NCT06789406

Brief Summary

Post-market clinical follow-up for continued assessment of safety and performance to confirm long-term outcomes of the Axonics SNM System INS Model 5101.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
65mo left

Started Sep 2025

Longer than P75 for not_applicable

Geographic Reach
2 countries

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress11%
Sep 2025Oct 2031

First Submitted

Initial submission to the registry

January 17, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 23, 2025

Completed
8 months until next milestone

Study Start

First participant enrolled

September 18, 2025

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
4.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2031

Last Updated

April 15, 2026

Status Verified

April 1, 2026

Enrollment Period

1.3 years

First QC Date

January 17, 2025

Last Update Submit

April 13, 2026

Conditions

Urinary Urge Incontinence (UUI)Urinary Frequency (UF)Overactive Bladder (OAB)

Outcome Measures

Primary Outcomes (2)

  • Performance/Effectiveness - Improvement in Qualify of Life scoring (OAB)

    To demonstrate an improvement in Overactive Bladder Quality of Life using the International Consultation of Incontinence Questionnaire Overactive Bladder Qualify of Life (ICIQ-OABqol): questions in each subscale are scored by a summed range of 0 to 100, with a higher score indicating better quality of life. Overall score ≥ 10 points from baseline to follow-up is indicative of a clinically meaningful improvement.

    3 months

  • Adverse event reporting (Safety)

    Device related, procedure-related and all serious adverse events

    3 months

Secondary Outcomes (2)

  • Performance/Effectiveness - Improvement in Qualify of Life scoring (OAB)

    12 months

  • Performance/Effectiveness - Improvement in Qualify of Life scoring (FI)

    12 months

Study Arms (1)

Overactive Bladder

OTHER

Participants with the Axonics SNM System Model 5101 and followed up regarding their overactive bladder symptoms.

Device: Axonics SNM System INS Model 5101 (R20)

Interventions

Axonics SNM System INS Model 5101 (R20)DEVICE

Participants treated with the rechargeable Axonics SNM System Model 5101 also referred to as R20. Commercial devices used in this study are within their intended use as described in each geography's approved instructions for use.

Overactive Bladder

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or older
  • Primary indication of OAB (urinary urgency incontinence (UUI) / urinary frequency (UF) who are not candidates for, or who have failed conservative treatment
  • Willing and capable to provide written consent and agrees to comply with specified evaluations at clinical centers for all follow-up assessments

You may not qualify if:

  • Any significant medical condition that is likely to interfere with procedures, device operation, or likely to confound evaluation of endpoints (i.e., neurological conditions such as multiple sclerosis)
  • Any psychiatric or personality disorder that is likely to interfere with procedures at the discretion of the participating physician; this may include poor understanding or compliance with requirements
  • Previously underwent an external sacral neuromodulation SNM trial and was deemed a non-responder or was previously implanted with a sacral neuromodulation device and did not get therapeutic benefit (a non-responder)
  • History of allergic response to titanium, zirconia, polyurethane, epoxy, or silicone
  • A female who is breastfeeding
  • A female with a positive urine pregnancy test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University of Chicago

Chicago, Illinois, 60637, United States

RECRUITING

Bradford Royal Infirmary

Bradford, West Yorkshire, BD96RJ, United Kingdom

RECRUITING

Pinderfields Hospital

Wakefield, West Yorkshire, WF1 4DG, United Kingdom

RECRUITING

University College London Hospital

London, W1G 8PH, United Kingdom

RECRUITING

MeSH Terms

Conditions

Urinary Incontinence, UrgeUrinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary IncontinenceUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsUrinary Bladder Diseases

Study Officials

  • Mahreen Pakzad, MD

    University College London Hospitals

    PRINCIPAL INVESTIGATOR

  • Gita Ghadimi, OD

    Boston Scientific Corporation

    STUDY DIRECTOR

Central Study Contacts

Anna Selverian

CONTACT

714-262-1787anna.selverian@bsci.com

Erum Shaikh

CONTACT

657-626-4310Erum.Shaikh@bsci.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2025

First Posted

January 23, 2025

Study Start

September 18, 2025

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

October 1, 2031

Last Updated

April 15, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)GB(3)