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# MYOPOWERS - DRY

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- CZ1-01
- CZ1-03-RE
- CZ1-03
- CZ1-04
- CZ1-02
- PL1-01

CZ1 - Fakultní Thomayerova nemocnice vbuzalka - Log out
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CZ1-01 CZ1-02 CZ1-03 CZ1-04 CZ1-03-RE »

# CZ1-01

## H Date of birth : 05/1955 / Center : CZ1 - Fakultní Thomayerova nemocnice

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- 1- CZ1-01 : Subject

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Eligibility Criteria
Eligibility Criteria
4 16/02/2024 Eligibility Criteria
V-3 - Baseline Within 3 weeks before the implant procedure
V-3 : Baseline Within 3 weeks before the implant procedure
4 16/02/2024 V-3 : Baseline Within 3 weeks before the implant procedure
V-3 : Day 1 - Voiding diary
4 22/02/2024 V-3 : Day 1 - Voiding diary
V-3 : Day 2 - Voiding diary
4 23/02/2024 V-3 : Day 2 - Voiding diary
V-3 : Day 3 - Voiding diary
4 24/02/2024 V-3 : Day 3 - Voiding diary
V-3 : ICIQ-MLUTS
4 27/02/2024 V-3 : ICIQ-MLUTS
V-3 : ICIQ-LUTSQol
4 27/02/2024 V-3 : ICIQ-LUTSQol
V-3 : EQ-5D-5L
4 27/02/2024 V-3 : EQ-5D-5L
V-3 : MSHQ
4 27/02/2024 V-3 : MSHQ
V-1 - Phone Call (1 Week before Implantation)
V-1 : Phone Call (1 Week before Implantation)
4 21/02/2024 V-1 : Phone Call (1 Week before Implantation)
V0 - Operative period
V0 : Implantation Visit (or implantation attempt)
4 28/02/2024 V0 : Implantation Visit (or implantation attempt)
DV - Discharge Visit
DV : Discharge Visit
4 05/03/2024 DV : Discharge Visit
V1 - 6 Weeks Post-Operative Period (Device Activation)
V1 : 6 Weeks Post-Operative Period (Device Activation)
4 17/04/2024 V1 : 6 Weeks Post-Operative Period (Device Activation)
V1 : Device Activation
4 17/04/2024 V1 : Device Activation
V1 : Physician Usability Questionnaire
4 17/04/2024 V1 : Physician Usability Questionnaire
V2 - 8 Weeks Post-Operative Period
V2 : 8 Weeks Post-Operative Period
4 24/04/2024 V2 : 8 Weeks Post-Operative Period
V2 : Device Adjustment
4 24/04/2024 V2 : Device Adjustment
V2 : Physician Usability Questionnaire
4 24/04/2024 V2 : Physician Usability Questionnaire
V3 - 3 Months Post-Operative Period
V3 : 3 Months Post-Operative Period
4 16/05/2024 V3 : 3 Months Post-Operative Period
V3 : Device Adjustment
4 16/05/2024 V3 : Device Adjustment
V3 : Physician Usability Questionnaire
4 16/05/2024 V3 : Physician Usability Questionnaire
V4 - Phone Call (10 Weeks after device activation)
V4 - Phone Call (10 Weeks after device activation)
4 26/06/2024 V4 - Phone Call (10 Weeks after device activation)
V5 - 3 Months Post-Device Activation
V5 : 3 Months Post-Device Activation
4 17/07/2024 V5 : 3 Months Post-Device Activation
V5 : Day 1 - Voiding diary
4 14/07/2024 V5 : Day 1 - Voiding diary
V5 : Day 2 - Voiding diary
4 15/07/2024 V5 : Day 2 - Voiding diary
V5 : Day 3 - Voiding diary
4 16/07/2024 V5 : Day 3 - Voiding diary
V5 : Device Adjustment
V5 : Unlocking additional modes
V5 : ICIQ-MLUTS
4 17/07/2024 V5 : ICIQ-MLUTS
V5 : ICIQ-LUTSQol
4 17/07/2024 V5 : ICIQ-LUTSQol
V5 : EQ-5D-5L
4 17/07/2024 V5 : EQ-5D-5L
V5 : MSHQ
4 17/07/2024 V5 : MSHQ
