A Prospective Randomized Trial Comparing Restorelle® Y Mesh vs. Vertessa® Lite Y Mesh for Laparoscopic and Robotic-assisted Laparoscopic Sacrocolpopexy
Phase: NA
Conditions: Vaginal Vault Prolapse
Sponsor: The Cleveland Clinic

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A prospective randomized trial comparing Restorelle® Y mesh vs. Vertessa® lite Y 
mesh for laparoscopic and robotic-assisted laparoscopic sacrocolpopexy  
 
Cecile A. Unger, MD MPH; Assistant Professor of Surgery. Center for Urogynecology 
and Pelvic Reconstructive Surgery; Obstetrics/Gynecology and Women’s Health 
Institute, Cleveland Clinic, Cleveland OH 
 
Marie Fidela R. Paraiso, MD; Professor, Section Head of the Center for Urogynecology 
and Pelvic Reconstructive Surgery; Obstetrics/Gynecology and Women’s Health 
Institute, Cleveland Clinic, Cleveland OH 
 
 
Background and Significance: 
 
Abdominal sacrocolpopexy is considered the gold standard for vault prolapse, and has 
demonstrated superior anatomic outcomes compared to transvaginal suspension 
procedures. Laparoscopic sacrocolpopexy has become an alternative to open abdominal 
sacrocolpopexy as this mode of surgery bridges the gap between the advantages of 
vaginal surgery, namely decreased morbidity and faster patient recovery, with the 
surgical success rates of abdominal sacrocolpopexy (1). For young women who are 
sexually active with symptomatic pelvic organ prolapse, reconstruction with a 
sacrocolpopexy procedure is beneficial because the success rates are high as the 
procedure adequately restores support of the vaginal apex and maintains vaginal length 
(2). Robotic-assisted laparoscopic sacrocolpopexy has also emerged as a mode of vaginal 
vault prolapse surgery, and is a good option for patients with significant body mass index, 
or known pelvic adhesive disease that may make a conventional laparoscopic approach 
more challenging.  
 
Sacrocolpopexy involves suspension of the vagina to the anterior longitudinal ligament of 
the sacrum at the level of S1 using a bridging graft which can be made of biologic or 
synthetic materials. The graft is sutured to the anterior as well as the posterior vagina and 
then attached to the anterior longitudinal ligament of the sacrum. There are a number of 
prosthetic materials available for use in pelvic reconstructive surgery, including 
sacrocolpopexy.  Mersilene was a popular prosthetic for many decades, but its use rapidly 
declined in favor of polypropylene which is now the most commonly used synthetic 
product (3). The ideal prosthetic material is biocompatible, inert, has minimal allergic or 
inflammatory reaction, is sterile, non-carcinogenic, resistant to infection, and avoids 
shrinkage and mechanical stress and is easy to handle and readily available at a 
reasonable cost (4). Additionally, pore size of the graft material affects resistance to 
infection and cellular infiltration and also the flexibility of the mesh (5). Lastly, the 
interaction at the tissue interface of the graft material is also very important, with the 
ideal prosthesis causing minimal initial inflammatory and cellular response followed by 
adequate vascular and fibroblastic infiltration (6). Many different materials have been 
used as a graft in sacrocolpopexy including biologic materials (fascia lata, rectus fascia, 
dura mater) and synthetic materials (polypropylene mesh, polyester fiber mesh, 
polytetrafluorethylene mesh, Dacron mesh, and Silastic silicone rubber).  Large pore 
light-weight polypropylene mesh is a monofilament graft and is most commonly used 

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today as it meets the above-mentioned requirements, and likely has fewer complications 
compared to other synthetics because of these characteristics (2). Both the Restorelle® 
Smartmesh (Coloplast, Inc., Minneapolis, MN, USA) and the Vertessa® lite mesh 
(Caldera Medical. Inc., Agoura Hills, CA, USA) are ultra-light macroporous 
polypropylene mesh grafts that are intended for pelvic floor reconstruction. Currently, 
both types of grafts are used to perform sacrocolpopexy.  
 
In our urogyneoclogy practice at Cleveland Clinic, we currently routinely use the 
Restorelle® Smartmesh and we have experienced good clinical outcomes using this graft. 
This mesh seems to have been widely adopted by many surgeons performing 
sacrocolpopexy.  To our knowledge, the only prospective study that exists looking at this 
mesh at the time of sacrocolpopexy was published by Salamon et al. (7) in 2013 in the 
International Urogynecology Journal. In this study, the authors sought to prospectively 
evaluate the use of Restorelle® Y mesh for robotic sacrocolpopexy. They implanted a 
total of 120 patients and obtained one year follow-up data from 118 of these patients. 
They reported an anatomic success rate of 89%, a subjective cure rate of 94% and no 
mesh erosions. Currently no prospective data exists on the Vertessa® lite mesh for 
sacrocolpopexy. It is used by many surgeons, but there are no data showing that it is as 
efficacious in treating prolapse and avoiding mesh erosion in those patients undergoing 
sacrocolpopexy. Therefore, the primary objective of the proposed study is to compare 
outcomes between the Restorelle® Y mesh and Vertessa® lite Y mesh at the time of 
laparoscopic and robotic-assisted laparoscopic sacrocolpopexy.  
 
