Incontinence, Overactive Bladder, Stress Urinary IncontinenceNCT01227447
Investigation of the Suburothelial Myofibroblast Network and of Smooth Muscle Function and Control in the Human Urinary Outflow Tract
An observational study of Incontinence, Overactive Bladder, Stress Urinary Incontinence, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
Trial summary
The aim is to find out if adreno-muscarinic synergy is present also in human tissues of the urinary outflow tract that have a dual adrenergic-muscarinic receptor fitting. To further characterise morphology and function of the suburothelial myofibroblast network in the human bladder outlet. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Incontinence, Overactive Bladder, Stress Urinary Incontinence
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2010to not given
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Human tissue from the urinary outflow tract (bladder base and urethra) of patients undergoing cystectomy or radical prostatectomy (for cancer treatment) with pre-operatively documented voiding disorders/incontinence - in particular SUI
Who may be able to join
- Tissue will be collected from the operation theatre only after having obtained the patient´s consent and in strictest accordance with histopathological requirements, i.e. after assessment of resection margins. It might be necessary to retrieve the tissue from the pathologist after first pathological assessment is completed. Tissue will be placed in Tyrode´s solution, gassed with 95 % O2 and 5 % CO2, for functional and RT-PCR or Western blot experiments, or in OCT (optimal cutting temperature) compound, snap-frozen in liquid nitrogen, and stored in a -80°C freezer until cutting for immunohistochemical experiments.
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Ludwig Maximilians University Munich, Dep Urology
Munich, 81377
Roosen, +49-89-7095 ext. 0
About this study
Official title: Investigation of the Suburothelial Myofibroblast Network and of Smooth Muscle Function and Control in the Continent and Incontinent Human Urinary Outflow Tract
The aim is to find out if adreno-muscarinic synergy is present also in human tissues of the urinary outflow tract that have a dual adrenergic-muscarinic receptor fitting. To further characterise morphology and function of the suburothelial myofibroblast network in the human bladder outlet.
- Medical subject headings
- Urinary Bladder, Overactive, Urinary Incontinence, Stress
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2010 (estimated)
- Study startJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Incontinence, Overactive Bladder, Stress Urinary IncontinenceStudies 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
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexander Roosen, Ludwig-Maximilians - University of Munich
- Investigators
- Alexander Roosen, PD Dr, Principal investigator, LMU Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01227447
- Sponsor's protocol ID
- RO 3589/2-1
- Status last verified
- Mar 2012
- First submitted
- 22 Oct 2010
- Last updated
- 5 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Walther S, Strittmatter F, Hennenberg M, Gratzke C, Stief CG, Roosen A. Adreno-muscarinic synergy in the male human urinary outflow tract. Neurourol Urodyn. 2018 Sep;37(7):2128-2134. doi: 10.1002/nau.23578. Epub 2018 Apr 20.
PubMed 29675856
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Suburothelial Myofibroblast Network and of Smooth Muscle Function and Control in the Continent and Incontinent Human Urinary Outflow Tract
- ClinicalTrials.gov ID
- NCT01227447
- Acronym / sponsor ID
- RO 3589/2-1
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Study start
- Jan 2010
- First posted
- 25 Oct 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 aim is to find out if adreno-muscarinic synergy is present also in human tissues of the urinary outflow tract that have a dual adrenergic-muscarinic receptor fitting. To further characterise morphology and function of the suburothelial myofibroblast network in the human bladder outlet.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Human tissue from the urinary outflow tract (bladder base and urethra) of patients undergoing cystectomy or radical prostatectomy (for cancer treatment) with pre-operatively documented voiding disorders/incontinence - in particular SUI
Key inclusion criteria (1 listed)
- Tissue will be collected from the operation theatre only after having obtained the patient´s consent and in strictest accordance with histopathological requirements, i.e. after assessment of resection margins. It might be necessary to retrieve the tissue from the pathologist after first pathological assessment is completed. Tissue will be placed in Tyrode´s solution, gassed with 95 % O2 and 5 % CO2, for functional and RT-PCR or Western blot experiments, or in OCT (optimal cutting temperature) compound, snap-frozen in liquid nitrogen, and stored in a -80°C freezer until cutting for immunohistochemical experiments.
Key exclusion criteria (1 listed)
- None.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2012.
- Derived from this study: PubMed 29675856Walther S, Strittmatter F, Hennenberg M, Gratzke C, Stief CG, Roosen A. Adreno-muscarinic synergy in the male human urinary outflow tract. Neurourol Urodyn. 2018 Sep;37(7):2128-2134. doi: 10.1002/nau.23578. Epub 2018 Apr 20.
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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.
Alexander Roosen, PD Dr principal investigator
LMU Munich
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 Incontinence, Overactive Bladder, Stress Urinary Incontinence, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
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 1 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 Mar 2012. 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 Germany. 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 Alexander Roosen, MD (+49-89-7095 ext. 0, alexander.roosen@med.uni-muenchen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01227447, which also lists 1 linked publication.
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 Mar 2012.