Sponsored by

AAGLAdvancing Minimally Invasive Gynecology Worldwide

Plenary 5 – Urogynecology

MODERATORS

Cheryl B. Iglesia, MD & Bruce S. Kahn, MD

John R. Miklos, MDSuran R. Ramphal, MD

Erinn M. Myers, MDDouglas Van Drie, MD

Melissa Pendergrass, MDMing-Ping Wu, MD

Professional Education Information   Target Audience This educational activity is developed to meet the needs of residents, fellows and new minimally invasive specialists in the field of gynecology.  Accreditation AAGL is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.  The AAGL designates this live activity for a maximum of 1.0 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.   DISCLOSURE OF RELEVANT FINANCIAL RELATIONSHIPS As  a  provider  accredited  by  the Accreditation  Council  for  Continuing Medical  Education, AAGL must ensure balance, independence, and objectivity in all CME activities to promote improvements in health care and not proprietary interests of a commercial interest. The provider controls all decisions related to identification  of  CME  needs,  determination  of  educational  objectives,  selection  and  presentation  of content,  selection  of  all  persons  and  organizations  that will  be  in  a  position  to  control  the  content, selection  of  educational methods,  and  evaluation  of  the  activity.  Course  chairs,  planning  committee members,  presenters,  authors, moderators,  panel members,  and  others  in  a  position  to  control  the content of this activity are required to disclose relevant financial relationships with commercial interests related  to  the subject matter of  this educational activity. Learners are able  to assess  the potential  for commercial  bias  in  information  when  complete  disclosure,  resolution  of  conflicts  of  interest,  and acknowledgment of  commercial  support are provided prior  to  the activity.  Informed  learners are  the final safeguards in assuring that a CME activity is independent from commercial support. We believe this mechanism contributes to the transparency and accountability of CME.   

Table of Contents 

 Course Description ........................................................................................................................................ 1  Disclosure ...................................................................................................................................................... 2  Unanticipated Pathology in the Uterine Specimen at the Time of Robotic Sacrocolpopexy  M. Pendergrass  ............................................................................................................................................ 4  Laparoscopic Non‐O’Connor Transperitoneal Extravesical Vesicovaginal Fistula Repair in 41 Patients:  A Descriptive Technique and Feasibility Study  J.R. Miklos  .................................................................................................................................................... 7  Feasibility of Laparoscopic Repair of Urogenital Fistulae   S.R. Ramphal  .............................................................................................................................................. 10  Twelve‐Month Results for an Adjustable Single Incision Sling in the Treatment of Female Stress  Urinary Incontinence  D. Van Drie  ................................................................................................................................................. 14  Interactive Web‐Based Tool for Pelvic Organ Prolapse: Impact on Patient Understanding and  Provider Counseling  E.M. Myers  ...................................................................................................................................... 17  The Choice of Repeat Surgeries after Failed Primary Surgeries for Female Stress Urinary Incontinence, 1997‐2010: A Population‐based Nation‐wide Descriptive Study  M‐P Wu  ...................................................................................................................................................... 20  Cultural and Linguistics Competency  ......................................................................................................... 23 

 

Plenary 5 – Urogynecology

Moderators: Cheryl B. Iglesia and Bruce S. Kahn Faculty: John R. Miklos, Erinn M. Myers, Melissa Pendergrass, Suran R. Ramphal,

Douglas Van Drie, Ming-Ping Wu This session will include reviews several submissions related to urogynecology including: 1) the need for screening patients for uterine pathology prior to laparscopic sacrocolpopexy at the time of supracervical hysterectomy; 2) a description and review of a techniques for laparoscopic transperitoneal extravesical vesico-vaginal fistula repair as well as , 3) laparoscopic repair of uterogential fistulas; 4) 12 month results for an adjustable sling for the treatment of SUI; 5) The utility of a web-based interactive educational tool for counseling patients with POP; 6) review of risk factors for and procedures performed in repeat surgery for SUI. Learning Objectives: At the conclusion of this course, the clinician will be able to: 1) Reduce the risk of unanticipated uterine neoplasia at the time of supracervical hysterectomy; 2) consider further exploration of laparoscopic repair of VVF; and 3) counsel patients more effectively prior to surgery for POP.

Course Outline 11:00 Unanticipated Pathology in the Uterine Specimen at the Time of

Robotic Sacrocolpopexy M. Pendergrass

11:10 Laparoscopic Non-O’Connor Transperitoneal Extravesical Vesicovaginal Fistula Repair in 41 Patients: A Descriptive Technique and Feasibility Study J.R. Miklos

11:20 Feasibility of Laparoscopic Repair of Urogenital Fistulae S.R. Ramphal

11:30 Twelve-Month Results for an Adjustable Single Incision Sling in the Treatment of Female Stress Urinary Incontinence D. Van Drie

11:40 Interactive Web-Based Tool for Pelvic Organ Prolapse: Impact on Patient Understanding and Provider Counseling E.M. Myers

11:50 The Choice of Repeat Surgeries after Failed Primary Surgeries for Female Stress Urinary Incontinence, 1997-2010: A Population-based Nation-wide Descriptive Study M-P Wu All Faculty

12:00 Closing Remarks/Adjourn

1

PLANNER DISCLOSURE The following members of AAGL have been involved in the educational planning of this workshop and have no conflict of interest to disclose (in alphabetical order by last name). Art Arellano, Professional Education Manager, AAGL* Viviane F. Connor Consultant: Conceptus Incorporated Kimberly A. Kho* Frank D. Loffer, Executive Vice President/Medical Director, AAGL* Linda Michels, Executive Director, AAGL* M. Jonathan Solnik* Johnny Yi*

