Phase 2
N=8
Prospective Trial Comparing Response to Hyperbaric Oxygen Treatment in Patients With Interstitial Cystitis
Interstitial Cystitis
Bottom Line
View on ClinicalTrials.gov: NCT01479725 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcome: Primary: Global Response Assessment (GRA) — 0; 1; 1; 0 number of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- HBOT (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Kenneth Peters, MD
- Primary completion
- Aug 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Global Response Assessment (GRA) |
0; 1; 1; 0; 4; 0 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01479725). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.