Restorelle® Y Mesh vs. Vertessa® Lite Y Mesh for Laparoscopic and Robotic-assisted Laparoscopic Sacrocolpopexy

This is a randomized single-blind, non-inferiorty trial. Abdominal sacrocolpopexy is
considered the gold standard for vault prolapse, and has demonstrated superior anatomic
outcomes compared to transvaginal suspension procedures. 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. ). 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, both types of grafts are used to perform sacrocolpopexy. 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.

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. All subjects will be predetermined by their surgeon
to undergo either a laparoscopic or robotic assisted laparoscopic sacrocolpopexy depending
upon their clinical evaluation. The subjects will then we 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.

All subjects will be seen at a preoperative visit, then again at 6, 12 and 24 months
postoperatively. During each visit. a vaginal exam and a complete Pelvic Organ Prolapse
Quantification (POP-Q) exam will be performed. In addition, patients will be asked to
complete the Pelvic Floor Distress Inventory (PFDI-20), Incontinence Severity Index (ISI) and
Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) questionnaires at
the preoperative visit as well as the 6, 12, and 24 month postoperative visits.

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
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.

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

- Supracervical hysterectomy

- Anterior colporrhaphy

- Posterior colporrhaphy

- Perineorrhaphy

- Midurethral sling

- Estimated blood loss

- Intraoperative complications

- EBL > 500cc

- Vascular Injury

- Cystotomy

- Ureteral Injury

- 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

- Review of electronic medical record (inpatient notes, d/c summary, ER visits), assessing
for postoperative complications

- Reoperation for immediate complications = reoperation within 30 days of surgery

- Abdominal Wound infection = fascial, subcutaneous, cutaneous infection requiring
antibiotic treatment

- Hematoma = intrapelvic/abdominal

- Vaginal cuff cellulitis/Pelvic Abscess = requiring IV/PO antibiotic therapy and/or
transvaginal, trangluteal or percutaneous drainage

- DVT/PE = diagnosed with Doppler US or CT scan

- Reoperation for SUI with pubovaginal sling (synthetic or fascial), colposuspension,
injection with periurethral bulking agents

- Reoperation for mesh exposure

- Reoperation for recurrent POP

- Bowel Injury/Bowel Obstruction = enterotomy, perforation, ileus, partial/complete
obstruction

- Port site or incisional hernia

- Need for any radiologic imaging

- Lower urinary tract injury = bladder, ureteral

- Neurologic Injury = brachial plexus, abdominal wall (ilioinguinal,
iliohypogastric), lower extremity (femoral, sciatic, common peroneal)

- Pulmonary complications = pneumonia, pulmonary hypertension, pulmonary edema within
14 days of surgery

- Cardiac = ACS, MI, HF within 14 days of surgery

- 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.

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.

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)