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NCT02701413 · ClinicalTrials.gov registry record · NA

Vaginal Electrical Stimulation for Postpartum Neuromuscular Recovery

A NA study, sponsored by Northwestern University.

Completed
Registry status
NA
Development phase
66
Enrollment target

NCT02701413 is a NA study that has completed, run by Northwestern University. The registered enrollment target is 66 participants.

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The verdict

NCT02701413, a NA study, has completed, sponsored by Northwestern University.

COMPLETED
Registry status
NA
Development phase
66 participants
Enrollment target

Study Summary

For too many women, childbirth results in devastating consequences: involuntary loss of feces or urine (fecal or urinary incontinence). In fact, up to 50 percent of women with severe tears during childbirth may develop these problems. These new mothers avoid leaving home in order to stay close to a toilet, wear protective pads every day, and avoid activities they previously enjoyed such as exercise and sexual intercourse. It is not surprising that many of these women suffer from postpartum depression, and bonding with their newborns is compromised. Fecal and urinary incontinence occur due to injuries to the pelvic nerves and muscles during childbirth. Many researchers have focused on what can be done to prevent these injuries; however, few have investigated how to help the countless women who have already suffered from these injuries to the nerves and muscles. In other fields such as orthopedics and neurology, research shows that electrical stimulation can provoke nerve regeneration after injury. Applying this technology to women who have recently suffered from nerve injury during childbirth could have profound and life-changing effects. Investigators hypothesize that electrical stimulation immediately postpartum will markedly help pelvic nerves regenerate, minimizing rates of fecal and urinary incontinence for this vulnerable population of new mothers.

Interventions

  • DEVICE Sham Device
  • DEVICE ApexM (Stimulation) Device

Trial Details

FieldValue
Enrollment Target 66 participants
Start Date 2016-02-26
Est. Completion 2020-01
Phase NA

Sponsor

Northwestern University

1,209 total trials

What the Registry Record Tells You About NCT02701413

The ClinicalTrials.gov registry entry for NCT02701413 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 66 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Northwestern University, which has 1,209 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Sham Device is the first listed.

NCT02701413 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02701413 about?

NCT02701413 is a clinical study titled "Vaginal Electrical Stimulation for Postpartum Neuromuscular Recovery". For too many women, childbirth results in devastating consequences: involuntary loss of feces or urine (fecal or urinary incontinence). In fact, up to 50 percent of women with severe tears during childbirth may develop these problems. These new mothers avoid leaving home in order to stay close to a ...

What is the current status of trial NCT02701413?

This trial is currently completed. It is a NA study. The enrollment target is 66 participants. The study started on 2016-02-26. Estimated completion is 2020-01.

What interventions are being tested in trial NCT02701413?

The interventions under investigation include: Sham Device (DEVICE), ApexM (Stimulation) Device (DEVICE).

Who is sponsoring clinical trial NCT02701413?

This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.