Barbed Suture Versus Non-Barbed Suture for Posterior Colporrhaphy: A Randomized Controlled Trial
Phase: NA
Conditions: Rectocele
Sponsor: Wake Forest University Health Sciences

Protocol Version Number: 5 
04/18/2022 
 
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STUDY TITLE: Barbed Suture versus Non-Barbed Suture for Posterior Colporrhaphy: A 
Randomized Controlled Trial 
 
NCT04658784 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Principal Investigator 
Erinn Myers, MD 
 
2001 Vail Avenue, Suite 360 
 
Charlotte, NC 28207 
 
704-304-1160 
 
Co-Investigators:  
Amanda Merriman, MD, MPH 
2001 Vail Avenue, Suite 360 
Charlotte, NC 28207 
704-304-1160 
 
Megan Tarr, MD 
 
2001 Vail Avenue, Suite 360 
 
Charlotte, NC 28207 
 
704-403-6350 
 
 
 
Heather Winn, MD 
 
2001 Vail Avenue, Suite 360 
 
Charlotte, NC 28207 
 
704-304-1160 
 
 
            William E. Anderson, MS 
   
Center for outcomes Research and Evaluation (CORE) 
Charlotte, NC  
 
704-355-3934 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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BACKGROUND 
 
 
Pelvic organ prolapse (POP) is a growing concern for the aging female 
population, and symptomatic women often require surgical intervention. Approximately 
200,000 surgical procedures for POP are performed annually in the United States. This 
number is anticipated to increase with the growth in the aging population.1 Surgical 
prolapse repairs are often categorized into either mesh augmented or native tissue repairs. 
During a native tissue repair, the surgeon uses a woman’s natural tissue to repair the 
prolapse without augmenting the repair with synthetic mesh.  
Women often have post-operative pain with native tissue posterior colporrhaphy.2 
Native tissue posterior repairs are performed to address symptomatic posterior 
compartment prolapse, defects in the rectovaginal fibromuscularis, and/or a widened 
genital hiatus. This type of repair may improve obstructed defecatory dysfunction and 
bulge symptoms, but can be associated with postoperative pelvic pain and dyspareunia.3 
Paraiso et al evaluated three surgical techniques for posterior colporrhaphy (site-specific, 
midline plication, and porcine graft) and found no difference in overall symptom 
improvement, quality of life, and post-operative sexual function.4 Regardless of the 
technique used, a posterior colporrhaphy can cause considerable postoperative pain and 
can contribute to de novo dyspareunia in 9-20% of women.2, 4-6  Most studies evaluating 
pain after posterior colporrhaphy tend to focus on various methods of analgesia and 
surgical technique rather than the suture materials used.7 
Suture choice may contribute to postoperative pain at the time of posterior 
colporrhaphy. There are few studies evaluating suture in the posterior compartment with 
no defined standard suture material for posterior colporrhaphy. Luck et al found that 
suture erosion and wound dehiscence were noted after using a permanent suture during 
posterior colporrhaphy; consequently, permanent suture is now seldomly used.8 Available 
studies, when comparing subjective bulge and quality of life outcomes, do not 
demonstrate superiority of one suture type over the other.9-11 Delayed absorbable suture 
has the benefit of retaining tensile strength for approximately 3 months. Delayed 
absorbable suture material itself, however, can remain in place for 6-8 months.12  Barbed 
delayed absorbable suture has unique properties. The small barbs on the delayed 
absorbable sutures allow for even distribution of suture strength along the incisional 
closure without the need for knots. These properties may decrease postoperative pain by 
decreasing knot burden. Barbed suture has been successfully applied to vaginal cuff 
closure, myomectomy, sacrocolpopexy mesh attachment, and closure of bowel and 
bladder injuries with demonstrated reduced operative times. 13-16 To date, no studies have 
evaluated the impact of barbed suture on postoperative pain or surgical time after 
posterior colporrhaphy. 
 
STUDY PURPOSE 
 
To compare the use of barbed suture versus non-barbed suture at the time of posterior 
colporrhaphy and describe an innovative suturing technique for posterior repair using 
barbed suture. 
 

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STUDY OBJECTIVES 
Primary Objective 
1. To compare delayed absorbable barbed suture versus non-barbed delayed absorbable 
suture at the time of posterior repair on post-operative posterior compartment pain 
scores, as measured by the Visual Analog Scale (VAS), at 6 weeks 
2. To describe an innovative technique for posterior repair using barbed suture 
 
Secondary Objectives 
1. To compare VAS pain scores in the posterior compartment at 6-months and 12-
months 
2. To evaluate operative time for posterior repair in minutes 
3. To evaluate suture burden and pelvic pain on examination of the posterior 
compartment 
4. To evaluate pain versus the length of a repair in cm measured by length of defect 
from hymen to most proximal delayed absorbable suture 
5. To evaluate postoperative patient quality of life (QoL) using Pelvic Floor Distress 
Inventory- 20 (PFDI-20), specifically the Colorectal-Anal Distress Inventory-8 
(CRADI-8) and the Pelvic Organ Prolapse Distress Inventory- 6 (POPDI-6) 
6. To evaluate postoperative sexual function using the PISQ-12 
7. To evaluate cost of delayed absorbable suture choice based on sutures used 
8. To evaluate anatomical failure of posterior compartment at 6-weeks and 12-months 
9. To evaluate subjective failure of posterior compartment at 6-weeks, 6-months, 12-
months 
10. To evaluate differences in adverse outcomes using modified Clavien-Dindo 
classification system 
 
We plan to perform a prospective analysis of secondary outcomes outlined above at 12 months. 
 
