Acontractile BladderNCT00970242
Ambulatory Urodynamic Evaluation of Sacral Neuromodulation for Non-Obstructive Urinary Retention
An observational study of Acontractile Bladder, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Ambulatory Urodynamic measurement on patients with diminished or absent bladder contractility before and after trial with Sacral Neuromodulation therapy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acontractile Bladder
- How many people
- 25 participants
- Where
- 1 siteNetherlands
- Study dates
- Aug 2009to Jan 2012
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with diminished or absent bladder contraction
Who may be able to join
- Patients with diminished or absent bladder contraction
Who cannot join
- Prior Neuromodulation therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ambulatory Urodynamic Evaluation of Sacral Neuromodulation for Non-obstructive Urinary Retention
Ambulatory Urodynamic measurement on patients with diminished or absent bladder contractility before and after trial with Sacral Neuromodulation therapy.
- Conditions
- Acontractile Bladder
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2009 (estimated)
- Study startAug 2009
- Primary completionJan 2012 (estimated)
- Study completionJan 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acontractile BladderStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- 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
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Sajjad Rahnama'i, MD, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00970242
- Sponsor's protocol ID
- MEC 09-4-053
- Status last verified
- Sep 2009
- First submitted
- 1 Sep 2009
- Last updated
- 4 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ambulatory Urodynamic Evaluation of Sacral Neuromodulation for Non-obstructive Urinary Retention
- ClinicalTrials.gov ID
- NCT00970242
- Acronym / sponsor ID
- MEC 09-4-053
- Conditions
- Acontractile Bladder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Jan 2012 (estimated)
- Study completion
- Jan 2012 (estimated)
- First posted
- 2 Sep 2009 (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.
Ambulatory Urodynamic measurement on patients with diminished or absent bladder contractility before and after trial with Sacral Neuromodulation therapy.
Study design
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with diminished or absent bladder contraction
Key inclusion criteria (1 listed)
- Patients with diminished or absent bladder contraction
Key exclusion criteria (1 listed)
- Prior Neuromodulation therapy
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 4 Sep 2009.
Related trials for Acontractile Bladder
Not yet recruitingObservational study
Long-Term Effectiveness and Safety of Sacral Neuromodulation With InterStim for Lower Urinary Tract Dysfunction
Overactive Bladder (OAB), Urgency Urinary Incontinence
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.
Sajjad Rahnama'i, MD principal investigator
Maastricht University Medical Center
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 Acontractile Bladder, run by Maastricht University Medical Center at 1 site in Netherlands.
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 4 Sep 2009. 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 Netherlands. 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?
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?
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 4 Sep 2009.