Clinical trial NCT04197869
Conditions: Constipation Post-Op Complication
Sponsor: Northwell Health
Start date: 2019-12-09; Completion date: 2023-06-21
Enrollment: 71 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The hypothesis is that starting a bowel regimen with Polyethylene Glycol prior to robotic assisted sacrocolpopexy will decrease time to first bowel movement after surgery. The experimental group will take a pre-operative course of polyethylene glycol daily for seven days prior to procedure date. The control group will not be given any intervention preoperatively. All patients will take polyethylene glycol postoperatively.

Detailed description:
In order to assess bowel characteristics and assess for pre-existing constipation a standardized questionnaire will be distributed to all patients prior to surgery at their pre-operative visit. The patients in the experimental group will have follow up via phone call, 3-4 days prior to surgery to assess for medication compliance or any side effects/complications. Patients will record if they are taking their Miralax as prescribed daily. They will also record their bowel movements and pain levels during evacuation. Prior to surgery, in the pre-operative area, medication compliance will be assessed once again. Post operatively all patients will take polyethylene glycol for seven days, once a day. They will maintain a bowel diary, which will record bowel movements, stool type and pain with evacuation. The primary objective is to determine if the preoperative use of polyethylene glycol decreases time to first bowel movement after robotic sacral colpopexy. Secondary outcomes include pain with first bowel movement, stool consistency and daily pain levels.

Arms: arm 1: The experimental group will take a pre-operative course of polyethylene glycol daily for seven days prior to procedure date. arm 2: The control group will not be given any intervention preoperatively.
Interventions: intervention 1: Polyethylene Glycol Powder
Intervention descriptions: intervention 1: Polyethylene Glycol 3350 17g should be mixed in 8 ounces of fluid for administration. Polyethylene glycol is a high molecular weight, water soluble polymer which can form hydrogen bonds with water molecules. It is an osmotic laxative solution which stimulates bowel movements by increasing the amount of water absorbed in the GI tract. It decreases feces consistency and increases their volume by promoting peristalsis and evacuation. The side effects of polyethylene glycol are bloating, gas or diarrhea. The half-life of polyethylene glycol is 4-6 hours and after 18 hours the concentration declines to non-quantifiable levels.

Protocol documents:
Prot_SAP_000.pdf: 
 
Version Date: 04/20/2022  
 
Page 1 of 18 
 
 
RESEARCH PROTOCOL 
 
 
Protocol Title: 
Does a preoperative bowel regimen change time to first bowel 
movement after robotic sacral colpopexy: A Randomized 
Controlled Trial 
Principal Investigator: 
Peter Finamore, MD 
Primary Contact Name: 
Alexandra Goodwin, MD; Danielle O’Shaughnessy, MD 
Primary Contact Phone: 
917-969-1654 
Primary Contact E-mail: 
agoodwin2@Northwell.edu 
Date Revised: 
4/20/2022 
IRB Number: 
19-0802 
ClinicalTrials.gov ID 
NCT04197869 
 
 
Guidelines for Preparing a Research Protocol 
 
Instructions: 
 
• You do not need to complete this document if you are submitting an Application for 
Exemption or Application for a Chart Review.   
• Do not use this template if: 
o  Your study involves an FDA regulated product.  In this case, use the Clinical 
Trial Protocol Template. 
o Your study has a protocol from a sponsor or cooperative group.  In this case, use 
the Protocol Plus.   
o Your study is a registry or repository for data and/or samples, In this case, use 
Protocol Template – Registry Studies.  .   
• If a section of this protocol is not applicable, please indicate such. 
• Do not delete any of the text contained within this document. 
• Please make sure to keep an electronic copy of this document.  You will need to use it, if 
you make modifications in the future.   
• Start by entering study information into the table above, according to these rules: 
o Protocol Title:  Include the full protocol title as listed on the application. 
o Investigator:  include the principal investigator’s name as listed on the application 
form 
o Date Revised:  Indicate the date at which the protocol was last revised 
o IRB Number:  Indicate the assigned IRB number, when known.  At initial 
submission, this row will be left blank.   
• Once the table information in entered, proceed to page 2 and complete the rest of the 
form. 
 
 
 
 


 
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Page 2 of 18 
â Continue to next page to begin entering information about this study â 
 
 
1.  PREVIOUS STUDY HISTORY 
 
Has this study ever been reviewed and rejected/disapproved by another IRB prior to 
submission to this IRB? 
 
