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

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

      • 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.

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

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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