Table G1. Ongoing and recently completed CPP intervention studies

Study Name, Location, Trial# / Inclusion/Exclusion Criteria / Interventions / Sponsor / Start Date ~ Anticipated Completion Date / Estimated Enrollment
Role Of Paroxetine As Add-On Therapy To GnRH Agonist In The Treatment Of Endometriosis-Related Chronic Pelvic Pain,
Italy,
EudraCT Number:2008-008722-73 / Principal inclusion criteria:
  • Age between 30 and 45 years old
  • Caucasian
  • Diagnosis of endometriosis associated chronic pelvic pain made by a ginecologist at the Endometriosis Center in S. Chiara Hospital. The endometriosis diagnosis confirmation includes specific bioptic report performed after surgical operation.
  • Disease phase on the basis of III-IV endometriosis classification proposed by American Fertility Society. The disease phase definition performed during previous surgical operation.
  • Entering treatment with GnRH agonist (leuproreline) to reduce pain symptoms
  • VAS score =>3 before treatment
  • HAM-A and HAM-D =>7 before treatment. All participants will sign a written informed consent; at any time they could decide to discontinue the treatment.Women on antidepressants, psychostimulants, sedative-hypnotics or narcotic analgesic require to remain off of them for at least two weeks before entry into the study and for the duration of the study.
Principal exclusion criteria:
  • Pregnancy
  • Feeding
  • Use of oral contraceptives
  • Alcohol or illicit drug use (according to DSM-IV criteria) HIV/HCV positivity
  • Experimental drugs and excipients hypersensitivity reactions
  • Withdraw of written consent during the study
/ Experimental Group: Paroxetine: 1 mg
Controlled Group: Leuprorelin: 3.75 mg / AziendaOspedalieraPisana / April 2009  / 40
Female Chronic Pelvic Pain (Female CPP),
Denmark,
NCT01255345 / Inclusion Criteria:
  • Women ≥ 18 years
  • Living in Copenhagen Country (Region H)
  • Capable of reading, writing and speaking Danish
Exclusion Criteria:
  • Pain limited solely to the perineal skin or introitus (vulvodynia)
  • Pregnancy, cancer, active pelvic inflammatory disease
  • Operation in the pelvic during the last 6 months
  • Cognitively impaired individuals
/ A physioterapeutic examination of abnormal muscular findings, i.e. tonus, elasticity and strength, in the pelvic area connected to female CPP. / Copenhagen University Hospital at Herlev / January 2011  December 2012 / 2500
Transcranial Direct Stimulation in Chronic Pelvic Pain,
United States,
NCT01143636 / Inclusion Criteria:
  • Providing informed consent to participate in the study
  • 18 to 64 years old
  • Having symptoms of pelvic pain for more than 6 months with an average of 3 on a 0-10 VAS scale (for pelvic pain subjects only)
  • No history of or current genitourinary tuberculosis as self reported
  • No history of urethral cancer as self reported
  • No history or current bladder malignancy, high grade dysplasia or carcinoma in situ as self reported
  • No occurrence of ovarian, vaginal or cervical cancer in the previous 3 years as self reported
  • No current vaginal infection as self reported
  • No active herpes in previous 3 months as self reported
  • No antimicrobials for urinary tract infections in previous 3 months as self reported
  • Never treated with cyclophosphamide as self reported
  • No radiation cystitis as self reported
  • No neurogenic bladder dysfunction (due to a spinal cord injury, stroke, Parkinson’s disease, multiple sclerosis, spina bifida or diabetic cystopathy) as self reported
  • Absence of bladder, ureteral or urethral calculi for previous 3 months as self reported
  • No urethritis for previous 3 months as self reported
  • No urethral dilatation, cystometrogram, bladder cystoscopy with full anesthesia or bladder biopsy in previous 3 months as self reported
  • Must not be pregnant
  • Eligible to MRI according to MRI screening checklist
  • No contraindications to Transcranial Direct Stimulation:
  • No history of alcohol or drug abuse within the past 6 months as self reported
  • No use of carbamazepine as self reported