 No  
 Yes -  if yes, please explain:  
 
 
2. BRIEF SUMMARY OF RESEARCH 
• The summary should be written in language intelligible to a moderately educated, 
non-scientific layperson.  
• It should contain a clear statement of the rationale and hypothesis of your study, a 
concise description of the methodology, with an emphasis on what will happen to the 
subjects, and a discussion of the results.  
• This section should be ½ page 
 
 
Constipation is a prevalent problem following urogynecological procedures. 
Patients suffering from constipation are more often bearing down, which increases 
their risk of pelvic organ prolapse. It severely impacts patient quality of life, post-
operative pain as well as recovery. No standardized pre or post-operative bowel 
regimen exists for patients undergoing urogynecology procedures. There is a need 
for a simple bowel regimen which can increase patient compliance and decrease 
time and pain with first post-operative bowel movement. This study could 
potentially uncover a simple and low risk intervention, which could positively 
impact patient care. While, previous studies focused on post-operative bowel 
regimens, this study aims to take a novel approach in pre-operative interventions. 
The study subjects will be exposed to a low risk medication, which could make a 
substantial difference in their post-operative pain, comfort and recovery.  
 
The hypothesis is that starting a bowel regimen with Polyethylene Glycol prior to 
robotic assisted sacrocolpopexy will decrease time to first bowel movement after 
surgery. The experimental group will take a pre-operative course of polyethylene 
glycol daily for seven days prior to procedure date. The control group will not be 
given any intervention preoperatively. All patients will take polyethylene glycol 
postoperatively. 
 
In order to assess bowel characteristics and assess for pre-existing constipation a 
standardized questionnaire will be distributed to all patients prior to surgery at their 
pre-operative visit. The patients in the experimental group will have follow up via 
phone call, 3-4 days prior to surgery to assess for medication compliance or any 
side effects/complications. Patients will record if they are taking their Miralax as 
prescribed daily. They will also record their bowel movements and pain levels 


 
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Page 3 of 18 
during evacuation. Prior to surgery, in the pre-operative area, medication 
compliance will be assessed once again. Post operatively all patients will take 
polyethylene glycol for seven days, once a day. They will maintain a bowel diary, 
which will record bowel movements, stool type and pain with evacuation. Prior to 
discharge from the hospital, subjects will be reminded to fill out the bowel diary 
and return it to the study team. The primary objective is to determine if the 
preoperative use of polyethylene glycol decreases time to first bowel movement 
after robotic sacral colpopexy. Secondary outcomes include pain with first bowel 
movement, stool consistency and daily pain levels. 
 
 
 
3. INTRODUCTION/BACKGROUND MATERIAL/PRELIMINARY STUDIES AND 
SIGNIFICANCE 
• Describe and provide the results of previous work by yourself or others, including 
animal studies, laboratory studies, pilot studies, pre-clinical and/or clinical studies 
involving the compound or device to be studied.  
• Include information as to why you are conducting the study and how the study differs 
from what has been previously researched, including what the knowledge gaps are. 
• Describe the importance of the knowledge expected to result 
 
Constipation is a prevalent problem in the United States and is more commonly 
seen in women1. An epidemiologic study of constipation identified it as an inability 
to evacuate stool completely and spontaneously three or more times per week1. A 
significant correlation was noted between constipation and posterior genital 
prolapse2. Of POP patients, 24-52% complain of difficulties in defecation2. 
Increased bearing down pressure to evacuate stool during constipation produces 
anatomic changes in the pelvic floor3, which increases the risk for prolapse. 
Constipation causes significant discomfort post-operatively following 
urogynecological procedures. A pre-operative medication regimen can decrease 
constipation, which in turn can work to reduce prolapse recurrence.  
 
Prolonged time to first bowel movement after surgery impacts patient comfort 
levels, increases post-operative pain and causes anxiety4. Prior investigations reveal 
that among gynecologic surgical patients, the first bowel movement after surgery 
typically does not occur until 2 to 4 days postoperatively4. There is no established 
generally accepted regimen used to minimize postoperative defecatory discomfort 
in those undergoing gynecologic surgery4. Previous studies recognized these issues 
and aimed at finding a bowel regimen to aid in decreasing defecatory discomfort 
postoperatively.  
 
The aim of this study is to take a novel approach and find a pre-operative bowel 
regimen. Patients in the experimental group will receive a seven-day pre-operative 
treatment with polyethylene glycol, and patients in both arms will take 
polyethylene glycol post-operatively as part of their routine clinical care. 
Polyethylene glycol has been studied and proven to be safe and effective in aiding 


 
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with constipation. This regimen offers a simple and novel approach which could 
potentially decrease constipation and post-operative pain and patient discomfort. 
This could ultimately aid in decreasing recurrent prolapse rates.  
 
 
4. OBJECTIVE(S)/SPECIFIC AIMS AND HYPOTHESES 
• A concise statement of the goal(s) of the current study.  
• The rationale for and specific objectives of the study.  
• The goals and the hypothesis to be tested should be stated. 
 
The primary objective of this study is to assess whether a pre-operative treatment 
with a laxative will decrease the time to first bowel movement following a robotic 
sacrocolpopexy. The secondary objective of the study is to assess for pain with first 
bowel movement, stool consistency and daily pain levels.   
 