SCIENTIFIC PROGRAM COMMITTEE Ceana H. Nezhat Consultant: Ethicon Endo-Surgery, Lumenis, Karl Storz Other: Medical Advisor: Plasma Surgical Other: Scientific Advisory Board: SurgiQuest Arnold P. Advincula Consultant: Blue Endo, CooperSurgical, Covidien, Intuitive Surgical, SurgiQuest Other: Royalties: CooperSurgical Linda D. Bradley* Victor Gomel* Keith B. Isaacson* Grace M. Janik Grants/Research Support: Hologic Consultant: Karl Storz C.Y. Liu* Javier F. Magrina* Andrew I. Sokol* FACULTY DISCLOSURE The following have agreed to provide verbal disclosure of their relationships prior to their presentations. They have also agreed to support their presentations and clinical recommendations with the “best available evidence” from medical literature (in alphabetical order by last name). Cheryl B. Iglesia* Bruce S. Kahn Grants/Research: Boston Scientific, Karl Storz Consultant: Karl Storz Speakers Bureau: Abvie, Johnson & Johnson, Shionogi, Warner Chillcott John R. Miklos Consultant: Coloplast Speakers Bureau: Coloplast Other: Preceptor: Coloplast, Cook Medical, Gyrus ACMI (Olympus), SurgiQuest Stock Ownership: Holstor, T-DOC, LLC Erinn M. Myers* Melissa Pendergrass* Suran R. Ramphal* Douglas Van Drie

Grants/Research: Coloplast Consultant: Coloplast Speakers Bureau: Astellas Other: Preceptor: Medtronic Ming-Ping Wu* Asterisk (*) denotes no financial relationships to disclose.

Unanticipated pathology in the uterine specimen at the time of

robotic sacrocolpopexy

Melissa Pendergrass, M.D. - MIGS Fellow, Legacy Health

I have no financial relationships to disclose.

Objectives

1) Measure the prevalence of unanticipated gynecologic pathology at the time of hysterectomy with robotic sacrocolpopexy

2) Identify predictive risk factors for having unanticipated gynecologic pathology at the time of robotic hysterectomy with sacrocolpopexy

Background Women have an 11% - 19% lifetime risk of undergoing

surgery for pelvic organ prolapse and/or urinary incontinence

Robotic sacrocolpopexy gaining popularity

47% of women underwent a concomitant hysterectomy

Many reconstructive surgeons now prefer LSH to TLH in order to decrease the risk of mesh complications, specifically erosion

Background Current endometrial screening models are from the

abnormal uterine bleeding population

No screening recommendations in asymptomatic patient population

Rates of abnormal uterine pathology reported in literature = 0.2 – 2.6%

Materials and Methods Cross-sectional prevalence study

Four large metropolitan based community hospitals in

Portland, Oregon; March 2010 and March 2012

Inclusion criteria: women undergoing a hysterectomy at the

time of sacrocolpopexy using the DaVinci surgical robot

Exclusion criteria: known cases of pre-malignant or

malignant uterine/cervical pathology, and known adnexal

masses

Chart review of patient demographics, operative and

pathology reports.

4

Demographic data

119 patients

88 LSH 31 TLH

Demographic data 98% Caucasian

Mean age of 59

Mean BMI of 27

11% prevalence of diabetes

8% of women were using systemic hormone therapy

12% of women were noted to have abnormal uterine bleeding pre-operatively and appropriately evaluated

Results

The prevalence of unanticipated uterine pathology was6% (95% CI 1%-10%)

7 cases of abnormal pathology

3 CAEH4

endometrial cancer

Results

Logistic regression analysis revealed a trend towards:

Increasing BMI OR= 1.19 (0.99-1.43), p = 0.07

Diabetes OR=25 (1.47-423), p = 0.03

Discussion ConclusionThis study exposes a possible need for pre-operative screening of asymptomatic women who are undergoing a robotic hysterectomy and sacrocolpopexy.

This may be particularly true for those with risk factors such as obesity and diabetes.

5

References 1. Wu JM, Hundley AF, Fulton RG, Myers ER. Forecasting the prevalence of pelvic floor disorders in U.S. women: 2010 to 2050. Obstet Gynecol. 2009;114(6):1278-

1283. doi: 10.1097/AOG.0b013e3181c2ce96.

2. Maher C, Feiner B, Baessler K, Adams EJ, Hagen S, Glazener CM. Surgical management of pelvic organ prolapse in women. Cochrane Database Syst Rev. 2010;(4)(4):CD004014. doi: 10.1002/14651858.CD004014.pub4.

3. Elliott CS, Hsieh MH, Sokol ER, Comiter CV, Payne CK, Chen B. Robot-assisted versus open sacrocolpopexy: A cost-minimization analysis. J Urol. 2012;187(2):638-643. doi: 10.1016/j.juro.2011.09.160.

4. Seror J, Yates DR, Seringe E, et al. Prospective comparison of short-term functional outcomes obtained after pure laparoscopic and robot-assisted laparoscopic sacrocolpopexy. World J Urol. 2012;30(3):393-398. doi: 10.1007/s00345-011-0748-2.

5. Antosh DD, Grotzke SA, McDonald MA, et al. Short-term outcomes of robotic versus conventional laparoscopic sacral colpopexy. Female Pelvic Med ReconstrSurg. 2012;18(3):158-161. doi: 10.1097/SPV.0b013e31824b218d.

6. Geller EJ, Siddiqui NY, Wu JM, Visco AG. Short-term outcomes of robotic sacrocolpopexy compared with abdominal sacrocolpopexy. Obstet Gynecol. 2008;112(6):1201-1206. doi: 10.1097/AOG.0b013e31818ce394.

7. Cundiff GW, Varner E, Visco AG, et al. Risk factors for mesh/suture erosion following sacral colpopexy. Am J Obstet Gynecol. 2008;199(6):688.e1-688.e5. doi: 10.1016/j.ajog.2008.07.029.

8. Osmundsen BC, Clark A, Goldsmith C, et al. Mesh erosion in robotic sacrocolpopexy. Female Pelvic Med Reconstr Surg. 2012;18(2):86-88. doi: 10.1097/SPV.0b013e318246806d.

9. Frick AC, Walters MD, Larkin KS, Barber MD. Risk of unanticipated abnormal gynecologic pathology at the time of hysterectomy for uterovaginal prolapse. Am J Obstet Gynecol. 2010;202(5):507.e1-507.e4.

