The Ins and Outs of Pelvic         Organ Prolapse                     Dr. Kristina Cvach                   Urogynecology F...
POP• Prolapse likened to a hernia of pelvic  contents through genital hiatus• Significant QOL issues       – Physical disco...
Anatomy• Bony pelvis• Pelvic diaphragm• Endopelvic fascia                              5      Anatomy - Bony pelvis       ...
Anatomy• Pelvic diaphragm  – Levator Ani :    puborectalis,    pubococcygeus,                      x    ileococcygeus     ...
9Etiology of prolapse                       10
Etiology of POP• Normal form maintained by action of pelvic  diaphragm and endopelvic fascia• Pelvic diaphragm  – Resting ...
Page 27 of 30                                    International Urogynecology Journal                                1     ...
Etiology of POP - Parity                                                   15          Management of POP• Prolapse present...
Management of Prolapse                    ConservativeObservation                                              PessaryAsym...
Management of POP             Surgery• Choice of procedure  – Patient characteristics: age, suitability for    surgery, pr...
Reconstructive Surgery                                Apex        Abdominal                                    VaginalSacr...
Reconstructive Surgery                        Apex        Abdominal                           VaginalSacrocolpopexy       ...
Reconstructive Surgery            Apical compartment                                                                      ...
Reconstruve Surgery            Apical compartment                       x                                                 ...
Reconstructive Surgery         Apical compartment                                                    29        Reconstruct...
Reconstructive Surgery                                                    31         Reconstructive Surgery      Anterior ...
Procedure               Level I      Level II   Level IIISacrocolpopexy                             +Sacrospinousfixation  ...
Grafts in Pelvic Surgery   • Introduced in an effort to address the high     reoperation rate of prolapse surgery   • Graf...
Grafts in Pelvic Surgery  • “Ideal” Graft           •   High efficacy           •   Low cost           •   Low complication...
Grafts in Pelvic Surgery-                  Biologic• Allograft - cadaveric fascia lata, dura, dermis• Xenograft - porcine ...
Synthetic Non-absorbable              Mesh• Synthetic mesh classified according to:   – pore size: macro (>75 microns) vs m...
Synthetic Non-absorbable       Mesh Classification    Type I             Type II             Type III    Large pores       ...
Evidence for grafts in pelvic           surgery• Sacrocolpopexy  – “Gold standard” for apical prolapse repair  – 8 RCT’s  ...
Evidence for grafts in pelvic            surgery• Anterior wall repair  – 10 RCT’s, 1148 women  – Mesh/graft (any type) be...
Evidence for grafts in pelvic             surgery- PosteriorAuthor            N                F/U   OutcomeSand 01       ...
Mesh kits• Introduced 2001• Gynecare (Johnson & Johnson):  – Prolift• American Medical Systems:  – Perigee  – Apogee• Bard...
Mesh KitsPerigee                 Apogee              Prolift Avaulta Anterior and Posterior                               ...
Mesh Kits            55Mesh Kits            56
Mesh Kits - Literature                 Level III EvidenceAuthor          Device                 N      F/U              An...
Mesh Complications - Erosion• Transvaginal mesh  – Paucity of quality    data  – Mesh erosion greater    with synthetic no...
FDA - Center for Devices and      Radiological Health• Obtain specialized training for each mesh placement  technique, and...
SGS Guidelines for Use of        Vaginal Graft• Anterior compartment  – Non-absorbable synthetic mesh may    improve anato...
SGS Guidelines for Use of        Vaginal Graft• Multiple compartment  – There are no comparative studies to guide    any r...
Pre-operative Patient  Counseling when using Graft• Unknown durability• Risk of erosion• Lack of long-term data on adverse...
Summary• Use of graft  – Sacrocolpopexy  – Recurrent prolapse  – High risk for recurrence• Full disclosure of risks to pat...
