Minimally Invasive Burch Colposuspension to Reduce Occult Stress Incontinence
Phase: NA
Conditions: Pelvic Organ Prolapse, Urinary Incontinence,Stress, Urinary Incontinence, Urge, Bowel Dysfunction, Sexual Dysfunction
Sponsor: Northwestern University

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PROTOCOL TITLE: MICRO (Minimally Invasive Burch Colposuspension to Reduce Occult Stress 
Incontinence) 
Clinical trial registration: NCT03841513 
 
PRINCIPAL INVESTIGATOR: 
Name: Sarah Collins, MD 
Department: Obstetrics and Gynecology, Division of Female Pelvic Medicine and Reconstructive 
Surgery 
Telephone Number: 312-926-4747 
Email Address: Sarah.Collins@nm.org 
 
CO-INVESTIGATORS: 
Name: Akira Gillingham, MD 
Department: Obstetrics and Gynecology, Division of Female Pelvic Medicine and Reconstructive 
Surgery 
Telephone Number: 312-472-4023 
Email Address: Akira.Gillingham@nm.org 
Name: Kimberly Kenton, MD 
Department: Obstetrics and Gynecology, Division of Female Pelvic Medicine and Reconstructive 
Surgery 
Telephone Number: 312-472-3874  
Email Address: Kimberly.Kenton@nm.org 
VERSION NUMBER: 5  
 
VERSION DATE: 10/6/20 
 
STUDY SUMMARY: 
 
Investigational Agent(s)  
(Drugs or Devices) 
N/A 
IND / IDE / HDE #   
Indicate 
Special Population(s) 
Children  
 Children who are wards of the state  
 Adults Unable to Consent   
 Cognitively Impaired Adults  
 Neonates of Uncertain Viability  
 Pregnant Women  
 Prisoners (or other detained/paroled individuals)  
 Students/Employees  
Sample Size 50 
Funding Source Northwestern Friends of Prentice Grants Initiative 
Indicate the type of consent 
to be obtained 
Written  
Verbal/Waiver of Documentation of Informed 
Consent 

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Waiver of HIPAA Authorization  
Waiver/Alteration of Consent Process   
Site 
 Lead Site (For A Multiple Site Research Study) 
 Data Coordinating Center (DCC) 
Research Related Radiation 
Exposure 
Yes  
 No  
DSMB / DMC / IDMC 
Yes  
No 
 
 
OBJECTIVES: 
 
Purpose: The purpose of this study is to examine surgical outcomes when prophylactic 
minimally-invasive laparoscopic (including robotic) Burch colposuspension is performed at the 
time of laparoscopic sacrocolpopexy. 
 
Hypothesis: Stress-continent women undergoing laparoscopic sacrocolpopexy will have higher 
rates of occult stress urinary incontinence without the addition of the laparoscopic Burch 
colposuspension. 
 
Specific Goals and Objectives: 
 
Primary Objective: 
1. To determine if addition of laparoscopic Burch colposuspension to planned laparoscopic 
sacrocolpopexy improves rates of stress urinary incontinence (SUI) in stress-continent 
women undergoing sacrocolpopexy for pelvic organ prolapse (POP). SUI will be defined 
by a composite outcome of: positive retro-fill cough stress test at 300mL, answer of 
“yes” to question #17 of Pelvic Floor Distress Inventory 20 (PFDI-20), or any treatment 
for SUI. 
 
Secondary Objectives:  
1. To compare short-term complications in women with and without addition of 
laparoscopic Burch to sacrocolpopexy. 
2. To compare urinary symptoms (urgency urinary incontinence, urgency/frequency, UTI, 
and retention) in women with and without addition of laparoscopic Burch to 
sacrocolpopexy utilizing Pelvic Floor Distress Inventory 20 (PFDI-20). 
3. To compare bowel symptoms in women with and without addition of laparoscopic 
Burch to sacrocolpopexy utilizing Pelvic Floor Distress Inventory 20 (PFDI-20). 
4. To compare sexual function in women with and without addition of laparoscopic Burch 
to sacrocolpopexy, utilizing Pelvic Organ Prolapse/Urinary Incontinence Sexual 
Questionnaire 12 (PISQ-12). 
 