10. Bonnar J, Kraszewski A, Davis WB. Incidental pathology at vaginal hysterectomy for genital prolapse. J Obstet Gynaecol Br Commonw. 1970;77(12):1137-1139.

11. - RO, - GJ, - SS, - AD, - KK. Utility of preoperative endometrial assessment in asymptomatic women undergoing hysterectomy for pelvic floor dysfunction. International Urogynecology Journal. 2012(23):913-917.

6

1

LAPAROSCOPIC NON-O’CONOR TRANSPERITONEAL EXTRAVESICAL VESICOVAGINAL FISTULA REPAIR IN 41 PATIENTS: A DESCRIPTIVE TECHNIQUE & FEASIBILITY

STUDY

LAPAROSCOPIC NON-O’CONOR TRANSPERITONEAL EXTRAVESICAL VESICOVAGINAL FISTULA REPAIR IN 41 PATIENTS: A DESCRIPTIVE TECHNIQUE & FEASIBILITY

STUDY

JOHN R MIKLOS MD & R0BERT D MOORE DO

ATLANTA UROGYNECOLOGY ASSOCIATES

ATLANTA GA

JOHN R MIKLOS MD & R0BERT D MOORE DO

ATLANTA UROGYNECOLOGY ASSOCIATES

ATLANTA GA

DISCLOSUREDISCLOSURE

Consultant: Coloplast

Stockholder: T-DOC, LLC, HolstOR

Speakers Bureau: Coloplast

Other: Preceptor: Coloplast, Cook Medical, Gyrus ACMI Olympus, SurgiQuest

Consultant: Coloplast

Stockholder: T-DOC, LLC, HolstOR

Speakers Bureau: Coloplast

Other: Preceptor: Coloplast, Cook Medical, Gyrus ACMI Olympus, SurgiQuest

OBJECTIVEOBJECTIVE

• Differentiate between O’Conor & transperitoneal extravesical non – cystotomy

• Apply the steps of a transperitoneal extravesical VVF repair

• Recognize the feasibility of the this approach

• Summarize the current literature regarding this technique

• Differentiate between O’Conor & transperitoneal extravesical non – cystotomy

• Apply the steps of a transperitoneal extravesical VVF repair

• Recognize the feasibility of the this approach

• Summarize the current literature regarding this technique

O’Conor TechniqueO’Conor Technique

• First Described -19501

• Abdominal approach

• Bivalve the bladder

• GOLD STANDARD

• First Described -19501

• Abdominal approach

• Bivalve the bladder

• GOLD STANDARD

TRANSPERITONEAL EXTRAVESICALVVF TECHNIQUE

TRANSPERITONEAL EXTRAVESICALVVF TECHNIQUE

• 1998- Von Theobold2

• Bladder only??????

• 1999- Miklos et al3

• Vagina & bladder

• 1999-Miklos4

• VUF w/o cystotomy

• 2005-Sotelo et al5

• N=15 Cure=93%

• 1998- Von Theobold2

• Bladder only??????

• 1999- Miklos et al3

• Vagina & bladder

• 1999-Miklos4

• VUF w/o cystotomy

• 2005-Sotelo et al5

• N=15 Cure=93%

Materials & MethodsMaterials & Methods

• Retrospective Chart Review

• Primary or Recurrent VVF

• Laparoscopic Repair

• Atlanta Urogynecology Associate Surgeon

• (JRM & RDM)

• Retrospective Chart Review

• Primary or Recurrent VVF

• Laparoscopic Repair

• Atlanta Urogynecology Associate Surgeon

• (JRM & RDM)

7

2

Material & Methods Material & Methods

• Age

• Etiology of VVF

• Number of previous repairs

• Length of Hospital Stay

• EBL

• Intraoperative or Postoperative Complications

• Success or Failure (cystoscopy/urogram/…)

• Age

• Etiology of VVF

• Number of previous repairs

• Length of Hospital Stay

• EBL

• Intraoperative or Postoperative Complications

• Success or Failure (cystoscopy/urogram/…)

Material & MethodsMaterial & Methods

MATERIAL & METHODSMATERIAL & METHODS Material & MethodsMaterial & Methods

• 98% (40/41)– No omental flap

• 100% Suprapubic catheter

• 14 days -Average SP catheter

• 100% Antibiotics ( p.o.) post operatively

• 98% (40/41)– No omental flap

• 100% Suprapubic catheter

• 14 days -Average SP catheter

• 100% Antibiotics ( p.o.) post operatively

RESULTSRESULTS

• Age 46.7 (range 31-73)

• 41 VVF• 95%(39/41) Hysterectomy

• No cancer or radiation patients

• 10 Recurrent VVF (25%)**• 1---- 3 previous failures

• 3-----2 previous failures

• 6-----1 previous failure

** 3 of the recurrent fistulas were after omental flaps

• Age 46.7 (range 31-73)

• 41 VVF• 95%(39/41) Hysterectomy

• No cancer or radiation patients

• 10 Recurrent VVF (25%)**• 1---- 3 previous failures

• 3-----2 previous failures

• 6-----1 previous failure

** 3 of the recurrent fistulas were after omental flaps

RESULTSRESULTS

• Hospital stay -1.2 DAY (1-3) Hospital stay

• EBL--70 mL (5-200mL)

• 98% (40/41) Cure Rate

• 1 failure repaired via open technique

• 100% (10/10) cure – recurrent VVFs

• 100% (3/3) cure - recurrent VVF - omental flap6

• No complications

• No laparotomies

• Hospital stay -1.2 DAY (1-3) Hospital stay

• EBL--70 mL (5-200mL)

• 98% (40/41) Cure Rate

• 1 failure repaired via open technique

• 100% (10/10) cure – recurrent VVFs

• 100% (3/3) cure - recurrent VVF - omental flap6

• No complications

• No laparotomies

8

3

ConclusionConclusion

Transperitoneal Extravesical (Non Cystotomy) VVF repair without omental flaps:

1. Acceptable cure rates

2. Primary or recurrent VVF6

3. Can be performed successfully on failed VVF w/omentalflaps7

4. Require less trauma to the bladder wall

5. Safe & viable technique for the skilled laparoscopist

Transperitoneal Extravesical (Non Cystotomy) VVF repair without omental flaps:

1. Acceptable cure rates

2. Primary or recurrent VVF6

3. Can be performed successfully on failed VVF w/omentalflaps7

4. Require less trauma to the bladder wall

5. Safe & viable technique for the skilled laparoscopist

REFERENCE SLIDEREFERENCE SLIDE

• 1) O’Conor VJ Jr. Review of experience with vesicovaginal fistula repair. J Urol (1980) 123:367-378.

• 2) Von Theobald, P., Hamel, P. and Febbraro,W. Laparoscopic repair of a VVF using an omenatal J flap. BJOG: An International Journal of OB & Gyn (1998) 105: 1216-18.

• 3) Miklos JR, Sobolewski C, Lucente V. Laparoscopic Management of a Recurrent VVF. Int Urogynecol J (1999) 10:116-117.

• 4) Miklos JR. Laparoscopic treatment of vesicouterine fistula. J Am Assoc Gynecol Laparosc (1999) 6(3):339-41.

• 5) Sotelo R, Mariano MB, Garcia-Segul A, et al. Laparoscopic repair of VVF. J Urol. (2005); 173:1615-1618.

• 6) Miklos JR and Moore RD. VVF failing multiple surgical attempts salvaged laparoscopically without an interposition omental flap. JMIG (2012) 19,794-797.

• 7) Miklos JR and MooreRD. Failed Omental flap VVF repair subsequently repaired laparoscopically without an omental flap. Female Pelvic Med Reconstr Surg (2012); 18: 372-373.

• 1) O’Conor VJ Jr. Review of experience with vesicovaginal fistula repair. J Urol (1980) 123:367-378.

• 2) Von Theobald, P., Hamel, P. and Febbraro,W. Laparoscopic repair of a VVF using an omenatal J flap. BJOG: An International Journal of OB & Gyn (1998) 105: 1216-18.

• 3) Miklos JR, Sobolewski C, Lucente V. Laparoscopic Management of a Recurrent VVF. Int Urogynecol J (1999) 10:116-117.

• 4) Miklos JR. Laparoscopic treatment of vesicouterine fistula. J Am Assoc Gynecol Laparosc (1999) 6(3):339-41.

• 5) Sotelo R, Mariano MB, Garcia-Segul A, et al. Laparoscopic repair of VVF. J Urol. (2005); 173:1615-1618.

• 6) Miklos JR and Moore RD. VVF failing multiple surgical attempts salvaged laparoscopically without an interposition omental flap. JMIG (2012) 19,794-797.

• 7) Miklos JR and MooreRD. Failed Omental flap VVF repair subsequently repaired laparoscopically without an omental flap. Female Pelvic Med Reconstr Surg (2012); 18: 372-373.

9

LAPAROSCOPIC REPAIR OF UROGENITAL FISTULAE

SURAN RAMPHAL

Disclosure

I have no financial relationships to disclose.

INTRODUCTIONFistulae

• One of the most difficult clinical conditions encountered by pelvic surgeons.

• Most common cause in developed countries is iatrogenic

‐ anxious patient and referring physician

• Incidence of 0.2‐2.5%

• 90%  occur after hysterectomy

SURGICAL APPROACH

SURGERY IS THE GOLD STANDARD

• Abdominal

• Vaginal

• Combined

Success repair – 75‐97%

ABDOMINAL APPROACH

• Inadequate vaginal exposure and access

• Close proximity to ureters

• Multiple fistula

• Associated gynecological pathology

LAPAROSCOPY

• Minimally invasive

• Shorter hospital stay

• Quicker recovery time

• Minimal scars

• Magnification and more precise surgery

• Better access to pelvic pathology

7 CASES

• 5 cases of laparoscopic repair following TAH

• 2 cases with vesico‐uterine fistula following caeserean section

10

• Ages – 41,47, 55, 41,38

• BMI – 31.2, 32.4, 28,33,34’1

• Average surgical time – 147 min (130‐170)

• 3 way foleys catheter – kept in for 21 days

• Prophylactic antibiotics at surgery

• Nitrofurantoin for duration of catheterization

• Stents removed at 6 weeks in outpatient clinic

• Average hospital stay – 12 days (8 ‐ 21)

• 6 months – one failure . Successfully repaired with an extraperitoneal approach

• No complications

11

UTEROVAGINAL FISTULA

• Ages 30 and 32

• Both had 2 previous c/s

• Incontinence occurred 1 and 2 months after C/S  BUT diagnosis made 12 and 14 months

• Both had dysmenorrhoea

• Regular periods but no cyclical haematuria

• No irritative bladder symptoms

SURGICAL MANAGEMENT

• Cystoscopy with ureteric stents inserted

• Bladder was densely adherent to the uterus

• Uterine curette for manipulation

• Bladder dissected of uterus

• Bladder repaired with vicryl 2.0 (2 layers)

• Uterine incision repaired 

• Surgical time – 130 and 140 minutes

• 6 months – both patients were continent 

• 13 patients• Average age 37.2 years• All had previous abdominal hysterctomies• All the fistulae were supratrigonal• Surgery – 2‐4 weeks after initial surgery• Conversion to laparotomy in one d/t adhesions• Vicryl 2.0 sutures – both vaginal and bladder repair• Omental graft• Discharged on day 5, foleys removed day 15• At 21 months‐ one failure 

2007

12

CONCLUSION

• Laparoscopic VVF repair following hysterectomies and laparoscopic uterovesicalfistula repair following caeserean sections are  feasible and associated with good surgical outcome.