  • Does not have severe depression (with a score of >30 in the Beck Depression Inventory)
  • No history of neurological disorders as self reported
  • No history of unexplained fainting spells as self reported,
  • No history of head injury resulting in more than a momentary loss of consciousness as self reported
  • Have had no neurosurgery as self reported
  • No history of psychological disorders as self reported
  • Must have the ability to feel pain as self reported
/ Transcranial Direct Current Stimulation / Spaulding Rehabilitation Hospital / April 2010  April 2012 / 68
Efficacy of Acupuncture on Chronic Pelvic Pain in Women With Endometriosis or Adenomyosis,
Korea, Republic of,
NCT01259180 / Inclusion Criteria:
  • Patients diagnosed pathologically of Endometriosis or Adenomyosis among those who had undergone laparoscopic surgery due to pelvic pain
  • Patients who have been on GnRH agonist treatment for 6 months after being diagnosed Endometriosis or Adenomyosis
  • Patients who agreed a written consent by their own will
  • Patients’ compliance and geographical adjacency appropriate for proper follow up survey
  • Continuous pelvic pain over VAS 5 during past 1 week on screening visit(after 6 weeks of surgery) (0=‘no pain’, ‘10=most severe’)
Exclusion Criteria:
  • Those who had taken hormones or drugs that can affect diagnosis of endometriosis or adenomyosis for past 1 year
  • Patients found to have malignant tumor of uterus and adenexa, PID or pregnancy during surgery
  • Allergies to metal or contraindications for acupuncture treatment (ex: coagulopathy, epilepsy)
  • Unable to participate in clinical trial by doctor’s judgment
  • Irritable bowel syndrome
/ Active: acupuncture treatment
Placebo: Sham acupuncture / East West Neo Medical Center / December 2010 September 2011 / 30
EMG Guided Botulinum Toxin Type A Injections for Refractory High Tone Pelvic Floor Dysfunction (BTXA EMG),
United States,
NCT01323829 / Inclusion Criteria:
  • Participant must be diagnosed with High Tone Pelvic Floor Dysfunction(HTPMFD).
  • Participant must have tried and failed at least one other conventional mode of therapy for HTPMFD.
  • Participant must be a female at least 18 years of age.
  • Participant must give written informed consent to participate in this study.
  • Participant must be able to make decisions for herself.
  • Participant must not be undergoing another procedure at the time of BTX A injection.
Exclusion Criteria:
  • Participant is male.
  • Patient has a history of past BTX A use
  • Patient has had pelvic organ prolapse repair
  • Participant is pregnant or intends to get pregnant during the study period or is breastfeeding.
  • Participant is unwilling or unable (because of long distance from office) to follow-up.
  • Participant has a neuro-modulator device implanted.
  • Participant has a known bleeding disorder or is on anticoagulation.
  • Participant has a known hypersensitivity to BTX A.
  • Participant has a pre-existing neuromuscular disorder such as amytrophic lateral sclerosis, motor neuropathy, myasthenia gravis or Lambert-Eaton syndrome.
  • Participant with skin infection at the perineum at the site of injection.
/ Other: EMG Guidance of Injection
The use of the EMG guidance is the experimental part of the study. We will perform EMG Needle testing in order to pin-point the best location for the patients Botox injections. / Pelvic and Sexual Health Institute;
Allergan / November 2010  / 20
Medical Treatment of Endometriosis-Associated Pelvic Pain,
United States,
NCT00229996 / Inclusion Criteria:
  • Age greater than 18 and pre-menopausal.
  • Pelvic pain of at least 3 months duration.
  • Diagnosis of endometriosis by laparoscopy or laparotomy within three years of entry. The diagnosis of endometriosis will require either histology consistent with endometriosis or operative records indicating visual evidence of lesions consistent with endometriosis.
  • Moderate to severe pelvic pain preoperatively attributable to endometriosis (average Numerical Rating Scale of 5 or more for three or more months).
  • Willingness to comply with visit schedule and protocol.