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BACKGROUND: 
 
In the United States it is estimated that 13% of women will undergo surgery for POP by 
age 80. [1] In patients without symptoms of stress urinary incontinence (SUI), surgical 
correction of pelvic organ prolapse (POP) by itself can result in postoperative occult SUI. Two 
multicenter randomized trials of stress-continent women undergoing vaginal or open prolapse 
surgery showed lower rates of postoperative SUI if patients undergo concomitant anti-
incontinence procedures. [2, 3] However, adverse outcomes vary based on the type of anti-
incontinence procedure (open Burch colposuspension or retropubic midurethral sling) and 
route of surgery (open or vaginal), and therefore the preferred approach to address occult SUI 
is unknown. 
 
Sacrocolpopexy is the gold standard surgical repair of pelvic organ prolapse of the apical 
compartment.  The Burch colposuspension is a retropubic procedure in which the periurethral 
tissue of the anterior vagina is affixed to Cooper’s ligament on either side using permanent 
suture bridges. In the Colpopexy and Urinary Reduction Efforts (CARE) trial [2] patients without 
preoperative symptoms of SUI were randomized to receive or not to receive concomitant 
prophylactic Burch colposuspension at the time of abdominal sacrocolpopexy. At three months, 
the subjects who underwent the Burch procedure were found to have lower rates of SUI after 
surgery (33.6%) compared to the control group (57.4%). Furthermore, of patients who tested 
negative for SUI on preoperative urodynamic testing, 22.9 % of those who underwent the Burch 
procedure had SUI compared to 47.9% in the control group. Burch colposuspension did not 
increase the rate of urinary retention, urge incontinence, urinary urgency, urinary tract 
infection, intra or post-operative complications. The data in this trial supported the placement 
of prophylactic Burch colposuspension at the time of abdominal sacrocolpopexy.  
 
Over the last decade, there has been a shift away from open routes of surgical access 
secondary to decreased morbidity and quicker recovery associated with minimally invasive 
procedures. [4-7] As a result, open abdominal sacrocolpopexy with Burch colposuspension has 
fallen out of favor, and minimally invasive laparoscopic sacrocolpopexy is performed with 
greater frequency. Additionally, midurethral slings (MUS) have become the gold standard 
surgical procedure for the treatment of SUI and are performed more frequently than Burch 
colposuspension at the time of prolapse surgery. The Outcomes Following Vaginal Prolapse 
Repair and Midurethral Sling (OPUS) study [3] examined the placement of prophylactic MUS at 
the time of vaginal prolapse surgery. Patients with MUS had lower rates of SUI than control 
group at 3 months (23.6% vs 49.4%) and at 12 months (27.3% vs 43%). However, unlike the 
CARE trial, patients with concomitant anti-incontinence procedure had higher rates of adverse 
events including bladder perforation (6.7% vs 0%), UTI (31.0% vs 18.3%), major bleeding (3.1% 
vs 0%), and incomplete bladder emptying at 6 weeks (3.7% vs 0%). In addition, MUS carries the 
risk of mesh erosion into the vagina or urinary tract. 
 

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By studying the addition of laparoscopic (including robotic) Burch colposuspension to 
laparoscopic sacrocolpopexy, we anticipate optimizing surgical outcomes and minimizing 
complications for patients. 
REFERENCES: 
 
