The Use of Anchor Versus Suturing for Attachment of Vaginal Mesh in Minimally Invasive Sacrocolpopexy
Phase: PHASE3
Conditions: Pelvic Organ Prolapse
Sponsor: Kaiser Permanente

The Use of Anchor versus Suturing for Attachment of Vaginal Mesh in Minimally 
Invasive Sacrocolpopexy 
12/8/17 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

TABLE OF CONTENTS 
 
SECTION 
             PAGE 
1. OBJECTIVES ------------------------------------------------------------------------------------------------------3 
PRIMARY OBJECTIVESES -----------------------------------------------------------------------------------------------3 
SECONDARY OBJECTIVES-----------------------------------------------------------------------------------------------3 
2. HYPOTHESIS -----------------------------------------------------------------------------------------------------3 
PRIMARY HYPOTHESIS --------------------------------------------------------------------------------------------------3 
SECONDARY HYPOTHESIS ---------------------------------------------------------------------------------------------3 
3. BACKGROUND ---------------------------------------------------------------------------------------------------3 
PELVIC ORGAN PROLAPSE ---------------------------------------------------------------------------------------------3 
SACROCOLPOPEXY -------------------------------------------------------------------------------------------------------3 
ANCHOR MESH FIXATION -----------------------------------------------------------------------------------------------4 
RATIONALE AND POTENTIAL SIGNIFICANCE OF RESULTS -------------------------------------------------4 
4. OVERVIEW OF DESIGN ---------------------------------------------------------------------------------------5 
DESIGN DISCRIPTION ----------------------------------------------------------------------------------------------------5 
SCREENING PERIOD -----------------------------------------------------------------------------------------------------6 
STUDY PERIOD -------------------------------------------------------------------------------------------------------------6 
STUDY POPULATION -----------------------------------------------------------------------------------------------------7 
INCLUSION CRITERIA ----------------------------------------------------------------------------------------------------7 
EXCLUSION CRITERIA ---------------------------------------------------------------------------------------------------7 
METHOD OF RECRUITEMT AND MULTIPLE STRATEGY OF RETENTION-------------------------------7 
5. STUDY PROCEDURE------------------------------------------------------------------------------------------7 
INTERVENTION ------------------------------------------------------------------------------------------------------------7 
ASSESSMENTS ------------------------------------------------------------------------------------------------------------8 
STUDY SCHEDULE -------------------------------------------------------------------------------------------------------8 
POP DIAGNOSIS/BASELINE POPQ ---------------------------------------------------------------------------------9 
BASELINE DEMOGRAPHICS-------------------------------------------------------------------------------9 
INTRAOPERATIVE---------------------------------------------------------------------------------------------9 
IMMEDIDATE POSTOPERATIVE -------------------------------------------------------------------------------------10 
POSTOPERATIVE CLINIC VISITS -----------------------------------------------------------------------10 
SAFETY ASSESSMENTS------------------------------------------------------------------------------------------------10 
OUTCOMES -----------------------------------------------------------------------------------------------------------------10 
PRIMARY OUTCOME MEASURE -------------------------------------------------------------------------------------10 
VALIDATION OF PRIMARY OUTCOME; TIMING SURGICAL PROCEDURES ---------------------------10 
RANDOMIZATION/BLINDING ------------------------------------------------------------------------------------------10 
SECONDARY OUTCOME MEASURE -------------------------------------------------------------------------------10 
SAFETY AND TOXICITY MEASURES--------------------------------------------------------------------------------11 
MONITORING AND ETHICAL CONSIDERATIONS ---------------------------------------------------------------11 
6. DATA MANAGEMENT AND ANALYSIS -------------------------------------------------------12 
DATA COLLECTION PROCEDURES --------------------------------------------------------------------12 
ANALYSIS OF BASELINE DATA --------------------------------------------------------------------------12 
STATISTICAL ANALYSIS OF OUTCOMES-------------------------------------------------------------12 
SAMPLE SIZE AND POWER OF STUDY ---------------------------------------------------------------13 
7. REFERENCES ---------------------------------------------------------------------------------------------------13 
 
