Overactive Detrusor
Conditions
Keywords
Detrusor Overactivity, Plantarflexion, Urgency
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
Interventions
BEHAVIORALPlantarflexion 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.
BEHAVIORALPlantarflexion - 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.
Sponsors
Assaf-Harofeh Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
All patients with urodynamic detrusor overactivity
Exclusion criteria
Inability to perform plantarflexion due to mental or physical disability
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Peak Detrusor Pressures | through test completion, an average of 10 minutes | Mean peak detrusor pressures of each contraction |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
Israel
Participant flow
Recruitment details
Ninety three consecutive patients underwent multichannel urodynamic study. All patients were referred for urodynamics in order to evaluate lower urinary tract symptoms. Twenty seven were diagnosed with DO. Twenty two patients were included in the study and comprised the study cohort. Five patients were excluded due to physical disability.
Pre-assignment details
Twenty seven patients were diagnosed with DO. Twenty two patients were included in the study and comprised the study cohort. Five patients were excluded due to physical disability.
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 11 |
| 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 - 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. | 11 |
| Total | 22 |
Baseline characteristics
| Characteristic | Plantarflexion - 3rd Wave | Plantarflexion - 2nd Wave | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 7 Participants | 7 Participants | 14 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants | 4 Participants | 8 Participants |
| Age, Continuous | 68 years STANDARD_DEVIATION 12 | 66 years STANDARD_DEVIATION 11 | 67 years STANDARD_DEVIATION 11 |
| Region of Enrollment Israel | 11 participants | 11 participants | 22 participants |
| Sex: Female, Male Female | 5 Participants | 5 Participants | 10 Participants |
| Sex: Female, Male Male | 6 Participants | 6 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 11 |
| other Total, other adverse events | 0 / 11 | 0 / 11 |
| serious Total, serious adverse events | 0 / 11 | 0 / 11 |
Outcome results
Primary
Mean Peak Detrusor Pressures
Mean peak detrusor pressures of each contraction
Time frame: through test completion, an average of 10 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Plantarflexion - 2nd Wave | Mean Peak Detrusor Pressures | 58 cm H2O | Standard Deviation 14 |
| Plantarflexion - 3rd Wave | Mean Peak Detrusor Pressures | 31 cm H2O | Standard Deviation 19 |
Secondary
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).
Time frame: through test completion, an average of 10 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Plantarflexion - 2nd Wave | Severity of the Urgency by a 0-10 Visual Analogue Scale (VAS). | 4.7 units on a scale | Standard Error 1.8 |
| Plantarflexion - 3rd Wave | Severity of the Urgency by a 0-10 Visual Analogue Scale (VAS). | 4.7 units on a scale | Standard Error 1.7 |