V5 : PGI-I
4 17/07/2024 V5 : PGI-I
V5 : Subject Usability Questionnaire
4 17/07/2024 V5 : Subject Usability Questionnaire
V5 : Physician Usability Questionnaire
4 17/07/2024 V5 : Physician Usability Questionnaire
V6 - Phone Call (22 Weeks after Device activation)
V6 : Phone Call (22 Weeks after Device activation)
4 02/10/2024 V6 : Phone Call (22 Weeks after Device activation)
V7 - 6 Months Post-Device Activation
V7 : 6 Months Post-Device Activation
4 30/10/2024 V7 : 6 Months Post-Device Activation
V7 : Day 1 - Voiding diary
4 26/10/2024 V7 : Day 1 - Voiding diary
V7 : Day 2 - Voiding diary
4 27/10/2024 V7 : Day 2 - Voiding diary
V7 : Day 3 - Voiding diary
4 28/10/2024 V7 : Day 3 - Voiding diary
V7 : Device Adjustment
4 30/10/2024 V7 : Device Adjustment
V7 - Unlocking additional mode
4 05/11/2024 V7 - Unlocking additional mode
V7 : ICIQ-MLUTS
4 30/10/2024 V7 : ICIQ-MLUTS
V7 : ICIQ-LUTSQol
4 30/10/2024 V7 : ICIQ-LUTSQol
V7 : EQ-5D-5L
4 30/10/2024 V7 : EQ-5D-5L
V7 : MSHQ
4 30/10/2024 V7 : MSHQ
V7 : PGI-I
4 30/10/2024 V7 : PGI-I
V7 : Subject Usability Questionnaire
4 30/10/2024 V7 : Subject Usability Questionnaire
V7 : Physician Usability Questionnaire
4 30/10/2024 V7 : Physician Usability Questionnaire
V8 - Phone Call (46 Weeks after Device activation)
V8 : Phone Call (46 Weeks after Device activation)
4 07/04/2025 V8 : Phone Call (46 Weeks after Device activation)
V9 - 12 Months Post-Device Activation
V9 : 12 Months Post-Device Activation
4 24/04/2025 V9 : 12 Months Post-Device Activation
V9 : Day 1 - Voiding diary
4 15/04/2025 V9 : Day 1 - Voiding diary
V9 : Day 2 - Voiding diary
4 16/04/2025 V9 : Day 2 - Voiding diary
V9 : Day 3 - Voiding diary
4 17/04/2025 V9 : Day 3 - Voiding diary
V9 : Device Adjustment
V9 - Unlocking additional mode
V9 : ICIQ-MLUTS
4 15/04/2025 V9 : ICIQ-MLUTS
V9 : ICIQ-LUTSQol
4 15/04/2025 V9 : ICIQ-LUTSQol
V9 : EQ-5D-5L
4 15/04/2025 V9 : EQ-5D-5L
V9 : MSHQ
4 15/04/2025 V9 : MSHQ
V9 : PGI-I
4 15/04/2025 V9 : PGI-I
V9 : Subject Usability Questionnaire
4 15/04/2025 V9 : Subject Usability Questionnaire
V9 : Physician Usability Questionnaire
4 24/04/2025 V9 : Physician Usability Questionnaire
V10 - Long-term Annual Follow-up 2 Years
V10 : Long-term annual Follow-up
0 28/04/2026 V10 : Long-term annual Follow-up
V10 : Device Adjustment
V10 : Unlocking additional modes
V10 : ICIQ-MLUTS
0 24/04/2026 V10 : ICIQ-MLUTS
V10 : ICIQ-LUTSQol
0 24/04/2026 V10 : ICIQ-LUTSQol
V10 : EQ-5D-5L
0 24/04/2026 V10 : EQ-5D-5L
V10 : MSHQ
0 24/04/2026 V10 : MSHQ
V10 : PGI-I
0 24/04/2026 V10 : PGI-I
V10 : Subject Usability Questionnaire
0 24/04/2026 V10 : Subject Usability Questionnaire
V10 : Physician Usability Questionnaire
0 28/04/2026 V10 : Physician Usability Questionnaire
V11 - Long-term Annual Follow-up 3 Years
V11 : Long-term annual Follow-up
V11 : Device Adjustment
V11 : Unlocking additional modes
V11 : ICIQ-MLUTS
V11 : ICIQ-LUTSQol
V11 : EQ-5D-5L
V11 : MSHQ
V11 : PGI-I
V11 : Subject Usability Questionnaire
V11 : Physician Usability Questionnaire
UV - Unscheduled Visits
UV : Unscheduled Visit
4 24/04/2024 UV : Unscheduled Visit
4 30/04/2024 UV : Unscheduled Visit
4 09/05/2024 UV : Unscheduled Visit
