Vaginal Electrical Stimulation for Postpartum Neuromuscular Recovery
Phase: NA
Conditions: Obstetric Anal Sphincter Injury, Vaginal Electrical Stimulation
Sponsor: Northwestern University

PROTOCOL TITLE: Vaginal Electrical Stimulation for Postpartum neuromuscular 
Recovery (VESPR)  
  
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Protocol Title: Vaginal Electrical Stimulation for Postpartum neuromuscular  
Recovery (VESPR)  
  
NCT Number: NCT02701413  
  
Date: 12/23/2020  
  
  
 

PROTOCOL TITLE: Vaginal Electrical Stimulation for Postpartum neuromuscular 
Recovery (VESPR)  
  
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PROTOCOL TITLE:  
Vaginal Electrical Stimulation for Postpartum neuromuscular Recovery (VESPR)  
PRINCIPAL INVESTIGATOR:  
Dr. Christina Lewicky-Gaupp, MD  
Department of Obstetrics & Gynecology 
P. 312.472.3874 clewicky@nm.org   
VERSION NUMBER:  
Version 1.0  
VERSION DATE:  
2.23.16  
  
 

PROTOCOL TITLE: Vaginal Electrical Stimulation for Postpartum neuromuscular 
Recovery (VESPR)  
  
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Table of Contents  
1.0  
Objectives ...................................................................................................................................... 4  
2.0  
Background .................................................................................................................................. 4  
3.0  
Inclusion and Exclusion Criteria .......................................................................................... 5  
4.0  
Study Timelines .......................................................................................................................... 6  
5.0  
Study Endpoints ......................................................................................................................... 6  
6.0  
Procedures Involved ................................................................................................................. 7  
7.0  
Data and Specimen Banking .................................................................................................. 9  
8.0  
Data and Specimen Management ........................................................................................ 9  
9.0  
Provisions to Monitor the Data to Ensure the Safety of Subjects ......................... 10  
10.0  
Withdrawal of Subjects* ...................................................................................................... 11  
11.0  
Risks to Subjects* .................................................................................................................... 11  
12.0 Potential Benefits to Subjects ............................................................................................ 11 
18.0 Sharing of Results with Subjects ....................................................................................... 11 
19.0 Setting ......................................................................................................................................... 12  
20.0  
Resources Available ............................................................................................................... 12  
22.0 Recruitment Methods............................................................................................................ 13 
23.0 Local Number of Subjects .................................................................................................... 13  
24.0  Confidentiality .............................................................. Error! Bookmark not defined.  
25.0  Provisions to Protect the Privacy Interests of Subjects ........................................... 13  
27.0  
Economic Burden to Subjects ............................................................................................ 14  
28.0  
Consent Process ...................................................................................................................... 14  
29.0  
Process to Document Consent in Writing...................................................................... 14  
30.0 Drugs or Devices ..................................................................................................................... 14   
1.0  
Objectives  
1.1 Primary Aim: To compare fecal incontinence (FI) symptom severity at 
3 months postpartum using a validated questionnaire (Fecal 
Incontinence Severity Index (FISI)) in women who sustain an OASIS 
(Obstetric Anal Sphincter Injuries) with their first delivery and begin 
immediate vaginal electrical stimulation compared with those who 
receive sham therapy  
1.2 Secondary Aims:  
1. To compare neuromuscular function in these two groups using 
pudendal nerve terminal motor latencies (which measure neural 
function) and anal manometry (which measures muscle strength).     
2. To compare pelvic floor muscle strength in these two groups using a 
validated instrumented speculum that detects force in Newtons.  
3. To compare stress urinary incontinence (SUI) and overall urinary 
incontinence (UI) symptoms in these two groups using validated 
questionnaires (UDI-6, PFIQ-7)  
4. To determine the relationship between levator ani muscle defects 
and anal sphincter muscle defects and responses to vaginal 

PROTOCOL TITLE: Vaginal Electrical Stimulation for Postpartum neuromuscular 
Recovery (VESPR)  
  
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electrical stimulation in these two groups using endoanal and 
endovaginal ultrasound which allow visualization of muscle 
morphology and measurements of bloodflow.   
1.3 Hypothesis: We hypothesize that vaginal electrical stimulation given 
immediately after delivery and then regularly in the postpartum 
period will augment neuromuscular recovery, resulting in improved 
pelvic floor symptoms and function. Our previous work funded by the 
Evergreen Invitational Grants Initiative17 has shown high rates of 
both fecal and urinary symptoms in women who sustained 3rd or 4th 
degree obstetric anal sphincter injuries (OASIS) (i.e. severe tears) at 
the time of their first delivery.  Given the high rates of pelvic floor 
symptoms and muscular dysfunction in this group, they represent an 
ideal group to study.  
  