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Mar 4-09

  1. 1. The Ins and Outs of Pelvic Organ Prolapse Dr. Kristina Cvach Urogynecology Fellow University of British Columbia 1 Presentation Overview• Epidemiology of prolapse• Female pelvic anatomy• Etiology of prolapse• Management of prolapse• Grafts in pelvic surgery 2
  2. 2. POP• Prolapse likened to a hernia of pelvic contents through genital hiatus• Significant QOL issues – Physical discomfort – Effect on urinary, bowel and sexual function – Body image 3 Surgery for Urinary Incontinence or Pelvic Organ Prolapse 12 11.1% 29% reoperation 10 Incidence (%) 7.5% 8 6 4.7% 4 2.8% 2 0.9% 0.1% 0 20-39 30-39 40-49 50-59 60-69 70-79 Age Group Olsen et al. Obstet Gynecol 1997:89(4):501-506 4
  3. 3. Anatomy• Bony pelvis• Pelvic diaphragm• Endopelvic fascia 5 Anatomy - Bony pelvis x x 6
  4. 4. Anatomy• Pelvic diaphragm – Levator Ani : puborectalis, pubococcygeus, x ileococcygeus x – Coccygeus muscle x x 7 Anatomy• Endopelvic fascia – Continuous sheet of connective tissue – Fibromuscular layer – Supports pelvic viscera and pelvic muscles – Ligaments are condensations of CT 8
  5. 5. 9Etiology of prolapse 10
  6. 6. Etiology of POP• Normal form maintained by action of pelvic diaphragm and endopelvic fascia• Pelvic diaphragm – Resting tone – Active contraction during raised intra-abdominal pressure• Endopelvic fascia – Provides support to viscera during relaxation of pelvic diaphragm 11 Etiology of POP• Disruption of fascia and/or pelvic diaphragm results in POP – Stretching/tearing of fascia – Neuropathic injury - pudendal nerve – Disruption of muscle attachment 12
  7. 7. Page 27 of 30 International Urogynecology Journal 1 !! 2 3 ! 4 ! 5 !! 6 7 ! 8 9 10 11 12 13 14 15 16 17 18 Fo 19 20 21 22 r 23 13 24 13 Pe 25 !"#$%&()*&+,&%&,-./$0&1234+,5.0.#%467"8$/5%49.$+,1:3.;4 26 "+>$%<.;57&6$?.%&854/"90$98/&@499&&+.+5%4+9/4?"4/-./$0&$/5%49 27 ! 97.C948.%.+4/%&;&%&+8&"04#&1:@5.6/&;534+,&"#758.+9&8$5"-&4 28 009/"8&"+5&%-4/@;%.0F00?&/.C57&6/4+&.;0"+"04/7"454/,"0&+ 57"96/4+&AB7&4-$/9".+"+>$%<"997.C+494+495&%"9E1I3"+57&% er"67$6/5&",0%&,+&%&+815$7&14-0",&+1,3&58"/.511% 29 5.0.#%467"89/"8&91:3A!.%4,&54"/&,,&98%"65".+.;57&0&57.,./.#<.#"--05-%0,6504"058"&;<-2&"70#&1,-2&%"#2-0%&,+&%&+ 30 %&;&%&+8&1J3A 3"@&56/1,-0",&+",-2&A%&#"1,1.",-&%&6-A<"9&9<-2&0%&0 31er GKGDFK001JKKDJKKLMN3 0#&9!1%0+&-0"5&++&6/%"3-"1,1.-2&7&-21+151#B6&& 32 ! Etiology of POP Re &%&,/&6C0,+D9 33 !G77=DFF@DFFHI*? 34 35 Re 36 • Risk factors 37 38 – Age : effect on connective tissue and muscle 39 vi function 40 ew vi 41 – Vaginal parity : tearing/detachment of CT and 42 levator ani, neuropathy 43 ew 44 – Menopause : role of estrogen unclear 45 – Previous pelvic surgery : hysterectomy 46 47 – Race 48 – Chronic increased intra-abdominal pressure : 49 COPD, constipation, obesity 50 51 – Lifestyle : high-impact activities 52 53 14 54 55
  8. 8. Etiology of POP - Parity 15 Management of POP• Prolapse presents with wide range of clinical findings• Management guided by patient symptoms Jelovsek 2007 16
  9. 9. Management of Prolapse ConservativeObservation PessaryAsymptomaticProgression 11%Regression 2% (1) (1)Bradley CS et al. Obstet Gynecol. 2007 Apr;109(4):848-54. 17 Pessary PESSRI Study Cundiff et al. Am J Obstet Gynecol 2007;196(4):405.e1-8 18
  10. 10. Management of POP Surgery• Choice of procedure – Patient characteristics: age, suitability for surgery, primary or recurrent prolapse, site of prolapse, risk for recurrence – Surgeon experience and preference 19 Management of Prolapse Surgery Obliterative Reconstructive •Colpocleisis •Apex •Anterior •Posterior Compensatory •Use of graft 20