4 23/10/2024 UV : Unscheduled Visit
4 05/11/2024 UV : Unscheduled Visit
4 13/11/2024 UV : Unscheduled Visit
4 20/11/2024 UV : Unscheduled Visit
4 27/11/2024 UV : Unscheduled Visit
4 17/12/2024 UV : Unscheduled Visit
0 15/12/2025 UV : Unscheduled Visit
0 31/12/2025 UV : Unscheduled Visit
UV : Voiding diary - Day 1 to Day 3 (if applicable)
4 10/12/2024 UV : Voiding diary - Day 1 to Day 3 (if applicable)
0 22/04/2026 UV : Voiding diary - Day 1 to Day 3 (if applicable)
UV : Device Adjustment
0 30/04/2024 UV : Device Adjustment
0 09/05/2024 UV : Device Adjustment
0 16/05/2024 UV : Device Adjustment
4 23/10/2024 UV : Device Adjustment
4 05/11/2024 UV : Device Adjustment
4 13/11/2024 UV : Device Adjustment
4 20/11/2024 UV : Device Adjustment
4 27/11/2024 UV : Device Adjustment
UV : Unlocking additional modes
4 05/11/2024 UV : Unlocking additional modes
UV : Physician Usability Questionnaire
Concomitant Medication
Concomitant Medication
4 01/2014 Concomitant Medication
4 01/2014 Concomitant Medication
4 01/2014 Concomitant Medication
4 03/2024 Concomitant Medication
4 03/2024 Concomitant Medication
4 03/2024 Concomitant Medication
4 03/2024 Concomitant Medication
4 03/2024 Concomitant Medication
4 03/2024 Concomitant Medication
4 03/2024 Concomitant Medication
Adverse Events
Adverse Event
4 08/03/2024 Adverse Event
4 11/09/2024 Adverse Event
4 16/12/2024 Adverse Event
4 23/02/2025 Adverse Event
4 10/03/2025 Adverse Event
4 28/03/2025 Adverse Event
4 01/07/2025 Adverse Event
0 20/12/2025 Adverse Event
Device Deficiencies
Device Deficiency
4 23/02/2025 Device Deficiency
4 10/03/2025 Device Deficiency
4 01/07/2025 Device Deficiency
4 01/07/2025 Device Deficiency
0 20/12/2025 Device Deficiency
Deviations
Deviation
Subsequent surgeries
Subsequent surgery
4 11/09/2024 Subsequent surgery
End of study
End of study
Forms
4 Concomitant Medication01/2014
4 Concomitant Medication01/2014
4 Concomitant Medication01/2014
4 V-3 : Baseline Within 3 weeks before the implant procedure16/02/2024
4 Eligibility Criteria16/02/2024
4 V-1 : Phone Call (1 Week before Implantation)21/02/2024
4 V-3 : Day 1 - Voiding diary22/02/2024
4 V-3 : Day 2 - Voiding diary23/02/2024
4 V-3 : Day 3 - Voiding diary24/02/2024
4 V-3 : MSHQ27/02/2024
4 V-3 : EQ-5D-5L27/02/2024
4 V-3 : ICIQ-LUTSQol27/02/2024
4 V-3 : ICIQ-MLUTS27/02/2024
4 V0 : Implantation Visit (or implantation attempt)28/02/2024
4 Concomitant Medication03/2024
4 Concomitant Medication03/2024
4 Concomitant Medication03/2024
4 Concomitant Medication03/2024
4 Concomitant Medication03/2024
4 Concomitant Medication03/2024
4 Concomitant Medication03/2024
4 DV : Discharge Visit05/03/2024
4 Adverse Event08/03/2024
4 V1 : Physician Usability Questionnaire17/04/2024
4 V1 : Device Activation17/04/2024
4 V1 : 6 Weeks Post-Operative Period (Device Activation)17/04/2024
4 UV : Unscheduled Visit24/04/2024
4 V2 : Physician Usability Questionnaire24/04/2024
4 V2 : Device Adjustment24/04/2024
4 V2 : 8 Weeks Post-Operative Period24/04/2024
0 UV : Device Adjustment30/04/2024
4 UV : Unscheduled Visit30/04/2024
0 UV : Device Adjustment09/05/2024
4 UV : Unscheduled Visit09/05/2024