1. 
Wu, J.M., et al., Lifetime risk of stress urinary incontinence or pelvic organ prolapse 
surgery. Obstet Gynecol, 2014. 123(6): p. 1201-6. 
2. 
Brubaker, L., et al., Abdominal sacrocolpopexy with Burch colposuspension to reduce 
urinary stress incontinence. N Engl J Med, 2006. 354(15): p. 1557-66. 
3. 
Wei, J.T., et al., A midurethral sling to reduce incontinence after vaginal prolapse repair. 
N Engl J Med, 2012. 366(25): p. 2358-67. 
4. 
Geller, E.J., et al., Short-term outcomes of robotic sacrocolpopexy compared with 
abdominal sacrocolpopexy. Obstet Gynecol, 2008. 112(6): p. 1201-6. 
5. 
Hsiao, K.C., et al., Comparison of laparoscopic and abdominal sacrocolpopexy for the 
treatment of vaginal vault prolapse. J Endourol, 2007. 21(8): p. 926-30. 
6. 
Klauschie, J.L., et al., A comparison of laparoscopic and abdominal sacral colpopexy: 
objective outcome and perioperative differences. Int Urogynecol J Pelvic Floor Dysfunct, 
2009. 20(3): p. 273-9. 
7. 
Paraiso, M.F., et al., Laparoscopic and abdominal sacral colpopexies: a comparative 
cohort study. Am J Obstet Gynecol, 2005. 192(5): p. 1752-8. 
 
STUDY ENDPOINTS: 
 
1. The primary study endpoint is to compare rates of SUI at 3 month post-operatively in 
patients who undergo laparoscopic sacrocolpopexy with and without Burch 
colposuspension. SUI will be defined by a composite outcome of: positive retro-fill 
cough stress test at 300mL, answer of “yes” to question #17 of Pelvic Floor Distress 
Inventory 20 (PFDI-20), or any treatment for SUI. 
 
2. The secondary study endpoint is to compare complications, urinary symptoms, bowel 
symptoms, and sexual function in women with and without addition of laparoscopic 
Burch to sacrocolpopexy using the Pelvic Floor Distress Inventory 20 (PFDI-20) and Pelvic 
Organ Prolapse/Urinary Incontinence Sexual Questionnaire 12 (PISQ-12). 
 
PROCEDURES INVOLVED: 
 
Randomization: Enrolled subjects will be assigned to one of two treatment groups with equal 
probability: laparoscopic Burch colposuspension or no incontinence procedure. A randomly 
permuted blocked randomization schema will be generated and maintained by a statistician not 
otherwise involved in the study. Treatment allocation will be performed in the operating room 
on the day of surgery via email. Electronic records of when the email is opened will be tracked 
to ensure study allocation is not done prior to the day of surgery. Participants and study 

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coordinators will be blinded to study intervention until 3-month data are collected. 
 
Blinding: The study surgeons will provide clinical care to study participants, and therefore 
blinding the surgeon to treatment allocation is not feasible. However, we intend that all 
outcomes assessors and participants will be blinded to treatment allocation until 3-months 
outcomes are collected.  
 
To maintain blinding in the dictated operative note under the “Procedure” heading, the 
procedure will be listed as “laparoscopic or robotic-assisted laparoscopic sacrocolpopexy per 
study protocol”; however, details of the approach including performance of Burch 
colposuspension will be described in the text of the operative note when applicable. Similarly, 
all notes in the electronic medical record and the surgical consent will be listed as “laparoscopic 
or robotic-assisted laparoscopic sacrocolpopexy per study protocol”. A flag will be placed in the 
inpatient and outpatient electronic medical record indicating that the patient is enrolled in the 
study so her study procedure is not revealed to her. If unblinding does occur, the study 
coordinator will complete a protocol deviation form.  
 
Study Intervention: On the day of surgery patients will undergo standard laparoscopic or 
robotic sacrocolpopexy. The patients randomized to receive the Burch colposuspension will 
undergo this procedure as described below:  
 
The retropubic space is exposed by dissecting the bladder and urethra posteriorly off of the 
pubic bone. Next, the area lateral to the urethra is cleared until anterior vaginal wall is 
identified. Non-absorbable monofilament suture (such as polytetrafluoroethylene or Gore-tex) 
is placed through Cooper’s ligament, followed by a full thickness bite (excluding epithelium) of 
the anterior vaginal wall parallel to the urethra, and then back up through Cooper’s ligament, 
so that the suture ends can be tied above the ligament. The location of each suture is as 
follows: a distal suture is placed approximately 2cm lateral to the proximal third of the urethra, 
and a proximal suture is placed 2cm lateral to the bladder wall at the level of the urethrovesical 
junction. This is repeated on the contralateral side for a total of 4 sutures. The sutures are tied 
down to form a suture bridge between the anterior vagina and Cooper’s ligament, resulting in 
the gentle elevation of the anterior vaginal wall. Finally, the retropubic space is re-
peritonealized using delayed absorbable suture. (Walters and Karram, Urogynecology and 
Reconstructive Pelvic Surgery 2015). 
 
