MAPP Investigation of Pelvic Floor-Brain Neurobiologic Axis in IC/IBS and IBS

Stopped early

Conditions studied: Interstitial Cystitis, Irritable Bowel Syndrome

In brief

Hypotheses: 1. The bidirectional signaling between the cortex, and the pelvic floor/gut is deranged in patients with IC and in IBS. Consequently, they will demonstrate hyperexcitability of the pelvic floor/brain axis as evidenced by shorter latencies and increased amplitudes for both the afferent anorectal-cortical evoked potentials and efferent cortically-induced (magnetic) anorectal motor evoked potentials. 2. Unlike patients with IC alone, patients with IBS will also demonstrate anorectal visceral hypersensitivity and anorectal sensory-motor dysfunction.

Key facts

Study ID

NCT01280864

Run by

Augusta University

People needed

36

Starts

2010-03-01

Expected to finish

2011-08-01

Last updated by the study team

2018-07-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• During the previous year, all patients must have recurrent abdominal discomfort or pain for at least 3 days per month in the last 3 months associated with two or more of the following symptoms (6): i) improvement with defecation; ii) onset associated with a change in frequency of stool; and/or iii) onset associated with a change in form (appearance) of stool (83);
• No evidence for structural diseases (excluded by colonoscopy/ barium enema and metabolic problem by lab tests; and
• On a prospective symptom/stool diary [Appendix 1] patients reported i) presence of abdominal pain/discomfort for at least 2 days per week; ii) hard or lumpy stools >25% and loose or watery stools in < 25% of bowel movements (IBS-C); (iii) loose or watery stools in >25% of bowel movements and hard stools <25% of BMs(IBS-D); >25% of hard or loose stools within one week (IBS-M) (6).

You may not qualify if…

• Patients with laxative abuse, anorexia nervosa, and bulimia;
• Patients taking constipating drugs, (e.g. opioids), tricyclics (because of increased seizure risk), serotonin modulators (tegaserod), antispasmodics (dicyclomine or hyoscyamine), muscle relaxants (e.g. cyclobenzaprine) unless the drug is stopped at least 2 weeks before enrollment;
• Patients with a current history of depression and/or taking antidepressants;
• Patients with comorbid illnesses, severe cardiac disease, chronic renal failure or previous gastrointestinal surgery except cholecystectomy and appendectomy;
• Patients with neurologic diseases (e.g. head injuries, epilepsy, multiple sclerosis, strokes, spinal cord injuries) or brain disorders prone to causing seizures;
• Patients experiencing impaired cognizance (mini mental score of < 15) and/or legally blind;
• Women who are pregnant or likely to conceive (women with potential for pregnancy must use contraceptive measures to be included);
• Patients with ulcerative and Crohns colitis;
• Patients with rectal prolapse, anal fissure, anal surgery or inflamed hemorrhoids.
• Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS) Study Population
• Inclusion Criteria:
• IC/PBS patients who have met all three of the modified NIDDK criteria (84) for IC/PBS as described below on a urinary symptom assessment form (Appendix 3):
• Participants will report the occurrence of bladder pain with a score of >3 on a Likert scale of 1-10.
• Participants will report the presence of increased urinary frequency with a score of >3 on a Likert scale of 1 -10.
• The bladder pain and increased urinary frequency will have been present for at least 6 weeks.
• We recognize that the NIDDK is currently working on recommending new diagnostic criteria for interstitial cystitis. We will adopt any revised criteria commiserate with the new recommendations of the NIDDK as our study progresses.
• Exclusion Criteria:
• History of genitourinary tuberculosis, bladder cancer, high grade dysplasia, carcinoma in situ, urethra, vaginal, or cervical cancer.
• Previous treatment with cytoxan or cyclophosphamide (as reported by the patient).
• Radiation cystitis (as reported by the patient).
• Neurogenic bladder dysfunction (e.g.,) due to spinal cord injury, stroke, Parkinson's, MS, spina bifida, or diabetic cystopathy (reported by the patient or determined during a neurologic exam.
• Having had an augmentation cystoplasty (as reported by the patient).
• Having undergone a cystectomy, cystolysis, or neuroectomy as reported by the patient.
• Having a urethral stricture of less than 12 French (as reported by the patient).
• Urinalysis with >10 white blood cells per high-powered field.

Where it is running

• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States

Full record on ClinicalTrials.gov

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