 
5.  RESOURCES AVAILABLE TO CONDUCT THE HUMAN RESEARCH 
• Explain the feasibility of meeting recruitment goals of this project and demonstrate a 
potential for recruiting the required number of suitable subjects within the agreed 
recruitment period 
o How many potential subjects do you have access to? 
• Describe your process to ensure that all persons assisting with the trial are 
adequately informed about the protocol and their trial related duties and functions 
 
The Suffolk Urogynecology practice performs approximately 100 robotic assisted 
sacrocolpopexies per year. The recruitment period will last around 3  years, given 
the amount of such operations and the need for 24 patients in each study arm. This 
time period also accounts for a patient dropout rate of 20%. All patients who are 
eligible and meet inclusion criteria will be offered participation in the study during 
their preoperative patient visit. In order for all persons assisting with the trial to be 
adequately informed, several meetings will take place to clarify goals, roles and 
expectations of all team members.  
 
 
6.  RECRUITMENT METHODS 
• Describe the source of potential subjects 
• Describe the methods that will be used to identify potential subjects 
• Describe any materials that will be used to recruit subjects.  A copy of any 
advertisements (flyers, radio scripts, etc.) should be submitted along with the 
protocol.  
• If monetary compensation is to be offered, this should be indicated in the protocol 
 
Suffolk Urogynecology patients who are planning on undergoing a robotic assisted 
sacrocolpopexy will be screened preoperatively and offered participation in the 
study during their office visit. If a patient meets inclusion criteria, then the study 


 
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purpose and design will be explained to the patient. No monetary compensation 
will be offered. No advertisements will be used.   
 
 
7.  ELIGIBILITY CRITERIA 
• Describe the characteristics of the subject population, including their anticipated 
number, age, ranges, sex, ethnic background, and health status. Identify the criteria 
for inclusion or exclusion of any subpopulation.  
• Explain the rationale for the involvement of special classes of subjects, such as 
fetuses, pregnant women, children, prisoners or other institutionalized individuals, or 
others who are likely to be vulnerable.   You cannot include these populations in your 
research, unless you indicate such in the protocol 
• Similarly, detail exclusionary criteria: age limits, special populations (minors, 
pregnant women, decisionally impaired), use of concomitant medications, subjects 
with other diseases, severity of illness, etc. 
 
The subject population consists mostly of healthy, pre and postmenopausal 
females. The majority of the patients are Caucasian, with a small percentage of 
Hispanic and African American patients. Study consents will be available in 
English and Spanish languages. Patients whose preferred language is not English or 
Spanish will not be offered participation in the study. All patients will be cleared 
for surgery preoperatively by their primary medical doctor.  
 
Inclusion criteria are the following: patients undergoing a robotic assisted 
sacrocolpopexy with or without hysterectomy and with or without anti-
incontinence procedures. 
 
Exclusion criteria are the following: age under 18 or over 90, planned laparotomy, 
planned posterior colporrhaphy, regular pre-operative use of stool 
softeners/laxatives, presence of colostomy, inability to give informed consent, 
inability to take medication by mouth, chronic kidney disease (Cr > 1.2), 
esophageal strictures, persistent nausea and vomiting, bowel obstruction, and 
inflammatory bowel disease. Special subjects, minors or vulnerable individuals are 
not to be included in the study. Minorities will be offered participation.   
 
 
8.  NUMBER OF SUBJECTS 
• Indicate the total number of subjects to be accrued locally.  If applicable, distinguish 
between the number of subjects who are expected to be pre-screened, enrolled 
(consent obtained), randomized and complete the research procedures. 
• If your study includes different cohorts, include the total number of subjects in each 
cohort. 
• If this is multisite study, include total number of subjects across all sites.   
 
We anticipate pre-screening approximately 110 patients. 24 subjects are needed in 
each study arm, but 36 subjects will be randomized to account for the 34% drop out 


 
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rate. The study will be done with patients who are being treated at Suffolk 
Urogynecology which includes three attending physicians and four different 
outpatient offices located in Plainview, Bay Shore, Huntington and Wading River. 
The distribution of subjects across sites is anticipated to be even. We expect 66% 
of patients to complete the study. 
 
 
9. STUDY TIMELINES 
• Describe the duration of an individuals participation in the study 
• Describe the duration anticipated to enroll all study subjects 
• The estimated date of study completion 
 
The individuals will be offered participation in the study during their regular 
scheduled pre-operative appointment within 90 days of their surgery date. Those 
who agree to participate will sign consent for the study at that time and fill out the 
pre-operative questionnaire. The patients will go home with 2 different packets of 
bowel diaries (one for the experimental arm and one for the control). 7-14 days 
prior to their surgery date the patients will be randomized to one of two groups and 
they will receive a phone call to notify them of which group they are in and 
whether or not they will be taking Miralax pre-operatively. Prior to discharge from 
the hospital, subjects will be reminded to fill out the bowel diary and return it to the 
study team.  The patients will attend a follow up visit 7-14 days after their surgery, 
which will be in accordance to their standard of care. The total duration of their 
participation in the study will be approximately 4 months. The anticipated duration 
to enroll all study subjects is 3 years. The estimated date of study completion is 
December of 2022.  
 
