Current status in pelvic organ prolapse surgery: an evidence based review Christian Falconer, MD, PhD Department of Obstetrics and Gynecology Danderyd University Hospital Stockholm, Sweden Finnish Society of Gynaecological Surgery Helsinki 080926
Surgery for prolapse and incontinence Incidence rate per 1000 females Total 4.25 / 1000 7 6 5 4 3 2 1 0 30 40 50 60 70 80+ Kleeman SD et al, AUGS 23rd Annual Scientific Meeting, San Francisco Oct 17-19, 2002
Anterior compartment Colporraphy Paravaginal repair Mesh Middle compartment Sacral colpopexy Colposuspension Mesh Posterior compartment Coporraphy Site specific Midline fascial plication Transanal Mesh Review content
Evidence based methodology Definition: Use of the best available evidence for medical decisions in the care of individual patients Or simply: The scientific basis for clinical praxis
Levels of evidence Evidence Level I: Meta-analysis or RCT s of high quality Evidence Level II: Low quality RCT s or prospective cohort studies Evidence Level III: Cross-sectional and retrospective studies or high quality case series Evidence Level IV: Expert opinion och case reports
Grades of recommendation The Delphi process- recommendations for clinical practise Grade A: consistent level 1 evidence Grade B: consistent level 2 evidence Grade C: level 4 studies or expert opinions Grade D: no recommendation possible
Quality assessment: Jadad Scale for quality of RCTs Jadad AR, et al. Assessing the quality of reports on randomized clinical trials: Is blinding necessary? Controlled Clin Trials 1996;17:1-12. URL: http://www.bmjpg.com/rct/chapter4.html
Summary of studies in pelvic reconstructive surgery Current evidence based practise in pelvic reconstructive surgery is based on: 111 studies 10 RCT s A total of 6 026 patients
Anterior compartment
Anterior colporraphy 7 studies 3 retrospective case series, 1 prospective cohort study 4 RCT s Longest FU 20 y (Macer, AJOG 1978) Number of patients 787 110 patients/ study
Anterior paravaginal repair 6 studies (vaginal), 5 studies (abdominal) 6 prospective and 5 retrospective No RCT s Longest FU 3y (Richardson, 1981) Number of patients 800 73 patients/ study
Summary anterior repair- RCT s and controlled studies Evidence level Comparison Main outcome Colombo BJOG 2000 I AC vs. Colposusp AC anatomically superior Sand AJOG 2001 I AC vs. AC+Vicryl AC+mesh anatomically superior Weber AJOG 2001 I AC vs. AC+Vicryl No significant difference Bruce Urology 1999 II Ant paravaginal repair vs. Ant paravaginal repair + sling APVR+sling anatomically superior
Anterior compartment-mesh 33 different studies 5 RCT 16 prospectiva 1451 patients Mean FU 1.7 y 26 techniques using 15 different materials 2 RCT for permanent biomaterials 1 controlled nonrandomised 14 retrospective 39 patients/ study
Anterior compartment RCT s Colporraphy vs colporraphy&implant Subjects Anatomical cure FU Sand et al. Am J Obstet Gynecol 2001 n= 161 93% in Vicryl group 71% in non- Vicryl group(p< 0.05) 1 y Weber et al. Am J Obstet Gynecol 2001 Hiltunen et al. Obstet Gynecol 2007 Meschia et al. J Urol 2007 n= 109 42% in Vicryl group 30% in non-vicryl group (NS) n=202 89% in polypropylene mesh group 63% in non-mesh group (p<0.001) n= 201 95% in Pelvicol group 79% in non-implant group (p<0.001) 23 m 1 y 1 y Nguyen,Burchette Obstet Gynecol 2008 n= 75 87% in mesh group 55% in non-mesh p< 0.05 1 y
Conclusion anterior compartment Generally grade B-D recommendations Level I evidence that polyglactin may improve short-term anatomical outcomes Level I evidence that colporraphy is anatomically superior to colposuspension Level I evidence that colporraphy+polypropylene mesh is superior to colporraphy alone Current evidence does not support the routine use of biological or synthetical mesh
Anterior Compartment Follow-up Failure (variably defined) Midline fascial plication 1 20 yrs 3-58 % Site-specific fascial repair 6 mths 2 yrs 10-32 % Vaginal-paravaginal repair 6 mths 6 yrs 30-67 % Abdominal paravaginal repair 6 mths 6 yrs 20 % Concomitant sling support 17 mths 4 yrs 2-57 %
Middle compartment
Middle compartment Colposacropexy 62 studies 4 RCT s FU 13.7 y (Hilger. Br J Obstet Gynecol 2003) Number of patients 3881 62 patients/ study
Middle compartment Sacrospinous fixation 15 studies 3 RCT s Longest FU 5.3 y Number of patients: 1854 123 patients/ study H Koelbl. ICI Rome 2005.
