Overactive DetrusorNCT01408771
"Swallow my Urine Back" : Inhibition of Detrusor Overactivity by Swallowing Maneuver
An observational study of Overactive Detrusor, run by Assaf-Harofeh Medical Center.
Trial summary
The purpose of this study is to find out whether swallowing has an effect on the degree of urinary urgency and on the amplitude of detrusor contraction during filling cystometry in patients with detrusor overactivity (DO). Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Overactive Detrusor
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Apr 2011to Jul 2011
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are sedignated for urodynamic study with overactive bladder symptoms
Who may be able to join
- patients with DO in filling cystometry
- antimuscarinic medications were requested to stop for 7 days before the cystometry
Who cannot join
None listed.
About this study
The purpose of this study is to find out whether swallowing has an effect on the degree of urinary urgency and on the amplitude of detrusor contraction during filling cystometry in patients with detrusor overactivity (DO).
Read the detailed description
Consecutive patients with DO will be included in this study. During urodynamics, the amplitude of the waves of DO will be documented and compared. At the beginning of the 2nd wave, patients will be asked to perform 5 repetitive swallows. Following each wave, patients will be asked to grade the severity of the urgency by a visual analogue scale (VAS).
- Conditions
- Overactive Detrusor
- Keywords
- Urodynamics, Overactive Bladder
- Medical subject headings
- Urinary Bladder, Overactive
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2011 (estimated)
- Study startApr 2011
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive DetrusorStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Investigators
- Kobi Stav, MD, Principal investigator, Assaf Harofeh Medical Center, Zeriffin, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01408771
- Sponsor's protocol ID
- 35/11
- Status last verified
- Jul 2011
- First submitted
- 2 Aug 2011
- Last updated
- 9 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Swallow my Urine Back" : Inhibition of Detrusor Overactivity by Swallowing Maneuver
- ClinicalTrials.gov ID
- NCT01408771
- Acronym / sponsor ID
- 35/11
- Conditions
- Overactive Detrusor
- Keywords
- Urodynamics, Overactive Bladder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- Apr 2011
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 3 Aug 2011 (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 find out whether swallowing has an effect on the degree of urinary urgency and on the amplitude of detrusor contraction during filling cystometry in patients with detrusor overactivity (DO).
Detailed description
Consecutive patients with DO will be included in this study. During urodynamics, the amplitude of the waves of DO will be documented and compared. At the beginning of the 2nd wave, patients will be asked to perform 5 repetitive swallows. Following each wave, patients will be asked to grade the severity of the urgency by a visual analogue scale (VAS).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are sedignated for urodynamic study with overactive bladder symptoms
Key inclusion criteria (2 listed)
- patients with DO in filling cystometry
- antimuscarinic medications were requested to stop for 7 days before the cystometry
Key exclusion criteria (0 listed)
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
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2011.
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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.
Kobi Stav, MD principal investigator
Assaf Harofeh Medical Center, Zeriffin, Israel
Questions about this trial
What is this clinical trial studying?
An observational study of Overactive Detrusor, run by Assaf-Harofeh Medical Center.
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 2 inclusion and 0 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: finished, as of the sponsor's last update on 9 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 9 Aug 2011.