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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: Completed NA study, sponsored by Northwestern University.
NCT02701413 is a NA study that has completed, run by Northwestern University. The registered enrollment target is 66 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The FISI is a validated instrument for assessing fecal incontinence symptom severity. The questionnaire contains 4 questions that assess the frequency of incontinence of solid stool, liquid stool, mucus and gas. FISI total scores range from 0-61 points and higher scores on the scale indicate greater severity of anal incontinence symptoms (worse symptoms). The following are ranges of the scores for each subscale, similarly higher scores on the scale indicate greater severity of subtype of anal in
Interventions
- DEVICE Sham Device
- DEVICE ApexM (Stimulation) Device
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2016-02-26 |
| Est. Completion | 2020-01 |
| Phase | NA |
What the finished NCT02701413 record still lists
NCT02701413 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which Sham Device is the first listed.
NCT02701413 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02701413's enrollment target sits among peer trials
66 1139th of 2000 higher than 857 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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