A Randomized Controlled Trial of Permanent vs Absorbable Suture for Uterosacral Ligament Suspension
Phase: NA
Conditions: Pelvic Organ Prolapse, Cystocele, Uterine Prolapse
Sponsor: Joseph Kowalski

MANUAL OF PROCEDURES/PROTOCOL  
 
October 13, 2016 
 
 
A randomized controlled trial of permanent vs absorbable suture for 
uterosacral ligament suspension 
 
NCT02888093 
 
PI: Joseph Kowalski, MD 
Mentor: Catherine Bradley, MD, MSCE 

Section 1. Study Overview 
 
 
 
 
 
Specific Aims 
Primary: Demonstrate that absorbable 0 polydioxanone (PDS, Ethicon, 
Somerville, NJ, USA) suture is not inferior to permanent polytetrafluoroethylene 
(CV-2 Gore-Tex, WL Gore and Associates, Flagstaff, AZ, USA) suture for 
uterosacral ligament suspension (USLS) as measured by POP-Q point C at 12 
month follow up. 
 
We hypothesize that absorbable suture is not inferior to permanent suture for 
USLS as measured by POP-Q point C at 12 month follow up. 
 
Secondary: (1) Compare suture-related complications between groups, including 
erosion, granulation tissue and need for suture excision. (2) Compare subjective 
outcomes between groups with the PFDI-20 questionnaire. 
 
 
 
Background and Significance 
Scheduled for 
USLS
Enrollment (in 
clinic or 
DOSA)
Randomization 
(in OR)
Permanent 
(Gore-Tex)
6 week follow 
up
12 month 
follow up
Absorbable 
(PDS)
6 week follow 
up
12 month 
follow up

The lifetime risk of surgery for pelvic organ prolapse (POP) or stress urinary 
incontinence (SUI) has been estimated to be as high as 20%.1 USLS is a very 
commonly performed vaginal-approach surgical procedure for correction of apical 
vaginal prolapse. Anatomic cure rates for apical prolapse following USLS have 
recently been shown to be 89.7%.2 The original description of the USLS 
procedure by Shull included the use of permanent sutures for the apical 
suspension.6 Subsequent, high-quality trials evaluating USLS, such as the 
OPTIMAL trial, have also included the use of permanent sutures.2 Thus, 
permanent apical sutures may be considered the “gold-standard”. Nonetheless, 
debate persists as to the optimal suture selection for this procedure. 
 
Some have advocated choosing an absorbable suture.3 This allows a full-
thickness incorporation of the vaginal wall with the apical suture and may reduce 
suture-related complications. The procedure was initially described using 
permanent suture to suspend the fibromuscular apical vaginal tissue to the 
uterosacral ligaments. Symptomatic suture erosion rates of 22% in the 
permanent suture group were noted in one retrospective comparison of 
permanent and absorbable sutures.3 No suture erosions were noted in the 
absorbable suture group. However, others have advocated continued use of 
permanent suture, citing increased failure rates with absorbable sutures.4 The 
evidence for either approach is limited by having just a few retrospective 
studies.3-4 A high-quality, randomized controlled trial to evaluate the optimal 
suture for this common procedure is needed. The IUGA grant is an ideal funding 
mechanism for answering this clinically relevant question with a focused 
randomized trial. 

Section 2. Participant Screening and Enrollment  
 
Adult women (age 18-99) scheduled for USLS can be approached for the study 
prior to surgery or at the time of the pre-operative clinic appointment or in DOSA.  
All women preparing for surgery can be given information (a study flier) prior to 
surgery once they are scheduled for USLS.  
 
After review of eligibility criteria (see below), a study team member will determine 
eligibility and obtain informed consent.  Once consent is obtained, the participant 
is enrolled into the study. However, a study ID number is not assigned until the 
patient is randomized.  
 
Inclusion criteria will be: (1) scheduled for USLS. 
 
Exclusion criteria will be: (1) age under 18 years, (2) non-English speaking, (3) 
prisoner, (4) cognitive impairment precluding informed consent and (5) planned 
hysteropexy. We will only plan to include post-hysterectomy procedures and 
procedures including a concomitant vaginal hysterectomy. 
 
A screening log will be maintained for all potential participants for this study (i.e. 
all patients who are scheduled for USLS during the recruitment period) and 
whether they were enrolled into the study. The screening results from this log will 
be tallied at the conclusion of enrollment, and patient identifiers will be destroyed. 
 