  11. 11. Reconstructive Surgery Apex Abdominal VaginalSacrocolpopexyOpen(1) 78-100% (apex) 58-100% (any)!Laparoscopic(2) 94% (1) Nygaard et al. Obstet Gynecol 2004;103:805-23 (2)Ganatra AM, et al., Eur Urol 2009. Epub Feb 4 21 Reconstructive Surgery Apical compartment 22
  12. 12. Reconstructive Surgery Apex Abdominal VaginalSacrocolpopexy Sacrospinous ligament suspensionOpen ! 63-97%! 78-100%(apex)! 58-100%(any)!Laparoscopic! 93-98% Nichols et al. J Pelvis Surg 1996;2:87-94 Lantzsch et al. Arch Gynecol Obstet 2001;265:21-25 Benson et al. Am J Obstet Gynecol 1996;175:1418-1422 Paraiso et al. Am J Obstet Gynecol 1996;175:1423-1430 23 Reconstructive Surgery Apical compartment X 24
  13. 13. Reconstructive Surgery Apical compartment 25 Reconstructive Surgery Apex Abdominal VaginalSacrocolpopexy Sacrospinous ligament suspensionOpen ! 63-97%! 78-100%(apex)! 58-100%(any)! Ileococcygeal fixationLaparoscopic ! 53%! 93-98% Maher et al.Obstet Gynecol 2001;98:40-44 26
  14. 14. Reconstruve Surgery Apical compartment x 27 Reconstructive Surgery Apex Abdominal VaginalSacrocolpopexy Sacrospinous ligament suspensionOpen ! 63-97%! 78-100%(apex)! 58-100%(any)! Ileococcygeal fixationLaparoscopic ! 53%! 93-98% Uterosacral ligament suspension ! ! 82-96% Yazdany et al. Curr Opin Obstet Gynecol 2008, 20:484-488 28
  15. 15. Reconstructive Surgery Apical compartment 29 Reconstructive Surgery Anterior PosteriorTraditional colporraphy Traditional colporraphy! 37-57% ! 76-96% 30
  16. 16. Reconstructive Surgery 31 Reconstructive Surgery Anterior PosteriorTraditional colporraphy Traditional colporraphy 37-57% ! 76-96%Site-specific repair Site-specific repair 75-97% ! 56-100% 32
  17. 17. Procedure Level I Level II Level IIISacrocolpopexy +Sacrospinousfixation +USL fixation +Iliococcygeal fixation +Colporraphy +Site specific repair + 33 Grafts 34
  18. 18. Grafts in Pelvic Surgery • Introduced in an effort to address the high reoperation rate of prolapse surgery • Graft provides reinforcement of fascial repair by acting as a scaffold for tissue ingrowth 35 Grafts in Pelvic Surgery• Graft cut to size & shape required• Placed or sutured• May be combined with apical support procedure 36
  19. 19. Grafts in Pelvic Surgery • “Ideal” Graft • High efficacy • Low cost • Low complication rate • Doesn’t exist! • Biologic ! vs ! Synthetic grafts ! Autologous! ! Absorbable ! Allograft! ! Non-absorbable ! Xenograft 37 Grafts in Pelvic Surgery- Biologic• Autologous - fascia lata, rectus sheath – Pros: • No risk of communicable disease • No erosion • Incorporated without disintegration – Cons: • Separate incision, increased operating time • Inconsistent quantity and quality • Pain at donor site • Herniation at donor site 38
  20. 20. Grafts in Pelvic Surgery- Biologic• Allograft - cadaveric fascia lata, dura, dermis• Xenograft - porcine dermis/small intestine, bovine pericardium• Pros: – Low erosion risk• Cons: – Potential for prion/viral infection; rejection – Expensive ($200 - $1200) – Availability(cadaveric) – Limited durability: processing may weaken material 39 Grafts in Pelvic Surgery- Synthetic• Absorbable (Vicryl, Dexon) vs• Non-absorbable (Prolene, Gore-tex, Teflon) vs• Combined (Vypro)• Pros: – Cost-effective cf. allo- & xenograft – Consistent material and availability – No disease transmission• Cons: – Infection – Erosion: vagina, urethra/bladder, bowel 40