2.0  
Background  
2.1  
 Pregnancy and vaginal childbirth are prevailing risk factors for pelvic 
floor disorders (PFD), including fecal and urinary incontinence, during the 
reproductive years.1-3 Within 3-months of vaginal delivery, approximately one 
third of women report symptoms of a PFD.  The onset of symptoms during 
pregnancy is strongly predictive of postpartum symptoms; even when symptoms 
resolve immediately postpartum, women remain at higher risk for return of 
symptoms later in life. It is thought that temporary physiologic or neuromuscular 
changes during pregnancy may predispose certain women to symptomatic PFD 
later in life.  Specific neuromuscular changes (histologic and electromyographic) 
consistent with neuromuscular injury to pelvic floor muscles immediately after 
childbirth were first described over 20 years ago, establishing neuromuscular 
injury as an essential component of PFD after vaginal delivery. 4-7 More recently, 
investigators demonstrated that clear anatomic disruptions or defects in the 
levator ani muscles after delivery are also associated with the development of 
PFD.8, 9 Studies have shown that neural recovery after vaginal delivery mirrors 
pelvic floor symptom improvement; electrodiagnostic findings and stress urinary 
incontinence (SUI) symptoms improve simultaneously in the first 3-6 months after 
delivery.10 Despite this, however, the risk of SUI symptoms 5-years after vaginal 
delivery has been shown to be 4.6 times higher (95%CI 1.8-11.8) in women who 
reported SUI in the first 3-months after delivery. In fact, 42% of women with 
resolution of SUI symptoms in the first 3-months postpartum reported recurrent 
SUI symptoms 5-years later, suggesting incomplete neuromuscular recovery.10, 11  
  
Other medical fields routinely employ neuro-regenerative techniques to improve 
neuromuscular recovery after peripheral nerve injury.  In the orthopedic 
literature, electrical stimulation after surgery and strenuous exercise can 
facilitate neuromuscular recovery and improve outcomes.12, 13 One recent study 
applied electrical stimulation for only 1 hour to the medial nerve after carpal 

PROTOCOL TITLE: Vaginal Electrical Stimulation for Postpartum neuromuscular 
Recovery (VESPR)  
  
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tunnel release surgery and demonstrated accelerated and completely restored 
muscle innervation at 6-months compared to patients who did not receive ES of 
the median nerve. 15, 16 Electrical stimulation (ES) depolarizes the actual 
peripheral neurons and subsequently elicits muscle contractions, inducing 
physiologic changes that remain after the actual stimulation, facilitating plastic 
changes during recovery and leading to improvement of voluntary functions. 
Increasing data suggest when administered appropriately, electrical stimulation 
results in neuroplastic changes, including increased nerve fiber density. 
Application of this technology of electrical stimulation to women after childbirth 
may result in profound neuromuscular recovery, thus minimizing rates of pelvic 
floor disorders in this population.   
  
3.0  
Inclusion and Exclusion Criteria  
3.1 Women who sustain an OASIS during their first delivery will be 
approached for study participation in the hospital within 12-48 
hours of delivery or at their first clinic visit (within 1 week of 
delivery) to the peripartum evaluation and assessment of the pelvic 
floor after delivery (PEAPOD) clinic. The Northwestern Enterprise 
Data Warehouse (EDW) will be used to identify women who have 
sustained an OASIS in the past 12-hours, and checked between 7am 
to 7pm.   
3.2 Inclusion Criteria:  
• 
Women who sustain OASIS during first vaginal delivery  
• 
Between age of 18-50 years of age  
• 
English speaking and reading  
 
