NCT06347380

Brief Summary

The objective of the study is to demonstrate that the FemPulse System can be used as indicated in the Instructions for Use (IFU), as applicable.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2024

Geographic Reach
1 country

2 active sites

Status
completed

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

First Submitted

Initial submission to the registry

March 29, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 4, 2024

Completed
5 months until next milestone

Study Start

First participant enrolled

September 11, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
Last Updated

February 6, 2026

Status Verified

February 1, 2025

Enrollment Period

11 months

First QC Date

March 29, 2024

Last Update Submit

February 4, 2026

Conditions

Overactive Bladder

Keywords

neuromodulation

Outcome Measures

Primary Outcomes (1)

  • Patient Satisfaction

    Proportion of subjects reporting satisfaction with the use of the FemPulse System

    28 days

Study Arms (1)

Subjects receiving FemPulse System

EXPERIMENTAL

Subjects will receive the Ring for the treatment of their OAB symptoms

Device: FemPulse System

Interventions

FemPulse SystemDEVICE

Subjects to receive the FemPulse System consisting of a non-implanted, vaginal electrical stimulation device (Ring) and other patient accessories.

Subjects receiving FemPulse System

Eligibility Criteria

Age21 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemales, defined as a person with a uterus and cervix.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Females, defined as a person with a uterus and cervix, ≥21 years old, with a diagnosis of OAB and symptoms for more than 6 months, as confirmed by a physician
  • Able to read, comprehend, and reliably provide informed consent and study-related information.
  • Willing and able to comply with study required procedures and visits (e.g., maintaining consistent medication use, fluid intake, diary completion).
  • Has adequate cognitive and manual capabilities to operate the FemPulse System and other components (e.g., mobile app) as assessed by the investigator.

You may not qualify if:

  • Currently pregnant, was pregnant in the past 12 months or intending to conceive during the study period.
  • Plans to begin other OAB therapies or otherwise change their existing therapy regimen during the study period.
  • Not an appropriate study candidate as determined by investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Holy Cross Women's Hospital

Fort Lauderdale, Florida, 33334, United States

Location

Univ. of Washington

Seattle, Washington, 98133, United States

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Roshini Jain

    Sponsor GmbH

    STUDY DIRECTOR

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

March 29, 2024

First Posted

April 4, 2024

Study Start

September 11, 2024

Primary Completion

July 31, 2025

Study Completion

July 31, 2025

Last Updated

February 6, 2026

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

US(2)