Table Of Content

CochraneDatabaseofSystematicReviews Surgery for women with apical vaginal prolapse (Review) MaherC,FeinerB,BaesslerK,Christmann-SchmidC,HayaN,BrownJ MaherC,FeinerB,BaesslerK,Christmann-SchmidC,HayaN,BrownJ. Surgeryforwomenwithapicalvaginalprolapse. CochraneDatabaseofSystematicReviews2016,Issue10.Art.No.:CD012376. DOI:10.1002/14651858.CD012376. www.cochranelibrary.com Surgeryforwomenwithapicalvaginalprolapse(Review) Copyright©2016TheCochraneCollaboration.PublishedbyJohnWiley&Sons,Ltd. TABLE OF CONTENTS HEADER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 PLAINLANGUAGESUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 SUMMARYOFFINDINGSFORTHEMAINCOMPARISON . . . . . . . . . . . . . . . . . . . 4 BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 OBJECTIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 METHODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Figure1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 RESULTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Figure2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 Figure3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 Figure4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 Figure5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 Figure6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 Figure7. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 Figure8. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 ADDITIONALSUMMARYOFFINDINGS . . . . . . . . . . . . . . . . . . . . . . . . . . 35 DISCUSSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38 AUTHORS’CONCLUSIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40 ACKNOWLEDGEMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40 REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41 CHARACTERISTICSOFSTUDIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45 DATAANDANALYSES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86 Analysis1.1.Comparison1Vaginalprocedureversussacralcolpopexy,Outcome1Awarenessofprolapse(2years). . 96 Analysis1.2.Comparison1Vaginalprocedureversussacralcolpopexy,Outcome2Repeatsurgery(2-4years). . . . 97 Analysis1.3.Comparison1Vaginalprocedureversussacralcolpopexy,Outcome3Anyrecurrentprolapse(1-2years). 98 Analysis1.4.Comparison1Vaginalprocedureversussacralcolpopexy,Outcome4Meshexposure(1-4years). . . . 99 Analysis1.5.Comparison1Vaginalprocedureversussacralcolpopexy,Outcome5Injuries. . . . . . . . . . 100 Analysis1.6.Comparison1Vaginalprocedureversussacralcolpopexy,Outcome6Repeatsurgeryformeshexposure(2-4 years). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101 Analysis1.7.Comparison1Vaginalprocedureversussacralcolpopexy,Outcome7Objectivefailure(2-4years). . . 102 Analysis1.8.Comparison1Vaginalprocedureversussacralcolpopexy,Outcome8POPQassessment(2years). . . 103 Analysis1.9.Comparison1Vaginalprocedureversussacralcolpopexy,Outcome9Stressurinaryincontinence(2years). 104 Analysis1.10.Comparison1Vaginalprocedureversussacralcolpopexy,Outcome10Urgeincontinence(denovo(2 years). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105 Analysis1.11.Comparison1Vaginalprocedureversussacralcolpopexy,Outcome11UrinaryVoidingdysfunction(de novo). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105 Analysis1.12.Comparison1Vaginalprocedureversussacralcolpopexy,Outcome12Dyspareunia. . . . . . . 106 Analysis1.13.Comparison1Vaginalprocedureversussacralcolpopexy,Outcome13Sexualfunction. . . . . . 107 Analysis1.14.Comparison1Vaginalprocedureversussacralcolpopexy,Outcome14Qualityoflifeandsatisfaction(4 years). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 108 Analysis1.15.Comparison1Vaginalprocedureversussacralcolpopexy,Outcome15Operatingtime(minutes). . . 109 Analysis1.16.Comparison1Vaginalprocedureversussacralcolpopexy,Outcome16Lengthofhospitalstay. . . . 110 Analysis1.17.Comparison1Vaginalprocedureversussacralcolpopexy,Outcome17Bloodtransfusion. . . . . . 111 Analysis2.1.Comparison2Vaginalsurgerywithmeshversuswithoutmesh,Outcome1Awarenessofprolapse(3years). 112 Analysis2.2.Comparison2Vaginalsurgerywithmeshversuswithoutmesh,Outcome2Repeatsurgery(1-3years). 113 Analysis2.3.Comparison2Vaginalsurgerywithmeshversuswithoutmesh,Outcome3Recurrentprolapseonexamination (1-3years). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114 Analysis2.4.Comparison2Vaginalsurgerywithmeshversuswithoutmesh,Outcome4Injuries. . . . . . . . 115 Analysis2.5.Comparison2Vaginalsurgerywithmeshversuswithoutmesh,Outcome5Objectivefailure. . . . . 116 Analysis2.6.Comparison2Vaginalsurgerywithmeshversuswithoutmesh,Outcome6POPQassessment(1year). 117 Surgeryforwomenwithapicalvaginalprolapse(Review) i Copyright©2016TheCochraneCollaboration.PublishedbyJohnWiley&Sons,Ltd. Analysis2.7.Comparison2Vaginalsurgerywithmeshversuswithoutmesh,Outcome7Stressurinaryincontinence(1-3 years)). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118 Analysis2.8.Comparison2Vaginalsurgerywithmeshversuswithoutmesh,Outcome8Urgeincontinence. . . . 119 Analysis2.9.Comparison2Vaginalsurgerywithmeshversuswithoutmesh,Outcome9Voidingdysfunction. . . 120 Analysis2.10.Comparison2Vaginalsurgerywithmeshversuswithoutmesh,Outcome10Dyspareunia(1-3years). 121 Analysis2.11.Comparison2Vaginalsurgerywithmeshversuswithoutmesh,Outcome11Pelvicorganprolapse/urinary incontinencesexualquestionnaire(PISQ)(1year). . . . . . . . . . . . . . . . . . . . . . 122 Analysis2.12.Comparison2Vaginalsurgerywithmeshversuswithoutmesh,Outcome12PatientGlobalImpressionof Improvement(PGI-I)(muchorverymuchbetter3years). . . . . . . . . . . . . . . . . . . 123 Analysis2.13.Comparison2Vaginalsurgerywithmeshversuswithoutmesh,Outcome13QualityoflifePROLAPSE. 123 Analysis2.14.Comparison2Vaginalsurgerywithmeshversuswithoutmesh,Outcome14Operatingtime(mins). . 124 Analysis2.15.Comparison2Vaginalsurgerywithmeshversuswithoutmesh,Outcome15Bloodtransfusion. . . 125 Analysis3.1.Comparison3Vaginalsurgery:comparisonofonenativetissuerepairversusanother,Outcome1Awareness ofprolapse(2years). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125 Analysis3.2.Comparison3Vaginalsurgery:comparisonofonenativetissuerepairversusanother,Outcome2Repeat surgery(2years). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 126 Analysis3.3.Comparison3Vaginalsurgery:comparisonofonenativetissuerepairversusanother,Outcome3Injuries. 127 Analysis3.4.Comparison3Vaginalsurgery:comparisonofonenativetissuerepairversusanother,Outcome4Objective failure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 128 Analysis3.5.Comparison3Vaginalsurgery:comparisonofonenativetissuerepairversusanother,Outcome5POPQ assessment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129 Analysis3.6.Comparison3Vaginalsurgery:comparisonofonenativetissuerepairversusanother,Outcome6Stress urinaryincontinencedenovo(1year). . . . . . . . . . . . . . . . . . . . . . . . . . 130 Analysis3.7.Comparison3Vaginalsurgery:comparisonofonenativetissuerepairversusanother,Outcome7Urge incontinence. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 131 Analysis3.8.Comparison3Vaginalsurgery:comparisonofonenativetissuerepairversusanother,Outcome8Dyspareunia (1year). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 132 Analysis3.9.Comparison3Vaginalsurgery:comparisonofonenativetissuerepairversusanother,Outcome9Blood transfusion. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133 Analysis4.1.Comparison4Vaginalhysterectomyvsalternativesforuterineprolapse,Outcome1Awarenessofprolapse. 134 Analysis4.2. Comparison 4Vaginal hysterectomyvsalternativesforuterineprolapse,Outcome2Repeatprolapse surgery. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135 Analysis4.3.Comparison4Vaginalhysterectomyvsalternativesforuterineprolapse,Outcome3Objectivefailureanysite (POP). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 136 Analysis4.4.Comparison4Vaginalhysterectomyvsalternativesforuterineprolapse,Outcome4Bladderinjuries. . 137 Analysis4.5.Comparison4Vaginalhysterectomyvsalternativesforuterineprolapse,Outcome5Bowelinjuries(1year review). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 138 Analysis4.6.Comparison4Vaginalhysterectomyvsalternativesforuterineprolapse,Outcome6Meshexposure. . 139 Analysis4.8.Comparison4Vaginalhysterectomyvsalternativesforuterineprolapse,Outcome8Repeatsurgeryfor incontinence. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140 Analysis4.9.Comparison4Vaginalhysterectomyvsalternativesforuterineprolapse,Outcome9Anteriorcompartment prolapse(1yearreview). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 141 Analysis4.10.Comparison4Vaginalhysterectomyvsalternativesforuterineprolapse,Outcome10Apicalcompartment prolapse. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 142 Analysis4.11.Comparison4Vaginalhysterectomyvsalternativesforuterineprolapse,Outcome11Posteriorcompartment prolapse. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143 Analysis4.12.Comparison4Vaginalhysterectomyvsalternativesforuterineprolapse,Outcome12POPQassessment PointBa. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 144 Analysis4.13.Comparison4Vaginalhysterectomyvsalternativesforuterineprolapse,Outcome13POPQassessment: PointBp. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 145 Analysis4.14.Comparison4Vaginalhysterectomyvsalternativesforuterineprolapse,Outcome14POPQassessment: PointC. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 146 Surgeryforwomenwithapicalvaginalprolapse(Review) ii Copyright©2016TheCochraneCollaboration.PublishedbyJohnWiley&Sons,Ltd. Analysis4.15.Comparison4Vaginalhysterectomyvsalternativesforuterineprolapse,Outcome15POPQassessment: Totalvaginallength. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147 Analysis4.16.Comparison4Vaginalhysterectomyvsalternativesforuterineprolapse,Outcome16Dyspareunia. . 148 Analysis4.17.Comparison4Vaginalhysterectomyvsalternativesforuterineprolapse,Outcome17Qualityoflife:Pelvic organprolapse/urinaryincontinencesexualquestionnaire. . . . . . . . . . . . . . . . . . . 148 Analysis4.18.Comparison4Vaginalhysterectomyvsalternativesforuterineprolapse,Outcome18Operatingtime (minutes). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 149 Analysis4.19.Comparison4Vaginalhysterectomyvsalternativesforuterineprolapse,Outcome19Hospitalstay. . 150 Analysis4.20.Comparison4Vaginalhysterectomyvsalternativesforuterineprolapse,Outcome20Bloodtransfusion. 151 Analysis5.1.Comparison5Sacralcolpopexymeshversusbiological,Outcome1Awarenessofprolapse(1-5years). . 151 Analysis5.2.Comparison5Sacralcolpopexymeshversusbiological,Outcome2Prolapsesurgery(1-5year). . . . 152 Analysis5.3.Comparison5Sacralcolpopexymeshversusbiological,Outcome3Surgerystressurinaryincontinence5 years. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 153 Analysis5.4. Comparison 5Sacral colpopexy meshversusbiological, Outcome 4Recurrentprolapse(any site on examination(1-5year)). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 154 Analysis5.5.Comparison5Sacralcolpopexymeshversusbiological,Outcome5Meshexposure(1-5year). . . . 155 Analysis5.6.Comparison5Sacralcolpopexymeshversusbiological,Outcome6Bladderinjury. . . . . . . . 156 Analysis5.7.Comparison5Sacralcolpopexymeshversusbiological,Outcome7Bowelinjury. . . . . . . . . 157 Analysis5.8.Comparison5Sacralcolpopexymeshversusbiological,Outcome8Surgerymeshexposure1-5years. . 158 Analysis5.9.Comparison5Sacralcolpopexymeshversusbiological,Outcome9apicalprolapse. . . . . . . . 159 Analysis5.10.Comparison5Sacralcolpopexymeshversusbiological,Outcome10POPQassessment. . . . . . 160 Analysis5.11.Comparison5Sacralcolpopexymeshversusbiological,Outcome11Dyspareunia(denovo1year)). . 161 Analysis5.12.Comparison5Sacralcolpopexymeshversusbiological,Outcome12Sexualfunction. . . . . . . 162 Analysis5.13.Comparison5Sacralcolpopexymeshversusbiological,Outcome13QualityoflifePROLAPSE(iyear). 163 Analysis5.14.Comparison5Sacralcolpopexymeshversusbiological,Outcome14Operatingtime(mins). . . . 164 Analysis5.15.Comparison5Sacralcolpopexymeshversusbiological,Outcome15Hospitalstay. . . . . . . . 164 Analysis5.16.Comparison5Sacralcolpopexymeshversusbiological,Outcome16Bloodtransfusion. . . . . . 165 Analysis5.17.Comparison5Sacralcolpopexymeshversusbiological,Outcome17painatnormalacivities(weekone). 166 Analysis5.18.Comparison5Sacralcolpopexymeshversusbiological,Outcome18Surgeryorpessaryforprolapse. . 166 Analysis6.1.Comparison6Sacralcolpopexy:Laparoscopicversusother,Outcome1RepeatProlapseSurgery. . . . 167 Analysis6.2.Comparison6Sacralcolpopexy:Laparoscopicversusother,Outcome2Recurrentprolapse(anysiteon examination). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 168 Analysis6.3.Comparison6Sacralcolpopexy:Laparoscopicversusother,Outcome3Meshexposure. . . . . . . 169 Analysis6.4.Comparison6Sacralcolpopexy:Laparoscopicversusother,Outcome4Bladderinjury. . . . . . . 170 Analysis6.5.Comparison6Sacralcolpopexy:Laparoscopicversusother,Outcome5Bowelinjury. . . . . . . . 171 Analysis6.6.Comparison6Sacralcolpopexy:Laparoscopicversusother,Outcome6PointBa. . . . . . . . . 172 Analysis6.7.Comparison6Sacralcolpopexy:Laparoscopicversusother,Outcome7PointBp. . . . . . . . . 173 Analysis6.8.Comparison6Sacralcolpopexy:Laparoscopicversusother,Outcome8PointC. . . . . . . . . 174 Analysis6.9.Comparison6Sacralcolpopexy:Laparoscopicversusother,Outcome9Stressurinaryincontinence(denovo andpersistent). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 175 Analysis6.10.Comparison6Sacralcolpopexy:Laparoscopicversusother,Outcome10QualityoflifePROLAPSE. . 175 Analysis6.11.Comparison6Sacralcolpopexy:Laparoscopicversusother,Outcome11Operatingtime(mins). . . 176 Analysis6.12.Comparison6Sacralcolpopexy:Laparoscopicversusother,Outcome12Hospitalstay. . . . . . . 177 Analysis6.13.Comparison6Sacralcolpopexy:Laparoscopicversusother,Outcome13Bloodtransfusion. . . . . 178 Analysis6.14.Comparison6Sacralcolpopexy:Laparoscopicversusother,Outcome14continencesurgery. . . . . 179 Analysis7.1.Comparison7Sacralcolpopexywithcontinencesurgeryvswithout,Outcome1Awarenessofprolapse(7 years). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 180 Analysis7.2.Comparison7Sacralcolpopexywithcontinencesurgeryvswithout,Outcome2Repeatprolapsesurgeryor pessary(2-7years)). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 180 Analysis7.3. Comparison 7Sacralcolpopexy with continence surgery vswithout, Outcome 3Repeatsurgery for incontinence(7years)). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 181 Analysis7.4.Comparison7Sacralcolpopexywithcontinencesurgeryvswithout,Outcome4Objectivefailureanysite (POP7years). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 182 Surgeryforwomenwithapicalvaginalprolapse(Review) iii Copyright©2016TheCochraneCollaboration.PublishedbyJohnWiley&Sons,Ltd. Analysis7.5.Comparison7Sacralcolpopexywithcontinencesurgeryvswithout,Outcome5POPQassessmentPoint Ba. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 182 Analysis7.6.Comparison7Sacralcolpopexywithcontinencesurgeryvswithout,Outcome6POPQassessment:Point Bp. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 183 Analysis7.7.Comparison7Sacralcolpopexywithcontinencesurgeryvswithout,Outcome7POPQassessment:Point C. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 183 Analysis7.8.Comparison7Sacralcolpopexywithcontinencesurgeryvswithout,Outcome8Stressurinaryincontinence (4-7years). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 184 Analysis7.9.Comparison7Sacralcolpopexywithcontinencesurgeryvswithout,Outcome9Operatingtime(minutes). 185 Analysis7.10.Comparison7Sacralcolpopexywithcontinencesurgeryvswithout,Outcome10Bloodtransfusion. . 185 ADDITIONALTABLES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 186 APPENDICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 186 WHAT’SNEW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 188 HISTORY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 188 CONTRIBUTIONSOFAUTHORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 189 DECLARATIONSOFINTEREST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 190 SOURCESOFSUPPORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 190 DIFFERENCESBETWEENPROTOCOLANDREVIEW . . . . . . . . . . . . . . . . . . . . . 190 Surgeryforwomenwithapicalvaginalprolapse(Review) iv Copyright©2016TheCochraneCollaboration.PublishedbyJohnWiley&Sons,Ltd. [InterventionReview] Surgery for women with apical vaginal prolapse ChristopherMaher1,BenjaminFeiner2,KavenBaessler3,CorinaChristmann-Schmid4,NirHaya5,JulieBrown6 1RoyalBrisbaneWomen’sHospital,Brisbane,Australia.2HeadofUrogynecology&ReconstructivePelvicSurgery,HillelYaffeMedical Center, Technion University, Hadera, Israel. 3Urogynaecology Department, Pelvic Floor Centre Charite, Berlin, Germany. 4New Women’sClinic,LucerneCantonalHospital,Lucerne,Switzerland.5DepartmentofObstetricsandGynaecology,LadyDavisCarmel MedicalCenter,andtheRuthandBruceRappaportSchoolofMedicine,Technion-IsraelInstituteofTechnology,Haifa,Israel.6Liggins Institute,TheUniversityofAuckland,Auckland,NewZealand Contact address: Christopher Maher, Royal Brisbane Women’s Hospital, University Queensland, Brisbane, Queensland, Australia. [email protected]. Editorialgroup:CochraneGynaecologyandFertilityGroup. Publicationstatusanddate:New,publishedinIssue10,2016. Reviewcontentassessedasup-to-date: 6July2015. Citation: MaherC,FeinerB,BaesslerK,Christmann-SchmidC,HayaN,BrownJ.Surgeryforwomenwithapicalvaginalprolapse. CochraneDatabaseofSystematicReviews2016,Issue10.Art.No.:CD012376.DOI:10.1002/14651858.CD012376. Copyright©2016TheCochraneCollaboration.PublishedbyJohnWiley&Sons,Ltd. ABSTRACT Background Apicalvaginalprolapseisadescentoftheuterusorvaginal vault(post-hysterectomy).Various surgicaltreatmentsareavailableand therearenoguidelinestorecommendwhichisthebest. Objectives Toevaluatethesafetyandefficacyofanysurgicalinterventioncomparedtoanotherinterventionforthemanagementofapicalvaginal prolapse. Searchmethods We searchedthe Cochrane Incontinence Group’s Specialised Register of controlledtrials, which contains trials identified from the Cochrane CentralRegisterof ControlledTrials(CENTRAL), MEDLINE, ClinicalTrials.gov, WHOICTRP andhandsearchingof