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CompletedNCT03874637Updated Mar 14, 2019

FemPulse Therapy First-in-Human Experience

An interventional study of Treament and Sham Control in Urinary Bladder, Overactive, sponsored by FemPulse Corporation. Completed at 2 sites in United States. Open to female participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2019-03-14.

Sponsored by FemPulse Corporation · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was May 2017, 9 years 5 months ago, and no results have been posted to the registry.
  • Registered 2 years after the study started (first participant enrolled Feb 2017, registered Mar 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Randomized
Ages
21 Years and older
Sex
Female
01

Study summary

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

Read the detailed description

The FemPulse System is a vaginal ring intended to provide mild electrical stimulation to nerves in the lower abdomen that regulate bladder function. It is believed that stimulation of these nerves may help relieve the symptoms of OAB.

02

Conditions studied

  • Urinary Bladder, Overactive

Keywords

  • Overactive Bladder
  • Women
  • Neuromodulation
  • Bioelectronic Medicine
  • Non-significant Risk
03

In context

Urinary Bladder, Overactive

858 studies on the registry are indexed under Urinary Bladder, Overactive; 127 are open to participants now.

This study's enrollment of 15 is below the median of 70 across 649 interventional studies indexed under Urinary Bladder, Overactive.

Browse Urinary Bladder, Overactive studies →

Lead sponsor

FemPulse Corporation is the lead sponsor of 6 studies on the registry; 1 is open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Females ≥21 yrs with Overactive Bladder

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
15 participants (actual)

Study arms

  • Experimental
    Treatment

    Active therapy

    Device: Treament

  • Sham comparator
    Sham Control

    Sham Control

    Device: Sham Control

Interventions

  • DeviceTreament

    Placement of the FemPulse System with therapy delivery

  • DeviceSham Control

    Placement of the FemPulse System without therapy delivery

06

What researchers measure

Primary outcomes

  1. Adverse Events

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

    Time frame: 3 days in total

  2. 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.

    Time frame: 3 days in total

Secondary outcomes

  1. Frequency of urinary voids

    The number of voids per day will be tabulated

    Time frame: 3 days in total

  2. Intervals between urinary voids

    The time between voids (hours:minutes) will be tabulated

    Time frame: 3 days in total

  3. Urge urinary incontinence (UUI)

    Presence or absence of UUI with each void

    Time frame: 3 days in total

07

Study locations

2 sites
  • Minnesota Urology
    Woodbury, Minnesota 55125, United States
  • University of Washington Medical Center
    Seattle, Washington 98195, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2017 to primary completion in May 2017, 3 months.

Of 41 industry-sponsored interventional studies with no phase under Urinary Bladder, Overactive, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 25. This study's 3 months is below that.

Counting every sponsor, half of 174 studies reached it within 19 months; a quarter within 10 and three quarters within 40.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 4, 2019
First posted
Mar 14, 2019
StartActual
Feb 14, 2017
Primary completionActual
May 17, 2017
CompletionActual
May 17, 2017
Last update
Mar 14, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 14, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03874637
Lead sponsor
FemPulse Corporation
Responsible party
Sponsor
First posted
Mar 14, 2019
Start date
Feb 14, 2017
Primary completion
May 17, 2017
Completion
May 17, 2017
Last update
Mar 14, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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