 
10.  ENDPOINTS 
• Describe the primary and secondary study endpoints 
• Describe any primary or secondary safety endpoints  
 
The primary study endpoint will be time of the first post-operative bowel 
movement. Safety endpoints will include: persistent nausea and vomiting, more 
than 3 lose bowel movements a day. There are no secondary safety end points.  
 
 
11.  RESEARCH PROCEDURES 
• Include a detailed description of all procedures to be performed on the research 
subject and the schedule for each procedure. 
• Include any screening procedures for eligibility and/or baseline diagnostic tests 
• Include procedures being performed to monitor subjects for safety or minimize risks 
• Include information about drug washout periods 
• If drugs or biologics are being administered provide information on dosing and route 
of administration 
• Clearly indicate which procedures are only being conducted for research purposes. 


 
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• If any specimens will be used for this research, explain whether they are being 
collected specifically for research purposes.   
• Describe any source records that will be used to collect data about subjects 
• Indicate the data to be collected, including long term follow-up 
 
The research subjects will be randomized to a control group that receives no 
medications pre-operatively and an experimental group which receives 
polyethylene glycol once a day for seven days pre-operatively. All subjects will be 
enrolled during their pre-operative visit within 90 days of their scheduled surgery 
(as is standard of care), and they will be asked to fill out a pre-operative 
questionnaire regarding their bowel habits. All patients will also complete a pre-
operative bowel diary indicating a number on the pain scale with their bowel 
movements for the 7 days leading up to surgery. They will record information 
about their first post-operative bowel movement, such as: time, date, pain with and 
consistency of. They will record a daily pain level post-operatively. Patients will 
have telephone follow up to assess their symptoms 3-4 days after surgery. All 
patients will record their use of pain medication pre and post operatively. In 
addition, the patients in the group receiving Miralax will also fill out a form 
indicating if they have taken their daily dose of Miralax pre-operatively. They will 
also have a telephone follow up to assess their symptoms 3-4 days before surgery. 
Prior to discharge from the hospital, subjects will be reminded to fill out the bowel 
diary and return it to the study team. 
 
Polyethylene Glycol 3350 17g should be mixed in 8 ounces of fluid for 
administration. Polyethylene glycol is a high molecular weight, water soluble 
polymer which can form hydrogen bonds with water molecules.5 It is an osmotic 
laxative solution which stimulates bowel movements by increasing the amount of 
water absorbed in the GI tract. It decreases feces consistency and increases their 
volume by promoting peristalsis and evacuation.5 The side effects of polyethylene 
glycol are bloating, gas or diarrhea. The half-life of polyethylene glycol is 4-6 
hours and after 18 hours the concentration declines to non-quantifiable levels.6 
 
The pre-operative 7 day polyethylene glycol regimen for the experimental group 
will be conducted for research purposes, as well as the questionnaires and bowel 
diaries. The remainder of the patients’ treatment will not be done as part of the 
research trial and will adhere to the usual standard of care (including the pre and 
postoperative visits). Data will be collected from the Allscripts and Sunrise EMRs 
as well as in the form of questionnaires and bowel diaries. This data will be kept on 
RedCap. Subject names and initials, elements of date, telephone and medical record 
numbers will be collected from the EMR and recorded in RedCap. All other patient 
identifiers will be accessed in the EMR, but not recorded such as: address, fax 
number, email address and health plan beneficiary number.  
 
 
12.  STATISTICAL ANALYSIS 
• Describe how your data will be used to test the hypotheses.  


 
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• State clearly what variables will be tested and what statistical tests will be used. 
• Include sample size calculations.  
• If this is a pilot study, state which variables will be examined for hypothesis 
generation in later studies.  
 
The post-operative bowel diary will provide the time to first bowel movement of 
each patient and the data will be averaged for the control and experimental groups. 
Other variables to be tested will be: pain with first bowel movement, stool 
consistency and daily pain levels. Patient will undergo a 1:1 randomization 7-14 
days prior to their scheduled surgery date.  
For continuous outcomes, such as the primary endpoint, (time to observe the first 
bowel movement after surgery) 2-sample t test (given large sample size) or 
Wilcoxon rank-sum test (given smaller sample size) will be used to compare the 
difference between the control and treatment groups. For categorical outcomes, chi-
sq test or Fisher’s exact test will be used to determine the difference between the 
control and treatment groups. A significant level of 0.05 will be used for all 
statistical tests. All data manipulation will be carried out by the department 
biostatistician using RStudio Version 1.1.463 5 (built on R version 3.5.1). 
Sample size calculation: Previous research conducted by McNanley et al. [4] 
suggested an average of 3.6 ± 1.2 days to observe the first bowel movement after 
robotic sacrocolpopexy. Therefore, in order to observe a delta=1 day (24hr) shorter 
time post-surgery, we calculated that a sample size of 24 patients per study 
randomization group is needed at a significance level 0.05 and power level 0.8 
(delta represents the time you expect to shorten with polyethylene glycol 
treatment). 
 