3.3  
Exclusion Criteria:  
• 
implanted electrical device  
• 
neurological disorder  
• 
inflammatory bowel disease  
• 
wound breakdown and infection  
• 
anticipated geographic relocation   
• 
mediolateral episiotomy   
3.4 The following special populations will not be included in the study:  
• 
Adults unable to consent  
• 
Individuals who are not yet adults (infants, children, 
teenagers)  
• 
Pregnant women  
• 
Prisoners  

PROTOCOL TITLE: Vaginal Electrical Stimulation for Postpartum neuromuscular 
Recovery (VESPR)  
  
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4.0 
Study-Wide Number of Subjects  
4.1 
100 women will be recruited to this study (50 in each arm).   
5.0  
Study Timelines  
5.1 Subjects will be approached 12-48 hours of their delivery. If they  
Overall Timeline  
Month 1-5  
Month 6-
10  
Month 
1115  
Month 
1618  
Subject  
Recruitment/Initial 
Evaluation  
X  
X  
  
  
Electrical stimulation 
protocol  
X  
X  
X  
  
13 wk postpartum 
evaluation  
  
X  
X  
  
Data Analysis and  
Manuscript Preparation  
  
  
X  
X  
consent to the study, they will remain in the study for 13 weeks after 
starting therapy   
5.2 It is anticipated that it will take approximately 10 months to enroll all 
study subjects.   
5.3 It is estimated that it will take 18 months to complete this study, 
including the data analysis and manuscript preparation.   
  
  
  
  
6.0  
Study Endpoints  
6.1 The primary study endpoint is 13 weeks, when the subject undergoes a 
clinical assessment and completes validated questionnaires.   
  
  

PROTOCOL TITLE: Vaginal Electrical Stimulation for Postpartum neuromuscular 
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7.0 
 Procedures 
Involved  
  
7.1 This 
will be a 
double-blinded, randomized clinical trial of vaginal electrical 
stimulation versus sham stimulation to determine the effect of 
vaginal electrical stimulation on pelvic floor symptoms and 
neuromuscular recovery in women with OASIS.   
7.2 Research Procedures:  
• Randomization: Enrolled participants will be randomized into 
one of two intervention groups (vaginal electrical stimulation 
or sham stimulation) with equal probability.  A randomly 
permuted block randomization schema will be generated and 
maintained using the REDCAPs database. Treatment 
allocation will be done by a separate investigator, a nurse 
practitioner.  
• Masking: Patients and study physicians will be masked to 
treatment allocation until obtaining primary outcome at 13 
weeks after delivery.  The research coordinator will be 
responsible for randomizing participants and providing a 
functioning or sham electrical stimulation device to the patient 
at their 1 week postpartum visit. Interrogation of stimulation 
devices will be performed by the research coordinator. All 
postpartum evaluations, symptom, and quality of life data will 
be obtained by a trained examiner masked to the intervention.  
This will reduce bias by maintaining masking in data collection 
of outcome measures.  All research staff will be trained and 
certified to perform data collection procedures.  Baseline data 
will be obtained within 1-week of delivery, and the primary 
outcome will be evaluated within 13 weeks of delivery with a 
three-week window on either side.  
• 1 week clinical assessment: All women will undergo 
standardized assessment within 1 week of delivery, including 
demographic information (age, race/ethnicity, BMI, etc), 
obstetrical and medical data (medical/surgical history, type of 
Subject Timeline  
12-48  
hr   
1 wk  
5wk  
10wk  
13wk  
Recruitment   
X  
X  
  
  
X  
Questionnaires  
  
X  
X  
X  
X  
Instrumented 
speculum exam of 
pelvic floor muscle 
strength  
  
X  
  
  
X  
Neuromuscular 
testing  
  
X  
  
  
X  
Endoanal and 
endovaginal 
ultrasound  
  
X 
(endovaginal 
only)  
  
  
X  
Device interrogation  
  
  
X  
X  
X   

PROTOCOL TITLE: Vaginal Electrical Stimulation for Postpartum neuromuscular 
Recovery (VESPR)  
  