 
 
 
1. OBJECTIVES 

1. PRIMARY OBJECTIVE: To assess the effect of absorbable anchor 
compared to suturing for mesh attachment to vagina in robotic assisted 
sacrocolopexy on the length of surgery for this portion of the procedure. 
2. SECONDARY OBJECTIVES:  
i. To assess intraoperative and 
ii. postoperative complication rates, 
iii. Intraoperative 10 cm visual analog scale (VAS), to subjectively 
assess surgeon satisfaction with the technique  
iv. post-operative Pelvic Organ Prolapse Quantification (POPQ) 
evaluation for anatomic failure and  
v. a VAS of the vaginal walls overall appearance 
2. HYPOTHESES For women undergoing sacrocolpopexy surgery at a large 
managed care organization: 
1. PRIMARY HYPOTHESIS: Attachment of the mesh to the vagina with 
absorbable anchors compared to standard treatment (suturing) will require 
50% shorter surgical time for the mesh attachment portion of the 
procedure. 
2. SECONDARY HYPOTHESIS: Anchor suture staples compared to 
standard treatment will: 
i. have similar rates of intra-operative and post-operative 
complications 
ii. have similar rates of surgical failure 
iii. not have different appearance on the VAS of the vaginal walls 
iv. elicit higher reported satisfaction from surgeons  
3. BACKGROUND 
1. PELVIC ORGAN PROLAPSE; Pelvic organ prolapse (POP) is the 
descent of one or more of four different anatomic structures: a) the uterus 
(cervix), b) the apex of the vagina (in those status post-hysterectomy) c) 
the anterior vaginal wall, or d) the posterior vaginal wall.  It is caused by 
chronic intra-abdominal pressure on weakened pelvic organ supports.  An 
estimated 41.1% of women aged 50-79 have some degree of prolapse on 
exam [1,2], while only 2.9-8% of all adult women report symptomatic 
prolapse symptoms [3-5]. Severity of POP is defined by the Pelvic Organ 
Prolapse Quantification (POPQ) system [6].  Risk factors include age, 
childbirth (especially vaginal and operative vaginal deliveries), white race, 
family history, constipation, obesity, smoking, and menopause. Symptoms 
can include a vaginal bulge, pressure, or discomfort. 
2. SACROCOLPOPEXY: Sacrocolpopexy (SCP) is a common surgical 
treatment for symptomatic pelvic organ prolapse. While traditionally 
reserved for women with recurrent or vaginal vault prolapse SCP is 
becoming more common as the first surgical option for women with 
prolapse [7], because benefits are long-lasting with less than 5% of 
patients undergoing reoperation [8-11]  However, SCP is associated with 
an increased rate of intraoperative and post-operative complications 
compared to other surgical treatments [12], including bowel obstruction, 
mesh erosion, and venous thromboembolism. More recently minimally 

