Back to resultsPlantarflexion Reduces Urgency and Peak Detrusor Pressure in Patients With Detrusor Overactivity (DO)
Primary Purpose
Overactive Detrusor
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Plantarflexion 2nd wave
Plantarflexion - 3rd wave
Sponsored by
About this trial
This is an interventional treatment trial for Overactive Detrusor focused on measuring Detrusor Overactivity, Plantarflexion, Urgency
Eligibility Criteria
Inclusion Criteria:
All patients with urodynamic detrusor overactivity
Exclusion Criteria:
Inability to perform plantarflexion due to mental or physical disability
Sites / Locations
- Assaf Harofe Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Plantarflexion - 2nd wave
Plantarflexion - 3rd wave
Arm Description
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 3rd wave, patients will be asked to perform continuous plantar-flexion by pushing their tiptoes against the floor.
Outcomes
Primary Outcome Measures
Mean Peak Detrusor Pressures
Mean peak detrusor pressures of each contraction
Secondary Outcome Measures
Severity of the Urgency by a 0-10 Visual Analogue Scale (VAS).
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).
Full Information
NCT ID
NCT01837654
First Posted
April 18, 2013
Last Updated
November 20, 2018
Sponsor
Assaf-Harofeh Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01837654
Brief Title
Plantarflexion Reduces Urgency and Peak Detrusor Pressure in Patients With Detrusor Overactivity
Acronym
DO
Official Title
Plantarflexion Reduces Urgency and Peak Detrusor Pressure in Patients With Detrusor Overactivity
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assaf-Harofeh Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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).
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Detrusor
Keywords
Detrusor Overactivity, Plantarflexion, Urgency
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Plantarflexion - 2nd wave
Arm Type
Experimental
Arm Description
At the beginning of the 2nd wave, patients will be asked to perform continuous plantar-flexion by pushing their tiptoes against the floor.
Arm Title
Plantarflexion - 3rd wave
Arm Type
Experimental
Arm Description
At the beginning of the 3rd wave, patients will be asked to perform continuous plantar-flexion by pushing their tiptoes against the floor.
Intervention Type
Behavioral
Intervention Name(s)
Plantarflexion 2nd wave
Intervention Description
At the beginning of the 2nd wave, patients will be asked to perform continuous plantar-flexion by pushing their tiptoes against the floor.
Intervention Type
Behavioral
Intervention Name(s)
Plantarflexion - 3rd wave
Intervention Description
At the beginning of the 3rd wave, patients will be asked to perform continuous plantar-flexion by pushing their tiptoes against the floor.
Primary Outcome Measure Information:
Title
Mean Peak Detrusor Pressures
Description
Mean peak detrusor pressures of each contraction
Time Frame
through test completion, an average of 10 minutes
Secondary Outcome Measure Information:
Title
Severity of the Urgency by a 0-10 Visual Analogue Scale (VAS).
Description
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).
Time Frame
through test completion, an average of 10 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All patients with urodynamic detrusor overactivity
Exclusion Criteria:
Inability to perform plantarflexion due to mental or physical disability
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kobi Stav, MD
Organizational Affiliation
Assaf Harofe Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assaf Harofe Medical Center
City
Be'er Ya'aqov
ZIP/Postal Code
70300
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Plantarflexion Reduces Urgency and Peak Detrusor Pressure in Patients With Detrusor Overactivity
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