ACCEPTANCE: Efficacy Study of Pudendal Neuromodulation for the Treatment of Neurogenic Overactive Bladder
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: ON / OFF Stimulation ON for 4 weeks, followed by stimulation OFF for 4 weeks. |
Device: InterStim Therapy
Neuromodulation therapy which delivers low level electrical stimulation to bladder wall for the treatment of overactive bladder with urinary incontinence.
|
| Other: OFF / ON Stimulation OFF for 4 weeks, followed by stimulation ON for 4 weeks. |
Device: InterStim Therapy
Neuromodulation therapy which delivers low level electrical stimulation to bladder wall for the treatment of overactive bladder with urinary incontinence.
|
Outcome Measures
Primary Outcome Measures
- Functional Bladder Capacity [Baseline, 4 weeks after implant, 8 weeks after implant]
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.
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Universitair Ziekenhuis Gent | Gent | Belgium | ||
| 2 | Centre Hospitalier Universitaire de Lyon-Sud | Lyon | France | ||
| 3 | Hôpital de la Pitié Salpétrière | Paris | France | ||
| 4 | Marienhospital Herne, Klinikum der Ruhr-Universitaet Bochum | Herne | Germany | 44627 | |
| 5 | Klinik für Urologie Oberarzt-Sekretaria | Tübingen | Germany | ||
| 6 | Niguarda Ospedale Ca' Granda | Milan | Italy | 20162 | |
| 7 | Academisch Ziekenhuis | Maastricht | Netherlands | ||
| 8 | National Hospital for Neurology and Neurosurgery | London | United Kingdom |
Sponsors and Collaborators
- MedtronicNeuro
Investigators
- Principal Investigator: Michele Spinelli, MD, Ospedale Niguarda Ca' Granda, Milan, Italy
- Principal Investigator: Karel Everaert, MD, University Ghent
- Principal Investigator: Philip Van Kerrebroeck, MD, Academisch Ziekenhuis, Maastricht, The Netherlands
- Principal Investigator: Emmanuel Chartier-Kastler, MD, Hôpital de la Pitié Salpétrière, Paris, France
- Principal Investigator: Arndt Van Ophoven, MD, Marienhospital Herne Klinikum der Ruhr-Universität, Herne, Germany
- Principal Investigator: Karl Sievert, MD, Klinik für Urologie Oberarzt-Sekretariat, Tübingen, Germany
- Principal Investigator: Suzy Elneil, MD, National Hospital for Neurology and Neurosurgery, London, UK
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 1.02.7004
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | 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. |
| Arm/Group Title | ON / OFF | OFF / ON |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Period Title: Overall Study | ||
| STARTED | 3 | 2 |
| COMPLETED | 1 | 2 |
| NOT COMPLETED | 2 | 0 |
Baseline Characteristics
| Arm/Group Title | Total Patient |
|---|---|
| Arm/Group Description | The patient demographic were analysed without splitting by study intervention since all randomized subjects were to receive both stimulation options (ie, ON and OFF)." |
| Overall Participants | 5 |
| Age (year) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [year] |
41.60
(14.81)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
2
40%
|
| Male |
3
60%
|
| Region of Enrollment (participants) [Number] | |
| Belgium |
2
40%
|
| Italy |
1
20%
|
| United Kingdom |
1
20%
|
| France |
1
20%
|
Outcome Measures
| Title | Functional Bladder Capacity |
|---|---|
| Description | 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. |
| Time Frame | Baseline, 4 weeks after implant, 8 weeks after implant |
Outcome Measure Data
| Analysis Population Description |
|---|
| Due the small number of patients in each group, the summary on the functional bladder capacity was provided for the combined groups. |
| Arm/Group Title | All Randomized Patients |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 5 |
| Baseline |
186.02
(38.15)
|
| 4 weeks after impalnt |
367.16
(201.17)
|
| 8 weeks after implant |
346.07
(177.98)
|
Adverse Events
| Time Frame | Adverse event reporting started at enrollment until study completion and/or study exit, an average of 14 months, whatever applies. | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | All Enrolled Patients | |
| Arm/Group Description | 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. | |
All Cause Mortality |
||
| All Enrolled Patients | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/17 (0%) | |
Serious Adverse Events |
||
| All Enrolled Patients | ||
| Affected / at Risk (%) | # Events | |
| Total | 1/17 (5.9%) | |
| Infections and infestations | ||
| Infection of the device stimulator | 1/17 (5.9%) | 1 |
Other (Not Including Serious) Adverse Events |
||
| All Enrolled Patients | ||
| Affected / at Risk (%) | # Events | |
| Total | 7/17 (41.2%) | |
| Infections and infestations | ||
| URINARY INFECTION | 4/17 (23.5%) | 6 |
| Investigations | ||
| Battery empty at 07h30 and return of symptoms | 1/17 (5.9%) | 1 |
| Lead cut by the nurse | 1/17 (5.9%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||
| Bronchitis | 1/17 (5.9%) | 1 |
| Surgical and medical procedures | ||
| pain after surgery | 1/17 (5.9%) | 2 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Alexandra Delacour, Clinical Research Manager |
|---|---|
| Organization | Medtronic International Trading Sarl |
| Phone | 0041218027622 |
| alexandra.delacour@medtronic.com |
- 1.02.7004