invasive SCP (laparoscopic and robotic assisted) has become popular as 
it offers similar success rates with faster recovery, less pain, bleeding and 
cost [13-15]. Robotic surgery has several unique challenges including the 
absence of haptic feedback, and additional time required for setup. The 
mean time to complete robotic SCP is 79 minutes for attendings, and 76 
minutes for trainees, with total operating time of 182 minutes for 
attendings, and 200 minutes for trainees [16].   
3. ANCHOR MESH FIXATION: Anchor mesh fixation has been tested 
successfully in several applications.  In laparoscopic incisional and ventral 
hernia repair, anchors have been used to fixate mesh.  A systematic 
review [17] found four trials involving 207 surgeries comparing traditional 
suture mesh fixation to anchoring.  Anchoring was associated with shorter 
operative time, less postoperative pain and similar rates of perioperative 
complications and hernia recurrence and shorter hospital stay.  Both non- 
absorbable (titanium helical anchors) and absorbable anchors 
(AbsorboanchorTM, Covidien; SucerestrapTM, Ethicon) have been used 
with similar operating time, postoperative hospital stay, pain, morbidity and 
recurrence [18-21]. However longer term studies have reported more pain 
and erosion of non-absorbable anchors into hollow viscera [22] but 
perhaps higher recurrence rates with absorbable anchors[23]. Comparison 
of acute fixation strength of various attachment techniques has been 
performed, finding suture to provide the greatest strength and non-
absorbable to provide more strength then absorbable anchors [24].  
However, it is well know that mesh used for vaginal attachment is 
incorporated into the tissue after three months and the use of absorbable 
sutures for mesh attachment for sacrocolpopexy are commonly used [25]. 
4. PRIMARY OUTCOME MEASURE: The primary outcome measure is 
mesh attachment time to the fibromuscular tissue layer in the vagina.  In 
sacrocolpopexy done in a minimally invasive fashion, polypropylene mesh 
attachment to this layer of the vagina can be the most technically 
challenging and time intensive portion of the surgery.  This is traditionally 
performed with non-barbed, delayed absorbable interrupted, suture (such 
as 2-0 PDS), with 4-6 interrupted sutures with 4 to 6 knots each on both 
the anterior and posterior aspect of the vagina. The anterior mesh 
attachment took 15 minutes, while posterior mesh attachment took 16 
minutes on average [16] and the time to complete both took 42 minutes in 
another study[25].  The mesh attachment time has excellent validity as it 
directly measures the time it takes to complete the part of the surgery.  
With few exceptions, the measure of time has strong accuracy and 
precision due to the use of standardized procedures and consistent 
measurement technique.  
5. RATIONALE AND POTENTIAL SIGNIFICANCE OF RESULTS: By 
applying a commonly used surgical technique of absorbable anchors to a 
new surgery, SCP, operative time may be decreased while providing 
similar patient outcomes.  Absorbable anchors have been validated in 
mesh fixation during laparoscopic surgical repair of hernias.  This 

technique potentially takes less time than traditional suturing, thus 
decreasing cost and morbidity of anesthesia.  Our hypothesis proposes 
that for women undergoing SCP at a large managed care organization, 
those receiving anchor suture staples to attach the mesh to the vagina 
compared to those receiving standard treatment will require 50% shorter 
surgical time for the mesh attachment portion of the surgery. Our 
secondary hypothesis is for women undergoing SCP at a large managed 
care organization, those receiving anchor suture staples to attach the 
mesh to the vagina compared to those receiving standard treatment will 
have similar rates of intra-operative and post-operative complications and 
surgical failure. On VAS, patients will not have different appearance of the 
vaginal walls. Surgeons will report higher satisfaction with the anchor 
technique. 
4. OVERVIEW OF DESIGN 
1. DESIGN DESCRIPTION; This is a multi-site prospective, randomized, 
single-blind, 2 arms-parallel, clinical trial to evaluate the effect of 
absorbable anchor versus suturing of polypropylene mesh to the vaginas 
fibromuscular layer on the length of procedure for women undergoing SCP 
for POP. This effect will be studied using timing of the surgical procedure. 
2. The study consists of a 1-year enrollment period concurrent with a 1-year 
single blinded period (the intraoperative data in which the patient is 
blinded to group assignment, but the surgeon/investigator is not), followed 
by a 6-month postoperative double blinded period (in which both the 
patient and surgeon/investigator).  
3. During enrollment, patients who meet the inclusion and not the exclusion 
criteria and provide informed consent for participation will be assigned 
randomly to receive either absorbable anchor mesh fixation or suture 
mesh fixation.   
 