As per standard operative protocol, cystourethroscopy will be performed on every patient at 
the conclusion of the surgery to evaluate for any bladder, urethral, or ureteral injury. No sham 
procedure will be performed in patients in the control group. 
 
Participant Clinical Assessment: Participants will undergo standardized assessments at baseline 
and 3-months after surgery including demographics, past medical and surgical history, prolapse 
assessment using prolapse quantification system (POP-Q), retrofill cough stress test at 300mL, 
and completion of validated pelvic floor and sexual function symptom questionnaires including 

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Pelvic Floor Distress Inventory 20 (PFDI-20) and Pelvic Organ Prolapse/Urinary Incontinence 
Sexual Questionnaire 12 (PISQ-12). 
 
Safety Assessment and Follow up: Study participants will undergo established safety 
assessment and follow up protocols for post-operative patients. Participants will undergo 
standardized retrofill voiding trial in postoperative care unit (PACU) prior to hospital discharge 
to assess for voiding dysfunction. Patients with voiding dysfunction (defined as voiding less than 
150mL following instillation of 300mL of sterile water) will be instructed to perform clean 
intermittent straight catheterization (CISC) or have indwelling Foley catheter placed based on 
patient preference and ability. An after-hours answering service is available for urgent patient 
questions and concerns. Participants will receive a standard follow-up phone call by office staff 
on post-operative day #1. Participants will have standard postoperative follow up appointments 
at 2 weeks and 3 months to assess for postoperative complications (urinary tract infection, 
voiding dysfunction, surgical site infection, mesh erosion). 
 
No audio/video recordings will be utilized for this study. 
 
 
Pre-Op Visit 
PACU 
2 Week Post-
Op ± 2 weeks 
3 Month Post-
Op ± 4 weeks 
Subject 
Recruitment/Consenting 
X 
 
 
 
Collection of 
Clinical/Demographic 
Information 
X 
 
 
 
POPQ Measurements 
X 
 
X 
X 
PFDI-20 
X 
 
X 
X 
PISQ-12 
X 
 
X 
X 
Empty Supine Stress 
Test 
X 
 
 
 
Surgical Procedure Form 
 
X 
 
 
Retrofill Voiding Trial 
 
X 
 
 
Assessment of Adverse 
Events Form 
 
 
X 
X 
Retrofill Cough Stress 
Test at 300 mL 
 
 
 
X 
 
 
DATA AND SPECIMEN BANKING 
Data will be collected and stored at Northwestern Medicine. All study data will be recorded on 
Data Collection Forms by a research coordinator or study personnel and securely maintained in 
a locked cabinet that only study personnel have access to. Data will be entered by a research 
coordinator at Northwestern into a REDCap database that will be stored on a secure sever. Only 

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study staff will have passwords to access the project data on REDCap. All users of REDCap need 
an institutional username and password to log in and to enter data. Research personnel, 
including study staff as well as study doctors will be able to collect and have access to subject 
data. 
After all data is collected, it will be downloaded from REDCap to Excel and SPSS and analyzed on 
Northwestern servers only and on computers that are Northwestern property and password 
protected by Northwestern. 
 
SHARING RESULTS WITH PARTICIPANTS 
Participants may inquire about the individual measurements of their exam if desired. Patients 
can be unblinded after their 3 month visit. Study results may be given to patient at the 
completion of the study. 
 
STUDY TIMELINES 
 
An individual will participate in the study for a maximum of 4 months from the time of 
enrollment. Participants will be enrolled in the study at their preoperative visit and will be 
evaluated again in the postoperative recovery room, at the 2 week and 3 month post-operative 
visits. 
 