HYPOTHESIS 
Delayed absorbable barbed suture will have less post-operative pain in the posterior 
compartment than delayed absorbable non-barbed suture at the time of posterior repair, as 
measured by VAS at 6 weeks.  
 
NULL HYPOTHESIS (H0) 
There will be no difference in post-operative pain in the posterior compartment between delayed 
absorbable barbed suture and delayed absorbable non-barbed suture, as measured by VAS at 6 
weeks.  
 
STUDY DESIGN AND METHODS 
 
Randomized controlled superiority trial offered to patients undergoing posterior colporrhaphy for 
pelvic organ prolapse at Atrium Health. This study will be conducted at four clinical sites: 
 
1. Women’s Center for Pelvic Health (Mercy), Atrium Health, Charlotte, NC 

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2. One Day Surgery (ODS) Center, Atrium Health, Charlotte, NC 
3. Women’s Center for Pelvic Health (Cabarrus), Atrium Health, Concord, NC 
4. Carolinas Medical Center, Atrium Health, Charlotte, NC  
 
 
Human Subject Research and Informed Consent 
 
Each subject will be required to sign an Institutional Review Board (IRB) approved consent form 
prior to beginning any study-related interventions or assessments. The informed consent form 
will describe the study in detail. Additionally, the study consent form will disclose the planned 
uses of study data, as well as potential risks to the subjects. Each prospective subject will have 
the objectives of the study explained to them prior to enrollment. The subject will be given an 
opportunity to ask questions and decide whether or not to participate. Copies of the signed 
informed consent form will be provided to the subjects, and the originals will be stored with the 
research records for this study at the Mercy study center.  
 
Subjects have the right to: 
• Voluntarily participate in the study 
• Withdraw or refuse participation in the study at any point without questioning 
• Understand the objectives of the study 
• Understand the risks and benefits of the study 
• Have their confidentiality maintained 
Participant (Subject) Screening and Point of Enrollment 
Subjects scheduled to undergo posterior colporrhaphy with or without perineorrhaphy will be 
identified and screened against inclusion and exclusion criteria. If potential subjects meet the 
requirements for the study, they will be eligible to be invited to participate.  Subjects will be 
consented for study enrollment by physicians, fellow physicians, nurse practitioners, physician’s 
assistants, and/or a research nurse prior to surgery at either their pre-operative visit or the 
morning of surgery. Subjects will be randomized to one of the two treatment groups in the 
operating room prior to starting the surgical procedure. 
Provider and Clinical Staff Training  
To ensure consistent posterior colporrhaphy technique, the principal investigator will provide in-
service educational video to all participating providers who will be performing surgery. 
Educational review will include review of suture materials being used and specific repair 
protocol.  All clinical staff, including nursing and physicians, will receive in-service training 
about the study protocol and guidelines. Providers performing follow-up exams will be educated 
on pelvic organ prolapse quantification (POP-Q) examination technique, and a standardized 
method to digitally palpate suture burden and myofascial trigger points using a standardized 
pictorial tool. Personnel administering or collecting interviews/measurement 
scales/questionnaires will be trained on how each interview/measurement scale/questionnaire 
should be completed. 

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Inclusion Criteria 
1. Women 
2. Age 18yo or older 
3. English speaking 
4. Undergoing posterior colporrhaphy with or without perineorrhaphy  
a) Concomitant surgical procedures allowed 
 
Exclusion Criteria 
1. Documented allergy or contraindication to use of suture material (polydiaxonone, 
dioxanone, glycolide or trimethylene carbonate) 
2. Prior mesh in posterior compartment 
3. Planned colpocleisis 
4. Current or prior rectovaginal fistula 
5. Planned sacrospinous ligament fixation procedure 
6. Chronic pelvic pain diagnosis 
7. Chronic narcotic medication use (daily narcotic use for ³ 3 weeks before surgery by 
review of NC Controlled Substances Reporting System (CSRS)) 
8. Active vulvodynia 
9. Non-English speaking 
10. Inability to provide informed consent 
11. Planned concomitant anal or rectal surgery 
 
