Trial Outcomes & Findings for Efficacy Study of Pudendal Neuromodulation for the Treatment of Neurogenic Overactive Bladder (NCT NCT01023269)

Results Overview

Functional Bladder capacity is measured as the average passed volume per episode, in milliliters, as recorded in the patient's voiding diary during the observation period. Due to the small number of patients in each group, the summary on the functional bladder capacity was provided for the combined groups.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

17 participants

Primary outcome timeframe

Baseline, 4 weeks after implant, 8 weeks after implant

Results posted on

2019-01-31

Participant Flow

17 patients were included in the study: 9 patients did not pass the test stimulation period, 1 patient dropped out due to exclusion criteria, 1 patient dropped out due to protocol deviation during screening visit, 1 patient dropped out before test stimulation due to early termination of the study, leaving 5 patients who were randomized.

Participant milestones

Participant milestones
Measure	ON / OFF Stimulation ON for 4 weeks, followed by stimulation OFF for 4 weeks. InterStim Therapy: Neuromodulation therapy which delivers low level electrical stimulation to bladder wall for the treatment of overactive bladder with urinary incontinence.	OFF / ON Stimulation OFF for 4 weeks, followed by stimulation ON for 4 weeks. InterStim Therapy: Neuromodulation therapy which delivers low level electrical stimulation to bladder wall for the treatment of overactive bladder with urinary incontinence.
Overall Study STARTED	3	2
Overall Study COMPLETED	1	2
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	ON / OFF Stimulation ON for 4 weeks, followed by stimulation OFF for 4 weeks. InterStim Therapy: Neuromodulation therapy which delivers low level electrical stimulation to bladder wall for the treatment of overactive bladder with urinary incontinence.	OFF / ON Stimulation OFF for 4 weeks, followed by stimulation ON for 4 weeks. InterStim Therapy: Neuromodulation therapy which delivers low level electrical stimulation to bladder wall for the treatment of overactive bladder with urinary incontinence.
Overall Study early termination of the study	2	0

Baseline Characteristics

Efficacy Study of Pudendal Neuromodulation for the Treatment of Neurogenic Overactive Bladder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Total Patient n=5 Participants The patient demographic were analysed without splitting by study intervention since all randomized subjects were to receive both stimulation options (ie, ON and OFF)."
Age, Continuous	41.60 year STANDARD_DEVIATION 14.81 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Region of Enrollment Belgium	2 participants n=5 Participants
Region of Enrollment Italy	1 participants n=5 Participants
Region of Enrollment United Kingdom	1 participants n=5 Participants
Region of Enrollment France	1 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 4 weeks after implant, 8 weeks after implant

Population: Due the small number of patients in each group, the summary on the functional bladder capacity was provided for the combined groups.

Functional Bladder capacity is measured as the average passed volume per episode, in milliliters, as recorded in the patient's voiding diary during the observation period. Due to the small number of patients in each group, the summary on the functional bladder capacity was provided for the combined groups.

Outcome measures

Outcome measures
Measure	All Randomized Patients n=5 Participants All randomized patients have been used for the primary objective. Due to the small number of patients in each group, the summary on the functional bladder capacity was provided for the combined groups. Combined groups: * group ON/OFF :Stimulation ON for 4 weeks, followed by stimulation OFF for 4 weeks * group OFF/ON: Stimulation OFF for 4 weeks, followed by stimulation ON for 4 weeks.
Functional Bladder Capacity Baseline	186.02 ml Standard Deviation 38.15
Functional Bladder Capacity 4 weeks after impalnt	367.16 ml Standard Deviation 201.17
Functional Bladder Capacity 8 weeks after implant	346.07 ml Standard Deviation 177.98

Adverse Events

All Enrolled Patients

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	All Enrolled Patients n=17 participants at risk Adverse events in this study were reported on the 17 enrolled patients. Due to the small number of patients in each group, the summary on adverse events was provided for the combined groups.
Infections and infestations Infection of the device stimulator	5.9% 1/17 • Number of events 1 • Adverse event reporting started at enrollment until study completion and/or study exit, an average of 14 months, whatever applies.

Other adverse events

Other adverse events
Measure	All Enrolled Patients n=17 participants at risk Adverse events in this study were reported on the 17 enrolled patients. Due to the small number of patients in each group, the summary on adverse events was provided for the combined groups.
Infections and infestations URINARY INFECTION	23.5% 4/17 • Number of events 6 • Adverse event reporting started at enrollment until study completion and/or study exit, an average of 14 months, whatever applies.
Surgical and medical procedures pain after surgery	5.9% 1/17 • Number of events 2 • Adverse event reporting started at enrollment until study completion and/or study exit, an average of 14 months, whatever applies.
Respiratory, thoracic and mediastinal disorders Bronchitis	5.9% 1/17 • Number of events 1 • Adverse event reporting started at enrollment until study completion and/or study exit, an average of 14 months, whatever applies.
Investigations Battery empty at 07h30 and return of symptoms	5.9% 1/17 • Number of events 1 • Adverse event reporting started at enrollment until study completion and/or study exit, an average of 14 months, whatever applies.
Investigations Lead cut by the nurse	5.9% 1/17 • Number of events 1 • Adverse event reporting started at enrollment until study completion and/or study exit, an average of 14 months, whatever applies.

Additional Information

Alexandra Delacour, Clinical Research Manager

Medtronic International Trading Sarl

Phone: 0041218027622

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place