 
 
 
 
 
 
 
 
 
 

 
Figure 1. Flowchart of study schema  
 
4. SCREENING PERIOD: Subject will be screened for eligibility during a 1-
year period that will include the preoperative office visit and preoperative 
unit visit. Office staff (research nurses, nurse practitioners, residents, 
fellows, attendings) will obtain written informed consent from participants 
as a part of enrollment.  Standard physical exam measures (including 
POPQ) will be performed during the office visit. The suture allocation 
sealed envelope will be opened intra-operatively once it is certain the 
attachment of mesh will occur via a technique that is minimally invassive.   
5. STUDY PERIOD: Study duration will be the 1 year concurrent period 
where surgeries are performed as well as the subsequent 6 months where 
postoperative visits occur. After randomization and surgery occurs 
subjects will follow up for a total of 6 months, with three visits, one at 6 
weeks, one at 6 months.  During these postoperative visits, a standard 
physical exam will be performed looking for signs of POP recurrence, 
mesh erosion, palpable suture, anchors, and other physical findings.  The 
Enrollment: After decision made to treat POP with SCP, 
patients approached in the office or preoperative area for 
enrollment 
Undergoes SCP for POP 
Follow-up, at 6 weeks, and 6 months months. 
Exam(POPQ, mesh erosion assessed), questionnaire 
Outcome Analysis 
Assigned to have mesh 
fixation with  
-Absorbable Anchor 
N=25 
Assigned to have mesh 
fixation with 
-Suture 
N=25 

patient will complete standardized questionnaires accessing pain, 
satisfaction and other quality of life indicators.  
6. STUDY POPULATION: Women with POP, scheduled for minimally 
invasive SCP will be eligible for enrollment  
i. INCLUSION CRITERIA: All patients must meet all the following 
inclusion criteria.  
1. Age 21 or older 
2. Diagnosis of POP, defined as the descent of one or more of 
four different anatomic structures, a)the uterus(cervix), b)the 
apex of the vagina (in those status post hysterectomy) c) the 
anterior vaginal wall, or d) the posterior vaginal wall.  This is 
defined on exam as the POPQ points Ba, C, or Bp >0 cm 
beyond the hymen, uterine(cervix) descent into at least the 
lower half the vagina (defined as point c> -tvl/2) or post 
hysterectomy vault into the lower 2/3 of the vagina. 
Bothersome bulge symptoms as indicated on question 3 of 
the Pelvic Floor Disorder Inventory (PFDI-20) form relating to 
‘sensation of bulging’ or something ‘falling out’ 
3. Desire surgical treatment for POP with SCP 
4. Available for up to 6 months of follow up 
5. Not pregnant or desiring future pregnancy 
6. Written informed consent is obtained. 
ii. EXCLUSION CRITERIA; Patients are ineligible for the study if: 
1. Known adverse reaction to synthetic mesh, or complications 
including but not limited to erosion, fistula, or abscess. 
2. Cervical intraepithelial neoplasia (CIN2, CIN3, or cancer) 
3. Unresolved chronic pelvic pain 
4. Prior abdominal or pelvic radiation  
5. Contraindications to the surgical procedures including known 
horseshoe kidney, pelvic abscess or active diverticular 
abscess or diverticulitis 
7. METHODS OF RECRUITMENT AND MULTIPLE STRATEGY OF 
RETENTION: There are many women in the target population. We will 
educate the health personnel (research nurses, nurse practitioners 
residents, fellows, attendings) in two sites of a large managed care 
organization Female Pelvic Medicine and Reconstructive Surgery 
(FPMRS) to recruit this population. Subject retention strategies will include 
a $20 visa gift card given to the subject on completing the 6 month follow 
up appointment, as well as phone call reminders of those appointment. 
5. STUDY PROCEDURES 
1. INTERVENTION: On day of surgery eligible individuals are randomized to 
have either absorbable anchor or suture fixation of mesh (Figure 1). The 
patients and all postoperative study staff will be blinded to treatment 
assignment and surgical time measurements. A block stratification with a 
computer-generated randomization schedule will be performed. 
Equipment needed for both techniques will be stocked and readily 