 
 
13. SPECIMEN BANKING 
• If specimens will be banked for future research, describe where the specimens will be 
stored, how long they will be stored, how they will be accessed and who will have 
access to the specimens 
• List the information that will be stored with each specimen, including how specimens 
are labeled/coded 
• Describe the procedures to release the specimens, including:  the process to request 
release, approvals required for release, who can obtain the specimens, and the 
information to be provided with the specimens. 
 
N/A 
 
 
14.  DATA MANAGEMENT AND CONFIDENTIALITY 
• Describe the data and specimens to be sent out or received.  As applicable, describe: 


 
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o What information will be included in that data or associated with the 
specimens? 
o Where and how data and specimens will be stored? 
o How long the data will be stored? 
o Who will have access to the data? 
o Who is responsible for receipt or transmission of data and specimens? 
• Describe the steps that will be taken to secure the data during storage, use and 
transmission. 
 
The data obtained in this study will be stored on RedCap in an electronic online 
HIPAA compliant format. It will be data based off the questionnaires completed by 
the patients. The data will be stored for a period of 10 years after the completion of 
the study. Only the study investigators will have access to the data. Alexandra 
Goodwin will be responsible for the receipt and transmission of data. The data 
storage in RedCap will be under personal password protection.  
 
 
15.  DATA AND SAFETY MONITORING PLAN 
 
A specific data and safety monitoring plan is only required for greater than minimal risk 
research.  For guidance on creating this plan, please see the Guidance Document on the 
HRPP website. 
 
Part I – this part should be completed for all studies that require a DSMP.   
Part II – This part should be completed when your study needs a Data and 
Safety Monitoring Board or Committee (DSMB/C) as part of your Data and 
Safety Monitoring Plan.   
 
Part I:  Elements of the Data and Safety Monitoring Plan 
•  Indicate who will perform the data and safety monitoring for this study.   
• Justify your choice of monitor, in terms of assessed risk to the research subject’s 
health and well being.  In studies where the monitor is independent of the study staff, 
indicate the individual’s credentials, relationship to the PI, and rationale for selection 
• List the specific items that will be monitored for safety (e.g. adverse events, protocol 
compliance, etc) 
• Indicate the frequency at which accumulated safety and data information (items listed 
in # above) will be reviewed by the monitor (s) or the DSMB/C.   
• Where applicable, describe rules which will guide interruption or alteration of the 
study design.   
• Where applicable, indicate dose selection procedures that will be used to minimize 
toxicity. 
• Should a temporary or permanent suspension of your study occur, in addition to the 
IRB, indicate to whom will you report the occurrence.   
 
Dr. Danielle O’Shaughnessy will perform the data and safety monitoring for this 
study. She is a Urogynecology attending involved in the study. She is an expert in 
the field and has access to patient records. The risks to the research subjects are 
minimal.  
 


 
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Data and Safety Monitoring Plan (DSMP) 
The PI will identify a Safety Officer with expertise in Urogynecology who does not 
have any financial conflict of interest related to the study. Safety will be formerly 
monitored every 6 months by the study team and the Safety Officer throughout the 
duration of the study. Dr. Goodwin will prepare a safety report for these regular 
reviews comprised of anticipated safety events and actions taken. The PI will 
contact the Safety Officer for ad hoc reviews of any unanticipated safety events. 
The study protocol will be carried out in accordance with IRB guidelines and 
requirements. In the event of a serious adverse event during the study protocol, it 
will be reported immediately to the PI, the co-investigators, and the Safety Officer. 
It will also be reported to the IRB and to all members of the research team. With 
the approval of the participants and families, the information will be provided to 
other care providers as directed. 
Risk Assessment 
The primary concern is the development of adverse side effects to polyethylene 
glycol. 
Subjects will be monitored throughout the study for these potential adverse events 
by: assessing their symptoms and their tolerance to the medication administered. 
This will be monitored by phone calls before and after surgery, as well as in the 
pre-operative area. Symptoms and the development of any adverse effects will be 
assessed at least 3 times per each study individual every few days.  
The PI (or another designated Investigator in his absence) will be notified of any 
abnormal results so that the safety measures outlined below are implemented. The 
consenting physicians will also be notified of any abnormal results and any changes 
to the subject’s care, and will also be provided with the test results. The potential 
risks and protections are as follows: 
1. Adverse side effects to polyethylene glycol: 
• Monitoring: Phone calls to the patient every few days   
• Actions: 
o If the subjects report an allergic reaction to polyethylene glycol at 
screening, subject will not be enrolled. 
o If the subjects report adverse symptoms or side effects such as: 
diarrhea, gas or pain causing discomfort at any study point, subject 
will be taken off therapy, but will continue to be followed until end 
of study. 
o If the subject complains of symptoms concerning for rectal bleeding 
she will be checked and undergo any additional clinical testing 
requested by primary physician. 
  
 
 
Part II:  Data and Safety Monitoring Board or Committee 
 
 


 
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•  When appropriate, attach a description of the DSMB.   
• Provide the number of members and area of professional expertise.   
• Provide confirmation that the members of the board are all independent of the study. 
 
