Plantarflexion Reduces Urgency and Peak Detrusor Pressure in Patients With Detrusor Overactivity
DO
1 other identifier
interventional
22
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2012
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
April 18, 2013
CompletedFirst Posted
Study publicly available on registry
April 23, 2013
CompletedResults Posted
Study results publicly available
March 11, 2019
CompletedMarch 11, 2019
November 1, 2018
2 months
April 18, 2013
July 30, 2013
November 20, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean Peak Detrusor Pressures
Mean peak detrusor pressures of each contraction
through test completion, an average of 10 minutes
Secondary Outcomes (1)
Severity of the Urgency by a 0-10 Visual Analogue Scale (VAS).
through test completion, an average of 10 minutes
Study Arms (2)
Plantarflexion - 2nd wave
EXPERIMENTALAt the beginning of the 2nd wave, patients will be asked to perform continuous plantar-flexion by pushing their tiptoes against the floor.
Plantarflexion - 3rd wave
EXPERIMENTALAt the beginning of the 3rd wave, patients will be asked to perform continuous plantar-flexion by pushing their tiptoes against the floor.
Interventions
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.
Eligibility Criteria
You may qualify if:
- All patients with urodynamic detrusor overactivity
You may not qualify if:
- Inability to perform plantarflexion due to mental or physical disability
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assaf Harofe Medical Center
Be’er Ya‘aqov, 70300, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Kobi Stav
- Organization
- Assaf Harofhe MC
Study Officials
- PRINCIPAL INVESTIGATOR
Kobi Stav, MD
Assaf Harofe Medical Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 18, 2013
First Posted
April 23, 2013
Study Start
June 1, 2012
Primary Completion
August 1, 2012
Study Completion
August 1, 2012
Last Updated
March 11, 2019
Results First Posted
March 11, 2019
Record last verified: 2018-11