• Careful patient selection

• Specialized units

13

Douglas M. Van Drie, M.D.Director, Female Pelvic Medicine & Urogynecology Institute of Michigan

Grand Rapids, MI

Chairman, Spectrum Health Department of Obstetrics and Gynecology

Clinical Professor, Department of Obstetrics and GynecologyMichigan State University College of Human Medicine

Disclosure Grants/Research Support: Coloplast

Consultant: Coloplast

Speakers Bureau: Astellas

Other: Preceptor: Medtronic

Objectives:

Present 12 month data on the Altis Sling

Review Altis helical inside out single incision adjustable design

Discussion of the 12 month efficacy and safety data

Study Objective and Design

Objective: Evaluate the efficacy and safety of a novel

adjustable Altis® Single Incision Sling (SIS) for the

treatment of stress urinary incontinence (SUI).

Design: Prospective Investigational Device Exemption

study with two years follow‐up.

Study Setting and Enrollment

Setting: 17 sites (16 US and 1 CA)

Patients: 113 women with diagnosed SUI 

Implanted between December 2010 – January 2012

No more than 25% of patients implanted at any site

Interventions: Implant of single incision sling

Altis Single Incision Sling System

• 7.75cm length• Size 1 PP monofilament suture

•Helical inside-out approach•Ergonomic with visual cue•Tip leads into the membrane

•Anchors have semi-flexible tines designed for secure retention in tissue

•Dynamic anchor allows for intraoperative bi-directional tensioning and adjustability

14

Primary and Secondary Endpoints

Primary Endpoint Improvement > 50% measured by the 24-hour pad weight at 6 months

Secondary Endpoints Pad weight improvements over baseline at all other timepoints

Cough stress test in the standing and lithotomy positions

Assessment of subject Quality of Life (QoL)

Patient Global Impression of Improvement (PGI-I)

Assessment of device and procedure related adverse events

Inclusion and Exclusion CriteriaInclusion

Exclusion

Female > 18 years of age Confirmed SUI through CST or urodynamics Has failed 2 non-invasive incontinence therapies for > 6 months Is able and willing to participate

Neurogenic or urge predominant incontinence Active urogenital infection Pelvic organ prolapse stage II or greater Atonic bladder or post-void residual consistently >100 cc Prior surgical incontinence treatment Pregnant or desire to become pregnant Planning to undergo concomitant pelvic floor prolapse procedure

Baseline and Procedural Characteristics

Pre-operative Procedure Location

Pre-op antibiotics 97.3% (110/113) In-patient hospital 59.3% (67/113)

Pre-op estrogen 25.7% (29/113) ASC 23.9% (27/113)

Stress Urinary Incontinence History In-office 16.8% (19/113)

Hypermobility 81.4% (92/113) Anesthesia

Without hypermobility 19.5% (22/113) General 52.2% (59/113)

Mixed incontinence 37.2% (42/113) Spinal 2.7% (3/113)

Overactive bladder 5.3% (6/113) Local 45.1% (51/113)

Age: 54.5±14.0 (range: 25.3, 89.3)

Efficacy EndpointsPost‐hoc Analysis at 12 Months

Endpoint Success Lower 95%CL p-value*

Pad Testing1 90.1% (91/101) 85.2% <0.0001

Cough Stress Test2 90.1% (91/101) 85.2% <0.0001

UDI-6 Score3 89.3% (92/103) 84.3% <0.0001

IIQ-7 Score3 90.3% (93/103) 85.5% <0.0001

PGI-I4 89.3% (92/103) 84.3%1Percent of subjects with ≥ 50% reduction in pad weight2Percent of subjects with negative cough stress test3Percent of subjects with ≥ 50% reduction in UDI and IIQ Score4Percent of subjects with responses of “Very much better” or “Much better”*Observed success rate is greater than the performance goals of 50% for pad weight, UDI, and IIQ and 66% for CST

QOL Outcomes Results: 12 months

Quality of Life Scores at Baseline and 12 Months

Endpoint Mean ±SD Median Range 95% CL

UDI-6 at Baseline 55.6±18.8 55.5 16.7, 99.9 52.0, 59.1

UDI-6 at 12 months 9.9 ± 13.2 5.6 0.0, 66.6 7.3, 12.5

IIQ-7 at Baseline 54.3±25.4 57.0 4.0, 99.0 49.6, 59.0

IIQ-7 at 12 months 8.2±18.1 0.0 0.0, 99.0 4.7, 11.7

Quality of Life Score Reduction from Baseline to 12 Months

Endpoint Mean Reduction ±SD Median Range 95% CL

UDI-6* 45.6±20.3 44.4 -11.1, 94.4 41.6, 49.5

IIQ-7* 47.0±26.5 47.0 -9.0, 99.0 41.8, 52.1

*Statistically significant change from baseline to 12 months; p <0.0001

Baseline and 12 MonthUDI‐6 and IIQ‐7 Scores

55.6 54.3

9.9 8.20102030405060708090

100

Mean UDI-6 (Mean Reduction 45.6 ±20.3)*

Mean IIQ-7 (Mean Reduction 47.0 ±26.5)*

Baseline Month 12

55.6 54.3

9.9 8.20

10

20

30

40

50

60

70

80

90

100

Mean UDI-6 (Mean Reduction 45.6 ± 20.3)* Mean IIQ-7 (Mean Reduction 47.0 ± 26.5)*

Baseline Month 12

* Statistically significant change from baseline to 12 months (p-value <0.0001)

12 Months

15

Adverse Events- 12 month review 11 device-related events were reported in 8 study subjects:

One (0.9%) case of each: Urinary retention UTI Decreased urine stream Dyspareunia Inflammation Worsening OAB Voiding dysfunction

Four (3.5%) mesh extrusions

No unanticipated device effects (UADEs)

3 serious adverse events (SAEs) were reported

Conclusion Twelve month data support that the Altis SIS for the

treatment of SUI is safe and effective.

We will continue to follow these patients through 2 years.