 
Study Withdrawal 
Subjects may withdraw from the study at any point in time. Documentation of the reason for 
withdrawal will be captured in the data collection forms. There will be no risk to subjects that 
choose to withdraw from the study. 
Preoperative Period 
All eligible patients planned to undergo posterior colporrhaphy will be identified preoperatively, 
screened, and approached for participation in the study.  Concomitant pelvic reconstructive 
surgical procedures allowed.  Subjects who do not meet the inclusion and exclusion criteria will 
be considered screen failures. Screen failures will be captured, and the cause for screen failure 
will be documented.   
If a patient agrees to participate in study, baseline demographic information, as well as medical 
and medication history will be collected. A set of preoperative baseline questionnaires will also 
be administered, including the PFDI-20, PSQI-12, and a baseline pain assessment using VAS. If 
a prior POP-Q exam is not documented in the chart, a POP-Q and myofascial trigger point exam 
will be completed at this visit. 
Consent will either be obtained at the preoperative visit. Or, if they are undergoing a virtual 
preoperative visit, they will receive an email with consent to review and then sign consent on the 
day of surgery. 

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Perioperative and Surgery Period 
All subjects will receive routine preoperative intravenous antibiotic prophylaxis based on 
standard hospital protocols.  All subjects will receive standard of care anesthetic and 
prophylactic medications as determined by anesthesia providers.   
Intervention: Eligible subjects will be randomized using a computer-generated randomization 
scheme, with patients assigned in a blinded 1:1 ratio, stratified by concurrent minimally invasive 
abdominal surgery, to either: 
Group 1: Intervention 
1. Barbed suture: 2-0 dioxanone, glycolide and trimethylene carbonate (V-Loc 
90TMMedtronic), delayed absorbable, monofilament, barbed-suture 
(1) Violet dyed 
(2) Tapered needle 
Group 2: Control 
2. Non-barbed suture: 2-0 polydioxanone (PDS® EthiconTM) delayed absorbable, 
monofilament, non-barbed suture 
(1) Violet dyed 
(2) Tapered needle 
The allocation sequence will be in sealed, opaque envelopes. An envelope will be retrieved in the 
operating room.  The OR circulating nurse will assemble the appropriate intervention suture 
materials.  The envelope will then be labeled and given back to the research nurse. 
Procedures will be performed by 4 fellowship trained, board-certified female pelvic 
reconstructive surgeons and 3 fellows in training. Residents will not participate in posterior 
repair. Subjects will be positioned in dorsal lithotomy with the use of adjustable stirrups.  The 
patient will be prepped and draped as is standard of care at our institution, either for vaginal, or 
combined vaginal and abdominal surgery depending on planned concomitant surgery.  After 
surgical timeout, a Foley urinary catheter will be placed.  Concomitant procedures will be 
performed in the order that the surgeon deems necessary.  
The posterior repair will be repaired in the following standardized fashion, which is most similar 
to the technique described by prior studies.3, 12, 17-18 First, the posterior compartment vaginal 
epithelium and perineal body will be injected with local anesthetic with epinephrine (0.25% 
Marcaine with 1:200000 epinephrine) for tissue dissection and hemostasis prior to incision.  This 
local anesthetic may be diluted with normal saline to a final volume deemed appropriate by the 
surgeon. The vaginal epithelium is then incised as far proximal as is indicated to correct the 
rectocele.  The vaginal epithelium is dissected off the underlying connective tissue to expose the 
rectocele to the arcus tendineous rectovaginalis or as far as clinically indicated.  Prior to starting 
the posterior colporrhaphy plication, a sequentially numbered opaque sealed envelope will be 
opened by the circulating nurse, revealing the study group allocation. Sutures will then be placed 

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Control: Subjects randomized to the non-barbed suture (Group 2) will have rectovaginal 
fibromuscularis plicated in an interrupted fashion as described above. The polydioxanone 
suture was chosen as a control due it being both an institutional and national standard for 
suture and technique being used in the posterior compartment. Polydioxanone was chosen 
over polyglactin, due to its similarity to the barbed suture material and expert opinion 
recommendation that delayed absorbable suture be use in the posterior compartment for 
colporrhaphy (Culligan 2005). Additionally, prior study protocols have used 
polydioxanone. 11,17-18 This also allows us to control for specific suture properties, 
including: delayed absorbable nature (180-210 days for polydioxanone vs. 90-110 days 
for barbed suture), suture size, suture color (violet), synthetic monofilament, and tapered 
needle type (Appendix 4, Figure 1). 
 
Immediate Postoperative Period 
All surgery patients at our institution routinely receive enhanced recovery after surgery (ERAS) 
protocol for pain management by a department standardized order set pre and postoperatively, 
unless there is a contraindication. 
 
Most patients at our institution are discharged the same day of surgery. Discharge criteria include 
independent ambulation, tolerate an oral diet, adequate pain control with oral medications, and 
voiding trial. If a vaginal pack is placed, it is removed prior to discharge. There will be no 
changes in discharge criteria for this study. 
 
The standard ERAS calls for a multimodal pain regimen postoperatively.  Patients are discharged 
home on the following regimen: ibuprofen 600-800 mg every 8 hours, oxycodone/ 
acetaminophen (Percocet) 5mg/325 mg or or hydrocodone/acetaminophen (Norco/Lortab) 
5mg/325mg 1 pill every 4-6 hours as needed and, and may also receive gabapentin 100-600mg 
TID for 5 days. They are instructed to take MiraLAX, Colace, or another stool softener as 
needed. They receive counseling at preoperative visit on how to take these medications. Pain 
medications may be slightly altered based on allergies or intolerances. 
 
Patients are given a set of standard postoperative instructions, which include general precautions, 
nothing per vagina for 6-8weeks, no lifting greater than 10 pounds until 6-8weeks.  
 
6 weeks +/- 3 weeks 
Subjects will be scheduled for a postoperative follow up visit at approximately 6 weeks. 
At this visit they will have a structured postoperative interview and pelvic examination, 
including POP-Q, standardized assessment of suture burden and myofascial trigger 
points. They will also complete a VAS, validated questionnaires: PFDI-20 subscales 
(CRADI-8, POPDI-6). We will review bowel regimen and pain medications used during 
the past 6-weeks. We will also perform an adverse events screening. 
 
6months +/- 2 month 
Subjects will be called at approximately 6 months after their original surgery. During this 
phone call they will have a structured interview and complete VAS, validated 

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questionnaires: PFDI-20 subscales (CRADI-8, POPDI-6), PSQI-12 (if sexually active). 
We will also perform adverse events screening. The VAS/pain assessment form will be 
given to patient at their 6-week visit for their 6-month phone call. Another copy will be 
sent with a pre-paid return envelope approximately 2-weeks prior to anticipated phone 
call follow-up as a reminder. 
 
12 months +/- 3 month 
Subjects will be scheduled for a postoperative follow up visit at approximately 12 months 
after their original surgery. At this visit they will have a structured postoperative 
interview and pelvic examination, including POP-Q, assessment of suture burden and 
myofascial trigger points. The will also complete VAS, validated questionnaires: PFDI-
20 subscales (CRADI-8, POPDI-6), PSQI-12 (if sexually active). We will perform 
adverse events screening. 
Randomization: 
A biostatistician in the Center for Outcomes Research and Evaluation (CORE) at Atrium Health 
will generate a randomization sequence using SAS Enterprise Guide 7.1 (SAS Institute Inc., 
Cary, NC, USA).  A permuted block randomization scheme will be used to assign patients in a 
1:1 ratio to intervention or control.  Randomization will be stratified by presence or absence of 
concurrent minimally invasive abdominal surgery.  We feel this stratification of randomization 
sequence is necessary because we anticipate patients who undergo vaginal surgery alone versus 
vaginal and concurrent minimally invasive abdominal surgery experience a different quality and 
severity of postsurgical bowel function and pain. 
The study will be blinded such that both study subjects and investigators collecting postsurgical 
outcome data will be masked to treatment allocation and block size randomization.  The surgeon 
performing the posterior repair will be unblinded.  The surgical technician, operating room 
circulating nurse, and statistician will also not be blinded, but will have no contact with the 
patients.  
The operating room nurse will pull the study suture materials- consisting of either barbed suture 
or non-barbed suture. They will also pull the standardized suture materials for posterior repair as 
listed above, which includes caliber of suture and needle type for each suture used. 
After the posterior dissection is completed, the randomization will take place. The sequentially 
numbered opaque sealed envelope will be opened by the circulating nurse, revealing the study 
group allocation. The study suture will then be opened by the operating room nurse and placed 
on the surgical field.   
DATA COLLECTION AND MANAGEMENT:  
Case report forms will be developed by the investigators.  Data will be collected prospectively 
per the schedule in Table 1. All study data will be recorded by research staff and securely 
maintained at the Mercy study site.  The data flow will consist of paper data collection for 

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eligibility assessment, baseline data, randomization, intervention group, primary and secondary 
outcomes, adverse events, and protocol deviations.  
Data will be entered by study staff into Research Electronic Data Capture (REDCap) database 
that will be stored on a secure server at Atrium Health.  REDCap is a secure, web-based 
application designed to support data capture for research studies, providing:  1) an intuitive 
interface for validated data entry; 2) audit trails for tracking data manipulation and export 
procedures; 3) automated export procedures for seamless data downloads to common statistical 
packages; and 4) procedures for importing data from external sources. 20 Data will be entered 
into REDCap within 30 business days of collection. 
Each subject will have a unique identification number to which only the principal and sub-
investigators will have access. The data collection spreadsheet will not contain any patient 
identifiers and will be password protected. The master list that links the patients and their study 
identification number will be stored separately from the database. All collected information will 
be stored separately on a password protected hard drive. A back up copy of the file will be stored 
on a password protected hospital network drive.  All hard copies of study data will be stored in a 
locked cabinet in the office of the research nurse, which will also be locked. 
Table 1. Data Collection Schedule 
*Other demographic data includes: Age, Race, Body Mass Index (BMI), Stage of posterior compartment prolapse 
(per pre-operative POP-Q exam), post-menopausal status (yes/no), vaginal hormone replacement therapy  (HRT) 
(yes/no), smoking status (packs per day), if sexually active (yes or no) 
**Surgery data includes: surgeon, concurrent surgeries performed, type of suture used in posterior colporrhaphy, 
number of layers for posterior colporrhaphy (midline plication only), isolated defect (yes/no), suture used for 
isolated defects, number of barbed or non-barbed suture packets used for posterior colporrhaphy, number of 
transverse suture passes for barbed suture during posterior colporrhaphy, number of interrupted suture passes for 
non-barbed suture during posterior colporrhaphy, amount of remaining barbed or non-barbed suture left over after 
posterior colporrhaphy (cm), length of repair (cm) of posterior colporrhaphy, if packing placed (yes/no), total 
 
Pre-op 
Surgery 
(Intra-op) 
6 Week 
Follow-up 
6 Month 
Phone call 
12 Month 
Follow-up 
Informed Consent 
x 
 
 
 
 
Medical History  
x 
 
 
 
 
Medication review  
x  
 
 
 
 
*Other Demographics 
x 
 
 
 
 
**Surgery 
 
x 
 
 
 
Randomization 
 
x 
 
 
 
Hospital length of stay 
 
 
x 
 
 
Pain scale (VAS) 
x 
 
x 
x 
x 
Post-op pain medication use 
 
 
x 
 
 
***Examination 
x 
 
x 
 
x 
PFDI-20  
x 
 
x 
x 
x 
PSQI-12 
x 
 
 
x 
x 
Adverse events screen 
 
x 
x 
x 
x 
Suture and Operative cost 
 
 
x 
 
 

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Secondary Outcome Measures 
 
Suture burden and myofascial pain: This will be determined by standardized pelvic 
examination using digital palpation and/or visualization of knots/suture, as well as 
palpation of myofascial trigger points performed at 6-weeks and 12-months. Recorded 
using a diagram in the medical record at follow-up visits (Appendix 4, Figure 2). 
 
Surgical time for posterior repair (posterior colporrhaphy with or without 
perineorrhaphy): We will record total time of procedure start to finish in minutes, as well 
as total time of posterior repair from start to finish in minutes. 
 
Length of surgical repair (posterior colporrhaphy): We will measure the total length of 
the posterior colporrhaphy in centimeters (cm) (this will be measured from the hymen 
(most distal point) to the level of the first suture pass (most proximal)) at completion of 
the repair. 
 
Postoperative sexual function measures: We will record patient responses to the 
validated PISQ-12 questionnaire at preoperative visit, 6-months, and 12-months in the 
medical record at follow-up visits (Appendix 2, Figure 2). 
 
Postoperative patient quality of life (QOL) measures: We will record patient 
responses to the validated PFDI-20 subscales (CRADI-8, POPDI-6) at preoperative visit, 
6-weeks, 6-months, and 12-months in the medical record at follow-up visits (Appendix 2, 
Figure 1) 
 
Suture and Operative Costs: We will record cost of suture for the posterior repair by 
calculating number of sutures used by the cost charged per suture. We will also calculate 
how much a procedure costs based on posterior repair operative time (cost/minute).  
 
Anatomical and subjective surgical failure in posterior compartment: We will 
evaluate Stage of posterior prolapse on POP-Q examination, as well as with POPDI-6 
portion of the PFDI-20 questionnaire. Standard definition of anatomical cure will be 
defined as Ba or Bp at </= 0 on POP-Q examination (i.e.at or beyond hymenal ring) 
and/or patient subjective symptom response on PFDI-20 questionnaire, with a negative 
response to questions: “Do you usually have a sensation of bulging or protrusion from the 
vaginal area?” and “Do you usually have a bulge or something falling out that you can 
see or feel in the vaginal area?” 21 
 
Adverse events: Any adverse event related to posterior repair or suture type will be 
reported. We will use the Modified Clavien-Dindo Classification System for surgical 
complications (Figure 3). We will also collect information from the EMR on if patients 
are re-admitted during the study time period (yes or no).  Please refer to section on 
Adverse Events for details of reportable criteria. 
 
 
 

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was submitted to allow for enrollment of an additional 10 patients, for a total of 74 subjects, 36 
per arm to allow for improved power given calculation based on a single study. 
 
STUDY DOCUMENTATION AND MONITORING  
Site Documentation 
All study documents included in this protocol that will be presented to subjects will be submitted 
to the IRB for review. The Mercy site will maintain a study binder for all sites that will include 
the following:  
• Enrollment log of patients that have consented to be in the study (electronic version) 
• Protocol deviation log (electronic version) 
• Adverse event log (electronic version) 
• Investigator protocol and amendments 
• IRB submissions, modifications, and renewals 
• Data safety monitoring committee reports 
• IRB approved consent form 
• Data collection forms 
• Patient assessment forms 
• Patient questionnaires  
Data Safety Monitoring 
The research team will complete an initial report once 10% of the enrolled subjects have 
completed the 6 weeks outcome data collection; thereafter, a report will be completed every 6 
months from the receipt of the DSMB’s recommendations. This report will detail the progress 
and subject status, any adverse events, and any protocol deviation. The research coordinator will 
inform all study staff members of any unanticipated problems involving risks to study subjects or 
others.  The research coordinator will facilitate and participate in internal monitoring visits by 
staff of the Office of Clinical and Translational Research at Atrium Health.  This will include a 
thorough review of research subjects records, source documents, regulatory binders, and consent 
forms.  
The Principal Investigator will monitor the study and assess the need for amendments as the 
study progresses. The PI will review the progress of each subject on the study and will apprise 
the IRB of adverse events or unexpected problems that may influence the IRB’s decision to 
allow the trial to continue, in accordance with the IRB’s standard operating procedures and 
policies.  A protocol revision may be necessary for reasons including but not limited to rights, 
safety of subjects, welfare of subjects, and thus, an amendment will be required. Appropriate 
approvals (i.e., IRB) of the revised protocol must be obtained prior to implementation at each 
site.  

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The biostatistical team will generate periodic reports to monitor screening, enrollment, 
completeness of data for intervention implementation and outcomes, adverse events, and 
protocol deviations. 
Data safety monitors will serve as an independent body to review the study data on a regular 
basis. The data safety monitors will include an external physician and an external research nurse. 
Data and safety monitoring responsibilities will consist of review of the research protocol and 
ongoing study activities, including review of data quality and completeness, review of fidelity to 
the study protocol, review of adequacy of subject recruitment and retention, review of adverse 
events, and making recommendations to the study PI and to the IRB concerning trial 
continuation, modification, or conclusion.  Such monitoring helps to safeguard subject safety, 
ensure data quality, and provide ongoing training and support to ensure compliance.  The data 
safety monitors will first convene to approve the study protocol and determine the frequency of 
meetings.  After the first ten patients are enrolled and randomized, the study statisticians will 
generate a report for the data safety monitors to review.  Content and frequency of the reports 
will be agreed upon prior to implementation of the trial.  The PI will be responsible for ensuring 
that the study complies with the data safety monitors’ requests.  
 
Study Medical Device Information 
Medical Risks related to delayed absorbable monofilament suture include but are not limited 
to the following: injury to surrounding structures, allergic reaction to suture material, surgical 
dehiscence of wound, wound infection, sutures remaining in place for extended periods 
(>6weeks) which may be associated with localized irritation, localized erythema or induration if 
suture placed superficially, failure to provide adequate wound support in closure of sites where 
expansion, stretching, or distension occurs, suture extrusion and delayed absorption in tissue 
with poor blood supply, poor cosmetic result, and/or broken needles may result in extended or 
additional surgeries or residual foreign bodies. Additionally, inadvertent needle sticks, may 
expose patient to bloodborne pathogens.  
Protocol Deviations 
Protocol deviations will be documented and logged on the Protocol Deviations log (electronic 
version). This will be done for every protocol related deviation related to any portion of the study 
timeline. Deviations will be reviewed and evaluated on an ongoing basis, and, as necessary, 
appropriate corrective and preventive actions (including notification, re-training, or 
discontinuation) will be put in place. 
Data Safety Monitoring 
Data safety monitors will include an external physician and research nurse. They will be tasked 
to review all adverse events that occur. A semi-annual report of all adverse events will be 
generated and sent to the data safety monitors every 6 months. 

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All Serious Adverse Events (SAEs) will be reported to the data safety monitors via email within 
2 business days of site staff being informed of its occurrence. The PI and research nurse will be 
copied on all communications with the data safety monitors. Copies of de-identified source 
documentation regarding the SAE will be included, as well as other clinically meaningful 
documentation. 
The PI (Dr. Amanda Merriman) will be responsible for ensuring that the study complies with the 
data safety monitors’ requests. 
Reporting Adverse Events 
 
 
Adverse events (AE) will be recorded and reported per the criteria and timeline below.  
 
All AEs must be recorded and entered into the AE log and REDCap. An event number will be 
assigned by each site and recorded.  The DSMB will be tasked to review all adverse events that 
occur. A semi-annual report of all adverse events will be generated and sent to the DSMB every 
6-months. 
 
All Serious Adverse Events (SAEs) will be reported to the DSMB via email within 2 business days 
of site staff being informed of its occurrence. The PI and research nurse will be copied on all 
communications with the DSMB. Copies of de-identified source documentation regarding the SAE 
will be included, as well as other clinically meaningful documentation. 
 
Reportable AEs include those determined to be related to the study medication. AEs not related 
to the study medications will not be collected. Please note that underlying diseases are not 
reportable AEs unless there is an increase in severity or frequency during the investigation. 
Death should not be recorded as an AE, but as an outcome of a specific SAE.  
 
Any subject that suffers an allergic reaction to the study suture material will be unblinded. This 
will be a reported adverse event that will also be reported to the DSMB, as outlined above.  
 
Adverse Event Definitions 
 
Adverse Event: any untoward medical occurrence, unintended disease or injury, or any untoward 
clinical signs (including abnormal laboratory finding) in subjects, whether or not related to study 
medications 
 
Serious Adverse Event: an adverse event that led to: 
• Death 
• Serious deterioration in the health of the subject that either resulted in 
o A life-threatening illness or injury 
o A permanent impairment of a body structure or a body function 
o Medical or surgical intervention to prevent life-threatening illness or injury or 
permanent impairment to a body structure or body function 
 

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Unrelated: No evidence that the timing of the AE has a relationship to the time study medications 
were taken 
 
Possibly Related: The AE has a timely relationship to the study medications, however a potential 
alternative etiology may be responsible for the AE 
 
Probably Related: The AE has a timely relationship to the study medications and the causative 
relationship can clearly be established. No potential alternative etiology is apparent. 
 
Severity Definitions 
 
Mild: Awareness of signs or symptoms, but easily tolerated and are of minor irritant type causing 
no loss of time from normal activities. Symptoms do not require therapy or a medical evaluation; 
signs and symptoms are transient.  
 
Moderate: Events introduce a low level of inconvenience or concern to the subject and may 
interfere with daily activities but are usually improved by simple therapeutic measures; moderate 
experiences may cause some interference with functioning.  
 
Severe: Events interrupt the subjects’ normal daily activities and generally require systemic drug 
therapy or other treatment; they are usually incapacitating. 
 
Surgical complications 
Surgical complications will be classified according to the Modified Clavien-Dindo Scale (I-V) 
(Figure 3). 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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REFERENCES 
 
1. Jones, KA et al. Trends in inpatient prolapse procedures in the United States, 1979-2006. 
Am J Obstet Gynecol. 2010;202(5):501.e1. 
2. Kahn MA, Stanton SL. Posterior Colporrhaphy: its effects on bowel and sexual function. 
Br J Obstetrics and Gynaecology. 1997; 104:82–86.  
3. Karjalainen PK, Mattsson NK, Nieminen K, Tolppanen A-M, Jalkanen JT, The 
relationship of defecation symptoms and posterior vaginal wall prolapse in women 
undergoing pelvic organ prolapse surgery, American Journal of Obstetrics and 
Gynecology .2019. 221(5): 480.e1-480.e10.  
4. Paraiso, MFR et al. Rectocele repair: A randomized trial of three surgical techniques 
including graft augmentation. American Journal of Obstetrics and Gynecology (2006) 
195, 1762–71. 
5. Komesu YM, Rogers RG, Kammerer-Doak DN, Barber MD, Olsen AL. Posterior repair 
and sexual function. Am J Obstet Gynecol. 2007;197(1):101.e1–101.e1016.  
6. Mowat A, Maher D, Baessler K, Christmann-Schmid C, Haya N, Maher C. Surgery for 
women with posterior compartment prolapse. Cochrane Database of Systematic Reviews 
2018, Issue 3. 
7. Evans, S et al. Extended Release Local Anesthetic for Postsurgical Vaginal Pain after 
Posterior Colporrhaphy and Perineorrhaphy: A Randomized Controlled Study Journal of 
Minimally Invasive Gynecology. 2019, 26(7): S207 - S208. 
8. Luck, AM et al. Suture erosion and wound dehiscence with permanent versus absorbable 
suture in reconstructive posterior vaginal surgery. American Journal of Obstetrics and 
Gynecology (2005) 192, 1626–9. 
9. Madhuvrata, P et al. A randomized controlled trial evaluating the use of polyglactin 
(Vicryl) mesh, polydioxanone (PDS) or polyglactin (Vicryl) sutures for pelvic organ 
prolapse surgery: outcomes at 2 years. J Obstet Gynaecol 2011;31(5):429-435.  
10. Allahdin, S et al. A randomized controlled trial evaluating the use of polyglactin mesh, 
polydioxanone and polyglactin sutures for pelvic organ prolapse surgery. J Obstet 
Gynaecol 2008;28(4):427-431.  
11. Bergman, I, Söderberg, MW, Kjaeldgaard A and Marion, EK. Does the choice of suture 
material matter in anterior and posterior colporrhaphy? International Urogynecolology 
Journal, 2016, 27(9): 1357–1365. 
12. Greenberg JA, Clark RM.Advances in suture material for obstetric and gynecologic 
surgery. Rev Obstet Gynecol. 2009; 2(3): 146-58. 
13. Greenberg JA, Goldman RH. Barbed suture: a review of the technology and clinical uses 
in obstetrics and gynecology. Rev Obstet Gynecol. 2013;6(3-4):107–115. 
14. Iavazzo, C et al. The Role of Knotless Barbed Suture in Gynecologic Surgery: Systematic 
Review and Meta-Analysis. Surg Innov. 2015 Oct;22(5):528-39.  
15. Chamsy, D et al. The use of barbed suture for bladder and bowel repair. J Minim Invasive 
Gynecol. 2015 May-Jun;22(4):648-52. 
16. Wiggins, T, et al. Benefits of barbed suture utilisation in gastrointestinal anastomosis: a 
systematic review and meta-analysis. Ann R Coll Surg Engl. 2019 Sep 11:e1-e7. 
17. Maher, CF et al. Midline rectovaginal fascial plication for repair of rectocele and 
obstructed defecation. Obstet Gynecol. 2004 Oct;104(4):685-9. 

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18. Christmann-Schmid C, Wierenga AA, Frischknecht E, Maher CA Prospective 
Observational Study of the Classification of the Perineum and Evaluation of Perineal 
Repair at the Time of Posterior Colporrhaphy. Female Pelvic Medicine & Reconstructive 
Surgery. 2016;22(6):453–459.  
19. Walters MD, Karram MM. Urogynecology and Reconstructive Pelvic Surgery E-Book. 
Vol 4th ed. Pp 49-55. London Saunders: 2015. Accessed January 27, 2020. 
20. Harris PA, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture 
(REDCap) – a metadata-driven methodology and workflow process for providing 
translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. 
21. Crisp C,  Bandi S, Kleeman SD, Oakley SH, Vaccaro CM, et al. Patient-controlled versus 
scheduled, nurse-administered analgesia following vaginal reconstructive surgery: a 
randomized trial. Am J Obstet Gynecol. 2012 Nov;207(5):433.e1-6. doi: 
10.1016/j.ajog.2012.06.040. 
22. Barber MD, et al. Defining Success After Surgery for Pelvic Organ Prolapse. Obstet 
Gynecol. 2009 Sep; 114(3): 600–609. 
23. Bodian, CA et al. The visual analog scale for pain: Clinical significance for postoperative 
pain. Anesthesiology 2001; 95:1356 – 61. 
24. Jensen MP, Chen C, and Brugger AM Interpretation of visual analog scale ratings and 
change scores: a reanalysis of two clinical trials of postoperative pain. J Pain. 2003, 
4(7):407–414. 
25. Lee JS, Hobden E, Stiell IG, and Wells GA. Clinically important change in the visual 
analog scale after adequate pain control. Acad Emerg Med, 2003, 10(10):1128–1130. 
26. Westermann LB et al. Comparative Perioperative Pain and Recovery in Women 
Undergoing Vaginal Reconstruction Versus Robotic Sacrocolpopexy. Female Pelvic 
Medicine& Reconstructive Surgery. 2017; 23(2):95-100. 
27. Travell J, Simons D (1992) The trigger point manual. Vol. 2. Williams &Wilkins, 
Baltimore. 
28. Meister MR et al. Development of a standardized, reproducible screening examination 
for assessment of pelvic floor myofascial pain.Am J Obstet Gynecol. 2019 
Mar;220(3):255.e1-255.e9.  
Additional resources to be added in manuscript: 
29. Siping H, Falk K, Kannan, A, Kelley R An Alternative Approach to Posterior 
Colporrhaphy Plication Using Delayed Absorbable Unidirectional Barbed Suture. Female 
Pelvic Medicine & Reconstructive Surgery. 2020; 26 (2): 107-110. 
30. Culligan, P. Surgical Repair for the Posterior Compartment.  Clinical Obstertics and 
Gynecology. 2005. 48 (3): 704-712. 
 
 
 
 
 
 

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Appendix 1 
 
FIGURE 1. Study Trial Consort Diagram 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Appendix 2 (Questionnaires) 
Assessed for eligibility and 
Consented 
Excluded  
¨   Not meeting inclusion criteria 
¨   Declined to participate  
¨   Other reasons  
Patient returns for post-op visits at 6wk, undergoes examination and fills out appropriate questionnaires.  
6mo phone call with interviews/questionnaires. 
Cost data. 
Chart review for remaining outcome data completed. 
Allocated to intervention: barbed suture 
¨ Received allocated intervention  
¨ Did not receive allocated intervention (give reasons) 
Allocated to control: non-barbed suture 
¨ Received allocated intervention  
¨ Did not receive allocated intervention (give reasons)  
Allocation 
Data Analysis 
Follow-Up 
Randomized in OR 
Enrollment 
Patient returns for post-op visit at 12mo, undergoes examination and fills out 
appropriate questionnaires. 
Planned prospective study of 12mo outcome data.