  21. 21. Synthetic Non-absorbable Mesh• Synthetic mesh classified according to: – pore size: macro (>75 microns) vs microporous (<10 microns) – weave: mono vs multifilament• Pore size important in determining host inflammatory response and tissue incorporation 41 Synthetic Non-absorbable Mesh Classification• Type I - macroporous, monofilament – Prolene, Marlex• Type II - microporous(<10 microns), mono & multifilament – Gore-tex• Type III - macroporous, multifilament – Mersilene, OBtape, IVS tunneler• Type IV - submicronic pores, not used in pelvic surgery 42
  22. 22. Synthetic Non-absorbable Mesh Classification Type I Type II Type III Large pores Small pores Large pores Monofilament Multifilament Multifilament 43 Evidence for grafts in pelvic surgery• “Evidence” difficult to determine – Varying quality of study design • Majority are retrospective • Definition of outcomes varies - objective, subjective • Follow-up periods vary – Different materials used – Different techniques • Graft shape • Placement 44
  23. 23. Evidence for grafts in pelvic surgery• Sacrocolpopexy – “Gold standard” for apical prolapse repair – 8 RCT’s – Prolene most studied graft Maher C 2007. Surgical Management of Pelvic Organ Prolapse in Women (Review). Cochrane Collaboration 45 Evidence for grafts in pelvic surgery• Vaginal prolapse repair• Systematic review & meta-analysis – 49 studies - RCT (6 full, 11 abstracts), 7 non-randomised comparative studies, 1 prospective registry, 24 case series (>50 women) – Comparator either no mesh or different mesh • 50% used non-absorbable synthetic mesh Jia et al. BJOG 2008;115:1350-61 46
  24. 24. Evidence for grafts in pelvic surgery• Anterior wall repair – 10 RCT’s, 1148 women – Mesh/graft (any type) better than no mesh • RR 0.48 (95% CI 0.32-0.72) • Improved results with non-absorbable synthetic mesh (RR 0.24 CI 0.13-0.43) cf biological graft (RR 0.55 CI 0.37-0.81) and absorbable synthetic (RR 0.74 CI 0.46-1.18) 47 Evidence for grafts in pelvic surgery• Posterior vaginal repair – Role for mesh less clear as native tissue repair yields 76-90% success rates – 9 studies (3 RCT’s), 417 women – Trend in crude rates for better outcomes with non-absorbable mesh cf absorbable mesh/biologic graft and no mesh - too few data for statistical analysis 48
  25. 25. Evidence for grafts in pelvic surgery- PosteriorAuthor N F/U OutcomeSand 01 PC 70 12m 90% Vicryl 73 92%Paraiso 06 PC 37 17m 86% SSR 37 78% Porcine SIS 32 54%Lim 06 SSR 31 12m No significant difference in(AUGS abstract) Vypro2 25 anatomical outcomes Vicryl 9 49 Mesh kits • FDA - does not require pre-market approval for medical devices • Pre-market notification of proposed device only requires demonstration of “substantial equivalence” to another legally US marketed device 50
  26. 26. Mesh kits• Introduced 2001• Gynecare (Johnson & Johnson): – Prolift• American Medical Systems: – Perigee – Apogee• Bard – Avaulta 51 Mesh Kits - Anatomy x x x 52
  27. 27. Mesh KitsPerigee Apogee Prolift Avaulta Anterior and Posterior 53 Mesh Kits 54
  28. 28. Mesh Kits 55Mesh Kits 56
  29. 29. Mesh Kits - Literature Level III EvidenceAuthor Device N F/U Anatomical Mesh cure erosionCosson 05 Prolift 687 3m 94% 6.7%Garunder- Perigee 120 12m 93% 11%Burmester 07 ApogeeAltman 07 Prolift 123 2m Anterior 87% - Posterior 91% Combined 88%Abdel-Fatah Prolift (76%) 289 3m 94-100% 10%08 Perigee/Apogee (24%)Van Raalte 08 Prolift 97 19m Overall 86% 0% Apex 96%Balakrishnan Apogee 35 6m 97% 25%08Elmer 09 Prolift 232 12m Anterior 79% 11% Posterior 82% 57 Mesh Complications - Erosion• Sacrocolpopexy – Median erosion rates 3.4% (Prolene 0.5%, Teflon 5.5%) (1) – Risk factors for erosion(2) • Current smoking OR 5.2 • Concurrent hysterectomy OR 4.9 • Gore-tex mesh OR 4.2 (1) Nygaard et al. Obstet Gynecol 2004;103:805-23 (2) Cundiff et al. AmJOG 2008;199:688.e1-e5 58