 
Hypothesis: Vertessa® lite Y mesh is not inferior to Restorelle® Y mesh for the 
treatment of vaginal vault prolapse. 
 
Study Design: Randomized single-blind non-inferiorty trial 
 
Primary Outcome:  
 
Composite outcome measure of surgical success: 
 
(1) descent of the vaginal apex more than one-third into the vaginal canal 
(2) anterior or posterior vaginal wall descent beyond the hymen 
(3) bothersome vaginal bulge symptoms  
(4) retreatment for prolapse by either surgery or pessary 
 
Secondary Outcomes:  
1. Intraoperative, peri-operative and post-operative complications 
2. Pelvic floor symptoms (urinary, bowel, prolapse, sexual function): PFDI, ISI, 
PISQ)  
3. Retreatment for urinary incontinence 
 
 

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Study Population: Study subjects will be recruited from patients that present to the Center 
for Urogynecology & Pelvic Reconstructive Surgery in the Department of Obstetrics and 
Gynecology at the Cleveland Clinic Main campus, Hillcrest Hospital and Fairview 
Hospital, and their surgeries will be performed at either one of these sites. 
 
Inclusion Criteria: 
• Age ≥ 18, who are to undergo laparoscopic or robotic laparoscopic 
sacrocolpopexy for pelvic organ prolapse 
• Other concomitant laparoscopic or prolapse and anti-incontinence procedures 
(e.g., laparoscopic supracervical hysterectomy, cystocele repair, rectocele repair 
or mid-urethral sling procedures) will be performed at the primary surgeon’s 
discretion. 
Exclusion Criteria: 
• Inability to comprehend written and/or spoken English 
• Inability to provide informed consent 
• Medical illness precluding laparoscopy 
• Need for concomitant surgeries not related to pelvic organ prolapse or 
incontinence  
• Sacrocolpoperineopexy  
• Need for dual flat mesh for sacrocolpopexy procedure (determined by surgeon) 
 
 
Study Procedures: 
 
Study Identification and Recruitment 
Potential subjects will be identified by members of the Center for Urogynecology & 
Pelvic Reconstructive Surgery at the Cleveland Clinic Main campus and Fairview 
Hospital. Eligible patients that agree to participate will be provided written informed 
consent administered by the collaborators listed on this IRB. 
 
Randomization 
All subjects will be predetermined by their surgeon to undergo either a laparoscopic or 
robotic assisted laparoscopic sacrocolpopexy depending upon their clinical evaluation. 
The participants will then be randomized to either Restorelle® or Vertessa® Y 
sacrocolpopexy according to a computer-generated randomization schedule with random 
block sizes with the use of the SAS statistical software package (SAS Institute, Cary, 
NC). All patients will be blinded to their assignment.    
 
Office Interventions 
All patients will be seen for a preoperative visit and then postoperatively at 6, 12 and 24 
months. At each visit, a vaginal exam and a complete Pelvic Organ Prolapse 
Quantification (POP-Q) exam will be performed. Patients will also be asked to update 
their medical history. In addition, patients will be asked to complete the Pelvic Floor 

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Distress Inventory (PFDI-20), Incontinence Severity Index (ISI) and Pelvic Organ 
Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) questionnaires at the pre-
operative visit as well as the 6, 12, and 24 month postoperative visits. Completion of 
these questionnaire is the only additional assessment that is specific to participation in 
this study and is not usually included as part of the standard care of sacrocolpopexy. It 
should take no more than 10-15 minutes to complete the questionnaires. The study 
subjects will not be exposed to any additional risk by participating in this study except for 
the inconvenience of completing the questionnaire.  
 
Surgical Interventions 
Laparoscopic sacrocolpopexy  will be performed using four ports: an umbilical port for 
the laparoscope, two ports (either 5 or 10/12 mm) in the bilateral lower quadrants, and 
one 5-mm port placed at the level of the umbilicus, lateral to the rectus muscle on either 
side for retraction. The robotic-assisted hysterectomy will be performed using the da 
Vinci Surgical System (Intuitive Surgical Inc., Sunnyvale, CA, USA) using five ports: a 
12mm umbilical port for the laparoscopic, two 8 mm robotic ports placed 2cm inferior 
and 9-10cm lateral to the umbilicus bilaterally, an 8mm robotic port placed in the left 
axillary line at the level of the umbilicus, and a 8mm or 10/12mm accessory port either in 
the right upper quadrant approximately 3cm distal from the costal margin, or in the right 
lower quadrant, 2cm above and medial to the anterior superior iliac spine.  
 
