Prospective Trial Comparing Response to Hyperbaric Oxygen Treatment in Patients With Interstitial Cystitis

Interstitial Cystitis Clinical Trial

Official title:

A Prospective Trial Comparing the Response to Hyperbaric Oxygen Treatment in Patients With Ulcerative and Non-Ulcerative Interstitial Cystitis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01479725
• Other study ID #: 2010-247
• Status: Active, not recruiting
• Phase: Phase 2
• First received: November 22, 2011
• Last updated: August 12, 2016
• Start date: March 2011
• Est. completion date: December 2016

Study information

• Verified date: August 2016
• Source: William Beaumont Hospitals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

To review the results of Hyperbaric Oxygen therapy (HBOT) on the symptoms of interstitial cystitis (IC). To determine if there is greater symptom improvement in the ulcerative vs the non-ulcerative patients with interstitial cystitis.

Description:

There are multiple published studies outside of the United States on HBOT for treatment of interstitial cystitis. None of these studies compares ulcerative IC and non-ulcerative IC.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: December 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Interstitial cystitis.

• Urinary frequency of at least 8 times per 24 hours period.

• Patients with ulcerative IC must have undergone previous biopsy negative for cancer.

• Patients must agree to not begin any additional treatment for IC until study completion.

Exclusion Criteria:

• Absolute or relative contraindication to hyperbaric oxygen treatment.

• Patients dependent on intermittent catheterization or indwelling catheter to empty bladder.

• Any imminent change in residence, which could compromise compliance.

• Unlikely to be compliant due to unmanaged medical or psychological problems.

• Severe debilitating concurrent medical conditions.

• A history of pelvic radiation, bladder stone, bladder cancer or cancer in situ, or urethral cancer.

• Precious bladder or neurologic surgery which has affected bladder function.

• Currently has an active urethral stone, ureteral stone or urethral diverticulum.

• Subject misses more than 10 treatments.

• Severe claustrophobia.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cystitis
• Cystitis, Interstitial
• Interstitial Cystitis

Intervention

Procedure:
• HBOT
HBOT

Locations

Country	Name	City	State
United States	William Beaumont Hospital	Royal Oak	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Kenneth Peters, MD	William Beaumont Hospitals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global Response Assessment	Patients are asked if since the HBOT their bladder symptoms have been Markedly wose, Moderately worse, Mildly worse, Same, Mildly better, Moderately better, or Markedly better.	3 months	No