RECRUITING

Sacral Neuromodulation for Male Overactive Bladder (MOAB)

Conditions

Overactive Bladder Urinary Urgency Incontinence Benign Prostatic Hyperplasia Prostate Cancer Prostatectomy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

To assess the post-market clinical outcomes of the Axonics SNM System for treatment of overactive bladder in male patients.

Official Title

Sacral Neuromodulation for Male Overactive Bladder

Quick Facts

Study Start:2024-10-01

Study Completion:2027-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06511141

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Participants aged ≥ 18 years at the time of enrollment 2. Able to complete bladder diaries and patient questionnaires 3. Primary diagnosis of Urinary Urgency Incontinence (UUI) 4. Willing and capable to provide written informed consent and agrees to comply with specified evaluations at clinical investigational sites and attend all follow-up assessments for up to 1 year 5. Underwent prostatectomy for prostate cancer at least 6 months prior to enrollment 6. Underwent radiation therapy for prostate cancer at least 6 months prior to enrollment 7. Underwent cytoreductive surgical intervention for BPH at least 6 months prior to enrollment	1. Any patient that is not a suitable candidate per investigator discretion 2. Recent prostate therapy or procedure within the last 6 months at the time of enrollment 3. Any neurological condition that could interfere with normal bladder function, including stroke, epilepsy, multiple sclerosis, Parkinson's disease, clinically significant peripheral neuropathy, or spinal cord injury (e.g., paraplegia) 4. Previously implanted with a sacral neuromodulation device, including inactive SNM devices 5. Any prior treatment with an Implantable Tibial Nerve Stimulation (ITNS) 6. Percutaneous Tibial Nerve Stimulation (PTNS) within the last 3 months at the time of enrollment 7. Underwent an external trial with any sacral neuromodulation device and was deemed a non-responder by a physician 8. Any significant medical condition that is likely to interfere with study procedures, device operation, or likely to confound evaluation of study objectives (e.g. Crohn's disease, moderate to severe fibromyalgia, chronic pain) 9. Uncontrolled diabetes 10. Known allergic reactions to components of the Axonics SNM System, including titanium, zirconia, polyurethane, epoxy, or silicone

Inclusion Criteria

Exclusion Criteria

1. Participants aged ≥ 18 years at the time of enrollment
2. Able to complete bladder diaries and patient questionnaires
3. Primary diagnosis of Urinary Urgency Incontinence (UUI)
4. Willing and capable to provide written informed consent and agrees to comply with specified evaluations at clinical investigational sites and attend all follow-up assessments for up to 1 year
5. Underwent prostatectomy for prostate cancer at least 6 months prior to enrollment
6. Underwent radiation therapy for prostate cancer at least 6 months prior to enrollment
7. Underwent cytoreductive surgical intervention for BPH at least 6 months prior to enrollment

1. Any patient that is not a suitable candidate per investigator discretion
2. Recent prostate therapy or procedure within the last 6 months at the time of enrollment
3. Any neurological condition that could interfere with normal bladder function, including stroke, epilepsy, multiple sclerosis, Parkinson's disease, clinically significant peripheral neuropathy, or spinal cord injury (e.g., paraplegia)
4. Previously implanted with a sacral neuromodulation device, including inactive SNM devices
5. Any prior treatment with an Implantable Tibial Nerve Stimulation (ITNS)
6. Percutaneous Tibial Nerve Stimulation (PTNS) within the last 3 months at the time of enrollment
7. Underwent an external trial with any sacral neuromodulation device and was deemed a non-responder by a physician
8. Any significant medical condition that is likely to interfere with study procedures, device operation, or likely to confound evaluation of study objectives (e.g. Crohn's disease, moderate to severe fibromyalgia, chronic pain)
9. Uncontrolled diabetes
10. Known allergic reactions to components of the Axonics SNM System, including titanium, zirconia, polyurethane, epoxy, or silicone

Contacts and Locations

Study Contact

Gita Ghadimi, OD

CONTACT

949-510-1505

Gita.Ghadimi@axonics.com

Erum Shaikh

CONTACT

714-686-3644

Erum.Shaikh@axonics.com

Principal Investigator

Karen Noblett, MD

STUDY_DIRECTOR

Axonics, Inc.

Study Locations (Sites)

WK Clinical Research

Shreveport, Louisiana, 71103

United States

Collaborators and Investigators

Sponsor: Axonics, Inc.

Karen Noblett, MD, STUDY_DIRECTOR, Axonics, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-01

Study Completion Date2027-03

Study Record Updates

Study Start Date2024-10-01

Study Completion Date2027-03

Terms related to this study

Additional Relevant MeSH Terms

Overactive Bladder
Urinary Urgency Incontinence
Benign Prostatic Hyperplasia
Prostate Cancer
Prostatectomy