Interstitial CystitisNCT01069263
Comparative Study Between Hyperbaric Therapy and Intravesical Dimethyl Sulfoxide Instillation for Interstitial Cystitis
A study testing Hyperbaric Oxygen Therapy and DMSO in people with Interstitial Cystitis, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial summary
The purpose of this study is to compare the efficacy of hyperbaric oxygen therapy (HBOT) to intravesical Dimethyl Sulfoxide (DMSO) instillation for the treatment of patients who suffers from Interstitial Cystitis / Painful bladder syndrome. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Interstitial Cystitis
- What is being tested?
- Hyperbaric Oxygen Therapy and DMSO
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2010to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- NIDDK diagnosis of interstitial cystitis
Who cannot join
- Previous treatment of hyperbaric therapy
- Contraindication for hyperbaric therapy (mid-ear pathology, abnormal chest X-ray, Claustrophobia, pregnancy
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Assaf Harofe Medical Center
Zeriffin, 70300
Kobi Stav, MD, +972-577346778, stavkobi@yahoo.com.au
Shay Efrati, MD, +972-577346364, efratishai@013.net
About this study
Official title: Comparison Between Hyperbaric Oxygen Therapy (HBOT) and Intravesical Dimethyl Sulfoxide (DMSO) Instillation for the Treatment of Interstitial Cystitis - a Prospective, Randomized Cross-over Trial
The purpose of this study is to compare the efficacy of hyperbaric oxygen therapy (HBOT) to intravesical Dimethyl Sulfoxide (DMSO) instillation for the treatment of patients who suffers from Interstitial Cystitis / Painful bladder syndrome.
Read the detailed description
Interstitial cystitis / painful bladder syndrome (IC/PBS) presents as a pelvic pain condition associated with urinary urgency and frequency. These symptoms impair significantly the patient's quality of life. The etiology is yet not obvious. The current acceptable theory is injury or dysfunction of the Mucus (Glycosaminoglycans) layer that covers the inner surface of the urinary bladder. Abnormal diffusion of toxins from the urine to the walls of the bladder leads to inflammation, pain and scarring.
Many types of treatments were described but most of them were not evaluated in well designed randomized controlled studies. For now, there is no one single treatment that gives good outcome to every patient. Therefore, the treatment of patients with IC/PBS is challenging. In this study, we will compare the efficacy of hyperbaric oxygen therapy (HBOT) to intravesical dimethyl sulfoxide (DMSO) instillation for the treatment of patients who suffers from IC/PBS.
Patients with IC (NIDDK criteria) will be randomized to have either DMSO instillation or HBOT.
Before and after treatments the patients will fill out questionnaires (O'Leary-Sant Interstitial Cystitis Symptom and Problem Index), visual analogue scale for pain and bladder diaries. In addition, urodynamics will be performed before and after treatments. In case of incomplete symptoms remission, patients will be crossed over to have the other treatment.
- Conditions
- Interstitial Cystitis
- Being tested
- Hyperbaric Oxygen Therapy, DMSO
- Keywords
- Interstitial cystitis, Painful bladder syndrome, Chronic pelvic pain, DMSO, Hyperbaric oxygen therapy
- Medical subject headings
- Cystitis, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric Oxygen TherapyOther
Also called HBOT, Hyperbaric chamber, Hyperbaric therapy
60 treatments (12 weeks - 5 days a week) of hyperbaric (pressure of 2 atmospheres) with 100% oxygen inhalation.
DMSODrug
Also called dimethyl sulfoxide
50 mls of 50% DMSO instilled once a week to the urinary bladder for 12 consecutive weeks.
| Study group | Role | What they receive |
|---|---|---|
| Intravesical DMSO instillation | Active comparator | 50 mls of 50% DMSO instilled once a week to the urinary bladder for 12 consecutive weeks. Receives: Drug: DMSO |
| Hyperbaric Oxygen Therapy (HBOT) | Experimental | Overall 60 treatments (5 days per weeks for 12 weeks). 90 minutes every session. Pressure of 2 atm. Inhalation of 100% oxygen. Receives: Other: Hyperbaric Oxygen Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective improvement will be assessed by several questionnaires: the Oleary Sant symptom index score, bladder diary, 1-10 visual analogue scale for pain, PSQ4 questionnaire
Measured: 1-4 weeks post treatment
Secondary outcomes (1)
Objective improvement will be assessed by urodynamic test. The following parameters will be addressed: cystometric capacity, 1st sensation, normal sensation
Measured: 1-4 weeks post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionMar 2015 (estimated)
- Study completionJul 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Interstitial CystitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Investigators
- Kobi Stav, MD, Principal investigator, Assaf Harofe Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01069263
- Sponsor's protocol ID
- 04/10
- Status last verified
- Feb 2010
- First submitted
- 10 Jan 2010
- Last updated
- 5 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Perez-Marrero R, Emerson LE, Feltis JT. A controlled study of dimethyl sulfoxide in interstitial cystitis. J Urol. 1988 Jul;140(1):36-9. doi: 10.1016/s0022-5347(17)41478-9.
PubMed 3288775van Ophoven A, Rossbach G, Oberpenning F, Hertle L. Hyperbaric oxygen for the treatment of interstitial cystitis: long-term results of a prospective pilot study. Eur Urol. 2004 Jul;46(1):108-13. doi: 10.1016/j.eururo.2004.03.002.
PubMed 15183555
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Hyperbaric Oxygen Therapy (HBOT) and Intravesical Dimethyl Sulfoxide (DMSO) Instillation for the Treatment of Interstitial Cystitis - a Prospective, Randomized Cross-over Trial
- ClinicalTrials.gov ID
- NCT01069263
- Acronym / sponsor ID
- 04/10
- Conditions
- Interstitial Cystitis
- Keywords
- Interstitial cystitis, Painful bladder syndrome, Chronic pelvic pain, DMSO, Hyperbaric oxygen therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- Feb 2010
- Primary completion
- Mar 2015 (estimated)
- Study completion
- Jul 2015 (estimated)
- First posted
- 17 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the efficacy of hyperbaric oxygen therapy (HBOT) to intravesical Dimethyl Sulfoxide (DMSO) instillation for the treatment of patients who suffers from Interstitial Cystitis / Painful bladder syndrome.
Detailed description
Interstitial cystitis / painful bladder syndrome (IC/PBS) presents as a pelvic pain condition associated with urinary urgency and frequency. These symptoms impair significantly the patient's quality of life. The etiology is yet not obvious. The current acceptable theory is injury or dysfunction of the Mucus (Glycosaminoglycans) layer that covers the inner surface of the urinary bladder. Abnormal diffusion of toxins from the urine to the walls of the bladder leads to inflammation, pain and scarring.
Many types of treatments were described but most of them were not evaluated in well designed randomized controlled studies. For now, there is no one single treatment that gives good outcome to every patient. Therefore, the treatment of patients with IC/PBS is challenging. In this study, we will compare the efficacy of hyperbaric oxygen therapy (HBOT) to intravesical dimethyl sulfoxide (DMSO) instillation for the treatment of patients who suffers from IC/PBS.
Patients with IC (NIDDK criteria) will be randomized to have either DMSO instillation or HBOT.
Before and after treatments the patients will fill out questionnaires (O'Leary-Sant Interstitial Cystitis Symptom and Problem Index), visual analogue scale for pain and bladder diaries. In addition, urodynamics will be performed before and after treatments. In case of incomplete symptoms remission, patients will be crossed over to have the other treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravesical DMSO instillation | Active comparator | Drug: DMSO50 mls of 50% DMSO instilled once a week to the urinary bladder for 12 consecutive weeks. |
| Hyperbaric Oxygen Therapy (HBOT) | Experimental | Other: Hyperbaric Oxygen TherapyOverall 60 treatments (5 days per weeks for 12 weeks). 90 minutes every session. Pressure of 2 atm. Inhalation of 100% oxygen. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- NIDDK diagnosis of interstitial cystitis
Key exclusion criteria (2 listed)
- Previous treatment of hyperbaric therapy
- Contraindication for hyperbaric therapy (mid-ear pathology, abnormal chest X-ray, Claustrophobia, pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperbaric Oxygen TherapyAlso: HBOT, Hyperbaric chamber, Hyperbaric therapy60 treatments (12 weeks - 5 days a week) of hyperbaric (pressure of 2 atmospheres) with 100% oxygen inhalation. | Other | Hyperbaric Oxygen Therapy (HBOT) |
| DMSOAlso: dimethyl sulfoxide50 mls of 50% DMSO instilled once a week to the urinary bladder for 12 consecutive weeks. | Drug | Intravesical DMSO instillation |
Primary outcome
Subjective improvement will be assessed by several questionnaires: the Oleary Sant symptom index score, bladder diary, 1-10 visual analogue scale for pain, PSQ4 questionnaire
Time frame: 1-4 weeks post treatment
1 secondary outcome
Objective improvement will be assessed by urodynamic test. The following parameters will be addressed: cystometric capacity, 1st sensation, normal sensation
Time frame: 1-4 weeks post treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2011.
- Background: PubMed 3288775Perez-Marrero R, Emerson LE, Feltis JT. A controlled study of dimethyl sulfoxide in interstitial cystitis. J Urol. 1988 Jul;140(1):36-9. doi: 10.1016/s0022-5347(17)41478-9.
- Results publication: PubMed 15183555van Ophoven A, Rossbach G, Oberpenning F, Hertle L. Hyperbaric oxygen for the treatment of interstitial cystitis: long-term results of a prospective pilot study. Eur Urol. 2004 Jul;46(1):108-13. doi: 10.1016/j.eururo.2004.03.002.
- International Painful Bladder FoundationLink provided by the sponsor.
- Interstitial Cystitis AssociationLink provided by the sponsor.
Related trials for Interstitial Cystitis
Enrolling by invitationObservational study
Migraine Medication Effects on Urinary Symptoms
Overactive Bladder, Bladder Pain Syndrome
Recruiting
EPPIC: Easing Pelvic Pain Interventions Clinical Research Program
Urologic Chronic Pelvic Pain Syndrome (UCPPS), Interstitial Cystitis
Recruiting
Investigation of PEMF Therapy for Female Patients With IC/BPS
Interstitial Cystitis, Chronic Interstitial Cystitis
Recruiting
Aerobic Exercise and Connective Tissue Massage in Painful Bladder Syndrome
Bladder Pain Syndrome, Painful Bladder Syndrome
RecruitingPhase 2/3
Amniotic Membrane Therapy for Interstitial Cystitis/Painful Bladder Syndrome
Interstitial Cystitis, Painful Bladder Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kobi Stav, MD principal investigator
Assaf Harofe Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyperbaric Oxygen Therapy and DMSO in people with Interstitial Cystitis, run by Assaf-Harofeh Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kobi Stav, MD (+972-89779400, stavkobi@yahoo.com.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective improvement will be assessed by several questionnaires: the Oleary Sant symptom index score, bladder diary, 1-10 visual analogue scale for pain, PSQ4 questionnaire (time frame: 1-4 weeks post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01069263, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2011.