FemPulse Therapy for Overactive Bladder in Women

NCT03784170 | Completed FDA Device

• 1 other identifier: CIP-002
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 3

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; OAB; Women; Neuromodulation; Bioelectronic Medicine

Outcome Measures

Primary Outcomes (8)

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

  Adverse events

  Approximately 11 days in total

• Urinary frequency

  Frequency of and intervals between urinary voids (voids per day and time between voids)

  Approximately 11 days in total

• Urinary urgency

  Presence or absence of urgency with each void

  Approximately 11 days in total

• Urge urinary incontinence (UUI)

  Presence or absence of UUI with each void

  Approximately 11 days in total

• OAB-q - Short Form

  OAB bother quality of life questionnaire

  Approximately 11 days in total

• OAB Symptom Score

  OAB symptoms quality of life questionnaire

  Approximately 11 days in total

• Urogenital Distress Inventory - Short Form

  OAB-related distress quality of life questionnaire

  Approximately 11 days in total

• Incontinence Impact Questionnaire - Short Form

  Impact of OAB quality of life questionnaire

  Approximately 11 days in total

Study Arms (2)

Treatment

EXPERIMENTAL

FemPulse System at one device setting

Device: FemPulse System

Control

SHAM COMPARATOR

FemPulse System at a different device setting

Device: FemPulse System

Interventions

FemPulse System DEVICE

Device therapy with the FemPulse System

Control; Treatment

Eligibility Criteria

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

You may qualify if:

• Females 21 years or older with a diagnosis of Overactive Bladder
• If of reproductive age, must use a reliable form of contraception

You may not qualify if:

• Pregnant, was recently pregnant or is trying to conceive
• Has a metal pelvic implant or any electrically active implanted medical device
• Had a previous hysterectomy, pelvic radiation or pelvic cancer
• Has significant pelvic organ prolapse
• Had bladder treatment with onabotulinumtoxinA in the previous 12 months
• Has a significant heart condition

Sponsors & Collaborators

• FemPulse Corporation: lead

Study Sites (3)

Minnesota Urology

Woodbury, Minnesota, 55125, United States

Location

McKay Urology

Charlotte, North Carolina, 28207, 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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects will wear a device and will be treated at 1 of 2 device settings for approximately 3 days.

Study Record Dates

• First Submitted: December 14, 2018
• First Posted: December 21, 2018
• Study Start: December 11, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: February 6, 2026

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)