FemPulse Therapy First-in-Human Experience

NCT03874637 | Completed FDA Device

• 1 other identifier: CIP-001
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this clinical trial is to investigate a new medical device treatment for Overactive Bladder (OAB) in women.

Conditions

Urinary Bladder, Overactive

Keywords

Overactive Bladder; Women; Neuromodulation; Bioelectronic Medicine; Non-significant Risk

Outcome Measures

Primary Outcomes (2)

• Adverse Events

  All device- and procedure-related adverse events will be collected and tabulated

  3 days in total

• Placeability and comfort of the device

  Subjects will be observed for their ability to place, orient and wear the device without discomfort. The outcome is Pass or Fail as determined by the investigator.

  3 days in total

Secondary Outcomes (3)

• Frequency of urinary voids

  3 days in total

• Intervals between urinary voids

  3 days in total

• Urge urinary incontinence (UUI)

  3 days in total

Study Arms (2)

Treatment

EXPERIMENTAL

Active therapy

Device: Treament

Sham Control

SHAM COMPARATOR

Sham Control

Device: Sham Control

Interventions

Treament DEVICE

Placement of the FemPulse System with therapy delivery

Treatment

Sham Control DEVICE

Placement of the FemPulse System without therapy delivery

Sham Control

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Females ≥21 yrs with Overactive Bladder

You may not qualify if:

• Is or was recently pregnant
• Has a metal pelvic implant or any electrically active implanted medical device
• Has a urinary tract or vaginal infection
• Had a previous hysterectomy, pelvic radiation or pelvic cancer
• Has significant pelvic organ prolapse
• Had bladder treatment with onabotulinumtoxinA in the previous 12 months or Tibial Nerve stimulation within the previous 30 days
• Has a significant heart condition or a history of vasovagal reaction or low blood pressure

Sponsors & Collaborators

• FemPulse Corporation: lead

Study Sites (2)

Minnesota Urology

Woodbury, Minnesota, 55125, United States

Location

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects will be treated at 2 different device settings (one of which is Off) in random sequence during two 6-hour periods at least one week apart.

Study Record Dates

• First Submitted: March 4, 2019
• First Posted: March 14, 2019
• Study Start: February 14, 2017
• Primary Completion: May 17, 2017
• Study Completion: May 17, 2017
• Last Updated: March 14, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)