- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01837654
Plantarflexion Reduces Urgency and Peak Detrusor Pressure in Patients With Detrusor Overactivity (DO)
November 20, 2018 updated by: Assaf-Harofeh Medical Center
The purpose of this study is to find out whether plantarflexion 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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Patients with urodynamic DO will be included in this study.
During urodynamics, the mean peak detrusor pressures of each contraction will be documented and compared.
At the beginning of the 2nd or 3rd wave, patients will be asked to perform continuous plantar-flexion by pushing their tiptoes against the floor.
Following each wave, patients will be asked to grade the severity of the urgency by a visual analogue scale
Study Type
Interventional
Enrollment (Actual)
22
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Be'er Ya'aqov, Israel, 70300
- Assaf Harofe Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
All patients with urodynamic detrusor overactivity
Exclusion Criteria:
Inability to perform plantarflexion due to mental or physical disability
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Plantarflexion - 2nd wave
At the beginning of the 2nd wave, patients will be asked to perform continuous plantar-flexion by pushing their tiptoes against the floor.
|
At the beginning of the 2nd wave, patients will be asked to perform continuous plantar-flexion by pushing their tiptoes against the floor.
|
Experimental: Plantarflexion - 3rd wave
At the beginning of the 3rd wave, patients will be asked to perform continuous plantar-flexion by pushing their tiptoes against the floor.
|
At the beginning of the 3rd wave, patients will be asked to perform continuous plantar-flexion by pushing their tiptoes against the floor.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Peak Detrusor Pressures
Time Frame: through test completion, an average of 10 minutes
|
Mean peak detrusor pressures of each contraction
|
through test completion, an average of 10 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Severity of the Urgency by a 0-10 Visual Analogue Scale (VAS).
Time Frame: through test completion, an average of 10 minutes
|
Following each wave, patients will be asked to grade the severity of the urgency by a 0 (minimum) to 10 (maximum) visual analogue scale (VAS).
|
through test completion, an average of 10 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kobi Stav, MD, Assaf Harofe Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2012
Primary Completion (Actual)
August 1, 2012
Study Completion (Actual)
August 1, 2012
Study Registration Dates
First Submitted
April 18, 2013
First Submitted That Met QC Criteria
April 18, 2013
First Posted (Estimate)
April 23, 2013
Study Record Updates
Last Update Posted (Actual)
March 11, 2019
Last Update Submitted That Met QC Criteria
November 20, 2018
Last Verified
November 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 76/12
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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