Interstitial CystitisNCT00253006
Analysis of Expression of Nitric Oxide Syntheses and Their Functional Role in Human Urothelium
An observational study of Interstitial Cystitis and Bladder Diseases, run by Copenhagen University Hospital at Herlev at 1 site in Denmark.
Trial summary
Painful bladder syndrome (PBS)/interstitial cystitis (IC) may be due to the actions of nitric oxide (NO) in the bladder tissue. NO is a gaseous substance with a very short half-life, synthesized by a group of NO-synthase-enzymes in many tissues. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Interstitial Cystitis, Bladder Diseases, Urinary Incontinence
- What is being tested?
- Tissue examination for protein- and mRNA-expression of NO
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2006to Jan 2008
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PBS/IC according to International Continence Society (ICS)
- Cystoscopy with bladder distension and deep biopsies within last 5 years
- Cystometry within last 5 years
- Normal urine culture within last month
- Benign non-invasive bladder disease
- No PBS/IC
- Normal urine culture
- No functional bladder disease of known nature (ex. infravesical obstruction)
Who cannot join
- Age under 18 years
- Inability to understand instructions
- Pregnancy and lactation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Quantitative Analysis of Protein- and mRNA-Expression of Nitric Oxide Syntheses and Their Functional Role in Human Urothelium
Painful bladder syndrome (PBS)/interstitial cystitis (IC) may be due to the actions of nitric oxide (NO) in the bladder tissue. NO is a gaseous substance with a very short half-life, synthesized by a group of NO-synthase-enzymes in many tissues.
The goal of this study is to illuminate bladder tissue production of NO in individuals with PBS and healthy individuals, by quantification of NO and NO-enzyme expression by different molecular biological methods.
- Being tested
- Tissue examination for protein- and mRNA-expression of NO
- Keywords
- NO, mRNA-expression, pathophysiology, painful bladder syndrome
- Medical subject headings
- Cystitis, Interstitial, Urinary Bladder Diseases, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tissue examination for protein- and mRNA-expression of NOProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2005 (estimated)
- Study startJan 2006
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Observational
- Observational model
- Defined population
- Time perspective
- Other
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital at Herlev
- Sponsor type
- University, hospital or other
- Collaborators
- Zealand University Hospital
- Investigators
- Pierre Bouchelouche, MD, Study director, Roskilde County University Hospital at Koege, Dept. of Clinical Biochemistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00253006
- Sponsor's protocol ID
- UA_H_Ka-05104-m
- Status last verified
- Oct 2006
- First submitted
- 11 Nov 2005
- Last updated
- 9 Oct 2006
- Results posted
- No
Publications
Birder LA, Wolf-Johnston A, Buffington CA, Roppolo JR, de Groat WC, Kanai AJ. Altered inducible nitric oxide synthase expression and nitric oxide production in the bladder of cats with feline interstitial cystitis. J Urol. 2005 Feb;173(2):625-9. doi: 10.1097/01.ju.0000145900.22849.1d.
PubMed 15643277Bouchelouche K, Nordling J. Recent developments in the management of interstitial cystitis. Curr Opin Urol. 2003 Jul;13(4):309-13. doi: 10.1097/00042307-200307000-00007.
PubMed 12811295Logadottir YR, Ehren I, Fall M, Wiklund NP, Peeker R, Hanno PM. Intravesical nitric oxide production discriminates between classic and nonulcer interstitial cystitis. J Urol. 2004 Mar;171(3):1148-50; discussion 50-1. doi: 10.1097/01.ju.0000110501.96416.40.
PubMed 14767289
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Quantitative Analysis of Protein- and mRNA-Expression of Nitric Oxide Syntheses and Their Functional Role in Human Urothelium
- ClinicalTrials.gov ID
- NCT00253006
- Acronym / sponsor ID
- UA_H_Ka-05104-m
- Keywords
- NO, mRNA-expression, pathophysiology, painful bladder syndrome
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 60 participants
- Lead sponsor
- Copenhagen University Hospital at HerlevUniversity, hospital or other
- Collaborators
- Zealand University Hospital
- Study start
- Jan 2006
- Study completion
- Jan 2008
- First posted
- 15 Nov 2005 (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.
Painful bladder syndrome (PBS)/interstitial cystitis (IC) may be due to the actions of nitric oxide (NO) in the bladder tissue. NO is a gaseous substance with a very short half-life, synthesized by a group of NO-synthase-enzymes in many tissues.
The goal of this study is to illuminate bladder tissue production of NO in individuals with PBS and healthy individuals, by quantification of NO and NO-enzyme expression by different molecular biological methods.
Study design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- PBS/IC according to International Continence Society (ICS)
- Cystoscopy with bladder distension and deep biopsies within last 5 years
- Cystometry within last 5 years
- Normal urine culture within last month
- Benign non-invasive bladder disease
Key exclusion criteria (3 listed)
- Age under 18 years
- Inability to understand instructions
- Pregnancy and lactation
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 |
|---|---|---|
| Tissue examination for protein- and mRNA-expression of NO | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2006.
- Background: PubMed 15643277Birder LA, Wolf-Johnston A, Buffington CA, Roppolo JR, de Groat WC, Kanai AJ. Altered inducible nitric oxide synthase expression and nitric oxide production in the bladder of cats with feline interstitial cystitis. J Urol. 2005 Feb;173(2):625-9. doi: 10.1097/01.ju.0000145900.22849.1d.
- Background: PubMed 12811295Bouchelouche K, Nordling J. Recent developments in the management of interstitial cystitis. Curr Opin Urol. 2003 Jul;13(4):309-13. doi: 10.1097/00042307-200307000-00007.
- Background: PubMed 14767289Logadottir YR, Ehren I, Fall M, Wiklund NP, Peeker R, Hanno PM. Intravesical nitric oxide production discriminates between classic and nonulcer interstitial cystitis. J Urol. 2004 Mar;171(3):1148-50; discussion 50-1. doi: 10.1097/01.ju.0000110501.96416.40.
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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.
Pierre Bouchelouche, MD study director
Roskilde County University Hospital at Koege, Dept. of Clinical Biochemistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Interstitial Cystitis and Bladder Diseases, run by Copenhagen University Hospital at Herlev at 1 site in Denmark.
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 8 inclusion and 3 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: stopped early, as of the sponsor's last update on 9 Oct 2006. 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 Denmark. 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?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00253006, which also lists 3 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 9 Oct 2006.