Plantarflexion Reduces Urgency and Peak Detrusor Pressure in Patients With Detrusor Overactivity

Not Applicable

Completed

• Conditions: Overactive Detrusor
• Interventions: Behavioral: Plantarflexion - 3rd wave; Behavioral: Plantarflexion 2nd wave

• Registration Number: NCT01837654
• Lead Sponsor: Assaf-Harofeh Medical Center

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

Study Timeline

• Study Start: 2012-06
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Study First Submitted: 2013-04-18
• Study First Submitted QC: 2013-04-18
• Study First Posted: 2013-04-23
• Results First Submitted: 2013-07-30
• Status Verified: 2018-11
• Results First Submitted QC: 2018-11-20
• Last Update Submitted: 2018-11-20
• Results First Posted: 2019-03-11
• Last Update Posted: 2019-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

All patients with urodynamic detrusor overactivity

Exclusion Criteria

Inability to perform plantarflexion due to mental or physical disability

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Plantarflexion - 3rd wave	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.
Plantarflexion - 2nd wave	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.

Primary Outcome Measures

Name	Time	Method
Mean Peak Detrusor Pressures	through test completion, an average of 10 minutes	Mean peak detrusor pressures of each contraction

Secondary Outcome Measures

Name	Time	Method
Severity of the Urgency by a 0-10 Visual Analogue Scale (VAS).	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).

Trial Locations

Locations (1)

Assaf Harofe Medical Center; 🇮🇱 Be'er Ya'aqov, Israel