We originally anticipated that it would take 24 months to enroll 50 patients however 
recruitment has taken longer. Adding an additional recruitment site will help us with our 
efforts. We anticipate recruitment will be completed December 2021 with analysis completed 
by June 2022. 
 
 
 
Months 1-12 
Months 4-15 
Months 15-16 
Patient Enrollment 
X 
 
 
Patient Follow-up 
Period 
 
X 
 
Data Analysis 
 
 
X 
 
 
INCLUSION AND EXCLUSION CRITERIA 
 
Inclusion Criteria 
- Women over age 18 
- English or Spanish speaking and reading 
- Symptomatic pelvic organ prolapse with any compartment at or beyond the hymen 

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- Stress-continent, as defined as response of “no” to question 17 of PFDI-20: “Do you 
usually experience urine leakage related to coughing, sneezing, or laughing?”, as well as 
a negative empty supine stress test. 
- Planning laparoscopic or robotic sacrocolpopexy, with or without hysterectomy 
- Have completed childbearing 
 
Exclusion Criteria 
- Adults unable to consent 
- Pregnant women or patients desiring future pregnancy 
- Patients undergoing uterine sparing surgery 
- Individuals under age 18 
- Prior procedure for stress urinary incontinence 
- Prior retropubic surgery 
 
 
VULNERABLE POPULATIONS 
 
N/A 
 
RECRUITMENT METHODS 
 
This study will recruit patients who present to the Urogynecology Clinic at the Integrated Pelvic 
Health Program (IPHP), Lake Forest Hospital, and Central DuPage Hospital, at the time of their 
initial or follow up surgical consult appointment. Specifically, women without symptoms of SUI, 
defined as a negative answer in response to question #17 in the Pelvic Floor Distress Inventory 
(PFDI)-20 who are planning to undergo minimally invasive sacrocolpopexy for symptomatic POP 
at or beyond the hymen will be approached for recruitment. There will be no external 
advertising. 
 
COMPENSATION FOR PARTICIPATION IN RESEARCH ACTIVITIES 
 
Study participants will receive a $100 gift card at the end of the study follow up period. 
 
Participants will be notified of their blinded treatment allocation at the end of the 3 month 
follow up period. They will be informed, upon request, the findings of the study once all data 
have been collected and analyzed. 
 
WITHDRAWAL OF PARTICIPANTS 
 
We do not foresee any participants needing to be withdrawn without their consent. 
Participants who withdraw from the study for any reason will continue to be followed as 
routine post-surgical patients. 
 
RISKS TO PARTICIPANTS 

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Potential adverse events from Burch colposuspension include urinary tract infection, 
cystotomy, ureteral injury, and ureterovaginal fistula formation. In the CARE trial, the rates of 
adverse events were rare and similar in patients undergoing sacrocolpopexy with and without 
Burch colposuspension (4.5% and 3%, respectively). Patients randomized to the Burch 
colposuspension had longer operating room times (20 additional minutes) and increased blood 
loss (additional 73mL). The clinical impact of these factors is thought to be minimal. 
 
There are no foreseeable psychological, social, legal, or economic risks to participants. 
 
Patients undergoing sacrocolpopexy at our institution undergo concomitant hysterectomy, or 
have already had a hysterectomy in the past. Patients who desire uterine-sparing prolapse 
surgery will be excluded from this study. Therefore by design, this study will not pose any risk to 
an embryo or fetus. 
 
POTENTIAL BENEFITS TO PARTICIPANTS 
 
Our current standard of care for patients undergoing POP repair includes urodynamic testing. 
Per the study protocol, participants will not have to undergo urodynamic testing, thereby 
avoiding a potentially uncomfortable diagnostic test.  
 
Potential benefits to participants randomized to receive Burch colposuspension include possible 
decreased risk of developing occult SUI following prolapse repair and therefore a lower 
probability of needing subsequent treatment.  
 