Exclusion Criteria:
  • Use of oral contraceptives within one month of the surgery.
  • Dose of Lupron within three months if given monthly or within five months if given 3-month injection.
  • Any disorder that represents a contraindication to the use of oral contraceptives (e.g. insulin-dependent diabetes mellitus, history of thrombophlebitis, hypertension, history of cardiovascular disease, smoker at 35 or more years of age) or GnRH analogs (e.g., history of osteopenia).
  • History of hysterectomy and bilateral salpingoophorectomy.
  • Positive pregnancy test at first postoperative (i.e, intake visit).
  • Significant mental or chronic systemic illness that might confound pain assessment or the inability to complete the study.
/ Drug: Oral Contraceptive
Drug: Depot-Leuprolide/Norethindrone
InterventionModel:
ParallelAssignment
Masking:Double-Blind / Eunice Kennedy Shriver National Institute of Child Health and Human Development / July 2004  / 194
Addition of Pudendal Blocks to Pelvic Floor Physical Therapy for the Treatment of Pelvic Floor Tension Myalgia,
United States,
NCT00928564 / Inclusion Criteria:
  • Non-pregnant women over the age of 18 with the diagnosis of pelvic floor tension myalgia that are naive to pelvic floor physical therapy.
  • Able to provide informed consent.
  • Subjects must be willing to accept randomization.
Exclusion Criteria:
  • Previously treated with physical therapy.
  • An allergy to any component within the pudendal block.
  • Bleeding disorders.
  • Active vaginal infection.
  • Inability to complete the questionnaires.
  • Inability to read English (validated questionnaires are available in English only).
  • Inability to complete the follow-up visits.
/ InterventionModel:CrossoverAssignment
Masking:DoubleBlind(Subject,OutcomesAssessor)
Active: Drug: Pudendal block: 8ml of 0.5% bupivicaine, 1ml of 10mg/ml triamcinolone, 1ml of 8.4% sodium bicarbonate for a total volume of 10ml. Five ml will be used at each block site.
Placebo: 5ml of saline at each block site. / University of California, Irvine / April 2009  June 2011 / 140
Cortical Plasticity in a Complex Intervention for Endometriosis,
Germany,
NCT01321840 / Inclusion Criteria:
  • age > 18 years old
  • clinically or histologically ensured diagnosis of Endometriosis
  • preoperative and postoperative recurring ailments related to Endometriosis
  • no hormone therapy (GnRH analogues, contraceptives)
  • sufficient understanding of the German or English language
  • persisting pain during menstruation (also in between)
  • voluntary participation after information on the possible benefits and risks of the examination and intervention
  • written informed consent
Exclusion Criteria:
  • alcohol addiction, drug addiction
  • pregnancy
  • diseases and other criteria, preventing an MRI examination:
  • pacemaker
  • neurostimulator or drug pump
  • metal parts in the body (implants, splinters, etc.)
  • claustrophobia
/ InterventionModel:ParallelAssignment
Masking:SingleBlind(OutcomesAssessor)
Treatment: Experimental.
Specific Autoregulation Therapy
Complex intervention involving acupuncture and hypnotherapeutic techniques after an extensive diagnosis using Chinese medical concepts. Patients will receive a maximum of 10 treatments, which are delivered weekly.
No treatment: No Intervention:
This group will not be treated with Specific Autoregulation Therapy
but will regularly be examined by a gynecologist to detect sudden aggravation of the disease. / University of Jena
TechnischeUniversitätMünchen / March 2010  December 2011 / 60

Abbreviations:BTXA = Botulinum Toxin Type A; CPP = chronic pelvic pain; DSM-IV = Diagnostic and Statistical Manual of Mental Disorders, Fourth edition; EMG = electromyogram; GnRH = gonadotropin releasing hormone; HAM-A = Hamilton anxiety Scale; HAM D = Hamilton depression Scale; HCV = hepatitis C; HTPMFD =High Tone Pelvic Floor Dysfunction; MRI = magnetic resonance imaging; PID = pelvic inflammatory disease; VAS = visual analog scale.