If a supracervical hysterectomy is to be performed, it will be done in a standard fashion. 
A uterine manipulator will be placed inside of the uterus. The round ligaments will be 
transected using cautery. The fallopian tubes and ovaries will be left in situ or removed at 
the time of hysterectomy depending upon the preoperative decision made between the 
surgeon and patient. The uterine arteries and cardinal ligaments will be cauterized 
laparoscopically. The uterus will be amputated at the level of the internal cervical os and 
the endocervical canal will be cauterized.  
 
The sacrocolpopexy will also be performed and in a standard fashion. An end-to-end 
anastomosis (EEA) sizer will be placed in the vagina for manipulation of the apex as well 
as in the rectum for delineation of the rectovaginal septum. First, the presacral dissection 
will be performed with a longitudinal peritoneal incision over the sacral promontory and 
there is identification of the anterior longitudinal ligament. Dissection is then done 
caudally through the peritoneum and subperitoneal fat down to the level of the posterior 
cul-de-sac. The vagina is elevated cephalad using the EEA sizer and the peritoneum 
overlying the anterior vaginal apex is incised transversely, and the bladder is dissected off 
the anterior vagina using sharp dissection, creating a 4 to 5 cm pocket. If this plane is 
difficult to establish, the bladder will be filled in a retrograde fashion to find the correct 
dissection plane. Similarly, the peritoneum overlying the posterior vagina is incised, and 
dissection is then done overlying the vagina and extending into the posterior cul-de-sac, 
creating a 4 to 5 cm pocket. Once dissection is complete, the mesh graft is prepared. 
Subjects will have been randomized to either one of two mesh grafts: 
 
The Y mesh is introduced into the pelvis through one of the ports. First, either then 
anterior or the posterior arm is fixed to the anterior or posterior vaginal wall using 6 

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delayed- absorbable (PDS) No. 2-0 sutures in an interrupted fashion, 1 to 2 cm apart from 
each other. The opposing arm of the graft is then attached to either the anterior or 
posterior vaginal wall, depending on which arm was placed first, in a similar fashion 
using 6 delayed- absorbable (PDS) No. 2-0 sutures in an interrupted fashion, 1 to 2 cm 
apart from each other. The stem portion of the graft is then brought to the sacral 
promontory and sutured to the anterior longitudinal ligament using 2 permanent (prolene) 
No. 0 sutures. The excess mesh is then trimmed.  
 
The peritoneum is then closed over the exposed graft with absorbable suture.  
Routine cystoscopy will also be performed in order to assess for lower urinary tract 
injury. A vaginal exam is performed, and an anterior and/or posterior colporrhaphy and 
perineorrhaphy are performed if needed. Anti-incontinence procedures may also be 
performed if needed.  
 
**In laparoscopic cases, all suturing will be done extracorporeally while intracorporeal 
knot-tying technique will be performed in robot assisted laparoscopic cases.  
 
Data Collection & Management: 
 
Preoperative data will include the following: 
• Patient age, race, vaginal parity, menopausal sate, BMI, prior prolapse surgery, 
preoperative prolapse stage  
• PFDI-20, ISI, PISQ-12  
• Preoperative hemoglobin  
 
Data points recorded during the procedure will include:  
• Total OR time = operating room time of entry and exit 
• Total Case time = time from incision to closure  
• Concomitant procedures 
o Supracervical hysterectomy  
o Anterior colporrhaphy 
o Posterior colporrhaphy 
o Perineorrhaphy 
o Midurethral sling 
• Estimated blood loss 
• Intraoperative complications 
o EBL > 500cc 
o Vascular Injury 
o Cystotomy 
o Ureteral Injury 
o Bowel Injury - small bowel, large bowel, rectal 
 
Postoperative data will include the following: 6, 12, 24 months 
• POP-Q exam (performed by a provider blinded to the mesh used at the time of the 
procedure) 
• PFDI-20, ISI, PISQ-12 

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• Review of electronic medical record (inpatient notes, d/c summary, ER visits), 
assessing for postoperative complications  
o Reoperation for immediate complications = reoperation within 30 days of 
surgery 
o Abdominal Wound infection = fascial, subcutaneous, cutaneous infection 
requiring antibiotic treatment 
o Hematoma = intrapelvic/abdominal 
o Vaginal cuff cellulitis/Pelvic Abscess = requiring IV/PO antibiotic therapy 
and/or transvaginal, trangluteal or percutaneous drainage 
o DVT/PE = diagnosed with Doppler US or CT scan 
o Reoperation for SUI with pubovaginal sling (synthetic or fascial), 
colposuspension, injection with periurethral bulking agents 
o Reoperation for mesh exposure 
o Reoperation for recurrent POP 
o Bowel Injury/Bowel Obstruction = enterotomy, perforation, ileus, 
partial/complete obstruction 
o Port site or incisional hernia 
o Need for any radiologic imaging 
o Lower urinary tract injury = bladder, ureteral 
o Neurologic Injury = brachial plexus, abdominal wall (ilioinguinal, 
iliohypogastric), lower extremity (femoral, sciatic, common peroneal) 
o Pulmonary complications = pneumonia, pulmonary hypertension, 
pulmonary edema within 14 days of surgery 
o Cardiac = ACS, MI, HF within 14 days of surgery 
o Postoperative ICU admission 
 
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 
Cleveland Clinic. 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.  
 

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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 the Cleveland Clinic. 
All forms will contain de-identified information – identification numbers will correspond 
to the subjects listed in the master excel file.  
 
All study data will be transferred and managed electronically using REDCap (Research 
Electronic Data Capture). 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. They system was 
developed by a multi-institutional consortium which was initiated at Vanderbilt 
University and includes the Cleveland Clinic. The database is hosted at the Cleveland 
Clinic Research Datacenter in the JJN basement 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 as based on a 
study-specific data dictionary defined by the research team with guidance from the 
REDCap administrator in Quantitative Health Sciences at the Cleveland Clinic.  
 
Analysis Plan: 
There will be 2 arms to this study: laparoscopic (robotic-assisted and conventional) 
sacrocolpopexy with Restorelle® Y mesh and laparoscopic (robotic-assisted and 
conventional) sacrocolpopexy with Vertessa® Y mesh. Subjects will be chosen based on 
surgeon preference to either undergo RA LSC ASC or conventional LSC ASC. They will 
then be randomized to either the Restorelle® or Vertessa® Y mesh arm. We determined 
that if there is no difference between the two Y mesh grafts, 90 patients are required to be 
70% sure that the upper limit of a one-sided 95% confidence interval will exclude a 
difference in favor of the Restorelle® group of more than 10%. We will account for a 
potential 10% subject drop out and loss to follow-up as well as unforeseen factors in 
recruiting and will plan to recruit 50 subjects to each arm, for a total of 100 subjects.  
 
 
 
 
 
 
 
 
 
 
100 Subjects 
100 RA LSC ASC or LSC ASC  
(surgeon choice)  
50 Restorelle® 
Y Mesh  
50 Vertessa®  
Y Mesh 
Randomization

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All statistical analyses will be done using jmp 12. We will use descriptive statistics to 
show our demographic and baseline data: categorical variables will be presented as n/N 
(%) with 95% confidence intervals and continuous variables will be presented as mean 
+/-SD [range]. The two Y mesh grafts will be compared. Differences between the groups 
in the primary outcome of surgical success and other categorical outcomes were 
evaluated using generalized linear models. We will control for LSC ASC and RA LSC 
ASC by performing a logistic regression.  
 
Summary of tasks for study: 
 
Preop 
6 mo  
12 mo  
24 mo  
Informed consent 
X 
 
 
 
Demographic data 
X 
 
 
 
Randomization 
X 
 
 
 
PFDI-20 
X 
X 
X 
X 
ISI 
X 
X 
X 
X 
PISQ-12 
X 
X 
X 
X 
POP-Q 
X 
X 
X 
X 
Review of d/c summary, 
chart, postop Hct, 
complications  
(ER visits, etc) 
 
X 
 
 
Update medical history 
 
X 
X 
X 
References:  
1. Ganatra AM, Rozet F, Sanchez-Salas R, et al. The current status of laparoscopic 
sacrocolpopexy: A review. Eur Urol 2009;55(5):1089-1103.  
2. Walters MD, Ridgeway BM. Surgical treatment of vaginal apex prolapse. Obstet 
Gynecol 2013, 121(2):354-373. 
3. Porges RF & Smilen SW. Long term analysis of the surgical management of 
pelvic floor support defect. Am J Obstet Gynecol 1994;171:1518–1528. 
4. Birch C. The use of prosthetics in pelvic reconstructive surgery. Best Pract Res 
Clin Obstet Gyn 2005;19(6):979-991.  
5. Chu CC & Welch L. Characterisation of morphological and mechanical properties 
of surgical mesh fabrics. J Biomed Res 1985;19:903–916. 
6. Kaupp HA, Matulewicz TJ & Lattimer GL. Graft infection or graft reaction? Arch 
Surg 1979;114:1419-1423. 
7. Salamon CG, Lewis C, Priestley J, Gurshumov E, Culligan PJ. Prospective study 
of an ultra lightweight polypropylene Y mesh for robotic sacrocolpopexy. Int 
Urogynecol J 2013;24(8):1371-1375.