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Efficacy Study of Pudendal Neuromodulation for the Treatment of Neurogenic Overactive Bladder (ACCEPTANCE)

Primary Purpose

Neurogenic Overactive Bladder, Urinary Incontinence, Detrusor Overactivity

Status

Terminated

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

InterStim Therapy

About this trial

This is an interventional treatment trial for Neurogenic Overactive Bladder focused on measuring Neurogenic overactive bladder, Urinary incontinence due to incomplete spinal cord injury, Neuromodulation, Neuromodulation for treatment of neurogenic overactive bladder, Patients with Urge urinary incontinence and detrusor overactivity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Incomplete upper motor neuron lesion
Detrusor overactivity
Two leaks or two notices of leaks per day
Mean functional bladder capacity (volume voided per episode) of ≥100 ml

Exclusion Criteria:

Complete spinal lesion or complete bilateral lesion of sacral / pudendal nerves.
Degenerative disease of the central nervous system

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

ON / OFF

OFF / ON

Arm Description

Stimulation ON for 4 weeks, followed by stimulation OFF for 4 weeks.

Stimulation OFF for 4 weeks, followed by stimulation ON for 4 weeks.

Outcomes

Primary Outcome Measures

Functional Bladder Capacity

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01023269

First Posted

November 30, 2009

Last Updated

January 30, 2019

Sponsor

MedtronicNeuro

1. Study Identification

Unique Protocol Identification Number

NCT01023269

Brief Title

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

Acronym

ACCEPTANCE

Official Title

Phase IV, Multi-center, Randomized, Cross-over Study to Demonstrate the Efficacy of Pudendal Neuromodulation for the Treatment of Neurogenic Overactive Bladder

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Terminated

Why Stopped

difficulty in the enrolment

Study Start Date

December 2009 (undefined)

Primary Completion Date

June 2012 (Actual)

Study Completion Date

June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

MedtronicNeuro

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The study is designed to demonstrate that treatment with low level stimulation of the bladder muscles reduces symptoms of urinary incontinence in comparison with no stimulation.

Detailed Description

The Medtronic InterStim device delivers stimulation therapy for the treatment of chronic intractable (functional) disorders of the pelvis and lower urinary or intestinal tract through the sacral nerve or the pudendal nerve systems. This trial is designed to demonstrate that neuromodulation of the pudendal nerve will effectively treat patients with neurogenic overactive bladder. Symptoms of urinary incontinence are compared when stimulation is switched on for 4 weeks to stimulation switched off for 4 weeks. After the eight week crossover period, all patients receive treatment and are followed up within the study for 12 months post implant.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neurogenic Overactive Bladder, Urinary Incontinence, Detrusor Overactivity

Keywords

Neurogenic overactive bladder, Urinary incontinence due to incomplete spinal cord injury, Neuromodulation, Neuromodulation for treatment of neurogenic overactive bladder, Patients with Urge urinary incontinence and detrusor overactivity

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

17 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ON / OFF

Arm Type

Other

Arm Description

Stimulation ON for 4 weeks, followed by stimulation OFF for 4 weeks.

Arm Title

OFF / ON

Arm Type

Other

Arm Description

Stimulation OFF for 4 weeks, followed by stimulation ON for 4 weeks.

Intervention Type

Device

Intervention Name(s)

InterStim Therapy

Intervention Description

Neuromodulation therapy which delivers low level electrical stimulation to bladder wall for the treatment of overactive bladder with urinary incontinence.

Primary Outcome Measure Information:

Title

Functional Bladder Capacity

Description

Time Frame

Baseline, 4 weeks after implant, 8 weeks after implant

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Incomplete upper motor neuron lesion Detrusor overactivity Two leaks or two notices of leaks per day Mean functional bladder capacity (volume voided per episode) of ≥100 ml Exclusion Criteria: Complete spinal lesion or complete bilateral lesion of sacral / pudendal nerves. Degenerative disease of the central nervous system

Overall Study Officials: