Randomized Trial Comparing Anchorsure® Suture Anchoring System and the CapioTM Slim Suture Capturing Device for Sacrospinous Ligament Suspension.
Phase: NA
Conditions: Postoperative Pain
Sponsor: Wake Forest University Health Sciences

Protocol# IRB00051211 
 
Wake Forest Baptist Health 
 
Principal Investigator: Catherine Matthews, MD       Version #3                    Page 1/20 
Randomized Trial Comparing Anchorsure® Suture Anchoring System and 
the CapioTM Slim Suture Capturing Device for Sacrospinous Ligament 
Suspension. 
 
Principal Investigator: 
Catherine Matthews, MD 
 
 
 
 
Wake Forest Baptist Health, Winston Salem, NC 
 
 
Co-Investigators:  
Andre Plair, MD 
 
 
 
 
Wake Forest Baptist Health, Winston Salem, NC 
 
 
 
 
 
 
Gopal Badlani, MD 
 
 
 
 
Wake Forest Baptist Health, Winston Salem, NC 
 
 
 
 
 
 
Candace Parker-Autry, MD 
 
 
 
 
Wake Forest Baptist Health, Winston Salem, NC 
 
 
 
 
 
 
 
Jeffrey Schachar, MD 
 
 
 
 
Wake Forest Baptist Health, Winston Salem, NC 
 
 
 
 
 
 
Whitney Smith, MD 
 
 
 
 
Wake Forest Baptist Health, Winston Salem, NC 
 
 
 
 
 
 
7.10.2020

Protocol# IRB00051211 
 
Wake Forest Baptist Health 
 
Principal Investigator: Catherine Matthews, MD       Version #3                    Page 2/20 
ABSTRACT 
 
Sacrospinous ligament fixation is a common method of repairing apical support 
for pelvic organ prolapse but it currently suffers from a high rate of postoperative 
buttock and posterior thigh pain.  Rates of buttock and thigh pain 6 weeks after 
sacrospinous ligament fixation with the widely used Capio™ Slim device (Boston 
Scientific) are about 15-16% with immediate postoperative pain occurring in 55-
84% of patients.  Our study is a randomized controlled single-blind study with the 
primary goal of investigating if there is an improvement in the rate of buttock and 
posterior thigh pain 1 day, 1 week, and 6 weeks after sacrospinous ligament 
fixation with a new device, the Anchorsure® Suture Anchoring System 
(Neomedic) compared to the widely utilized Capio™ Slim (Boston Scientific) 
device.  We will enroll 60 patients who are planned to undergo sacrospinous 
ligament fixation for treatment of pelvic organ prolapse.  The patients will be 
randomized into two study groups; one will have sacrospinous ligament fixation 
using the Capio™ Slim device and the other with the Anchorsure® device.  The 
patient’s pain will be recorded via numerical rating scales (NRS), a validated pain 
evaluation tool.  The study is powered to detect a 2.5 point difference in pain 
between the two groups, a value that has been shown in studies to be clinically 
significant to patients.  Secondary outcomes of surgeon satisfaction and 
efficiency with the devices will be assessed via surgeon questionnaires.  The 
demonstration of a significant decrease in postoperative buttock or thigh pain, 
improved surgeon efficiency, or decreased operative time with the use of the 
Anchorsure device will demonstrate an advantage of the suture anchoring 
devices over suture capture devices and will fuel the need for a larger efficacy 
study for the Anchorsure device.  Demonstration of improved safety and/or 
improved surgical outcomes could ultimately change the standard in 
sacrospinous ligament fixation surgical technique. 
 
 
 
BACKGROUND AND SIGNIFICANCE 
 
Pelvic organ prolapse (POP) describes the loss of anatomic support of the 
vagina where women present with a vaginal bulge with or without associated 
bladder, bowel or sexual complaints.  The lifetime risk of undergoing surgery for 
female pelvic organ prolapse is estimated at 19%.1 One of the most common 
approaches to repair of apical vaginal prolapse is suspension of the vaginal apex 
or cervix to the sacrospinous ligament using suture material, a technique that 
avoids entry into the peritoneal cavity.   
The current standard practice is to use a self-capturing suture delivery systems 
like the Capio™ Slim Suture Capturing Device.  This procedure is associated 
with a significant risk of postoperative buttock and posterior thigh pain.2,3  
Such pain can arise from entrapment of the pudendal or sciatic nerves given their 
close anatomic proximity to the sacrospinous ligament suture fixation (Figure 1) 
or from entrapment of the levator ani nerve that runs along the surface of the 

Protocol# IRB00051211 
 
Wake Forest Baptist Health 
 
Principal Investigator: Catherine Matthews, MD       Version #3                    Page 3/20 
coccygeus muscle.4 Immediate postoperative buttock and posterior thigh pain 
with the Capio™ device has been reported in 55-84% of patients with persistent 
pain at 6 weeks postoperatively in 15-16%.4,2 
The use of an anchor-based system into the sacrospinous ligament, as opposed 
to a suture-based system, could theoretically reduce the risks of suture 
entrapment particularly of the levator ani nerve thereby reducing the high rate of 
postoperative buttock and thigh pain. Anchor-based pelvic organ prolapse repair 
systems have been studied and utilized domestically and internationally for 
mesh-based prolapse repair kits.  However, there is currently little evidence 
about the rates of postoperative buttock and posterior thigh pain from anchor-
based fixation to the sacrospinous ligament for native tissue vaginal repair. 
The Anchorsure® (Figure 2 and Figure 3) is a new FDA-approved sacrospinous 
ligament fixation device that deploys a permanent anchor directly into the 
ligament and requires high pull-out force for extraction. The device is a Class II 
surgical device that was FDA approved via a 510(k) premarket notification in 
2012.  Its approval was based on the FDA approved device Surelift® 
(Neomedic).  Surelift® uses the same anchoring system as Anchorsure but is 
attached to vaginal mesh as opposed to Anchorsure which is designed to attach 
to suture material.  Surelift® is used widely and has been studied in abstracts5-9 
and a published study10 confirming safety and surgical efficacy.  Abstracts on the 
use of Anchorsure have additionally been published indicating safety and efficacy 
of use.11,12  A summary of the available data for the Capio Slim™, Surelift®, and 
Anchorsure® devices is listed in Appendix 1. 
The primary aim of this study is to conduct a prospective randomized trial of this 
new anchor-based system versus our current suture-capture-based fixation 
systems to compare the rates of postoperative buttock and posterior thigh pain. 
This is important because decreased buttock and posterior thigh pain can reduce 
patient suffering and potentially reduce postop narcotic use.  Our secondary 
aims are to compare intraoperative complications, general postoperative pelvic 
pain and post-hospitalization opioid use as well as surgeon satisfaction and 
surgical efficiency with the device. The demonstration of a significant decrease in 
postoperative buttock or thigh pain, improved surgeon efficiency, or decreased 
operative time with the use of the Anchorsure device will demonstrate an 
advantage of the suture anchoring devices over suture capture devices and will 
fuel the need for a larger efficacy study for the Anchorsure device.  
Demonstration of improved safety and/or improved surgical outcomes could 
ultimately change the standard in sacrospinous ligament fixation surgical 
technique. 
 
 
 

Protocol# IRB00051211 
 
Wake Forest Baptist Health 
 
Principal Investigator: Catherine Matthews, MD       Version #3                    Page 4/20 
Figure 1.  Pelvic anatomy demonstrating the neurovascular structures near the 
sacrospinous ligament.4  
  
 
 
 
 
 
Figure 2. Anchorsure® System13 
 
 
 
 
 
 

Protocol# IRB00051211 
 
Wake Forest Baptist Health 
 
Principal Investigator: Catherine Matthews, MD       Version #3                    Page 5/20 
Figure 3. Anchorsure® System application to sacrospinous ligament13  
 
 
 
STUDY OBJECTIVES 
 
Hypothesis 1: Anchorsure® System will reduce postoperative buttock and 
posterior thigh pain at 1 day, 1 week, and 6 weeks following sacrospinous 
ligament fixation compared to the CapioTM Slim Suture Capturing Device 
 
Specific Aim 1: 
To conduct a prospective, randomized, single-blind trial of sacrospinous ligament 
fixation of the cervix or vaginal apex using Anchorsure® system versus the 
CapioTM Slim device in women with ≥ Stage II pelvic organ prolapse who are 
undergoing native tissue vaginal repair.   The primary outcome will be the level 
of postoperative pain using a 10-point numerical rating scale (NRS) on 
postoperative day 1, week 1, and 6 weeks postoperatively for pain that is 
localized to the posterior thigh or buttocks on the side(s) that the sacrospinous 
fixation was performed.  The difference in mean pain ratings will be at least 2.5 
on the 10-point NRS.   
 
Hypothesis 2: Surgeon satisfaction, surgical efficiency, intraoperative 
complications, objective surgical success, symptomatic success, opioid 
use within the first week postoperatively following hospitalization, and 
overall postoperative pelvic pain will be similar for both devices. 

Protocol# IRB00051211 
 
Wake Forest Baptist Health 
 
Principal Investigator: Catherine Matthews, MD       Version #3                    Page 6/20 
 
Specific Aim 2: 
The secondary outcomes will compare overall surgeon satisfaction with the 2 
devices using a 5-point Likert rating scale and surgical efficiency measured in 
minutes from the start of the use of the surgical device until the surgeon is 
satisfied with the application of all sacrospinous sutures (does not require the 
sutures to be tied down).  Intraoperative complication related to sacrospinous 
ligament suspension will be recorded including the need for suture or anchor 
replacement, hemorrhage that requires additional surgical interventions or blood 
transfusion, and equipment malfunction.  General postoperative pelvic pain will 
be assessed at postoperative day 1, week 1, and 6 weeks along with buttock and 
posterior thigh pain via NRS questionnaires.  Objective apical repair anatomical 
success will be assessed at the 6 week postoperative visit via a POP-Q 
examination with Stage II or greater indicating anatomical failure.  Symptomatic 
surgical success will be evaluated by statistically significant increases or 
decreases in the responses to the PFDI-20 and PFIQ-7 questionnaires at the 6 
week postoperative visit compared to preoperative values. 
 
 
 
SUBJECT SELECTION 
 
Inclusion Criteria 
 
 
1. Female patients 
2. At least 21 years of age 
3. Surgical plan that includes a native tissue vaginal repair with apical 
support via sacrospinous ligament fixation. We will permit both 
hysteropexy and post-hysterectomy sacrospinous ligament suspension 
4. Understanding and acceptance of the need to return for the 6 week follow-
up visit 
5. English speaking and able to give informed consent 
6. Willing and able to complete all study questionnaires 
7. Ambulatory  
 
Exclusion Criteria 
1. Prior sacrospinous ligament fixation procedure.   
2. Any serious disease or chronic condition that could interfere with the study 
compliance 
3. Inability to give informed consent 
4. Pregnancy or planning pregnancy prior to the 6 week postoperative visit  
5. Prior pelvic radiation 
6. Incarcerated    

Protocol# IRB00051211 
 
Wake Forest Baptist Health 
 
Principal Investigator: Catherine Matthews, MD       Version #3                    Page 7/20 
7. Prior augmented (synthetic mesh, autologous graft, xenograft, allograft) 
prolapse repair  
8. History of significant buttock or leg pain in the past 3 months 
9. History of fibromyalgia, polymyositis, dermatomyositis, systemic lupus 
erythematosus, or other auto-immune myalgic conditions 
10. Current regular narcotic drug therapy for any chronic pain condition 
11. History of loss of motor or sensory function of the lower extremities 
12. History of sacral decubitus ulcers  
13. Planned concomitant levatorplasty; anal sphincteroplasty, anal 
fissurectomy, rectopexy, or hemorrhoidectomy 
 
 
 
STUDY POPULATION, RECRUITMENT AND SCREENING 
 
Study population participants will consist of women who are scheduled to 
undergo native tissue POP repair using apical support to the sacrospinous 
ligament. Women scheduled to undergo sacrospinous hysteropexy and 
sacrospinous suspension of the vaginal vault will be recruited at Wake Forest 
Baptist Medical Center. 
 
Participants must have vaginal bulge symptoms defined by positive responses to 
a validated instrument, the Pelvic Floor Distress Inventory (PFDI)14,15, Stage II or 
greater POP in any vaginal compartment as determined by the Pelvic Organ 
Prolapse Quantification (POPQ) system,16 a validated tool designed to assess 
the degree of vaginal prolapse, and an apical prolapse contribution to the 
patient’s overall pelvic organ prolapse as deemed by the examining physician.  
An apical prolapse contribution is detected by either the descent of the “C” 
component of the POP-Q system or as the demonstration of at least partial 
correction of an anterior or posterior prolapse via manipulated suspension of the 
apex during on pelvic examination. 
 
Study subjects will be recruited from patients who present to the Urology or 
Gynecology clinical sites at Wake Forest Baptist Health.  Institutional review 
board (IRB) approval will be obtained at this site.  There will additionally be 
advertisement of the study through print or digital media to assist in patient 
recruitment.  All advertisements will abide by research study advertisement 
regulations set by Wake Forest Baptist Health. 
 
Potential subjects will be identified by members of the Urology and Gynecology 
departments at Wake Forest Baptist Health. Eligible patients who agree to 
participate will be provided written informed consent administered by the 
collaborators listed on the IRB document. 
 

Protocol# IRB00051211 
 
Wake Forest Baptist Health 
 
Principal Investigator: Catherine Matthews, MD       Version #3                    Page 8/20 
 
PRE-INTERVENTION ASSESSMENTS 
 
All women presenting to the participating clinical center with signs and symptoms 
of prolapse who have elected to undergo sacrospinous ligament suspension will 
be screened for their eligibility. If eligible and consenting, the following baseline 
data will be collected on paper forms that will then be transcribed into a secure 
REDCap (Research Electronic Data Capture) database:  
 
 
1. Demographic data including age, race, BMI, insurance  
   
     
   
 
    status, level of education obtained 
 
 
2. Pre-operative morbidity as measured using the Charlson Comorbidity  
 
    Index 
 
3. Smoking status 
 
4. POP-Q data 
 
5. Need for ambulation assistance  
 
6. History of lower extremity disease, injuries, and functionality 
 
7. Medical and surgical history 
 
8. Level of pre-operative pelvic pain using 10-point NRS 
 
9. PFDI questionnaire  
 
 
RANDOMIZATION AND MASKING 
A computer-generated random allocation using a randomly permutated block 
design (10-patients per block) will be utilized. Randomization will be performed at 
the start of the study with study group assignments placed in sealed non-
transparent envelopes.  The envelopes will be numbered in order.  The next 
envelope in numerical order will be brought to the operating room where it will be 
opened by a participating surgeon and another operating room staff member.  
Both personnel will sign the envelope to validate that proper envelope opening 
and interpretation were performed.  The envelopes will then be collected for 
record keeping.  This procedure will help to minimize surgeon bias as it is 
impossible for surgeons to be masked to the randomization.  Participants and 
research staff will be masked during the study as much as possible, however 
there will be a description of the type of sacrospinous ligament fixation device 
used within the body of the operative note for each patient that research staff 
could gain access to. Intraoperative data, including any adverse event that may 
unmask the study coordinators, will be reported by the surgeon directly to the 
study administrators.  
 
 
 
 

Protocol# IRB00051211 
 
Wake Forest Baptist Health 
 
Principal Investigator: Catherine Matthews, MD       Version #3                    Page 9/20 
STUDY INTERVENTION 
 
The primary intervention is sacrospinous fixation utilizing either the Anchorsure® 
system or the CapioTM Slim device. Concomitant anterior and/or posterior 
colporrhaphy (plication of fibromuscular vaginal tissue), enterocele repairs, 
transvaginal hysterectomy, bilateral salpingo-oophorectomy, perineoplasty, 
midurethral sling procedures, or other procedures not involving the pelvis, anus, 
buttock, or lower extremities may be performed.  Prolapse procedures will be 
recorded but not controlled by study protocol. Participating surgeons are all 
extensively experienced in sacrospinous ligament fixation.  Any use of allograft, 
xenograft, or synthetic graft material for POP repair will not be permitted.  
 
Access to the retroperitoneal space will be accomplished either via a 
circumferential pericervical, an anterior, or a posterior. The method of surgical 
approach will be recorded. Sharp and blunt dissection will be performed to gain 
access to the sacrospinous ligament(s). Surgeon discretion will determine if 
unilateral or bilateral fixation is performed for vaginal vault suspension but only 
unilateral sacrospinous ligament suspension will be permitted for hysteropexy. 
Surgeon discretion will determine the type and number of sutures or anchors to 
be placed through the sacrospinous ligament and this data will be recorded. All 
sutures and anchors placed into the sacrospinous ligament will be placed at least 
2cm medial to the ischial spine. Suture(s) will be placed through any anchors 
with the choice of suture to be determined by the surgeon as this is not 
anticipated to interfere with any results.  The suture(s) placed through anchors or 
the sacrospinous ligament directly will then be attached to the cervix and/or 
vaginal apex. Sacrospinous sutures will be tied down once all mid-vaginal repairs 
are completed. Transvaginal hysterectomy, bilateral salpingectomy, bilateral 
oophorectomy, and enterocele repair procedures will be performed prior to 
sacrospinous ligament fixation. 
 
 
 
POST-INTERVENTION ASSESSMENTS 
 
The primary study endpoints will be assessed on postoperative day 1, 
postoperative week 1, and postoperative week 6 via a NRS.  Day 1 
questionnaires will be given during morning rounds.  1 week following their 
procedure, patient’s will be called at home to remind them to fill out the week 1 
questionnaire that would have been given to them during their hospital stay.  This 
questionnaire will be accompanied with a pre-paid and pre-addressed envelope 
for the patient to use or, if desired, they can bring the completed week 1 
questionnaire to their week 6 follow up appointment.  All patients will return to the 
clinic for 1-week and 6-week  post-surgery follow up appointments and will fill out 
an NRS pain assessment (1-week and 6-week), opioid use questionnaire (1-
week), PFDI questionnaire (6-week), physical examination including POP-Q (6-
week), and review of any postoperative complications (1-week,6-week).   

Protocol# IRB00051211 
 
Wake Forest Baptist Health 
 
Principal Investigator: Catherine Matthews, MD       Version #3                    Page 10/20 
 
Clinical outcomes  
 
This trial has a primary outcome of level of postoperative buttock or posterior 
thigh pain on postoperative day 1, week1, and 6 weeks as measured using the 
NRS. An independent t-test will be used to compare the means of the NRS 
scores from the two groups.  The NRS is one of the most common validated pain 
questionnaire modalities.17,18,19,20,21  A clinically significant difference will be 
considered 2.5 on the 10-point NRS based on a prior paper assessing buttock 
pain from sacrospinous ligament fixation22 and with published studies assessing 
clinically meaningful decreases in acute pain.18,17  The patient’s will be given 
copies of the NRS questionnaire which will be collected in person on 
postoperative day 1, week 1, and 6 weeks postoperatively.   
 
Secondary outcome measures will assess the degree to which the study 
intervention influences surgeon satisfaction, surgical efficiency, adverse events 
intra- and postoperatively, surgical success, symptomatic success, and the level 
of postoperative general pelvic pain. Surgeon satisfaction will be assessed via a 
5-point rating scale (very dissatisfied, somewhat dissatisfied, neutral, satisfied, 
very satisfied) and treated as categorical values.  Surgical efficiency will be 
assessed as continuous data measured as a means in minutes. Adverse events 
will be evaluated as dichotomous data.  All adverse events will be reported by the 
Dindo classification system. Short-term objective surgical success will be 
assessed by a postoperative exam at 6 weeks and descent of the vaginal apex 
beyond TVL/2 will be considered surgical failure.  Symptomatic success will be 
assessed by the PDFI-20 questionnaires to be given at 6-weeks post-operation 
and compared to preoperative values.  The patient’s will also be queried about 
their general pelvic pain on the same questionnaires used to assess buttock and 
posterior thigh pain.  Oral opioid use following hospitalization until postoperation 
day 6 will be recorded via opioid use questions on the 1 week postoperation 
questionnaire.  The opioid dose will be converted into morphine equivalents for 
data analysis. Statistical analysis will be done in collaboration with the Wake 
Forest Baptist Hospital CTSI Biostatistics Department.  Independent t-tests will 
be used for all continuous data, except for the PFDI and PFIQ data that will use 
paired t-tests as the two samples are dependent.  Chi-square tests will be used 
for all dichotomous and categorical data.   
 
 
POWER CALCULATION: 
This study is a head to head two sample comparative study. The null hypothesis 
is that there is no difference in the prevalence of immediate postoperative new 
buttock or posterior thigh pain with the use of the Anchorsure® System 
compared to the Capio™ Slim device for sacrospinous ligament fixation. In prior 
published study by Ferrando et al the mean postoperative day 1 buttock or 
posterior thigh pain had a greater standard deviation (2.7-2.9) compared to week 

Protocol# IRB00051211 
 
Wake Forest Baptist Health 
 
Principal Investigator: Catherine Matthews, MD       Version #3                    Page 11/20 
1 and week 6 data.  Therefore for our power calculation used an expected 
standard deviation of 2.9 to provide confidence in our power of assessing the 
difference in pain scores across all three timepoints.22  A decrease in in-hospital 
postoperative buttock or posterior thigh pain prevalence of 2.5 on a 10-point 
scale was chosen as clinically significant and is consistent with published 
data.22,18,17  Using a standard deviation of 2.9 and a difference in pain scores of 
2.5 setting the level of significance, 21 patients are required in each group to 
provide a power of at least 80% to reject the null hypothesis (H0) that the 
Anchorsure® System does not lead to significantly less postoperative buttock 
and posterior thigh pain than does the Capio™ Slim Device in favor of the 
alternate hypothesis that the Anchorsure® System leads to significantly less 
postoperative pain than the Capio™ Slim Device using a two-sample normal 
approximation test of means with a two-sided 5% significance level. Assuming a 
15% loss to follow-up or drop-out rate for the duration of the study, the total 
enrollment goal is 48 patients (24 in each group).  The null hypothesis will be 
declared rejected if the mean of immediate postoperative buttock and posterior 
thigh pain with use of the Anchorsure® device is less from the mean with the use 
of the Capio™ Slim device with a p-value of 0.05 or less.  The power calculations 
and their adjustment from the original study goal of 60 recruited patients (using 
90% power and a standard deviation of 3) were confirmed with the Wake Forest 
Baptist Hospital CTSI Biostatistics Department. 
 
 
CALENDAR OF EVENTS  
Form / Intervention 
Preop 
Clinic 
Intra- 
operatively 
Day 
1  
Week 
1 
Week 
6  
Informed Consent 
X 
 
 
 
 
Study Inclusion Form 
X 
 
 
 
 
Preop Baseline Data Form with 
Charlson Comorbidity Index and 
POP-Q 
X 
 
 
 
 
PFDI-20 and PFIQ-7 Forms 
X 
 
 
 
X 
NRS Pain Questionnaires 
X 
 
X 
X 
X 
Oral Opioid Use Questionnaire 
 
 
 
X 
 
Randomization 
 
X 
 
 
 
Adverse events 
 
X 
X 
X 
X 
Surgeon Questionnaire 
 
X 
 
 
 
Gift Card Disbursement and Gift 
Card Confirmation Form 
 
 
 
 
X 
Completion of Study Form 
 
 
 
 
X 
 
 

Protocol# IRB00051211 
 
Wake Forest Baptist Health 
 
Principal Investigator: Catherine Matthews, MD       Version #3                    Page 12/20 
 
DATA COLLECTION & MANAGEMENT 
Data collection will occur in the clinic and in the hospital at each encounter 
outlined in the Calendar of Events.  All study data will be recorded on data 
collection sheets and will be transcribed into REDCap.  Any discrepancies 
between progress notes and supporting source documents such as physician’s 
notes should be explained in the progress notes.  Any changes made to original 
written entries in progress notes should be crossed through with a single line, 
initialed, and dated by the person making the correction to not obscure the 
original entry.  Any changes made to original electronic entries in progress notes 
should be implemented in an electronic note addendum that is signed and dated 
by the person making the correction to not obscure the original entry.   
Data will be entered by study staff into a REDCap database (described in detail 
in the “STUDY SUBJECT PROTECTION” section of this protocol) that will be 
stored on a secure server by the data coordinating center.  Study data source 
documentation and progress notes will be monitored by the data coordinating 
center as outlined in the “STUDY MONITORING AND DOCUMENTATION” 
section.  Data collected from visits should be entered into REDCap within 5 
business days.  Any queries to data entered into REDCap should be addressed 
within 5 business days.  The study coordinators will regularly check REDCap for 
queries.   
 
The study site will maintain all essential study documents in original format and 
source documentation that support the data collected on study participants in 
compliance with ICH/GCP guidelines.  Documents must be retained until at least 
2 years have elapsed since the formal discontinuation of the clinical investigation.  
The study site will be responsible to ensure that these essential documents are 
retained and are not accidentally damaged or destroyed prior to the required 
elapsed time.   
 
 
 
 
STUDY MONITORING AND DOCUMENTATION 
 
Study Monitoring 
 
The Principal Investigator will monitor the study and assess the need for 
amendments as the study progresses.  If a protocol revision is necessary for 
reasons including but not limited to the rights, safety, or welfare of participants, or 
scientific integrity of the data, an amendment is required.  IRB or equivalent 
approvals of the revised protocol—and if necessary, revised informed consent—
must be obtained prior to implementation.   
 

Protocol# IRB00051211 
 
Wake Forest Baptist Health 
 
Principal Investigator: Catherine Matthews, MD       Version #3                    Page 13/20 
 
Data Monitoring 
Semi-annual data verification will be conducted by Dr. Plair to verify that data 
entry into REDCap is accurate, and to assess compliance with the study protocol 
requirements.  Study data will be source verified for roughly 25% of the overall 
data collection efforts.   
   
Protocol Deviations 
Protocol deviations must be documented on the protocol deviation CRF provided 
by the study investigators, logged in the study site protocol deviation log, and 
entered into REDCap.   
Deviations will be reviewed and evaluated on an ongoing basis and, as 
necessary, appropriate corrective and preventative actions (including notification, 
personnel re-training, or discontinuation) will be put into place by the principal 
investigator. 
Study staff must not make any changes or deviate from this protocol, except to 
protect the life and physical well-being of a subject in an emergency. Study staff 
shall notify the PI and the reviewing IRB of any deviation from the investigational 
plan to protect the life or physical well-being of a subject in an emergency, and 
those deviations which affect the scientific integrity of the clinical investigation. 
Such notice shall be given as soon as possible, but no later than 5 working days 
after the emergency occurred.   All deviations from the investigational plan, with 
the reason for the deviation and the date of occurrence, must be documented 
and reported to the Data Coordinating Center.  
 
 
REPORTING ADVERSE EVENTS 
 
Adverse events (AEs) will be recorded and reported according to the criteria and 
timeline below.   
 
All AEs must be recorded on the AE CRF supplied by the study coordinator, 
entered into the site AE log, and then entered into REDCap.  Each AE will be 
sequentially numbered according to patient.  For example, patient 008’s first AE 
would be 008.01.  The principal investigator will determine the relationship of the 
AE to the operative procedures, the relationship of the AE to the device, along 
with the severity of each reportable AEs. All complications will be adjudicated by 
a Co-Investigator assigning DINDO scores. The adjudicating Co-Investigator will 
also determine if the complications are more likely to be related to the overall 
surgery, sacrospinous ligament fixation surgery or both. Complications that are 
deemed not related to the surgery will be excluded (such as, a carpal tunnel 

Protocol# IRB00051211 
 
Wake Forest Baptist Health 
 
Principal Investigator: Catherine Matthews, MD       Version #3                    Page 14/20 
syndrome exacerbation at 6 weeks post-operation).  
 
Severe AEs (SAEs) must be reviewed by the PI within two business days.   
 
 
TABLE 1. Classification of Surgical Complications DINDO Grade Definition  
 
Grade 1 
Any deviation from the normal postoperative course 
without the need for pharmacologic treatment. Allowed 
therapeutic interventions are: drugs as antiemetics, 
antipyretics, analgesics, physiotherapy 
Grade II 
Requiring pharmacological treatment with drugs other 
than such allowed for grade I complications.  Blood 
transfusions and total parenteral nutrition are also 
included 
Grade III 
 
     IIIA 
     IIIB 
 
Requiring surgical, endoscopic or radiological 
intervention 
       - Intervention not under general anesthesia 
       - Intervention under general anesthesia 
Grade IV 
 
    IVA 
    IVB 
Life-threatening complication (including CNS 
complications)* requiring IC/ICU management       
       - Single organ dysfunction (including dialysis)  
       - Multi-organ dysfunction 
Grade V 
Death 
 
 
Reportable AEs include those determined to be related to the operative 
procedures or the device as listed below:   
 
Intraoperative complications attributable to sacrospinous ligament fixation: 
 
Pelvic hemorrhage 
 
Buttock pain or posterior thigh pain on a side with a sacrospinous ligament 
fixation 
 
Lower extremity impaired sensation on a side with a sacrospinous ligament 
fixation 
 
New neurologic conditions in the lower extremity on a side with a sacrospinous 
ligament fixation 
 
Rectal or bladder injury during dissection or placement of sacrospinous ligament 
sutures 
 
Avulsion/loss of bullet on Capio™ device 
 
 
Postoperative complications: 
 
Infection requiring antibiotics 

Protocol# IRB00051211 
 
Wake Forest Baptist Health 
 
Principal Investigator: Catherine Matthews, MD       Version #3                    Page 15/20 
 
Cardiac or myocardial infarction  
 
New neurologic conditions 
 
New pulmonary conditions 
 
Pelvic abscess  
 
Blood transfusion  
 
Venous thromboembolism  
 
Hospital readmissions  
 
Emergency room evaluations  
 
Unplanned clinic visit  
 
Leg pain or difficulty ambulating on a side of the body without a sacrospinous 
ligament fixation 
 
Pelvic fistulas involving the vagina, bladder, or bowels  
 
Reoperations including repeat prolapse surgery  
 
 
Please note that underlying diseases are not reportable as AEs unless there is 
an increase of severity or frequency during the course of the study that is directly 
attributable to the surgical intervention.  If an AE has not resolved at the time of 
AE Form completion, the form will be saved as incomplete in REDCap until 
resolved. Once the AE is resolved, the AE form will be updated, saved as 
complete, and entered into REDCap. 
 
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 the operative procedures  
 
 
Serious Adverse Event: an adverse event that:  
 
  Led to death  
  Led to 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 in-subject or prolonged hospitalization of existing hospitalization  
o medical or surgical intervention to prevent life-threatening illness or 
injury or permanent impairment to a body structure or a body 
function  
 Led to fetal distress, fetal death or a congenital abnormality or birth defect  
 
 
Relationship of AE to Operative Procedures: 

Protocol# IRB00051211 
 
Wake Forest Baptist Health 
 
Principal Investigator: Catherine Matthews, MD       Version #3                    Page 16/20 
 
 Unrelated: No evidence that the timing of the AE has a relationship to the 
operative procedures performed.  
 Possibly Related: The AE has a timely relationship to the operative 
procedures performed, however a potential alternative etiology may be 
responsible for the AE.  
 Probably Related: The AE has a timely relationship to the operative 
procedures performed and the causative relationship can clearly be 
established. No potential alternative etiology is apparent.  
 
Relationship of AE to Device:  
 Unrelated: No evidence that the timing of the AE has a relationship to the 
device placement.  
 Possibly Related: The AE has a timely relationship to the device 
placement, however a potential alternative etiology may be responsible for 
the AE.  
 Probably Related: The AE has a timely relationship to the device 
placement performed and the causative relationship can clearly be 
established. No potential alternative etiology is apparent.  
 
 
 
STUDY SUBJECT PROTECTION 
 
Protection of each subject’s personal health information will be a priority in this 
study. One master Excel file containing subject personal information including 
name and medical record number will be kept in a password-protected file, on a 
designated protected research drive on a password-protected computer in a 
locked office at the study institution. In that file, each subject will be assigned a 
subject identification number that will be used for the purposes of data collection 
in order to de-identify subjects.  
 
All paper forms used for data collection will be kept in a research cabinet 
dedicated to this project, which will be locked at all times, in a locked office at 
Wake Forest Baptist Health. All forms will contain de-identified information when 
sent to the Data Monitoring Safety Board. Identification numbers will correspond 
to the subjects listed in the master excel file.  
 
All study data will be transferred and managed electronically using REDCap. 
Each subject will be entered into REDCap using the assigned identification 
number from the master excel file. REDCap is a secure, web-based application 
designed to support data capture for research studies, providing user-friendly 
web-based case report forms, real-time data entry validation, audit trials, and a 
de-identified data export mechanism to common statistical packages. The 

Protocol# IRB00051211 
 
Wake Forest Baptist Health 
 
Principal Investigator: Catherine Matthews, MD       Version #3                    Page 17/20 
system was developed by a multi-institutional consortium that was initiated at 
Vanderbilt University and includes Wake Forest Baptist Health. The database is 
hosted within the Clinical and Translational Research Unit at Wake Forest and is 
managed by the Quantitative Health Sciences Department. The system is 
protected by a login and Secure Sockets Layers (SSL) encryption. Data 
collection is customized for each study based on a study-specific data dictionary 
defined by the research team with guidance from the REDCap administrator in 
Quantitative Health Sciences at Wake Forest.  
 
 
 
AUTHORSHIP 
 
For the primary paper, Dr. Plair will serve as first author and Dr. Matthews as 
senior author. All study investigators and personnel will be listed as co-authors 
and the list of authorship will depend on subject enrollment. 
 
All investigators will have equal access to the primary data set for secondary 
analyses.  For any secondary analyses, Dr. Matthews will serve as the senior 
author and only those members of the group involved in the secondary analysis 
will be listed as authors on any subsequent papers. 
 
 
 
 

Protocol# IRB00051211 
 
Wake Forest Baptist Health 
 
Principal Investigator: Catherine Matthews, MD       Version #3                    Page 18/20 
Appendix 1. Current knowledge of the discussed sacrospinous ligament fixation 
devices 
Timeframe   
Pain Type 
Device Type 
Capio Slim2,3,22 
Anchorsure 
attached to suture12 
Surelift5,6,9,10 or Anchorsure 
attached to mesh11  
  
Intraop 
  
Surgical Time 
SSLF only - 6.9 
min 
Whole procedure – 
86 min* 
Whole procedure – 56 min +/-
12 min 
  
Day 1 
  
Gluteal or buttock 
pain 
55.4 - 90.2% 
NR 
NR 
Blood Transfusion 
0/44 
NR 
0.6% (2/300)*‡ 
Hematoma** 
UR 
NR 
5% (1/20)*; 2.6% (8/300)*‡ 
  
Week 1 
  
Gluteal or buttock 
pain 
63.2% 
NR 
NR 
  
Week 4-6 
  
Gluteal or buttock 
pain 
15.3-26.9% 
NR 
NR 
Pain intervention 
2.1% (5/242) 
NR 
NR 
  
Other 
  
Gluteal or buttock 
pain 
NR 
15.4% (2/13) 
[anytime up until 5 
months]* 
NR 
Pelvic pain 
NR 
NR 
11.6% [36mo]*; 0.3% (1/300) 
[unspecified time]* 
Success %*** 
92-95% 
[17months] 
92.3% (12/13) [5 
months]* 
77-92.4% [36mo]*; 80-94% 
(48-51/54) [unspecified 
time]*; 89.7% (26/29) [3yr]* 
Suture/Anchor 
Removal 
2.3% (1/44) 
[17 months] 
NR 
1.95% (1/49) [unspecified 
time] 
  
* Based on abstract data 
** Criteria not well described 
*** Surelift and Anchorsure with mesh success for any placement, anterior or posterior 
 
 
‡ Anchorsure used with custom mesh implants  
NR – Not Reported 
 
 
 
 

Protocol# IRB00051211 
 
Wake Forest Baptist Health 
 
Principal Investigator: Catherine Matthews, MD       Version #3                    Page 19/20 
REFERENCES 
1. 
Smith FJ, Holman CD, Moorin RE, Tsokos N. Lifetime risk of undergoing 
surgery for pelvic organ prolapse. Obstet Gynecol 2010;116:1096-100. 
2. 
Mowat A, Wong V, Goh J, Krause H, Pelecanos A, Higgs P. A descriptive study 
on the efficacy and complications of the Capio (Boston Scientific) suturing device for 
sacrospinous ligament fixation. Aust N Z J Obstet Gynaecol 2018;58:119-24. 
3. 
Unger CA, Walters MD. Gluteal and posterior thigh pain in the postoperative 
period and the need for intervention after sacrospinous ligament colpopexy. Female 
Pelvic Med Reconstr Surg 2014;20:208-11. 
4. 
Maher CF, Murray CJ, Carey MP, Dwyer PL, Ugoni AM. Iliococcygeus or 
sacrospinous fixation for vaginal vault prolapse. Obstet Gynecol 2001;98:40-4. 
5. 
Sousa A FJ, Leon J, Sousa-Gonzalez D. Results of efficiency and safety in 
repairing previous prolapse through the Surelift(R) System; 5 year results.  
International Continence Society Annual Meeting. Florence2017. 
6. 
Amat L GA, Martinez E, Kaplan E. Evaluation of the safety and efficacy of 
pelvic organ prolapse repair using Surelift(R) system - preliminary results.  
International Continence Society Annual Meeting. Toronto2010. 
7. 
Fuenfgeld C SM. A new procedure for pelvic floor reconstruction with an 
additional apical fixation of the vagina (Surelift system).  International Continence 
Society Annual Meeting. Toronto2010. 
8. 
Salicru S M-AA, Sabadell J, Rodriguez-Mias N, Gil-Moreno A, Poza-Barrasus JL. 
Surgical repair of severe prolapse with Surelift system.  International 
Urogynecological Association Annual Meeting. Vienna2018. 
9. 
Lin X M-FE, Amat-Tardiu L. Surgical treatment of genital prolapse with 
Surelift(S) mesh in patients at risk of recurrence.  International Urogynecological 
Association. Nice2015. 
10. 
Karacaoglu MU, Ozyurek ES, Mutlu S, Odacilar E. Unilateral sacrospinous 
ligament fixation (USLF) with a mesh stabilizing anchor set: clinical outcome and 
impact on quality of life. Clin Exp Obstet Gynecol 2016;43:216-9. 
11. 
Kaplan E. Anchorsure - Anchoring System: Outcomes and safety profile in 
vaginal reconstructive surgery.  International Urogynecological Association Annual 
Meeting. Nice2015. 
12. 
Pizarro-Berdichevsky J AM, Goldman HB. Sacrospinous ligament fixation 
using tissue anchoring systems may reduce the procedure length with similar 
outcomes compare with classical techniques.  Society of Urodynamics, Female Pelvic 
Medicine, & Urogenital Reconstruction. Arizona2017. 
13. 
International N. Anchorsure System Brochure. 
14. 
Barber MD, Walters MD, Bump RC. Short forms of two condition-specific 
quality-of-life questionnaires for women with pelvic floor disorders (PFDI-20 and 
PFIQ-7). Am J Obstet Gynecol 2005;193:103-13. 
15. 
Barber MD, Chen Z, Lukacz E, et al. Further validation of the short form 
versions of the Pelvic Floor Distress Inventory (PFDI) and Pelvic Floor Impact 
Questionnaire (PFIQ). Neurourol Urodyn 2011;30:541-6. 

Protocol# IRB00051211 
 
Wake Forest Baptist Health 
 
Principal Investigator: Catherine Matthews, MD       Version #3                    Page 20/20 
16. 
Bump RC, Mattiasson A, Bo K, et al. The standardization of terminology of 
female pelvic organ prolapse and pelvic floor dysfunction. Am J Obstet Gynecol 
1996;175:10-7. 
17. 
Cepeda MS, Africano JM, Polo R, Alcala R, Carr DB. What decline in pain 
intensity is meaningful to patients with acute pain? Pain 2003;105:151-7. 
18. 
Farrar JT, Berlin JA, Strom BL. Clinically important changes in acute pain 
outcome measures: a validation study. J Pain Symptom Manage 2003;25:406-11. 
19. 
Haefeli M, Elfering A. Pain assessment. Eur Spine J 2006;15 Suppl 1:S17-24. 
20. 
Ferreira-Valente MA, Pais-Ribeiro JL, Jensen MP. Validity of four pain 
intensity rating scales. Pain 2011;152:2399-404. 
21. 
Hjermstad MJ, Fayers PM, Haugen DF, et al. Studies comparing Numerical 
Rating Scales, Verbal Rating Scales, and Visual Analogue Scales for assessment of 
pain intensity in adults: a systematic literature review. J Pain Symptom Manage 
2011;41:1073-93. 
22. 
Ferrando CA, Walters MD. A randomized double-blind placebo-controlled 
trial on the effect of local analgesia on postoperative gluteal pain in patients 
undergoing sacrospinous ligament colpopexy. Am J Obstet Gynecol 2018.