An interventional study of FemPulse System in Urinary Bladder, Overactive, sponsored by FemPulse Corporation. Completed at 3 sites in United States. Open to female participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-02-06.
Sponsored by FemPulse Corporation · Not applicable, Interventional, and Treatment
The purpose of this clinical trial is to investigate a new medical device treatment for Overactive Bladder (OAB) in women.
The FemPulse System is a vaginal ring intended to provide mild electrical stimulation to nerves that regulate bladder function. It is believed that stimulation of these nerves may help relieve the symptoms of OAB.
858 studies on the registry are indexed under Urinary Bladder, Overactive; 127 are open to participants now.
This study's enrollment of 21 is below the median of 70 across 649 interventional studies indexed under Urinary Bladder, Overactive.
Browse Urinary Bladder, Overactive studies →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.
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.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FemPulse System at one device setting
Device: FemPulse System
FemPulse System at a different device setting
Device: FemPulse System
Device therapy with the FemPulse System
All device- and procedure-related adverse events will be collected and tabulated
Adverse events
Time frame: Approximately 11 days in total
Urinary frequency
Frequency of and intervals between urinary voids (voids per day and time between voids)
Time frame: Approximately 11 days in total
Urinary urgency
Presence or absence of urgency with each void
Time frame: Approximately 11 days in total
Urge urinary incontinence (UUI)
Presence or absence of UUI with each void
Time frame: Approximately 11 days in total
OAB-q - Short Form
OAB bother quality of life questionnaire
Time frame: Approximately 11 days in total
OAB Symptom Score
OAB symptoms quality of life questionnaire
Time frame: Approximately 11 days in total
Urogenital Distress Inventory - Short Form
OAB-related distress quality of life questionnaire
Time frame: Approximately 11 days in total
Incontinence Impact Questionnaire - Short Form
Impact of OAB quality of life questionnaire
Time frame: Approximately 11 days in total
Plan to share: No
No publications or documents are linked to this record.
Ran from Dec 2018 to primary completion in Dec 2019, 12 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 12 months is close to 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.
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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FemPulse Corporation