 
DATA MANAGEMENT AND CONFIDENTIALITY 
 
The primary outcome measure is stress incontinence symptoms 3-months after surgery. In 
CARE, 34% of women randomized to open Burch and 57% of controls had stress urinary 
incontinence 3-months after surgery. Assuming addition of a minimally invasive Burch 
colposuspension to minimally invasive sacrocolpopexy will result in similar rates of stress 
urinary incontinence, a sample size of 42 (21 in each group) would demonstrate that addition of 
a Burch is superior to no Burch with a superiority margin 15%, 80% power and type 1 error of 
5%.  Assuming a 15% study dropout rate, a total of 50 patients will be recruited for this study. 
Data will be collected at Northwestern Medicine. All study data will be recorded on Data 
Collection Forms by a research coordinator or other member of the study team and securely 
maintained in a locked cabinet to which only study personnel have access. Data will be entered 
by a research coordinator at Northwestern into a REDCap database that will be stored on a 
secure server. Only study staff will have passwords to access the project data on REDCap. All 
users of REDCap need an institutional username and password to log in and to enter data. 
Research personnel, including study staff as well as study doctors, will be able to collect and 
have access to subject data. 

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After all data is collected, it will be downloaded from REDCap to Excel and SPSS and analyzed on 
Northwestern servers only and on computers that are Northwestern property and password 
protected by Northwestern. 
 
PROVISIONS TO MONITOR THE DATA TO ENSURE THE SAFETY OF PARTICIPANTS 
 
Adverse events associated with Burch colposuspension in conjunction with sacrocolpopexy will 
be recorded, and will include events such as post-operative urinary retention requiring 
catheterization, post-operative urinary tract infection, and persistent urinary urgency.  
Subjects will be monitored at each study visit for adverse events. An assessment of adverse 
events form will be completed and will be recorded into REDCap electronic data capture 
system. The PI will be notified of any adverse events, which will be resolved with the patient. 
PROVISIONS TO PROTECT THE PRIVACY INTERESTS OF PARTICIPANTS 
 
To protect privacy interests, the personal health information collected for research purposes 
will be collected from the subject’s electronic medical record to limit the amount of people they 
interact with and provide personal information to. 
All interviews will be conducted in a private office or examination room to ensure 
confidentiality. Phone conversations will be conducted from private offices. Any study 
correspondence with patients will not indicate disease status or focus on the envelope. All 
physical exams will be conducted in a private examination room. Subjects will be allowed to 
skip any question on a questionnaire that makes them feel uncomfortable. 
The study staff, including investigators and the study coordinator, will have access to the 
subject’s medical record and study documents. All study documents will be kept in a locked 
cabinet and only those with password required access to EPIC will be able to access the 
subject’s electronic medical record. 
COMPENSATION FOR RESEARCH-RELATED INJURY 
 
Subjects in need of medical follow-up will be referred to their provider. There will be no 
compensation for research-related injury. 
 
ECONOMIC BURDEN TO PARTICIPANTS 
 
There are no economic costs to participants and no additional visits than would be expected of 
them for routine care. 
 
CONSENT PROCESS 
 

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A few days before the patient’s scheduled urodynamics appointment, a physician on the study 
team will call the patient to introduce the study and answer any questions they may have. The 
physician calling the patient will have a treatment relationship with the patient. This call is done 
because if the patient decides to participate in the study, they no longer have to undergo 
urodynamic testing. The research coordinator will email the patient a copy of the consent form 
after the physician speaks with them and will provide them with the research team’s direct 
phone number in case they would like any more information or questions answered. Emailing 
the consent form will give the patient an opportunity to read over the entire consent form and 
consult with family prior to coming in for their urodynamics and pre-op appointment.  
 
At the urodyanmics/pre-op appointment consent will be obtained from the patient by a 
member of the study team if the patient is ready to make a decision. The person obtaining 
consent will ensure the subject understands the purpose and procedures of the study. After all 
the subject’s questions have been answered, the subject will be given time to make a decision 
about enrollment. The original signed written consent form will be kept separately from 
research data at Northwestern, and a signed copy will be given to the patient. Decisionally-
impaired subjects will not be enrolled in our study. 
 
