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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01280864
Recruitment Status : Terminated (the study PI left the university of iowa)
First Posted : January 21, 2011
Last Update Posted : July 23, 2018
Information provided by (Responsible Party):
Satish Rao, Augusta University

Brief Summary:


  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.

Condition or disease
Interstitial Cystitis Irritable Bowel Syndrome

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Study Type : Observational
Actual Enrollment : 36 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Investigation of Pelvic Floor-Brain Neurobiologic Axis in IC/IBS and IBS
Study Start Date : March 2010
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Interstitial Cystitis Alone
Irritable Bowel Syndrome Alone
Healthy Controls

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Subjects: Sixty six consecutive adult, out-patients, over 18 years with IC alone and 66 adult patients with IBS alone and 30 healthy controls will be recruited for this 5 year study and to fulfill all 4 aims of this study. All study aims will recruit under a unified strategy. For most of the funding cycle, we will recruit simultaneously for several study aims. To prevent confusion about concordant studies, similar standardized forms and diagnostic tests will be used for each aim, with supplemental tools as needed.

Inclusion Criteria:Irritable Bowel Syndrome (IBS) Study Population

Inclusion criteria:

  1. 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);
  2. No evidence for structural diseases (excluded by colonoscopy/ barium enema and metabolic problem by lab tests; and
  3. 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).

Exclusion Criteria:

  1. Patients with laxative abuse, anorexia nervosa, and bulimia;
  2. 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;
  3. Patients with a current history of depression and/or taking antidepressants;
  4. Patients with comorbid illnesses, severe cardiac disease, chronic renal failure or previous gastrointestinal surgery except cholecystectomy and appendectomy;
  5. Patients with neurologic diseases (e.g. head injuries, epilepsy, multiple sclerosis, strokes, spinal cord injuries) or brain disorders prone to causing seizures;
  6. Patients experiencing impaired cognizance (mini mental score of < 15) and/or legally blind;
  7. Women who are pregnant or likely to conceive (women with potential for pregnancy must use contraceptive measures to be included);
  8. Patients with ulcerative and Crohns colitis;
  9. 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):

  1. Participants will report the occurrence of bladder pain with a score of >3 on a Likert scale of 1-10.
  2. Participants will report the presence of increased urinary frequency with a score of >3 on a Likert scale of 1 -10.
  3. 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:

  1. History of genitourinary tuberculosis, bladder cancer, high grade dysplasia, carcinoma in situ, urethra, vaginal, or cervical cancer.
  2. Previous treatment with cytoxan or cyclophosphamide (as reported by the patient).
  3. Radiation cystitis (as reported by the patient).
  4. 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.
  5. Having had an augmentation cystoplasty (as reported by the patient).
  6. Having undergone a cystectomy, cystolysis, or neuroectomy as reported by the patient.
  7. Having a urethral stricture of less than 12 French (as reported by the patient).
  8. Urinalysis with >10 white blood cells per high-powered field.
  9. A positive urine culture for bacterial cystitis within the past three months (by report) or a positive dipstick for leucocyte esterase or nitrates on urinary dipstick test at the time of presentation.
  10. Symptoms of vaginitis (as reported by the patient).
  11. Active herpes at presentation or has had active herpes in the last three months (by report).
  12. Use of antimicrobials in the past three months for urinary tract infections (by report).
  13. Presence of bladder, ureteral, or urethral calculi (as reported by the patient).
  14. Having undergone a cystometrogram, bladder cystoscopy under anesthesia or bladder biopsy under anesthesia or urethral dilation within the 6 weeks.
  15. Pregnancy.

Additional Criteria for recruitment:

Patients will be assessed no sooner than 6 weeks following a DMSO or other treatment or a hydrodistention as these treatments may influence inflammation. Subjects should have had no infectious illness within 2 weeks of participation. As estrogen levels are thought to contribute to IC symptoms, and symptom exacerbation has been reported perimenstrually (85), all menstruating subjects will be tested during the mid-luteal portions of their menstrual cycle (approx. days 7-14) to control for hormonal variability.

We weighed the issue of excluding IC patients taking pain and psychotropic medication vs. including these patients. Amitriptyline is commonly used for treatment of pain in both IC and IBS; these patients commonly take other psychotropic drugs, systemic antihistamines, and drugs for pain. If we were to exclude all patients on any medication, we would be able to recruit a small and unrepresentative sample of the healthiest IC patients. If we asked patients to refrain from using medication for 2 weeks before the study, we would be subjecting them to undue pain and hardship, and might trigger an exacerbation of the disease. However, use of antihistamines affect measurements of methylhistamine, and use of amitriptyline and other anti- depressants produce a general blunting of the HPA response to a stressful stimuli (86, 87) as well as modulate the neurobiologic responses. We will exclude all subjects on antidepressants to examine a more homogeneous population. To try to obtain as representative a sample as possible without confounding of results we used the following strategy in our pilot studies and plan to use the same strategy in the proposed study. Subjects taking systemic antihistamines could not be included if they had taken antihistamines within a week of the study. Our preliminary data indicated that there was no significant difference in the ACTH or cortisol response to the reactivity challenge among patients using vs. those not using amitriptyline or other psychotropic medications (p's = .45 to .90).

Healthy Controls study population:

Additionally, we will recruit 30 healthy controls matched for our patient group with regards to age, gender, hormonal status and parity. Controls will be healthy women with no history of urological disease or genito-urinary symptoms and no immunomodulatory disease such as rheumatoid arthritis, lupus, MS, chronic fatigue, fibromyalgia, diabetes, cancer, HIV, vestibulitis, allergies, chronic fungal infections, migraines, depression, or chronic pain conditions. Healthy controls will be asked to complete the Mayo Health Screening survey and this will be used to adjudicate their health status.

Healthy controls will be on NO meds other than multivitamins, oral contraceptives, and possibly low dose aspirin. They can not be taking anti-hypertensives, serotonin reuptake inhibitors, thyroid meds or other medications.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01280864

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United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52246
Sponsors and Collaborators
Augusta University
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Responsible Party: Satish Rao, Professor, Augusta University Identifier: NCT01280864    
Other Study ID Numbers: 200806750
First Posted: January 21, 2011    Key Record Dates
Last Update Posted: July 23, 2018
Last Verified: July 2018
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Cystitis, Interstitial
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Urinary Bladder Diseases
Urologic Diseases