16

DEPARTMENT OF OB/GYN

Interactive Web-based tool for Pelvic Organ Prolapse: Impact on Patient Understanding and

Provider Counseling

Erinn Myers MD

Division of Urogynecology and Reconstructive Pelvic Surgery University of North Carolina at Chapel Hill

Disclosures

• I have no financial relationships to disclose.

Objectives

At the conclusion of this presentation, the participant will be better able to:

•Use available web-based technology to educate patients on their pelvic anatomy

•Provide patients with individualized counseling

•Integrate a consistent tool for counseling without prolonging the time of the visit

Background

• Pelvic organ prolapse is common.1

• Patient understanding of pelvic anatomy is frequently limited.2

• Clear communication of physical exam findings to the patient at the time of evaluation is essential.3-6

• Improve patient understanding with technology 7-8

• Few studies have evaluated the use of interactive educational multimedia to facilitate an interactive counseling session.

Study Objective

• Primary

• To compare standard counseling (SC) with SC + iPad™ for effect on patient satisfaction with understanding of prolapse

• Secondary

• Assess patient anxiety

• Feasibility of use

• Provider satisfaction

17

iPad™ prolapse images

http://www.bostonscientific.com/templatedata/imports/HTML/PFI/PFI_bridge.html

Methods

• Primary outcome: Change between pre-visit and post-visit patient satisfaction with understanding of presenting bulge symptoms

• Responses from the Likert Scale Questionnaires were dichotomized for analysis.

• 90 patients required to achieve a power of 80% with an alpha of 0.05 to detect a 30% difference between the groups.

DemographicsSC

n=44SC + iPad™

n=46p-value

Age (years) 60.7 + 11.5 59.1 + 14.1 .6

Education (years) 14 + 2.5 14 + 2.4 1.0

BMI (kg/m2) 29.5 + 6.8 27.9 + 6.5 .3

POP-Q

Aa .5 (-2, 2) -.5 (-2,1) .2

Ba 1 (-2, 3) -.5 (-2, 2) .2

C -5 (-6, 2) -5 (-6, -1) .2

D -6 (-7, -4) -6 (-7.5, -4) .5

Ap -1 (-2, 0) -1.5 (-2, -.5) .2

Bp -1 (-2, 0) -1.5 (-2, 0) .2

GH 4.5 (3.5, 5) 4 (3, 5) .1

PB 3 (2.5, 3.5) 3 (3, 4) .1

TVL 9 (8, 9.5) 9 (8, 10) .4

Patient Understanding of Bulge Symptoms Before and After Counseling

p=.50

p=.50

p<0.001

Patient Anxiety Regarding Bulge Symptoms Before and After Counseling

p=.40

p=.70

p<0.001

Provider Results

• Total time in counseling (p=.40)• 9.5 minutes – SC

• 8.9 minutes – SC + iPad™

• All Providers (n=9) • iPad™ was easy to use

• Would incorporate it into practice

18

Conclusion

• Patient counseling with or without iPad™• Increased patient satisfaction

• Decreased patient anxiety

• The iPad™ web-based tool• Consistent counseling tool

• Provides each patient with an individualized visual representation of her anatomy

• Easily integrated into counseling session

• Did not increase counseling time

References1. Boyles SH, Webber Am Leyn L. Procedures for pelvic organ prolapse in the United

States, 1979-1997. AJOG 2003; 188(1):108-15.

2. Anger JT, Lee UJ, Mittal BM, et al. Health literacy and disease understanding among aging women with pelvic floor disorders. FPMRS 2012; 18(6):340-3.

3. Heller L, Parker PA, Youssef A, et al. Interactive digital education aid in breast reconstruction. Plast and reconst surg 2008;122(3):717-24.

4. Levinson W, Lesser CS, Epstein RM. Developing physician communication skills for patient-centered care. Health Aff 2010;29(7):1310-8.

5. Stein T, Frankel RM, Krupat E. Enhancing clinician communication skills in a large healthcare organization: a longitudinal case study. Pt ed and counsel 2005;58(1):4-12.

6. Brody DS, Miller SM, Lerman CE, et al.The relationship between patients' satisfaction with their physicians and perceptions about interventions they desired and received. Medical care 1989;27(11):1027-35.

7. Wofford JL, Smith ED, Miller DP. The multimedia computer for office-based patient education: a systematic review. Pt ed and counsel 2005;59(2):148-57.

8. Krishna S, Balas EA, Spencer DC, et al. Clinical trials of interactive computerized patient education: implications for family practice. JFP1997;45(1):25-33.

9. http://www.bostonscientific.com/templatedata/imports/HTML/PFI/PFI_bridge.html

19

The choice of repeat surgeries after failed primary surgeries for 

female stress urinary incontinence :

A population‐based nation‐wide follow‐up descriptive study

Ming‐Ping Wu, MD, PhD

Division of Urogynecology and Pelvic Floor Reconstruction, Department of Obstetrics and Gynecology, Chi Mei Foundation Hospital, Tainan, 

Taiwan

Disclosure

• I have no financial relationships to disclose.

• Abbreviation RPU: retro‐pubic urethropexy operations (ICD‐9 code 59.5) 

Marshall‐Marchetti‐Kranz procedure or Burch colposuspension

Laparotomy (open) or laparoscopy (LSC)

PVS: traditional pubovaginal sling (ICD‐9 code 59.4) 

MUS: mid‐urethral sling operations (ICD‐9 code 59.79) 

Vaginal procedure  Kelly (ICD‐9 code 59.3) : urethra‐vesical junction plication operations

Needle (ICD‐9 code 59.6) : bladder neck needle suspension and para‐urethral suspension operations

Injection (ICD‐9 code 59.72) : operations to inject an implant into the urethra/bladder neck

Objective

• To identify the choices of repeat surgeries after failed primary surgeries for stress urinary incontinence (SUI) among different surgical types.

• Material and methods

– Women who had National Health Insurance (NHI) in Taiwan 

– primary surgery during 2000 to 2006. 

– Identified repeat surgery, follow‐up 4 years

– Variables, 

• primary SUI surgical types, patient age, surgeon age and gender, specialty, hospital accreditation levels and ownership. 