N/A 
 
 
16. WITHDRAWAL OF SUBJECTS 
• Describe anticipated circumstances under which subjects will be withdrawn from the 
research without their consent 
• Describe procedures for orderly termination 
• Describe procedures that will be followed when subjects withdraw from the research, 
including partial withdrawal from procedures with continued data collection.   
 
Subjects will be withdrawn from the research if they develop any adverse reactions 
to the medication. Should early termination occur, the subject as well as the 
research team will be made aware and the data will be recorded accordingly. 
 
 
17. RISKS TO SUBJECTS 
• Describe any potential risks and discomforts to the subject (physical, psychological, 
social, legal, or other) and assess their likelihood and seriousness and whether side 
effects are reversible. Where appropriate, describe alternative treatments and 
procedures that might be advantageous to the subjects.  
• Include risks to others , like sexual partners (if appropriate) 
• Discuss why the risks to subjects are reasonable in relation to the anticipated benefits 
and in relation to the importance of the knowledge that may reasonably be expected 
to results 
• Describe the procedures for protecting against or minimizing any potential risks, 
including risks to confidentiality, and assess their likely effectiveness.   
 
The intervention that the experimental group would be undergoing is taking a 
laxative (polyethylene glycol) for seven days prior to surgery. The potential 
common side effects from polyethylene glycol include; bloating, cramping, gas, 
and diarrhea which may lead to dehydration. The subjects will be monitored for 
potential side effects via phone call prior to the surgery. The medication could be 
discontinued depending on the side effects and patient satisfaction. This is a 
standard laxative used for patient post-operatively and is known to be well 
tolerated. The possible side effects are not life threatening and will mostly cause 
discomfort. They are also reversible with cessation of the medication.  
 
We do not anticipate any psychological, social or legal side effects. The risks that 
this medication poses are minor, but the benefits could be major. Constipation is a 
common post-operative problem that has been known to cause a great deal of pain 
and discomfort. If pre-operative polyethylene glycol shows benefit in improving 
those symptoms, then a patient’s post-operative recovery could potentially be 


 
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quicker and less painful. This is a relatively simple and low risk intervention which 
could make a significant patient satisfaction impact. In order to minimize the risks 
and protect patients, the study investigators will call patients once they begin taking 
pre-operative polyethylene glycol to assess for any side effects or discomfort. The 
medication will be stopped if any adverse effects are seen.  
 
 
 
18. RESEARCH RELATED HARM/INJURY 
• Describe the availability of medical or psychological resources that subjects might 
need as a result of anticipated problems that may be known to be associated with the 
research. 
• If the research is greater than minimal risk, explain any medical treatments that are 
available if research-related injury occurs, who will provide it, what will be provided, 
and who will pay for it.   
 
The Suffolk Urogynecology practice will be available by phone or for appointment 
to discuss any medical or psychological issues at the time of the trial. Treatment 
will be provided to the patient if necessary. Appropriate referrals will be made if a 
necessary type of treatment or expertise is not available. If patients develop side 
effects, cessation of the medication will provide necessary resolution.  
 
 
19. POTENTIAL BENEFIT TO SUBJECTS 
 
• Explain what benefits might be derived from participation in the study, noting in 
particular the benefit over standard treatment (e.g. a once-a-day administration 
instead of four times a day, an oral formulation over an IV administration).  
• Also state if there are no known benefits to subjects, but detail the value of knowledge 
to be gained 
 
This study may not benefit the subjects directly. However, if the pre-operative 
polyethylene glycol regimen proves to decrease time to first bowel movement, as 
well as decrease post-operative pain and discomfort, then the patients in the 
experimental arm may benefit from participation in the study. This study could also 
provide knowledge in creating a helpful pre-operative regimen as a standard of care 
for future patients because currently a standard treatment does not exist.  
 
 
20. PROVISIONS TO PROTECT PRIVACY INTERESTS OF SUBJECTS 
 
• Describe the methods used to identify potential research subjects, obtain consent and 
gather information about subjects to ensure that their privacy is not invaded.  
• In addition consider privacy protections that may be needed due to communications 
with subjects (such as phone messages or mail).   
 


 
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Potential research subjects will be identified during their pre-operative visit with 
the Suffolk Urogynecology practice, using the inclusion and exclusion criteria. 
During this visit, consent will be obtained and the study design explained. 
Communication with patients will occur in the office in a private setting to ensure 
confidence. Follow ups will occur via phone and privacy will be ensured when 
speaking to the patient.  
 
 
 
21.  COSTS TO SUBJECTS 
 
• Describe any foreseeable costs that subjects may incur through participation in the 
research 
• Indicate whether research procedures will be billed to insurance or paid for by the 
research study.   
 
Patients who choose to participate in the study, will be asked to purchase Miralax 
over the counter. All patient pre and post-operative visits will be part of their 
standard of care regardless of study participation.  
 