available and all surgeons will be trained in the use of both techniques. 
The two groups will be mesh attachment with 0 non-barbed delayed 
absorbable suture or anchor suture using the ReliatackTM articulating 
reloadable fixation device (Medtronic). A minimum number of suture 
attachment points will be 4 on each side of the vagina.  The average 
number for most cases is typically 6 to 8 per side.  The same number 
minimum number of anchors will be required for the anchor arm.  The 
remaining portion of the procedures will be the same for both arms.  Intra-
operative details will be tracked including number of sutures/anchors 
placed per side, inability to complete anchor placement or suture 
placement and alternative method if needed, and anchor or suture 
exposure full thickness in the vagina, and insertion of anchor/suture in 
rectum or bladder requiring removal.  The type of suture will not be 
revealed in the operative procedure or heading but will be described in the 
description of procedure. Perioperative antibiotics will be administered per 
operating room protocol. Patients will all be prescribed vaginal estrogen 
after surgery.  
2. ASSESSMENTS 
i. STUDY SCHEDULE 
The timing of study is summarized in the Study Schedule. 
 
Scree
ning 
Surge
ry 
Post-Operative Visits 
Visit 
1 
1 
1 
2 
Month 
Pre-op 0 
1.5 
6 
Informed 
consent 
X 
 
 
 
Demographics X 
 
 
 
Pregnancy 
X 
 
 
 
Efficacy 
POPQ 
X 
 
 
X 
X 
Procedure 
length 
 
X 
 
 
Surgeon+Fello
w Satisfaction 
(VAS) 
 
X 
 
 
PGI-I 
 
 
X 
X 

PFDI 20 
X 
 
 
 
Safety 
Vaginal Wall 
Appearance 
(VAS) 
 
 
X 
X 
Adverse 
events 
 
X 
X 
X 
Patient VAS 
for Pain 
 
 
X 
X 
 
 
ii. POP DIAGNOSIS/BASELINE POPQ: During the preoperative visit 
for evaluation of POP, the provider (nurse practitioner, resident, 
fellow, and/or attending) will perform a POPQ exam.  Each 
component, Aa(midline anterior vaginal wall, 3cm above external 
urethral meatus), Ba(most distal point of the anterior vaginal wall 
from the vaginal cuff or cervix, C(most distal edge of the cervix or 
cuff), GH(the distance from the middle of the external urethral 
meatus to posterior hymen), PB(posterior margin of the genital 
hiatus to midanal opening), tvl(greatest depth of the vagina, 
Ap(midline posterior vaginal wall, 3cm proximal to the hymen), 
Bp(the most distal point of the posterior vaginal wall from the 
vaginal cuff or cervix), D(posterior fornix) will be assessed.  
Patient will be diagnosed with POP, defined as the descent of one 
or more of four different anatomic structures, a) the uterus(cervix), 
b)the apex of the vagina (in those status post hysterectomy) c) the 
anterior vaginal wall, or d) the posterior vaginal wall.  This is 
defined on exam as the POPQ points Ba, C, or Bp >0 cm beyond 
the hymen. In addition, uterine (Cervix) descent into at least the 
lower half of the vagina (defined as point C>-TVL/2) or post 
hysterectomy vault into the lower 2/3 of the vagina, Bothersome 
bulge symptoms as indicated on question 3 of the PFDI-20 form 
relating to ‘sensation of bulging’ or ‘something falling out,’ and 
desires surgical treatment for uterovaginal or vault prolapse 
undergoing minimally invasive SCP. 
iii. BASELINE DEMOGRAPHICS: Patient baseline demographic 
information will be assessed from the electronic medical record.  
Information on age, BMI, ethnicity, co-morbidities, and allergies will 
be obtained. 
iv. INTRAOPERATIVE:  The following will be tracked: intraoperative 
adverse events, total surgical time, sacrocolpopexy time, mesh 
attachment time, type of mesh, number of attachment points 