– the choice of either same‐ or different‐repeat surgical types, and same‐ or different‐specialty or surgeon. 

1. The reoperation rates among different primary surgical types for female stress urinary incontinence

Primary Repeat Interval

Surgical 

types

No. (%) Person 

Year

No. (%) Incidence 

rate*

(mons)

RPU 6237 42.68 30826.66 110 1.76 35.68  21.21±14.87

RPU open 5245 (35.89) 25912.62 96 (1.83) 37.05  21.26±14.75

RPU LSC 992 (6.79) 4914.04 14 (1.41) 28.49  20.91±16.25

PVS 2423 16.58 11934.74 51 2.10 42.73  17.84±15.42

MUS 4527 30.98 22170.25 138 3.05 62.25  19.87±14.27

Vaginal 1238 8.47 6082.91 31 2.50 50.96  18.82±15.32

Kelly 617 (4.22) 3027.84 15 (2.43) 49.54  14.48±12.25

Needle 621 (4.25) 3055.07 16 (2.58) 52.37  22.88±17.11

Injection 188 1.29 692.41 64 34.04 924.31  13.78±11.04

Total 14613 (100) 91648.74 394 (2.70) 42.99  18.91±14.36

*per 10,000 person year

Result I

• Reoperation rate: 2.70% (394/ 14613), with an incidence rate of 42.99 per 10,000 person year (PY).

– Injection procedures had highest reoperation rate, as compared with RPU, PVS, MUS, vaginal procedure, (p‐value all <0.0001). 

– The reoperation rate was higher in MUS > RPU and PVS.

• The intervals between primary and repeat surgery 

– Shortest in injection , followed by PVS, vaginal procedure, MUS, and RPU.

2‐1. The comparison of variables for the primary with repeat surgeries for stress urinary incontinence

Primary RepeatAdjusted HR (95%CI)

No. % No. %

Primary RPU open 5245 35.89 96 1.83 0.91(0.64‐1.28) Reference

surgical  RPU LSC 992 6.79 14 1.41 0.79(0.44‐1.45) 0.88(0.50‐1.54)

PVS 2423 16.58 51 2.10 Reference 1.10(0.78‐1.55)

MUS 4527 30.98 138 3.05 1.59*(1.15‐2.20) 1.75*(1.34‐2.29)

Vaginal  1238 8.47 31 2.50 1.33(0.85‐2.09) 1.47(0.97‐2.21)

Injection 188 1.29 64 34.04 13.56*(8.80‐20.91) 14.96*(10.04‐22.27)

Patient  <40 1307 8.94 49 3.75 Reference

age 40‐59 8751 59.89 204 2.33 0.86(0.62‐1.20)

≥60 4555 31.17 141 3.10 0.92(0.66‐1.28)

Surgeon  <40 3827 26.19 100 2.61 1.28(0.99‐1.65)

age 40‐49 7047 48.22 160 2.27 Reference

≥50 3739 25.59 134 3.58 1.23(0.97‐1.57)

Surgeon Female 745 5.10 13 1.74 Reference

gender Male 13868 94.90 381 2.75 1.24(0.71‐2.16)

20

2‐2. The comparison of variables for the primary with repeat surgeries for stress urinary incontinence

Primary Repeat Adjusted

(95%CI)No. % No. %

Specialty Gyn 11841 81.03 240 2.03 Reference

Urol 2711 18.55 150 5.53 1.80*(1.40‐2.31)

Others 61 0.42 4 6.56 0.91(0.32‐2.54)

Accreditation Center 9625 65.87 268 2.78 Reference

level Regional 4019 27.50 107 2.66 1.17(0.92‐1.49)

Local 969 6.63 19 1.96 0.84(0.51‐1.39)

Ownership Government 3183 21.78 87 2.73 Reference

Non‐for‐

profit

7707 52.74 222 2.88 0.94(0.73‐1.21)

Private 3723 25.48 85 2.28 0.93(0.68‐1.29)

Total 14613 100 394 2.87

Result II

• The adjusted hazard ratio (HR) of reoperation was highest in injection

– (HR 23.16) compared with RPU, or (HR 13.56) with PVS.

• MUS also had higher HR, 

– (HR 1.68) as compared with RPU, or (HR 1.59) with PVS.

• Other variables, patient age, surgeon age and gender, hospital accreditation levels and ownership were not significant.

• Urologists had higher reoperation rate, as compared with gynecologists (HR 1.80). 

3. The choice of repeat surgery after failed primary surgery for stress urinary incontinence

Repeat 

Primary RPU open RPU LSC PVS MUS vaginal injection Total

RPU open 38(39.58) 1(1.04) 12(12.50) 43(44.79) 2(2.08) 0(0.00) 96

RPU LSC 4(28.57) 1(7.14) 2(14.29) 7(50.00) 0(0.00) 0(0.00) 14

PVS 14(27.45) 1(1.96) 17(33.33) 16(31.37) 1(1.96) 2(3.92) 51

MUS 20(14.49) 0(0.00) 11(7.97) 91(65.94) 2(1.45) 14(10.14) 138

vaginal  9(29.03) 0(0.00) 5(16.13) 11(35.48) 5(16.13) 1(3.23) 31

injection 0(0.00) 0(0.00) 1(1.56) 1(1.56) 0(0.00) 62(96.88) 64

Total 85(21.57) 3(0.76) 48(12.18) 169(42.89) 10(2.54) 79(20.05) 394

4. The choice of either same‐type or different‐type repeat surgery after failed primary surgery 

Same‐type     Different type p‐value

No. (%) No. (%)

RPU  110 39 (35.45) 71 (64.55)

RPU open 96 38 (39.58) 58 (60.42)

RPU LSC 14 1 (7.14) 13 (92.86)

Sling  51 17 (33.33) 34 (66.67)

MUS  138 91 (65.94) 47 (34.06)

vaginal 31 5 (16.13) 26 (83.87)

injection 64 62 (96.88) 2 (3.13)