Middle compartment RCT s Benson et al. 1996 Am J Obstet Gynecol Lo et al 1998 J Gynecol Surg No. of subjects Anatomical cure n=101 84% Sacrocolpopexy 67% Sacrospinous fixation P<0.05 n=138 94% Sacrocolpopexy 80% Sacrospinous fixation (p<0.05) 2.1 y 2.5 y FU Maher et al. 2004 Am J Obstet Gynecol Culligan et al. 2005 Obstet gynecol n= 95 76% Sacrocolpopexy 69% Sacrospinous fixation (NS) n= 100 68% Sacrocolpopexy fascia 91% Sacrocolpopexy mesh (p=0.007) 2 y 1 y
Summary- Vaginal vault prolapse Consistent level I evidence that sacrocolpopexy is more effective when compared to sacrospinous fixation. Consistent level I evidence that sacrocolpopexy is associated with increased morbidity when compared to sacrospinous fixation No evidence for routine use of mesh
Middle Compartment Sacral colpopexy Sacrospinous fixation Prespinous fixation HUSL suspension Vaginal Hysterectomy +/- vault re-inforcement Failure rate: 6-40%
Posterior compartment
Site specific repair 4 studies, all retrospective (III) 3 case series, 1 case-control No RCT s Longest FU 18 months (Porter et al. AJOG 1999) Number of patients 373 93 patients/ study
Posterior colporraphy 4 studies 3 prospective single cohort (II) and 1 retrospective case-control (III) No RCT s Longest FU 5 y (Lopez et al. IUGJ 2001) Number of patients 249 62 patients/ study
Midline fascial plication 3 studies 2 prospective cohort studies (II) and 1 retrospective case-control (III) No RCT s Longest FU 18 months (Singh et al. Obstet Gynecol 2003) Number of patients 247 82 patients/ study
Transanal rectocele repair 11 studies 6 prosp cohort studies, 1 retrosp case-control, 3 retrosp case series 1 RCT, 15 patients in each arm Longest FU 4.8 y Number of patients 399 36 patients/ study
Summary posterior repair- controlled studies Evidence level Comparison Main outcome Arnold 1990 III Transanal repair vs. Colporraphy Abramov 2004 III Site specific vs. Midline fascial plication Nieminen 2004 I Transanal repair vs. Midline fascial plication No anatomical difference Midline fascial plication anatomically superior Midline fascial plication anatomically superior
Posterior compartment-mesh 13 studies 1 RCT 8 prospective 615 patients Mean FU 1.2 y 11 techniques using 10 different biomaterials 0 RCT for permanent implants 4 retrospective of which one was controlled 51 patients/ study
Posterior compartment mesh Site specific vs Site specific+porcine graft Subjects Anatomical cure Duration of FU Sand et al. Am J Obstet Gynecol 2001 n= 161 81 +Vicryl 80 Controls 75 57 (p< 0.05) 12 m Weber et al. Am J Obstet Gynecol 2001 n= 109 35 +Vicryl 74 Controls 42 36 (NS) 23 m Paraiso et al. Am J Obstet Gynecol 2006 n=106 37 colporraphy 37 ss+fortigen 32 ss 86 54 76 (p=0.02) 2 y
Summary- posterior repair MFP may improve anatomical outcome when compared to transanal suture repair (II) and subjective outcomes when compared to site specific repair (III) Generally grade B-D recommendations No evidence suggesting that biological or synthetical mesh improves outcomes compared to traditional repair
Posterior Compartment Failure Persistent POP symptoms Dyspareunia Levator plication 10-20 % <20 % 27-50 % Midline fascial plication 7-13 % 7-20 % 4.2 % Site-specific fascial repair 10-32 % Trans-anal repair 30-67 % 17-30 % Laparoscopic rectocoele repair 20 % 20 %
Summary EBM POP surgery General lack of level I evidence to support current clinical practice RCT s and high quality controlled studies needed Multicenter collaboration required Collaboration between clinical experts and researchers
The future Life-time risk for pelvic floor surgery in Europe? ~11% in US women of which 1/3 have secondary procedures (Olsen, Obstet Gynecol, 1997) Sweden 6-7,000 POP procedures/ year U.S.A. 250-350,000 POP procedures/ year 45% increase urogynecological care prognosticated over the next 20 years (Luber, AJOG, 2001)
We need to learn from the past but look to the future. Progress in POP surgery must be based on sound evidence and rigorous audit of outcome. Primum Non Nocere