Nocturia \<2 times
  13. Symptoms relieved by antibiotics, urinary antiseptics, urinary analgesics (for example phenazopyridine hydrochloride)
  14. Duration \< 12 months
  15. Involuntary bladder contractions (urodynamics)
  16. Capacity \> 400ml, absence of sensory urgency
* Automatic inclusions:

  1.Hunner's ulcer
* Positive factors: (two positive factors are necessary for inclusion)

  1. Pain on bladder filling relieved by emptying
  2. Pain (suprapubic, pelvic, urethral, vaginal or peripheral)
  3. Glomerulations on endoscopy
  4. Decreased compliance on cystometrogram
  5. Bladder distention is defined arbitrarily as 80 cm water pressure for 1 minute
* Use of Anticholinergic drugs, for the treatment of lower urinary tract symptoms who have an effect.
* Patients with severe cardiopulmonary disease and such as congestive heart failure, arrhythmia, poorly controlled hypertension, not able to receive regular follow-up.
* Patients with bladder outlet obstruction on enrollment.
* Patients with urinary retention, PVR≥150 ml.
* Patients with uncontrolled confirmed diagnosis of acute urinary tract infection.
* Patients have laboratory abnormalities at screening including:

  1. Alanine aminotransferase (ALT) \> 3 x upper limit of normal range
  2. Aspartate aminotransferase (AST) \> 3 x upper limit of normal range.
  3. Patients have abnormal serum creatinine level \> 2 x upper limit of normal range.
* Can not be used in the treatment of patients with transurethral catheter treatment.
* Pregnant and lactating women or women who intend to become pregnant during the study or have myasthenia gravis, Eaton Lambert syndrome.
* Patients with any other serious disease or condition considered by the investigator not suitable for entry into the trial.
* Patients participated investigational drug trial within 1 month before entering this study.
* Written informed consent has been obtained.
* Patient who did not complete the 3-day micturition diary according to the instruction.
* Intestinal bladder augmentation patients receive angioplasty for the treatment of overactive bladder.

Answer: B