Treatment for Cystitis, Interstitial

Phase-Based Estimates
1
Effectiveness
1
Safety
University of New Mexico, Albuquerque, NM
Cystitis, Interstitial+2 More
Treatment - Behavioral
Eligibility
18+
Female
Eligible conditions
Cystitis, Interstitial

Study Summary

This study is evaluating whether a combination of mindfulness and yoga may help improve pain and function for individuals with interstitial cystitis.

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Eligible Conditions

  • Cystitis, Interstitial
  • Cystitis
  • Interstitial Cystitis

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Treatment will improve 1 primary outcome and 1 secondary outcome in patients with Cystitis, Interstitial. Measurement will happen over the course of 3 months.

3 months
Global Response Assessment
O'Leary-Sant Symptom and Problem Index

Trial Safety

Trial Design

2 Treatment Groups

Control
Treatment

This trial requires 120 total participants across 2 different treatment groups

This trial involves 2 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

TreatmentThis is an individual treatment program devised by a pelvic floor physical therapist including a daily yoga series and mindfulness via a Smartphone app.
Control
Other
These are participants undergoing regular treatment for interstitial cystitis with their providers
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Treatment
2013
Completed Phase 3
~13430

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 3 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 3 months for reporting.

Closest Location

University of New Mexico - Albuquerque, NM

Eligibility Criteria

This trial is for female patients aged 18 and older. There are 8 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
IC/BPS diagnosis
English or Spanish reading/writing
Own a Smartphone and able to watch online yoga tutorials
Ability/willingness to participate in follow up questionnaires
Female
>=Age 18
ICSI/ICPI >6 at baseline
Physical exam in the past 2 years by urogynecology or gynecologist

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is treatment safe for people?

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Routine treatment is unlikely to cause harm in the community; however, there is little prospect of benefit for people who have risk factors for recurrent infections.

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How many people get cystitis, interstitial a year in the United States?

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About 250,000 cases of bladder infection in people >5 years of age and 25,000 cases in children and adults are reported in year 2000 annually.

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What are common treatments for cystitis, interstitial?

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Urine tests for leukocyturia and bacterial contamination in urine should reassure the patient that they do not require antibiotics. For patients who develop persistent cystitis, some clinicians are increasingly recommending surgical removal or biopsy of the abscess.

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What causes cystitis, interstitial?

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The causes of interstitial cystitis are diverse and may include bacterial, viral, autoimmune, and idiopathic diseases. Current research suggests bladder infections and a history of urinary tract infections are important factors.

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What is cystitis, interstitial?

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Data from a recent study indicates an important relationship between cystitis and interstitial cystitis, and points toward the necessity to provide careful evaluation in these patients, especially in order to reduce the chance of misdiagnosis leading to inappropriate, potentially burdensome treatment.

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What are the signs of cystitis, interstitial?

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The combination of urinary signs of infection with signs of interstitial cystitis may suggest the possibility of a more serious condition. Urinary signs of infection should be evaluated.

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Can cystitis, interstitial be cured?

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Recent findings, we show that it is safe to treat patients with cystitis, interstitial with antibiotic treatment on a daily basis. In some cases, the therapy needs to be prolonged or changed, depending on symptoms and progress.

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Does cystitis, interstitial run in families?

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A direct family relationship between CIII and other urological disorders is suggested, which implicates that cystitis, interstitial is a non-genetic urological disorder which can be transmitted from family to family. We suggest that cystitis, interstitial may be caused by an intra-urolological factor and cystitis, interstitial run in families are a new kind of urinary disorders.

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Does treatment improve quality of life for those with cystitis, interstitial?

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The treatment of cystitis, interstitial, leads to significant improvements in quality of life. The improvement is more significant for female patients and the patients with worse symptoms at the beginning of treatment. However, in male patients, the symptomatic score was not affected by the treatment.

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What does treatment usually treat?

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Most reported treatments for EI and CCF seem to be relatively straightforward in terms of the treatments that are actually used. The treatment regimens prescribed by gynaecologists in this study were typical of the gynaecological treatment of CCF and were generally consistent with the gynaecological treatments of EI in the preceding literature.

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How does treatment work?

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The use of antibiotics in children with uncomplicated bladder infections reduced by 30% the rate of febrile urinary tract infection in the next year. A similar benefit occurred for those with the bacterial species that were most often encountered. A randomized controlled trial of antibiotics must be considered as a control group and not as a treatment.

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Who should consider clinical trials for cystitis, interstitial?

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The benefits of clinical trials may be more applicable among specific populations, such as women with recurrent or new-onset interstitial cystitis, as opposed to those with existing interstitial cystitis.

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