journalsandconferenceproceedings(searchedJuly2015)andClinicalTrials.gov(searchedJanuary2016). Selectioncriteria Weincludedrandomisedcontrolledtrials(RCTs). Datacollectionandanalysis WeusedCochranemethods.Ourprimaryoutcomeswereawarenessofprolapse,repeatsurgeryandrecurrentprolapse(anysite). Mainresults Weincluded30RCTs(3414women)comparingsurgicalproceduresforapicalvaginalprolapse.Evidencequalityrangedfromlowto moderate.Limitationsincludedimprecision,poormethodologicalreportingandinconsistency. Vaginalproceduresversussacralcolpopexy(sixRCTs,n=583;onetofour-yearreview). Surgeryforwomenwithapicalvaginalprolapse(Review) 1 Copyright©2016TheCochraneCollaboration.PublishedbyJohnWiley&Sons,Ltd. Awarenessofprolapsewasmorecommonaftervaginalprocedures(riskratio(RR)2.11,95%confidenceinterval(CI)1.06to4.21,3 RCTs,n=277,I2=0%,moderate-qualityevidence).If7%ofwomenareawareofprolapseaftersacralcolpopexy,14%(7%to27%) arelikelytobeawareaftervaginalprocedures. Repeatsurgeryforprolapsewasmorecommonaftervaginalprocedures(RR2.28,95%CI1.20to4.32;4RCTs,n=383,I2 =0%, moderate-qualityevidence).Theconfidenceintervalsuggeststhatif4%ofwomenrequirerepeatprolapsesurgeryaftersacralcolpopexy, between5%and18%wouldrequireitaftervaginalprocedures. Wefoundnoconclusive evidence thatvaginal proceduresincreaserepeatsurgeryforstressurinaryincontinence(SUI)(RR1.87, 95% CI0.72to4.86;4RCTs,n=395;I2 =0%,moderate-qualityevidence).If3%ofwomenrequirerepeatsurgeryforSUIaftersacral colpopexy,between2%and16%arelikelytodosoaftervaginalprocedures. Recurrentprolapseisprobablymorecommonaftervaginalprocedures(RR1.89,95%CI1.33to2.70;4RCTs,n=390;I2 =41%, moderate-qualityevidence).If23%ofwomenhaverecurrentprolapseaftersacralcolpopexy,about41%(31%to63%)arelikelyto dosoaftervaginalprocedures. Theeffectofvaginalproceduresonbladderinjurywasuncertain(RR0.57,95%CI0.14to2.36;5RCTs,n=511;I2=0%,moderate- qualityevidence). SUIwasmorecommonaftervaginalprocedures(RR1.86,95%CI1.17to2.94;3RCTs,n=263;I2=0%,moderate-qualityevidence). Dyspareuniawasalsomorecommonaftervaginalprocedures(RR2.53,95%CI1.17to5.50;3RCTs,n=106,I2=43%,low-quality evidence). Vaginalsurgerywithmeshversuswithoutmesh(6RCTs,n=598,1-3yearreview). Awarenessofprolapse-Theremaybelittleornodifferencebetweenthegroupsforthisoutcome(RR1.0895%CI0.35to3.301RCT n=54,lowqualityevidence).Theconfidenceintervalwaswidesuggestingthatif18%ofwomenareawareofprolapseaftersurgery withoutmesh,between6%and59%willbeawareofprolapseaftersurgerywithmesh. Repeatsurgeryforprolapse-Theremaybelittleornodifferencebetweenthegroupsforthisoutcome(RR0.69,95%CI0.30to1.60; 5RCTs,n=497;I2=9%,low-qualityevidence).If4%ofwomenrequirerepeatsurgeryforprolapseaftersurgerywithoutmesh,1% to7%arelikelytodosoaftersurgerywithmesh. WefoundnoconclusiveevidencethatsurgerywithmeshincreasesrepeatsurgeryforSUI(RR4.91,95%CI0.86to27.94;2RCTs, n=220;I2=0%,low-qualityevidence).Theconfidenceintervalwaswidesuggestingthatif2%ofwomenrequirerepeatsurgeryfor SUIaftervaginalcolpopexywithoutmesh,2%to53%arelikelytodosoaftersurgerywithmesh. Wefoundnoclearevidencethatsurgerywithmeshdecreasesrecurrentprolapse(RR0.36,95%CI0.09to1.40;3RCTsn=269;I2= 91%,low-qualityevidence).Theconfidenceintervalwasverywideandtherewasseriousinconsistencybetweenthestudies. Otheroutcomes ThereisprobablylittleornodifferencebetweenthegroupsinratesofSUI(denovo)(RR1.37,95%CI0.94to1.99;4RCTs,n= 295;I2=0%,moderate-qualityevidence)ordyspareunia(RR1.21,95%CI0.55to2.66;5RCTs,n=501;I2=0%moderate-quality evidence).Weareuncertainwhetherthereisanydifferenceforbladderinjury(RR3.00,95%CI0.91to9.89;4RCTs,n=445;I2= 0%;verylow-qualityevidence). Vaginalhysterectomyversusalternativesforuterineprolapse(sixstudies,n=667) Noclearconclusionscouldbereachedfromtheavailableevidence,thoughoneRCTfoundthatawarenessofprolapsewaslesslikely