All 394 214 (54.31) 180 (45.69) <0.0001

5 The choice of either same‐or‐different‐specialty, same‐or‐different‐surgeon 

Same‐specialty Different‐specialty p‐value

No. (%) No. (%)

Gynecology 240 204 (85.00) 36 (15.00)

Urology 150 120 (80.00) 30 (20.00)

Others 4 2 (50.00) 2 (50.00)

All 394 326 (82.74) 68 (17.26) 0.0768*

Same‐surgeon Different‐surgeon

Gynecology 240 122 (53.51) 118 (49.17)

Urology 150 105 (70.00) 45 (30.00)

Others 4 1 (25.00) 3 (75.00)

All 394 228 (57.87) 166 (42.13) 0.0001*

The distributions of SUI surgeries among different specialties, 2000‐ 2006

Gynecologist Urologist Others

Vainal 9.27% 4.91% 11.48%

Injection 0.02% 6.34% 22.95%

MUS 31.84% 27.48% 19.67%

PVS 15.07% 23.28% 13.11%

RPU 43.81% 37.99% 32.79%

0.00%

10.00%

20.00%

30.00%

40.00%

50.00%

60.00%

70.00%

80.00%

90.00%

100.00%

21

Discussion

• Failed primary surgeries for SUI remain a concern 

– 2.7% and 42.99/ 10,000 person year. 

• reoperation is the ‘‘tip of the iceberg’’ of surgical failure

– The reported reoperation rates surely underestimated the failure rates 

– taken into consideration of the choice of more conservative modalities 

• MUS was the most commonly used as repeat SUI surgeries 42.89%.  

Discussion• Our study reported the variables related to failed primary 

surgeries. – The reoperation rates were differed among the surgical types 

(Injection, MUS> RPU, PVS), and specialties (urology> gynecology). 

– Surgical volume (gyn> urol), – Selected‐surgical types (gyn more RPU, MUS, vaginal) vs (urol

more PVS, injection)• For the repeat surgery 

– Tendency to choose the same‐specialty in gynecology and urology; 

– Tendency to choose same‐surgeon in urology, but not in gynecology.

References• Wu, M. P., K. H. Huang, C. Y. Long, K. F. Huang, K. J. Yu and C. H.

Tang (2008). "The distribution of different surgical types for female stress urinary incontinence among patients' age, surgeons' specialties and hospital accreditations in Taiwan: a descriptive 10-year nationwide study." Int Urogynecol J Pelvic Floor Dysfunct 19(12): 1639-1646.

• Liapis, A., P. Bakas and G. Creatsas (2009). “Tension-free vaginal tape in the management of recurrent urodynamic stress incontinence after previous failed midurethral tape.” Eur Urol 55(6): 1450-1455.

• Novara, G., W. Artibani, M. D. Barber, C. R. Chapple, E. Costantini, V. Ficarra, P. Hilton, C. G. Nilsson and D. Waltregny (2010). "Updated systematic review and meta-analysis of the comparative data on colposuspensions, pubovaginal slings, and midurethral tapes in the surgical treatment of female stress urinary incontinence." Eur Urol58(2): 218-238.

• Albo, M. E., H. E. Richter, L. Brubaker, et al.. Urinary Incontinence Treatment (2007). "Burch colposuspension versus fascial sling to reduce urinary stress incontinence." N Engl J Med 356(21): 2143-2155.

22

CULTURAL AND LINGUISTIC COMPETENCY Governor Arnold Schwarzenegger signed into law AB 1195 (eff. 7/1/06) requiring local CME providers, such as

the AAGL, to assist in enhancing the cultural and linguistic competency of California’s physicians

(researchers and doctors without patient contact are exempt). This mandate follows the federal Civil Rights Act of 1964, Executive Order 13166 (2000) and the Dymally-Alatorre Bilingual Services Act (1973), all of which

recognize, as confirmed by the US Census Bureau, that substantial numbers of patients possess limited English proficiency (LEP).

California Business & Professions Code §2190.1(c)(3) requires a review and explanation of the laws

identified above so as to fulfill AAGL’s obligations pursuant to California law. Additional guidance is provided by the Institute for Medical Quality at http://www.imq.org

Title VI of the Civil Rights Act of 1964 prohibits recipients of federal financial assistance from

discriminating against or otherwise excluding individuals on the basis of race, color, or national origin in any of their activities. In 1974, the US Supreme Court recognized LEP individuals as potential victims of national

origin discrimination. In all situations, federal agencies are required to assess the number or proportion of LEP individuals in the eligible service population, the frequency with which they come into contact with the

program, the importance of the services, and the resources available to the recipient, including the mix of oral

and written language services. Additional details may be found in the Department of Justice Policy Guidance Document: Enforcement of Title VI of the Civil Rights Act of 1964 http://www.usdoj.gov/crt/cor/pubs.htm.

Executive Order 13166,”Improving Access to Services for Persons with Limited English

Proficiency”, signed by the President on August 11, 2000 http://www.usdoj.gov/crt/cor/13166.htm was the genesis of the Guidance Document mentioned above. The Executive Order requires all federal agencies,

including those which provide federal financial assistance, to examine the services they provide, identify any

need for services to LEP individuals, and develop and implement a system to provide those services so LEP persons can have meaningful access.

Dymally-Alatorre Bilingual Services Act (California Government Code §7290 et seq.) requires every

California state agency which either provides information to, or has contact with, the public to provide bilingual

interpreters as well as translated materials explaining those services whenever the local agency serves LEP members of a group whose numbers exceed 5% of the general population.

~

If you add staff to assist with LEP patients, confirm their translation skills, not just their language skills.

A 2007 Northern California study from Sutter Health confirmed that being bilingual does not guarantee competence as a medical interpreter. http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=2078538.

US Population

Language Spoken at Home

English

Spanish

AsianOther

Indo-Euro

California

Language Spoken at Home

Spanish

English

OtherAsian

Indo-Euro

19.7% of the US Population speaks a language other than English at home In California, this number is 42.5%

23