(anchor or mesh) including total, anterior, posterior, inability to use 
randomized technique, conversion to open or alternative technique, 
surgeon satisfaction with method. 
v. IMMEDIDIATE POSTOPERATIVE:  Length of stay in hours, pain 
medication use will be assessed. 
vi. POSTOPERATIVE CLINIC VISITS: In addition to the preoperative 
visit, patients will have data collection intraoperatively and during 
postoperative visits at 6 weeks, and 6 months.  We will mask 
patients to the type of attachment used until after their 6 month 
visit. A provider (not the who did the surgery) will do the 
postoperative POPQ measurements to ensure masking to the 
attachment technique used during surgery. 
vii. SAFETY ASSESSMENTS: Safety is assessed as a component of 
the intraoperative record as well as a review of 6 months of 
electronic medical record of unscheduled office or emergency room 
visits in addition to assessments at the 6 week and 6 month 
postoperative visit.  
3. OUTCOMES 
i. PRIMARY OUTCOME MEASURE: The primary efficacy outcome 
is the mesh to vagina attachment time using these two techniques. 
The timing of the mesh attachment interval was defined as 
beginning at the time of the initial needle or anchor being loaded on 
the needle driver or anchor device within the body of the patient 
and was introduced into the tissue of the vagina to attach the piece 
of mesh. As long as minimum amounts are met, here is no 
boundary to the amount of passes used or the amount of sutures 
applied. The security of the attachment of mesh will be ascertained 
by the attending surgeon’s clinical reasoning. The time interval will 
end at the time the final suture is detached or anchor placed. A 
recording of the suture quantity utilized for each mesh attachment 
interval and the quantity of sutures placed in order to attach the 
mesh will be done.  As this a time consuming component of 
sacrocolpopexy, a reduction in time using the anchor technique 
would be of considerable interest. This Mesh Attachment Interval 
will be recorded along with occurrence of supracervical 
hysterectomy as well as number of sutures or anchors placed, 
technical difficulties experiences, and mesh type on a de-identified 
document for each subject 
1. Validation of primary outcome (timing surgical 
procedures): Measurement of time to complete a 
component of surgery has been validated in the surgical 
literature[16,25].    
2. Randomization/Blinding: While intraoperative outcomes 
are not blinded, the examining postoperative visit provider 
will be blinded to group allocation. Group assignment will be 
performed by randomization as above. 

ii. SECONDARY OUTCOME MEASURE: Our secondary efficacy 
objectives include: 1) VAS of the operating surgeon subjective 
technique satisfaction assessment 2) post-operative POPQ, mesh 
erosion anatomic assessment, palpable anchor assessment and 3) 
VAS of the vaginal walls general appearance. The latter two will be 
recorded by the provider who is blinded at 6 weeks and 6 months, 
who will perform POP-Q as well as the VAS assessment of the 
walls of the vagina’s general appearance.  Surgical failure of a 
patient is if the points on POP-Q, if Bp, Ba ≥ 0 cm, or C > - ½ TVL. 
The VAS will have four components, global satisfaction, apex, 
anterior wall, and posterior wall. The instructions for all four VAS 
will be as follows: “Please designate a “X” at the VAS that rates 
closest your sacrocolpopexy evaluation.” The anterior compartment 
assessment at the VAS left side will say “ the vaginal mesh at the 
ANTERIOR seems to lay level without folding or bunching.” At the 
other VAS side the text will say “mesh at the vaginal ANTERIOR is 
completely folded and bunched.” Comparable phrasing will be used 
on the for posterior and apical compartment VAS. For the global 
satisfaction VAS, the side on the left it will say “I will use this suture 
routinely;  as it meets my needs for attachment of mesh” and text at 
the other VAS end will say “I do appreciate the results, I will not use 
this attachment technique in my practice;”.  
iii. SAFETY AND TOXICITY MEASURES: Safety will be assessed as 
several points throughout the study. During the admission for 
surgical care, safety measures and complications will be assessed.  
During the surgery and admission, complications, including but not 
limited to hemorrhage, bleeding, nerve injury, infection, urinary 
retention, bowel injury, bladder/urethral injury will be assessed.  
Post-operatively at the 6 week, and month visit (along with query of 
electronic medical record for additional ER and ambulatory visits) 
additional safety measures will be assessed.  At the standardized 
postoperative visits mesh exposure and erosion will be assessed.  
In addition pain and reoperation for pain or mesh erosion and 
exposure will be assessed.   
4. MONITORING AND ETHICAL CONSIDERATIONS: To safeguard 
complete, reliable and accurate data, the principal investigator will: 
i. provide preliminary and follow up training to study coordinators and 
providers on research procedure, participant recruitment, and 
completion of outcome reports 
ii. work with the IRB to obtain approval of the study and the informed 
consent document before the study can begin. A study role list will 
be created to include all qualified persons to whom the investigator 
may delegate study-related duties 
iii. Periodically evaluate outcome reports for correctness and missing 
values as well as keep a research database for the same and to 
ensure compliance with the IRB 