0 UV : Device Adjustment16/05/2024
4 V3 : Physician Usability Questionnaire16/05/2024
4 V3 : Device Adjustment16/05/2024
4 V3 : 3 Months Post-Operative Period16/05/2024
4 V4 - Phone Call (10 Weeks after device activation)26/06/2024
3 months : 02/07/2024 - 30/07/2024
4 V5 : Day 1 - Voiding diary14/07/2024
4 V5 : Day 2 - Voiding diary15/07/2024
4 V5 : Day 3 - Voiding diary16/07/2024
4 V5 : Physician Usability Questionnaire17/07/2024
4 V5 : Subject Usability Questionnaire17/07/2024
4 V5 : PGI-I17/07/2024
4 V5 : MSHQ17/07/2024
4 V5 : EQ-5D-5L17/07/2024
4 V5 : ICIQ-LUTSQol17/07/2024
4 V5 : ICIQ-MLUTS17/07/2024
4 V5 : 3 Months Post-Device Activation17/07/2024
4 Subsequent surgery11/09/2024
4 Adverse Event11/09/2024
6 months : 14/09/2024 - 13/11/2024
4 V6 : Phone Call (22 Weeks after Device activation)02/10/2024
4 UV : Device Adjustment23/10/2024
4 UV : Unscheduled Visit23/10/2024
4 V7 : Day 1 - Voiding diary26/10/2024
4 V7 : Day 2 - Voiding diary27/10/2024
4 V7 : Day 3 - Voiding diary28/10/2024
4 V7 : Physician Usability Questionnaire30/10/2024
4 V7 : Subject Usability Questionnaire30/10/2024
4 V7 : PGI-I30/10/2024
4 V7 : MSHQ30/10/2024
4 V7 : EQ-5D-5L30/10/2024
4 V7 : ICIQ-LUTSQol30/10/2024
4 V7 : ICIQ-MLUTS30/10/2024
4 V7 : Device Adjustment30/10/2024
4 V7 : 6 Months Post-Device Activation30/10/2024
4 UV : Unlocking additional modes05/11/2024
4 UV : Device Adjustment05/11/2024
4 UV : Unscheduled Visit05/11/2024
4 V7 - Unlocking additional mode05/11/2024
4 UV : Device Adjustment13/11/2024
4 UV : Unscheduled Visit13/11/2024
4 UV : Device Adjustment20/11/2024
4 UV : Unscheduled Visit20/11/2024
4 UV : Device Adjustment27/11/2024
4 UV : Unscheduled Visit27/11/2024
4 UV : Voiding diary - Day 1 to Day 3 (if applicable)10/12/2024
4 Adverse Event16/12/2024
4 UV : Unscheduled Visit17/12/2024
4 Device Deficiency23/02/2025
4 Adverse Event23/02/2025
4 Device Deficiency10/03/2025
4 Adverse Event10/03/2025
12 months : 13/03/2025 - 17/05/2025
4 Adverse Event28/03/2025
4 V8 : Phone Call (46 Weeks after Device activation)07/04/2025
4 V9 : Subject Usability Questionnaire15/04/2025
4 V9 : PGI-I15/04/2025
4 V9 : MSHQ15/04/2025
4 V9 : EQ-5D-5L15/04/2025
4 V9 : ICIQ-LUTSQol15/04/2025
4 V9 : ICIQ-MLUTS15/04/2025
4 V9 : Day 1 - Voiding diary15/04/2025
4 V9 : Day 2 - Voiding diary16/04/2025
4 V9 : Day 3 - Voiding diary17/04/2025
4 V9 : Physician Usability Questionnaire24/04/2025
4 V9 : 12 Months Post-Device Activation24/04/2025
4 Device Deficiency01/07/2025
4 Device Deficiency01/07/2025
4 Adverse Event01/07/2025
0 UV : Unscheduled Visit15/12/2025
0 Device Deficiency20/12/2025
0 Adverse Event20/12/2025
0 UV : Unscheduled Visit31/12/2025
2 years : 12/01/2026 - 16/07/2026
0 UV : Voiding diary - Day 1 to Day 3 (if applicable)22/04/2026
0 V10 : Subject Usability Questionnaire24/04/2026
0 V10 : PGI-I24/04/2026
0 V10 : MSHQ24/04/2026
0 V10 : EQ-5D-5L24/04/2026
0 V10 : ICIQ-LUTSQol24/04/2026
0 V10 : ICIQ-MLUTS24/04/2026
0 V10 : Physician Usability Questionnaire28/04/2026
0 V10 : Long-term annual Follow-up28/04/2026
3 years : 12/01/2027 - 16/07/2027
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# 4 Device Deficiency - 23/02/2025