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delivery, duration of second stage, anesthesia utilized, 
antibiotic use, degree of tear, suture used for repair, birth 
weight, and fetal head position). Women will also complete all 
validated questionnaires and undergo clinical assessment 
including perineal exam, pelvic floor muscle strength with the 
instrumented speculum designed by the University of Michigan 
(see supplemental information), pelvic and perineal ultrasound 
to assess levator ani muscles and anal sphincter muscles 
morphology and vascular flow, and neurophysiologic testing 
including pudenal nerve latency and anal manometry. If 
women are found to have evidence of infection or wound 
breakdown, they will be excluded from the study. Their primary 
obstetrician will be notified, but we will assume responsibility 
for treating the breakdown/infection. Our peripartum 
evaluation and assessment of the pelvic floor after delivery 
(PEAPOD) clinic (run by Dr. Lewicky-Gaupp) is where most 
obstetricians refer patients with wound breakdown/infection. 
Thus, we routinely care for patients with these complications 
after delivery.   
• Treatment protocol: All of the patients will be given detailed 
instructions about the use of the device. Specifically, both the 
electrical stimulation and sham group will be instructed on 
how to insert the device into the vagina (depth of ~4inches) 
and turn the device on/off. The ‘on’ light will function in both 
groups. The electrical stimulation group will receive 
stimulation when the device is powered on. In the sham group, 
the light will turn on but no electrical stimulation will be 
delivered.   
• 5 and 10 week clinical assessment: Interrogation of the 
stimulator device as well as the sham device will be performed 
to ensure compliance and adjust amplitude settings as needed. 
At these time points, patient will fill out 2 questionnaires 
(PFDI-20 and FISI).  
• 13 week clinical assessment: Patients will complete validated 
questionnaires and undergo same clinical assessment as was 
performed during week 1.   
 
7.3  
Procedure safety and source records:  
• The device that will be used to provide vaginal electrical 
stimulation, In Control Medical’s Apex M Device, is available 
over the counter (4/9/2015 K150183) and designed specifically 
to provide stimulation to the pelvic floor muscles and 

PROTOCOL TITLE: Vaginal Electrical Stimulation for Postpartum neuromuscular 
Recovery (VESPR)  
  
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surrounding structures to improve strength and support. It is 
safe and there should be minimal to no discomfort with use.  
The current is set by the patient and physician together to 
minimize any discomfort and maximize comfort level.   
• The source records to collect demographic data and 
medical/surgical history from the patients will include the 
EDW as well as EPIC medical records. Other source records 
include questionnaires that will be administered via RedCAP, a 
secure, Northwestern approved, electronic data capture 
system.  
7.4 The data that will be collected includes:  
• Demographic information (Age, race/ethnicity, BMI)  
• Obstetrical and Medical Data (Medical/surgical history, type 
of delivery, duration of second stage of pregnancy, anesthesia 
utilized, antibiotic use, degree of tear, suture used for repair, 
birth weight, fetal head position).   
• Clinical exam findings (Perineal exam results, pelvic floor 
muscle strength, pelvic and perineal ultrasound results, 
neurophysiologic testing results, anal manometry results).   
• Questionnaire data from validated questionnaires (PFDI-20, 
PFIQ-7, FISI, PISQ-IR, SUS, BSS).   
8.0  
Data and Specimen Banking  
8.1 All data will be stored on the secure RedCAP server. The data will 
only be stored there during the duration of the study, including 
during the period of data analysis and manuscript preparation. Data 
will be destroyed 2 years following project completion.   
8.2 Data to be stored for each subject can be found in section 7.4.   
8.3 Only the PI and study staff at Northwestern will have access to the 
data.   
9.0  
Data and Specimen Management  
9.1 Statistical Analysis: SPSS statistical software will be used for data 
management and analysis.  Histograms will be used to assess data for 
normality and where possible any not normally distribute data will be log 
transformed to allow for parametric statistical test if needed.  However, 
nonparamentric tests will be used when appropriate. Continuous data will be 
compared between study groups using independent t-test or Mann-Whitney U 
Test.  Chi-squared test will be used to compare nominal variables. Repeated 
measures will be analyzed using paired t-tests, Wilcocxon signed rank test 
and ANOVA as appropriate.  

