|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
11 January 2021 |
|
Main ID: |
NCT03693001 |
|
Date of registration:
|
28/09/2018 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
HBOT for Patients With IC/FM (Interstitial Cystitis/Fibromyalgia)
IC/FMHBOT |
|
Scientific title:
|
Clinical and Morphological Effects of Hyperbaric Oxygen Therapy in Patients With Interstitial Cystitis Associated With Fibromyalgia |
|
Date of first enrolment:
|
June 1, 2016 |
|
Target sample size:
|
12 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT03693001 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Screening. Masking: None (Open Label).
|
|
Phase:
|
N/A
|
|
|
Contacts
|
|
Name:
|
Gerardo Bosco, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
University of Padova |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Presence of absence of Hunner's ulcers
- Pain in bladder that improves with urination
- pain(supra-pubic, pelvic, urethral, vaginal, or perineal)
- presence of glomerulation or bleeding +/- at the cystodistension
- reduced capacity
- increased proprioceptive sensitivity
- normal or reduced compliance
- number of tender points that establish that diagnosis
Exclusion Criteria:
- Pregnancy (diagnosed or within a year)
- age less than 18 years
- benign or malignant bladder tumors
- radiation cystitis
- symptomatic bladder diversions
- herpes in active phase
- bladder and urethral stones
- urinary frequency less than 10 times a day
- presence of symptoms less than 12 months
- bladder capacity>400ml with no sensitive urgency
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Interstitial Cystitis
|
|
Fibromyalgia
|
|
Intervention(s)
|
|
Device: Intermittent Exposure to Oxygen via Oro-Nasal Mask
|
|
Primary Outcome(s)
|
|
Bladder Capacity
[Time Frame: 1-3 months after completing procedure]
|
|
Bladder Capacity (as part of symptoms)
[Time Frame: 1-3 months after completing procedure]
|
|
Pain symptoms in IC patients
[Time Frame: 1-3 months after completing procedure]
|
|
Frequency of Urination
[Time Frame: 1-3 months after completing procedure]
|
|
Secondary ID(s)
|
|
HEC-DSB 07/16 Padua, It
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|