## Device Deficiency

Date of Onset 23/02/2025
Date device deficiency discovered by site 04/03/2025
Title of device deficiency
1 - Type of Device Deficiency Malfunction (failure of device to operate as intended when used per IFU and protocol)
Specify other type of device deficiency
2 - Description of Event Patient reported to site device malfunction. Device switched to emergency regime and kept being permanently open. It is not possible to control device. The sponsor informed abou the deficiency immediately. Patient has no pain, no urine retention, as per X-ray, positioning of control unit and cuff is correct.
3 - Information about Device(s) (name, lot and serial number) Remote control 052300185, control unit 210011, cuff 22-0224
4 - Consequence of Device Deficiency Led to adverse event
Lead to AE number

## Action(s) taken

Action(s) taken Other

### Other action(s)

If other action(s), specify Implementation of the new sofware leading to continence, time to activation emergency regime increased from 8 to 12hours

## Event Outcome

Event Outcome Resolved without Sequelae
Event End Date 07/04/2025

2025-03-12 11:21:35 : Created / Signed HanaFiserova Fiserová Hana
2025-03-12 11:22:22 : Modified HanaFiserova Fiserová Hana
2025-03-12 11:24:15 : Modified/ Signed HanaFiserova Fiserová Hana
2025-03-22 22:08:03 : Modified HanaFiserova Fiserová Hana
2025-04-17 10:11:55 : Modified HanaFiserova Fiserová Hana
2025-09-01 18:06:54 : Modified/ Signed HanaFiserova Fiserová Hana
2025-09-01 18:10:54 : Modified/ Accepted vbuzalka Buzalka Vladimir

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