 
22. PAYMENT TO SUBJECTS  
 
• Describe the amount of payment to subjects, in what form payment will be received 
and the timing of the payments.   
 
Subjects will not receive payment for study participation. 
 
 
23.  CONSENT PROCESS 
 
If obtaining consent for this study, describe: 
• Who will be obtaining consent 
• Where consent will be obtained 
• Any waiting period available between informing the prospective participant and 
obtaining consent 
• Steps that will be taken to assure the participants’ understanding 
• Any tools that will be utilized during the consent process 
•   Information about how the consent will be documented in writing.  If using a  
standard consent form, indicate such.   
• Procedures for maintaining informed consent.   
 
Dr. Finamore, Dr. Pillalamarri and Dr. O’Shaughnessy will be obtaining 
consent for study participation in one of the four office locations of the Suffolk 
Urogynecology practice (Plainview, Bay Shore, Huntington and Wading 
River). Consent will be obtained once the patient agrees to study participation, 
without a waiting period unless the patient requests otherwise. The details of 


 
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the study will be explained and all questions answered to ensure participants’ 
understanding. The consent form will be documented in writing explaining the 
details of the study as well as the risks and benefits of participation. Informed 
consent will be maintained by explaining the details of the study to each patient 
carefully. A standard consent form will be used.  
 
 
In the state of NY, any participants under the age of 18 are considered children.  If your 
study involves children, additional information should be provided to describe: 
• How parental permission will be obtained 
• From how many parents will parental permission be obtained 
• Whether permission will be obtained from individuals other than parents, and if 
so, who will be allowed to provide permission.  The process used to determine 
these individual’s authority to consent for the child should be provided 
• Whether or not assent will be obtained from the child 
• How will assent be documented 
• Whether child subjects may be expected to attain legal age to consent to the 
procedures for research prior to the completion of their participation in the 
research.  If so, describe the process that will be used to obtain their legal 
consent to continue participation in the study.  Indicate what will occur if consent 
is not obtained from the now-adult subjects.   
 
N/A. 
 
 
If the study involves cognitively impaired adults, additional information should be 
provided to describe: 
• The process to determine whether an individual is capable of consent 
• Indicate who will make this assessment 
• The plan should indicate that documentation of the determination  and 
assessment will be placed in the medical record, when applicable, in addition to 
the research record. 
• If permission of a legally authorized representative will be obtained, 
o  list the individuals from who permission will be obtained in order of priority 
o Describe the process for assent of subjects; indicate whether assent will be 
required of all, some or none of the subjects.  If some, which subjects will be 
required to assent and which will not. 
o If assent will not be obtained from some or all subjects, provide an 
explanation as to why not 
o Describe whether assent will be documented and the process to document 
assent 
o Indicate if the subject could regain capacity and at what point you would 
obtain their consent for continued participation in the study 
 
N/A 
 


 
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If the study will enroll non-English speaking subjects: 
• Indicate what language(s) other than English are understood by prospective 
subjects or representatives 
• Indicate whether or not consent forms will be translated into a language other 
than English 
• Describe the process to ensure that the oral and written information provided 
to those subjects will be in that language 
• If non-English speaking subjects will be excluded, provide a justification for 
doing so 
 
The study subjects will either be English or Spanish speaking. There will be 
English and Spanish consents available. The study will be explained to the 
patient in their preferred language and interpreter services will be used 
when necessary. 
 
 
24.  WAIVER OR ALTERATION OF THE CONSENT PROCESS       X N/A          
 
Complete this section if you are seeking an alteration or complete waiver of the consent   
process. 
• Describe the possible risks of harm to the subjects involved in this study and 
explain why the study involves no more than minimal risk to the subject:   
• Explain why the waiver/ alteration will not adversely affect the rights and welfare 
of subjects 
• Explain why it is impracticable to conduct this research if informed consent is 
required   
• Explain why it is not possible to conduct this research without using the 
information or biospecimens in an identifiable form 
• If appropriate, explain how the subjects will be provided with additional pertinent 
information after participation.   If not appropriate to do so, explain why.  
 
N/A 
 
Complete this section if you are obtaining informed consent but you are requesting a 
waiver of the documentation of consent (i.e., verbal consent will be obtained). To 
proceed with a waiver based on these criteria, each subject must be asked whether they 
wish to have documentation linking them to this study.  Only complete subsection 1 OR 
subsection 2.  
 
  SUBSECTION 1 
 
• Explain how the only record linking the subject to the research would be the 
consent document. 
• Explain how the principal risk of this study would be the potential harm resulting 
from a breach in the confidentiality 


 
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• Indicate whether or not subjects will be provided with a written statement 
regarding the research. 
 
N/A 
 
SUBSECTION 2 
•  Describe the possible risks of harm to the subjects involved in this study and 
explain why the study involves no more than minimal risk.   
• Confirm that the research only involves procedure for which consent is not 
normally required outside the research context.  
• Indicate whether or not subjects will be provided with a written statement 
regarding the research. 
 