  30. 30. Mesh Complications - Erosion• Transvaginal mesh – Paucity of quality data – Mesh erosion greater with synthetic non- absorbable mesh (10%) cf biological graft (6%) and synthetic absorbable mesh (0.7%) Jia et al. BJOG 2008;115:1350-61 59 FDA - Center for Devices and Radiological Health• FDA Public Health Notification: Serious Complications Associated with Transvaginal Placement of Surgical Mesh in Repair of Pelvic Organ Prolapse and Stress Urinary Incontinence• Issued: October 20, 2008 60
  31. 31. FDA - Center for Devices and Radiological Health• Obtain specialized training for each mesh placement technique, and be aware of its risks.• Be vigilant for potential adverse events from the mesh, especially erosion and infection.• Watch for complications associated with the tools used in transvaginal placement, especially bowel, bladder and blood vessel perforations. 61 FDA - Center for Devices and Radiological Health• Inform patients that implantation of surgical mesh is permanent, and that some complications associated with the implanted mesh may require additional surgery that may or may not correct the complication.• Inform patients about the potential for serious complications and their effect on quality of life, including pain during sexual intercourse, scarring, and narrowing of the vaginal wall (in POP repair).• Provide patients with a written copy of the patient labeling from the surgical mesh manufacturer, if available. 62
  32. 32. SGS Guidelines for Use of Vaginal Graft• Anterior compartment – Non-absorbable synthetic mesh may improve anatomical outcomes of anterior vaginal wall repair, but there are significant trade-offs in regard to the risk of adverse events Murphy M. Obstet Gynecol 2008;112(5):1123-1130 63 SGS Guidelines for Use of Vaginal Graft• Posterior compartment – It is suggested that native tissue repair remains appropriate in posterior vaginal wall repair when compared with biologic and absorbable synthetic graft – There are no comparative studies to guide any recommendation for the use of non-absorbable synthetic mesh in posterior vaginal wall repair when compared with native tissue repair 64
  33. 33. SGS Guidelines for Use of Vaginal Graft• Multiple compartment – There are no comparative studies to guide any recommendation for the use of biologic, absorbable synthetic or non-absorbable synthetic mesh in multiple compartment repair when compared with native tissue repair 65 SGS Guidelines for Use of Vaginal Graft• Need adequately powered randomized comparative studies – Outcomes assessments using validated, standardized tools – Subjective (function) AND objective cure (form) – Follow-up at least 1 year, ideally 5+ years – Complications 66
  34. 34. Pre-operative Patient Counseling when using Graft• Unknown durability• Risk of erosion• Lack of long-term data on adverse events – Chronic pain – Dyspareunia – Fistula – Infection – Delayed erosion/exposure 67 Summary• Pelvic organ prolapse is a complex problem• Lack of high quality evidence to guide surgical management• Use of graft in pelvic surgery is under evaluation, currently no strong evidence to guide it’s use 68
  35. 35. Summary• Use of graft – Sacrocolpopexy – Recurrent prolapse – High risk for recurrence• Full disclosure of risks to patient 69 THANKYOU 70

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