Vaginal Electrical Stimulation for Postpartum Neuromuscular Recovery

NCT02701413 | Completed Results

• 1 other identifier: STU00201026
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obstetric Anal Sphincter Injury; Vaginal Electrical Stimulation

Keywords

Apex M; Postpartum; Pelvic Floor rehabilitation

Outcome Measures

Primary Outcomes (1)

• Anal Incontinence

  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 incontinence (worse symptoms) Gas subscale- 0-12 points Mucus subscale: 0- 12 points Liquid stool subscale: 0-19 points Solid stool subscale: 0-18 points There are units for the scores on the scale. The Total FISI score is derived from the sum of all the scores on the subscales.

  13 weeks postpartum

Secondary Outcomes (4)

• Urinary Incontinence

  1 week postpartum and 13 weeks postpartum

• Number of Participants With Levator Ani Muscle Defects on Either Side of the Pelvis

  13 weeks postpartum

• Number of Patients With Anal Sphincter Muscle Defects

  13 weeks postpartum

• Maximum Squeeze Anal Pressure

  13 weeks postpartum

Study Arms (2)

ApexM Device

EXPERIMENTAL

The ApexM Device (InControl Medical) is a cylindrical inflatable instrument with electrodes on the dorsal and ventral sides. It is a battery operated, non-implanted device which will be inserted into the vagina and will stimulate the pelvic floor muscles. This device has been shown to be safe and effective for clinical use. Stimulation will alternate between 13 and 50Hz. The initial intensity will be set by the clinician at the patient's initial visit and will be increased in a standard fashion over the duration of the trial.

Device: ApexM (Stimulation) Device

Sham Device

SHAM COMPARATOR

The ApexM Device will be identical in every way but the electrical stimulation will be disabled. The device will still turn on and inflate to fit the contours of the vagina.

Device: Sham Device

Interventions

ApexM (Stimulation) Device DEVICE

Vaginal electrical stimulation will be administered via the Apex M Device. During each session, the patient will be supine, place conductive gel on the device, insert the device into the vagina, and inflate it to comfort. Subsequently, the device will be turned on and set to previously determined setting. Stimulation session will last 10 minutes and occur 6 times per week for a total of 12 weeks.

ApexM Device

Sham Device DEVICE

A sham Apex M device without electrical stimulation will be used. During each session, the patient will be supine, place conductive gel on the device, insert the device into the vagina, and inflate it to comfort. Subsequently, the device will be turned on and set to previously determined setting. Each session will last 10 minutes and occur 6 times per week for a total of 12 weeks.

Sham Device

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Primiparous (First delivery)
• Women who sustain Obstetric Anal Sphincter Injury (OASIS) during first vaginal delivery
• Between age of 18 - 50 years
• English speaking and reading

You may not qualify if:

• Implanted electrical device or cardiac arrhythmia
• Neurological disorder
• Inflammatory bowel disease
• Chronic Steroid Use
• Wound breakdown and infection
• Anticipated geographic relocation

Sponsors & Collaborators

• Northwestern University: lead
• Evergreen Invitational: collaborator

Study Sites (1)

Northwestern Medical Group's Integrated Pelvic Health Program

Chicago, Illinois, 60611, United States

Location

Related Publications (2)

• Rockwood TH, Church JM, Fleshman JW, Kane RL, Mavrantonis C, Thorson AG, Wexner SD, Bliss D, Lowry AC. Patient and surgeon ranking of the severity of symptoms associated with fecal incontinence: the fecal incontinence severity index. Dis Colon Rectum. 1999 Dec;42(12):1525-32. doi: 10.1007/BF02236199.

  PMID: 10613469 BACKGROUND

• Brown O, Heliker BD, Geynisman-Tan J, Tavathia M, Mueller MG, Collins S, Kenton K, Lewicky-Gaupp C. Vaginal Electrical Stimulation for Postpartum Neuromuscular Recovery: A Randomized Clinical Trial. Female Pelvic Med Reconstr Surg. 2021 Nov 1;27(11):659-666. doi: 10.1097/SPV.0000000000001037.

  PMID: 34608032 DERIVED

Limitations and Caveats

Approximately 27% of the enrolled participants dropped out before study completion. Therefore we had incomplete outcome data for these individuals which introduces attrition bias. Second, the study also was not powered to the secondary outcomes and results from our secondary analyses should be interpreted with this consideration.

Results Point of Contact

• Title: Dr. Christina Lewicky-Gaupp
• Organization: Northwestern University

christina.lewickygaupp@nm.org

312-472-3874

Study Officials

• Christina Lewicky-Gaupp, M.D.

  Northwestern University Feinberg School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Obstetrics & Gynecology

Study Record Dates

• First Submitted: February 10, 2016
• First Posted: March 8, 2016
• Study Start: February 26, 2016
• Primary Completion: December 1, 2019
• Study Completion: January 1, 2020
• Last Updated: June 29, 2021
• Results First Posted: June 29, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)