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9.2 Sample Size Determination:   
For the primary outcome for the study, anal incontinence symptom severity 
at 13 weeks postpartum as measured by total FISI scores, we determined that 
42 women (21 in each group) were needed to show a 4-point difference in 
symptom severity on the FISI questionnaire (MCID of the FISI) between 
treatment groups with 90% power and a significance level of .05.  However, 
to allow us to explore secondary outcomes like the proportion of women with 
reduction in FI symptoms, flatal incontinence, the relationship between 
levator muscle defects and FI symptoms after electrical stimulation and 
stress incontinence we planned to recruit 100women. This is based on the 
following: In a cohort of women at our institution with OASIS after their first 
vaginal delivery, 55% reported fecal incontinence symptoms 3-months after 
delivery.  We hypothesize that vaginal electrical stimulation will enhance 
neuromuscular recovery and decrease symptoms of FI by 15% in the first 
3months after delivery.  This secondary aim would require that we recruit 40 
patients in each group to show a 15% decrease in FI symptoms (from 55% to 
40%) with 80% power at a 0.5 significance level.  This sample size would 
also allow us to evaluate flatal incontinence (which has an 82% incidence in 
our population), the relationship between levator muscle defects and FI 
symptoms after electrical stimulation, as well as stress incontinence (as 31% 
of women will have these symptoms immediately after delivery and 17% will 
have them at 3-months).  Assuming a 25% dropout rate, we will ultimately 
recruit 100 women (50 in each arm) to be able to assess the primary and all 
secondary outcomes.   
9.3 Steps to Maintain Confidentiality: Data will be collected at 
Northwestern Medicine. All study data will be recorded on Case 
Report Forms by research coordinator and securely maintained in a 
locked cabinet that only the study coordinator has access to. CRFs 
will be derived from source documentation and/or participant 
selfreport. Data will be entered by the research coordinator at 
Northwestern into a RedCAP database that will be stored on a 
secure sever. Only study staff will have passwords to access the 
project data on RedCAP.   
9.4 The data that is banked locally will be entered into an electronic data 
capture website. All users of REDCap need an institutional 
username and password to log in and to enter data. Research 
personnel, including study staff as well as study doctors will be able 
to collect and have access to subject data.   
10.0 Provisions to Monitor the Data to Ensure the Safety of Subjects  
This section is required when research involves more than Minimal Risk to 
subjects.  

PROTOCOL TITLE: Vaginal Electrical Stimulation for Postpartum neuromuscular 
Recovery (VESPR)  
  
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10.1 Data Safety Monitoring Plan:  
• 
Adverse events associated with use of the electrical stimulation 
device will be recorded (wound breakdown, wound infection,  
pain, urinary tract infection). Adverse events will be recorded at 
each follow up visit on Case Report Forms and subsequently 
will be added in to RedCAP electronic data capture system. The 
PI will be notified of any adverse events, which will be resolved 
with the patient.   
• 
The use of the electrical stimulation device is not greater than 
the minimal risk to subjects,   
11.0 Withdrawal of Subjects*  
Subjects may withdraw from the trial at any point.   
  
12.0 Risks to Subjects*  
12.1 Risks associated with the project are minimal. Tolerance of the 
electrical stimulation device has been clearly demonstrated in 
patients with few side effects and excellent usability scores reported 
amongst users. Potential risks include discomfort, vaginal irritation, 
wound breakdown, wound infection, pain, urinary tract infection.  
12.2 Risks from the assessment tools include mild discomfort with 
insertion of the vaginal speculum, ultrasound probe, anal manometry 
probe. This should be mild discomfort comparable to that associated 
with a pelvic examination. The pudendal nerve testing includes a 
tingling sensation that lasts seconds and may be uncomfortable but 
is not painful.   
12.3 Another risk to subjects is that we will be collecting their personal 
health information in a database. All of the data will be kept 
confidential and will be stored on password protected, secure 
servers, or in locked cabinet files that only study staff on the project 
have access to. Personal health information will be stored on files 
that are separate from the subject’s name, all health information will 
be coded. Coded list will be kept on secure, password protected file.   
13.0 Potential Benefits to Subjects  
13.1 It is hypothesized that women who are randomized to the electrical 
stimulation group may have fewer symptoms of fecal incontinence/ 
urinary incontinence and greater pelvic floor strength than those 
receiving the sham stimulation and greater improvement in pelvic 
floor and neuromuscular strength and function.   
  