The participants will also be able to take the consent form home from their urodynamics and 
pre-op appointment to think about whether they would like to participate if they are 
undecided. Since they will not be coming in for any additional appointments before their 
scheduled surgery, we would like to have the option of electronic consent in RedCap. This will 
allow the participant to sign consent electronically and complete their baseline surveys via 
RedCap prior to surgery. This electronic consent form will not differ than the standard in-person 
consent form.  
 
PROTECTED HEALTH INFORMATION (PHI AND HIPAA) 
 
To protect privacy interests, the personal health information collected on the research forms 
for research purposes will be kept in a locked cabinet. 
The study staff, including investigators and the study coordinator, will have access to the 
subject’s medical record to confirm inclusion/exclusion criteria. Only those with password 
required access to EPIC will be able to access the subject’s electronic medical record. 
All interviews will be conducted in a private office or examination room to ensure 
confidentiality. Phone conversations will be conducted from private offices. Any study 
correspondence with participants will not indicate disease status. All physical exams will be 
conducted in a private examination room. Subjects will be allowed to skip any question on a 
questionnaire that makes them feel uncomfortable. 
NON-ENGLISH SPEAKING PARTICIPANTS 
 

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Some prospective participants will be Spanish speaking patients. Translational services will be 
utilized to translate study documents, including consent forms, from English to Spanish. In 
addition, several members of the clinic nursing staff are native speakers of Spanish.  
Unfortunately, study questionnaires are not consistently validated in other languages, and 
patients who are unable to speak and write in either English or Spanish will not be eligible for 
the study. 
 
QUALIFICATIONS TO CONDUCT RESEARCH AND RESOURCES AVAILABLE 
 
The research will be carried out within the Integrated Pelvic Health Program (IPHP) in the 
division of FPMRS at Northwestern University Feinberg School of Medicine. Our program is a 
well-funded, interdisciplinary, patient-oriented clinical and translational research program with 
a long track record of training successful surgeon-scientists. We have interdisciplinary faculty 
members who are dedicated to research and mentoring, which will help ensure the successful 
completion of the proposed project. 
 
Due to the high volume of patients that present with pelvic organ prolapse to our clinic, it is 
feasible that the required number of suitable subjects will be recruited within the estimated 
window of time. Also, study participants will be treated according to our practice’s standard 
treatment protocol, which includes 2 and 14 week postoperative appointments.  No additional 
appointments will be required to complete study procedures.  
Availability of mentors/colleagues: Sarah Collins, MD and Kimberly Kenton, MD, MS will serve 
as the primary investigators for this research. Dr. Collins is an experienced clinical investigator 
in the field of urogynecology. Dr. Kenton has over a decade of experience as a funded clinical 
investigator and a successful research mentor. Our research team meets weekly to ensure 
collaboration and timely progress of all on-going research. We review new project ideas, study 
design issues, ethical issues around human subject’s research, recruitment and retention in on-
going studies, database management and statistical analysis, and dissemination.  
Clinic Space: The Women’s IPHP is a state of the art, multifaceted clinic spaces designed for 
interdisciplinary care of women with pelvic floor disorders. Each year we see approximately 
1600 new FPMRS patients and engage in over 20 prospective, translation or randomized trials, 
many of which are multi-center and nationally-funded. There are 3 fully functional sites of the 
IPHP, and each one offers numerous examination rooms, procedure areas, and on-site physical 
therapy space. The clinics also house dedicated office space and equipment for our full-time 
research coordinators. 
Office/Computer: Each faculty, fellow, and research coordinator have unlimited access to 
computers equipped with SPSS Statistical Software located in their own academic offices. 
Research coordinators: The Division of FPMRS has two dedicated research coordinators. The 
coordinators are physically located in the clinic space so that they are available for sample 

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collection, consent, survey collection and data entry. They are present for every weekly 
research conference to ensure progress on all research projects.