Trial Outcomes & Findings for Plantarflexion Reduces Urgency and Peak Detrusor Pressure in Patients With Detrusor Overactivity (NCT NCT01837654)

Results Overview

Mean peak detrusor pressures of each contraction

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

22 participants

Primary outcome timeframe

through test completion, an average of 10 minutes

Results posted on

2019-03-11

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	Plantarflexion - 2nd Wave of Contraction 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.	Plantarflexion - 3rd Wave of Contraction 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.
Overall Study STARTED	11	11
Overall Study COMPLETED	11	11
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Plantarflexion - 2nd Wave n=11 Participants 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.	Plantarflexion - 3rd Wave n=11 Participants 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.	Total n=22 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Age, Continuous	66 years STANDARD_DEVIATION 11 • n=5 Participants	68 years STANDARD_DEVIATION 12 • n=7 Participants	67 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Region of Enrollment Israel	11 participants n=5 Participants	11 participants n=7 Participants	22 participants n=5 Participants

PRIMARY outcome

Timeframe: through test completion, an average of 10 minutes

Mean peak detrusor pressures of each contraction

Outcome measures

Outcome measures
Measure	Plantarflexion - 2nd Wave n=11 Participants 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.	Plantarflexion - 3rd Wave n=11 Participants 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.
Mean Peak Detrusor Pressures	58 cm H2O Standard Deviation 14	31 cm H2O Standard Deviation 19

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Plantarflexion - 2nd Wave n=11 Participants 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.	Plantarflexion - 3rd Wave n=11 Participants 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.
Severity of the Urgency by a 0-10 Visual Analogue Scale (VAS).	4.7 units on a scale Standard Error 1.8	4.7 units on a scale Standard Error 1.7

Adverse Events

Plantarflexion - 2nd Wave

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Plantarflexion - 3rd Wave

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Kobi Stav

Assaf Harofhe MC

Phone: 972-8-9779409

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place