PROTOCOL TITLE: Vaginal Electrical Stimulation for Postpartum neuromuscular 
Recovery (VESPR)  
  
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14.0 Sharing of Results with Subjects  
14.1 Results will not be shared with the patient specifically. At the end of 
the trial, patients will know which arm they were randomized to. 
Results of the trial will be published in the medical literature and 
made publically available.  
15.0 Setting  
15.1 Potential subjects will be identified and recruited by physicians and 
the study coordinator within the division of Female Pelvic Medicine 
& Reconstructive Surgery at Northwestern Medical HealthCare 
corporation. Subjects will be identified through the EDW from 7am 
to 7pm by study coordinator and team members. Patients that are 
eligible for the study will then be approached within Prentice 
Women’s Hospital and asked if they would like to participate in the 
study. Clinical assessments and follow up research visits will be 
conducted in Northwestern Medical Group’s outpatient clinic, the 
Integrated Pelvic Health Program (IPHP).  
16.0 Resources Available  
16.1 The faculty and staff that will be involved in this research are highly 
qualified. The Principle Investigator, Dr. Christina Lewicky-Gaupp, 
is an Assistant Professor of Female Pelvic Medicine and 
Reconstructive Surgery and is the director of the PEAPOD clinic. 
She has served as primary investigator on many studies, including 
studies with this same patient population. The other study physicians 
have also completed their fellowships in Female Pelvic Medicine & 
Reconstructive surgery and are both involved in numerous research 
studies and serve as reviewers for several scientific journals. The 
nurse practitioner on staff at the IPHP has worked on several other 
protocols during her time at Northwestern. The study coordinator on 
staff has over 3 years of research experience and 1 year of 
experience working in clinical trials and consenting patients.    
16.2 At Northwestern Prentice Women’s Hospital alone, nearly 400 
women per year suffer from severe lacerations (OASIS). Around the 
world, rates of OASIS are rising.18 In women with OASIS, more than 
50% will suffer from fecal or urinary incontinence. Problems of 
incontinence occur not only postpartum, but also often continue to 
impact women throughout their lives. Thus, an intervention targeting 
this large cohort of women would (1) have generalizability to women 
around the world and (2) have a long lasting impact. Our previous 
work has demonstrated the ability to successfully recruit subjects 
from Prentice Women’s Hospital. Furthermore, the large volume of 
deliveries and severe lacerations at this institution make recruitment 
of eighty patients feasible in the project’s timeframe  

PROTOCOL TITLE: Vaginal Electrical Stimulation for Postpartum neuromuscular 
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16.3 The Integrated Pelvic Health Program, affiliated with Northwestern 
Memorial Hospital, helps individuals with pelvic floor disorders. It is 
the only program in the Chicago area that brings together a 
multispecialty approach to pelvic floor disorders in one location. 
Our dedicated team of physicians, nurses, and physical therapists 
are committed to restoring the quality of life for people with such 
disorders. Both the physicians and the facilities offer state-of-the-art 
resources to ensure the highest quality evaluation, medical and 
surgical care to women with incontinence and prolapsed. Our 
physicians are national leaders in minimally invasive pelvic 
reconstructive surgery and sacral nerve stimulation for urinary and 
fecal incontinence.   
16.4 All study staff members are in possession of the protocol and the 
protocol has been reviewed by all of the study members during a 
research conference. Research procedures have been made clear 
and were outlined by the study coordinator and Principle 
Investigator.   
17.0 Recruitment Methods  
17.1 Subjects will be recruited from Prentice Women’s Hospital and the 
the peripartum evaluation and assessment of the pelvic floor after 
delivery (PEAPOD). They will be identified using Northwestern’s 
EDW, which will be monitored between the hours of 7AM-7PM or 
during from their clinic visit to PEAPOD. Once potential subjects 
are identified, they will be approached by a study team member or 
the study coordinator at Prentice Hospital or at their first 
postpartum visit.   
17.2 The source of our subjects will be women that have sustained OASIS 
after their first delivery within Prentice Women’s Hospital.   
17.3 Participants in this study will receive free parking vouchers for their 
follow up visits (2 visits). They will be able to keep the stimulation 
device at the end of the trial.   
18.0 Local Number of Subjects  
18.1 Assuming a 25% dropout rate, we will ultimately recruit 100 women 
(50 to each arm).   
19.0 Provisions to Protect the Privacy Interests of Subjects  
19.1 To protect privacy interests, the personal health information 
collected for research purposes will be collected from the subject’s 
electronic medical record to limit the amount of people they interact 
with and provide personal information to.   