N/A 
 
. 
 
25. WAIVER OF HIPAA AUTHORIZATION  
 
 
 X  N/A       
 
Complete this section if you seek to obtain a full waiver of HIPAA authorization to use 
and/or disclose protected health information.  
• Describe the risks to privacy involved in this study and explain why the study 
involves no more than minimal risk to privacy:   
• Describe your plan to protect identifiers from improper use or disclosure and to 
destroy them at the earliest time. 
•  Indicate why it is not possible to seek subjects’ authorization for use or 
disclosure of PHI. 
• Indicate why it is not possible to conduct this research without use or disclosure 
of the PHI.   
• Indicate if PHI will be disclosed outside NSLIJ Health System, and if so, to whom.   
Note:  PHI disclosed outside NSLIJ Health System, without HIPAA authorization 
needs to be tracked. Please see guidance at www.nslij.com/irb for information 
about tracking disclosures. 
 
N/A 
 
Complete this section if you seek to obtain a partial waiver of the patient’s 
authorization for screening/recruitment purposes (i.e., the researcher does not have 
access to patient records as s/he is not part of the covered entity) 
Note: Information collected through a partial waiver for recruitment cannot be shared 
or disclosed to any other person or entity. 
• Describe how data will be collected and used:  
• Indicate why you need the PHI (e.g.PHI is required to determine eligibility, 
identifiers are necessary to contact the individual to discuss participation, other) 


 
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• Indicate why  the research cannot practicably be conducted without the partial 
waiver (e.g. no access to medical records or contact information of the targeted 
population, no treating clinician to assist in recruitment of the study population, 
other) 
N/A 
 
 
26.  VULNERABLE POPULATIONS: 
 
Indicate whether you will include any of these vulnerable populations. If indicated, 
submit the appropriate appendix to the IRB for review: 
 
  Children or viable neonate 
  Cognitively impaired 
  Pregnant Women, Fetuses or neonates of uncertain viability or nonviable  
  Prisoners 
  NSLIJ Employees, residents, fellows, etc 
  poor/uninsured 
  Students 
X    Minorities 
  Elderly 
  Healthy Controls 
 
If any of these populations are included in the study, describe additional safeguards that 
will be used to protect their rights and welfare. 
 
Hispanic patients will be included in the study and consents in Spanish will be 
available to the patients. Interpreter services will be used to ensure patient 
understanding.  
 
 
27.  MULTI-SITE HUMAN RESEARCH (COORDINATING CENTER) 
 
If this is a multi-site study where you are the lead investigator, describe the management 
of information (e.g. results, new information, unanticipated problems involving risks to 
subjects or others, or protocol modifications) among sites to protect subjects. 
N/A  
 
 
 
28.  REFERENCES/BIBIOGRAPHY 
 
Provide a reasonable list of references directly related to the study. Any diagrams for 
new medical devices or brief reprints from journals might also prove useful. 
 


 
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1. Lembo, Anthony, and Michael Camilleri. Chronic Constipation | NEJM. 2 Oct. 
2003, www.nejm.org/doi/full/10.1056/NEJMra020995. 
 
2. Bove, Antonio. “Consensus Statement AIGO/SICCR Diagnosis and Treatment of 
Chronic Constipation and Obstructed Defecation (Part II: Treatment).” World Journal 
of Gastroenterology, vol. 18, no. 36, 28 Sept. 2012, pp. 4994–5013., 
doi:10.3748/wjg.v18.i36.4994. 
 
3. Arya LA, Novi JM, Shaunik A, Morgan MA, Bradley CS. Pelvic organ prolapse, 
constipation, and dietary fiber intake in women: a case-control study. Am J Obstet 
Gynecol. 2005 May;192(5):1687-91. doi: 10.1016/j.ajog.2004.11.032. PubMed PMID: 
15902178. 
 
4. McNanley A, Perevich M, Glantz C, Duecy EE, Flynn MK, Buchsbaum G. Bowel 
function after minimally invasive urogynecologic surgery: a prospective randomized 
controlled trial. Female Pelvic Med Reconstr Surg. 2012 Mar-Apr;18(2):82-5. doi: 
10.1097/SPV.0b013e3182455529. PubMed PMID: 22453316  
 
5. Mínguez M, López Higueras A, Júdez J. Use of polyethylene glycol in functional 
constipation and fecal impaction. Rev Esp Enferm Dig. 2016 Dec;108(12):790-
806. doi: 10.17235/reed.2016.4571/2016. Review. PubMed PMID: 27871178. 
 
6. Pelham RW, Nix LC, Chavira RE, Cleveland MV, Stetson P. Clinical trial: single- 
and multiple-dose pharmacokinetics of polyethylene glycol (PEG-3350) in healthy 
young and elderly subjects. Aliment Pharmacol Ther. 2008 Jul;28(2):256-65. doi: 
10.1111/j.1365-2036.2008.03727.x. Epub 2008 Apr 30. PubMed PMID: 18462266.