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Dietary Impact on Urinary pH in Women With Interstitial Cystitis

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: NCT03041194
Recruitment Status : Completed
First Posted : February 2, 2017
Last Update Posted : September 25, 2017
Information provided by (Responsible Party):
Rosemary Catanzaro, RD, St. Louis University

Brief Summary:
This is a pilot study on subjects who suffer from Interstitial Cystitis (IC) to assess the dietary affects on urine pH in relation to their symptoms. The goal of this pilot study is to determine which foods/beverages affect urinary pH and exacerbate patient's symptoms.

Condition or disease Intervention/treatment
Interstitial Cystitis Other: dietary affects

Detailed Description:
Interstitial cystitis or painful bladder syndrome is a condition that is chronic and often debilitating in nature. Interstitial cystitis is commonly defined by symptoms of urinary urgency and frequency associated with pelvic pain. Around one million men and women in the United States and Europe suffer from this condition. The diagnosis of Interstitial Cystitis is one of exclusion based on cystoscopy findings and clinical symptoms. Common symptoms of Interstitial Cystitis include urinary frequency, urinary urgency, dysuria, and pain in the lower abdominal region, bladder, vagina, urethra, or in the perinea . Women between ages 40 and 60 are the most commonly affect by Interstitial Cystitis. In the Nurses' Healthy Study I and II the prevalence of Interstitial Cystitis was 52-67 individuals out of 100,000. There is no single cause of Interstitial Cystitis however, there are several known theories to the cause of Interstitial Cystitis. A popular hypothesis is that a defect in the glycosaminoglycan layer of the bladder epithelium allows leakage and absorption of urinary solutes. The major solute that is responsible for causing bladder symptoms when the epithelium is injured is potassium. The long held notion is that patients with Interstitial Cystitis should avoid acidic foods. This logic is largely based on anecdotal data and questionnaires of foods, beverages and supplements that increase symptoms. Controversy exists that Interstitial Cystitis diet restricts many more foods than necessary in an attempt to decrease Interstitial Cystitis symptoms. Current questionnaires-based data suggest eliminating tomatoes, citrus fruits, vitamin C, artificial sweeteners, carbonated and alcoholic beverages, and spicy foods which are thought to exacerbate symptoms, while calcium glycerophosphate and sodium bicarbonate may improve symptoms. Though the literature review, the investigators did not find any analytical studies that correlated diet with Interstitial Cystitis symptoms or that the ingestion of acidic foods exacerbate Interstitial Cystitis symptoms. Based on the lack of analytical data and the impact of acidic food on IC symptoms this study is going to evaluate the potential renal acid load and net acid excretion of foods to determine which foods change urinary pH.

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Study Type : Observational
Actual Enrollment : 17 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Title A Pilot Study to Evaluate the Dietary Impact on Urinary pH in Interstitial Cystitis Pilot Study to Evaluate the Dietary Impact on Urinary pH in Interstitial Cystitis
Actual Study Start Date : January 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

Intervention Details:
  • Other: dietary affects
    Dietary affects on urine pH in relation to Interstitial cystitis symptoms

Primary Outcome Measures :
  1. The impact of urinary pH [ Time Frame: 1 year ]
    urinary pH.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
female, all backgrounds and races

Inclusion Criteria:

  • Women, diagnosed with Interstitial Cystitis or with a presumptive clinical diagnosis of IC
  • New IC patients who agree to hydrodistention and cystoscopy, the standard of care for diagnosis of IC

Exclusion Criteria:

  • Subjects who are diagnosed with Fibromyalgia Syndrome and subjects that are pregnant.

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): NCT03041194

Sponsors and Collaborators
St. Louis University
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Principal Investigator: Rosemary Catanzaro, MS RD St. Louis University
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Responsible Party: Rosemary Catanzaro, RD, Principal Investigator, St. Louis University Identifier: NCT03041194    
Other Study ID Numbers: 25300
First Posted: February 2, 2017    Key Record Dates
Last Update Posted: September 25, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Cystitis, Interstitial
Urinary Bladder Diseases
Urologic Diseases