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19.2 All interviews will be conducted in a private office or examination 
room to ensure confidentiality. Phone conversations will be 
conducted from private offices. Any study correspondence with 
patients will not indicate disease status or focus on the envelope. All 
physical exams will be conducted in a private examination room. 
Subjects will be allowed to skip any question on a questionnaire that 
makes them feel uncomfortable.   
19.3 The study staff, including investigators and the study coordinator, 
will have access to the subject’s medical record and study  
documents. All study documents will be kept in a locked cabinet and 
only those with password required access to EPIC will be able to 
access the subject’s electronic medical record.  
19.4 The study team will be permitted to access the subject’s electronic 
medical record to access information about the subject.   
20.0 Economic Burden to Subjects  
20.1 Describe any costs that subjects may be responsible for because of 
participation in the research. There will be no costs associated with 
participation in this study.   
21.0 Consent Process  
21.1 Consent will be obtained from the patient by research staff, either by 
the study coordinator or by one of the investigators. The informed 
consent process is expected to take up to 30 minutes. The person 
obtaining consent will verbally go through the form and also allow 
time for the subject to read the form in its entirety. The subject will 
be allowed to consult with family. The person obtaining consent will 
ensure the subject understands the purpose and procedures of the 
study. After all the subject’s questions have been answered, the 
subject will be given time to make a decision about enrollment. The 
original signed written consent form will be kept separately from 
research data, a signed copy will be sent to medical records, and a 
signed copy will be given to the patient. We will not be enrolling 
Non-English speaking subjects. Decisionally-impaired subjects will 
not be enrolled in our study.    
22.0 Process to Document Consent in Writing  
22.1 We will be following “SOP: Written Documentation of Consent 
(HRP-091)” and will be documenting process of consent in writing.  
  
  
REFERENCES  

PROTOCOL TITLE: Vaginal Electrical Stimulation for Postpartum neuromuscular 
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Rortveit G, Hannestad YS, Daltveit AK, Hunskaar S. Age- and type-dependent effects of 
parity on urinary incontinence: the Norwegian EPINCONT study. Obstet Gynecol 
2001;98:1004-10.  
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Rortveit G, Daltveit AK, Hannestad YS, Hunskaar S, Norwegian ES. Urinary incontinence 
after vaginal delivery or cesarean section. N Engl J Med 2003;348:900-7.  
3. 
Mant J, Painter R, Vessey M. Epidemiology of genital prolapse: observations from the 
Oxford Family Planning Association Study. Br J Obstet Gynaecol 1997;104:579-85.  
4. 
Marshall K, Walsh DM, Baxter GD. The effect of a first vaginal delivery on the integrity of 
the pelvic floor musculature. Clin Rehabil 2002;16:795-9.  
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Snooks SJ, Swash M, Mathers SE, Henry MM. Effect of vaginal delivery on the pelvic 
floor: a 5-year follow-up. Br J Surg 1990;77:1358-60.  
6. 
Allen RE, Hosker GL, Smith AR, Warrell DW. Pelvic floor damage and childbirth: a 
neurophysiological study. Br J Obstet Gynaecol 1990;97:770-9.  
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Shafik A, El-Sibai O. Study of the levator ani muscle in the multipara: role of levator 
dysfunction in defecation disorders. J Obstet Gynaecol 2002;22:187-92.  
8. 
Hoyte L, Schierlitz L, Zou K, Flesh G, Fielding JR. Two- and 3-dimensional MRI comparison 
of levator ani structure, volume, and integrity in women with stress incontinence and 
prolapse. Am J Obstet Gynecol 2001;185:11-9.  
9. 
DeLancey JO, Kearney R, Chou Q, Speights S, Binno S. The appearance of levator ani 
muscle abnormalities in magnetic resonance images after vaginal delivery. Obstet 
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PROTOCOL TITLE: Vaginal Electrical Stimulation for Postpartum neuromuscular 
Recovery (VESPR)  
  
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