iv. be continuously available to back the research staff by email, and 
telephone 
v. conduct quality review of the database 
vi. supervise that once entered, subject data will be accessed only for 
two purposes, analysis and validation/verification/auditing.   
 
6. DATA MANAGEMENT AND ANALYSIS 
1. PROCEDURES FOR DATA COLLECTION: Study participants will be 
closely observed by investigators to make sure that surgical appointments 
are set up.  Data from preoperative period will be taken from the the EMR 
for the subject.  Data for the primary outcome will be abstracted when the 
subject has their surgery.  
A Clinical report Form (CRF) will be used to collect history, physical 
examination, operation, operating times, technique, mesh attachment 
interval times, complications, and subsequent follow-up examination data. 
The investigators will input data into a pre-formatted spreadsheet.  The 
spreadsheet will be maintained through the Kaiser Permanente San Diego 
research department on a password protected server and will be audited, 
reviewed and maintained by the investigators 
i. Quality of Data: Data of the highest quality will be obtained from 
management data defined protocols for evaluating its accuracy 
(using source verification), completeness, accountability, and 
integrity. 
ii. Completeness: the investigators will identify and complete any 
missing data.    
iii. Accuracy:  Errors in data will likely stem from errors in data entry.  
To minimize this, confirmation of data with a second source and 
random checks of data, and will be done.  Error catching 
mechanisms in the Excel spread sheet and Access Database will 
be created with appropriate ranges and limits to help catch 
mistakes in data entry and allow for more accurate data entry.  
iv. Auditing: Both sample and schedule-based auditing will be 
performed. Quarterly audits will be performed with random 
selection of 10% of the data to verify. Administrative audits will be 
done on a similar schedule to ensure compliance with Good Clinical 
Practices of the FDA. 
v. Accountability:  Accountability for data entry and data management 
will be with the investigators and statistical consultants.    
vi. Integrity:  mirrored hard drives, data back ups and storage on 
Kaiser Permanente San Diego server, will insure for data integrity. 
2. ANALYSIS OF BASELINE DATA: Subject characteristics (measures and 
demographic information) collected at baseline will be compared across 
treatment groups, using either chi-square for categorical variables or t-test 
for continuous variables. We will examine these baseline characteristics  
for statistically significant differences between treatment groups, and use 
those that are identified for adjusted analysis correcting for these 

differences in analysis of outcome variables. 
3. STATISTICAL ANALYSIS OF OUTCOMES: The primary endpoint for this 
study is the time of completion of mesh attachment. Statistical methods 
will include t-test or Mann Whitney U test for continuous variables, and 
chi-squared or Fischer’s exact-test for categorical variables. We will collect 
the primary measure for outcomes of time of mesh attachment as a 
continuous variable.  In addition we will use t-tests to evaluate the mean 
times of the different attachment approaches.  Paired sample t test will be 
used to evaluate POP-Q values pre and postoperatively.  Chi-squared test 
will be used to examine anatomic failures between the two. We will do risk 
analysis as appropriate using 95% confidence intervals odds ratios. For 
the analysis we will use  SPSS 22.0.   
4. STUDY POWER AND SAMPLE SIZE: A time of mesh attachment power 
calculation was performed using Power and Sample Size program (PS 
version 3.1.2).  If suture mesh attachment interval = 40 ± 20 mins [16,25], 
a 50% reduction with use of anchors is = 20mins ± 20 mins. With 80% 
power and αlpha=0.05, 17 subjects will be needed for each arm.  
Anticipating a drop out of up to a 30% we will enroll 25 subjects in each 
group for a goal of at least 17 participants for each arm.  
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