Section 3. Randomization and Surgery 
 
Following enrollment, the subject will be randomized only after the subject is in 
the operating room. The study team member will then log on to the 
randomization software at www.randomize.net. The following steps are 
necessary to randomize the patient and obtain the treatment arm: 
 
1. Sign in. Click “SIGN IN” in the upper right hand corner. 
2. Enter user info. Your Login ID is your first initial followed by your last name 
(i.e. jkowalski). Your Password is uterosacral. 
3. Click “ENROLL A PATIENT”. 
4. Click “A randomized controlled trial of permanent vs absorbable suture for 
uterosacral ligament suspension”. 
5. Note the assigned Patient ID. This is a three-digit number between 001 and 
044. Write this number on the cover sheet of the enrollment package. This step is 
critical. Click “NEXT”. 
6. Confirm the inclusion and exclusion criteria are met by selecting the 
appropriate yes or no boxes. Click “NEXT”. 
7. Select the attending surgeon for the case. Click “NEXT”. 
8. This final screen will display the treatment assignment and confirm the Patient 
ID number. 
 
The surgery will then be completed. USLS with the assigned suture and any 
scheduled concomitant prolapse and anti-incontinence procedures will be 
performed. USLS will be performed as initially described by Shull et al with two 
important differences in technique. First, 2 sutures will be placed through the 
intermediate portion of each uterosacral ligament instead of 3. Second, when 
absorbable suture (PDS) is used, the suture will be placed through the full 
thickness of the anterior and posterior vaginal walls. 
 
Following surgery, the patient should be scheduled for a follow up visit at 6 
weeks with either Diane Elas (UIHC) or Nicole Myslinski (Quad Cities Outreach 
Clinic). 

Section 4. Follow-up and CRF Completion 
 
Patient demographics, relevant histories, baseline physical exam including POP-
Q and PFDI-20 data will be abstracted from the electronic medical record 
following enrollment. The PI will place this information into a secure database. 
 
Follow up exams will occur at 6 weeks and 12 months post-operatively and will 
include a POP-Q exam. All participants will also be assessed for any suture-
related complications, such as erosion or granulation tissue. Follow up exams will 
be completed by one of two urogynecology nurse practitioners who will be 
blinded to the surgery and suture choice. Both nurse practitioners have extensive 
experience in performing POP-Q exams. The examiners will complete a follow up 
data abstraction form for each follow up appointment (6 weeks and 12 months). 
 
The primary outcome will be measured by POP-Q point C. Specifically, the 
preferred method for measuring point C will be to identify point C visually with a 
speculum and to visually follow that point with the patient performing a Valsalva 
maneuver while simultaneously releasing pressure on the speculum. Should this 
method prove to not be feasible for any individual patient due to anatomy, the 
examiner will have the option to identify point C visually with the speculum in 
place, leave the Q-tip in place lying against point C, remove the speculum, and 
have the patient perform a Valsalva maneuver while allowing the Q-tip to 
descend against point C. As a last alternative, the provider may identify point C 
digitally, follow point C digitally while the patient performs a Valsalva maneuver 
and then measure the distance from the hymen to the tip of the finger with a Q-
tip. 
 
Subjects will also complete a set of questionnaires at each follow up 
appointment. See appendix 1. 
 
Subjects will be provided with compensation following completion of the 12-
month follow up. This will be provided in the form of a $100 check through the 
UIHC e-Voucher system. 
 
We anticipate a volume of approximately 50-60 USLS procedures between July 
2016 and June 2017. Based on enrollment rates in other ongoing studies at our 
institution, this volume should allow us to meet our recruitment goal of 44 
subjects within a 1-year period. 
 

Section 5. Ethics and Patient Consent 
 
The study is approved with the University of Iowa Institutional Review Board. The 
study will be discussed in detail and the informed consent reviewed with potential 
subjects prior to enrollment. 
 
Risk in this study is limited to loss of confidentiality of protected health 
information (PHI). However, maintaining records on a secure, password 
protected, local server will minimize this risk. Furthermore, no hard-copy forms 
will be utilized for this study that contain identifying data or PHI. Hard-copy data 
abstraction forms and questionnaires will only be labeled with the patient’s 
unique study ID number. All necessary PHI will be abstracted to the secure 
database directly from the patient’s electronic medical record. 
 
There is true equipoise between groups in this study. Both permanent and 
absorbable sutures are commonly used around the world in USLS procedures. 
As described above, low-quality retrospective studies have reported conflicting 
prolapse outcomes with the use of alternative suture choices. Patients 
randomized to the permanent suture group potentially stand to benefit from a 
more durable repair. Patients randomized to the absorbable suture group may 
potentially benefit from fewer suture-related complications (erosion, granulation 
tissue, etc.) and an equally durable prolapse repair.