afterhysterectomythanafterabdominalsacrohysteropexy(RR0.38,955CI0.15to0.98,n=84,moderate-qualityevidence). Othercomparisons Therewasnoevidenceofadifferenceforanyofourprimaryreviewoutcomesbetweendifferenttypesofvaginalnativetissuerepair(two RCTs),comparisonsofgraftmaterialsforvaginalsupport(twoRCTs),differentroutesforsacralcolpopexy(fourRCTs),orbetween sacralcolpopexywithandwithoutcontinencesurgery(fourRCTs). Authors’conclusions Sacralcolpopexyisassociatedwithlowerriskofawarenessofprolapse,recurrentprolapseonexamination,repeatsurgeryforprolapse, postoperativeSUIanddyspareuniathanavarietyofvaginalinterventions. Surgeryforwomenwithapicalvaginalprolapse(Review) 2 Copyright©2016TheCochraneCollaboration.PublishedbyJohnWiley&Sons,Ltd. Thelimitedevidencedoesnotsupportuseoftransvaginalmeshcomparedtonativetissuerepairforapicalvaginalprolapse.Mostof theevaluatedtransvaginalmeshesarenolongeravailableandnewlightermeshescurrentlylackevidenceofsafety Theevidencewasinconclusivewhencomparingaccessroutesforsacralcolpopexy. Noclearconclusioncanbereachedfromtheavailabledatacomparinguterinepreservingsurgeryversusvaginalhysterectomyforuterine prolapse. PLAIN LANGUAGE SUMMARY Surgicalmanagementofpelvicorganprolapseinwomen Reviewquestion Whichsurgicalinterventionsforapicalvaginalprolapsehavethebestoutcomes? Background Apical vaginal prolapse is a descent of the uterus or (after hysterectomy) the upper vagina (vault). Various surgical treatments are availableandtherearenoguidelinestorecommendwhichisthebest. Studycharacteristics Thirtyrandomisedcontrolledtrialsevaluated3414womenwhounderwentsurgeryforapicalvaginal prolapse.Themostcommon comparisonswerebetweenvaginalsurgeryandsacralcolpopexy(anabdominalproceduresuspendingtheuppervaginatothesacrum withagraft)(sixRCTs),vaginalsurgerywithmeshversuswithout(sixRCTs),vaginalhysterectomyversusalternatives(sixRCTs),and differenttypesorroutesofsacralcolpopexy(eightRCTs).TheevidenceiscurrenttoJuly2015. Keyresults Compared to various vaginal repairs, sacral colpopexy was associated with lower rates of awareness of prolapse, repeat surgery for prolapse,prolapseonexamination,urinarystressincontinence(SUI)andpainfulintercourse.If7%ofwomenareawareofprolapse aftersacralcolpopexy,14%(7%to27%)arelikelytobeawareaftervaginalprocedures.If4%ofwomenrequirerepeatprolapsesurgery aftersacralcolpopexy,between5%and18%wouldrequireitaftervaginalprocedures. WefoundnoconclusiveevidencethatvaginalproceduresincreasetheneedforrepeatsurgeryforSUI.If3%ofwomenrequirerepeat surgeryforSUIaftersacralcolpopexy,between2%and16%arelikelytodosoaftervaginalprocedures. Thelimitedevidencedoesnotsupporttheuseoftransvaginalmeshcomparedtonativetissuerepairs.Theevidencewasimprecise,but suggeststhatif18%ofwomenareawareofprolapseaftersurgerywithoutmesh,between6%and59%willbeawareaftersurgerywith mesh.If4%ofwomenrequirerepeatsurgeryforprolapseaftersurgerywithoutmesh,1%to7%arelikelytodosoaftersurgerywith mesh.Wefoundnoclearevidencethatsurgerywithmeshdecreasesrecurrentprolapse.Mostoftheevaluatedtransvaginalmeshesare nolongeravailableandnewlightermesheslackevidenceofsafety. Theevidencewasinconclusiveincomparisonsofuterinepreservingsurgeryversusvaginalhysterectomy,anddifferentaccessroutesfor sacralcolpopexy. Qualityoftheevidence Evidencequalityrangedfromverylowtomoderate.Limitationsincludedimprecision,poorreportingofstudymethodsandinconsis- tency. Surgeryforwomenwithapicalvaginalprolapse(Review) 3 Copyright©2016TheCochraneCollaboration.PublishedbyJohnWiley&Sons,Ltd. CopyrigSurgery SUMMARY OF FINDINGS FOR THE MAIN COMPARISON [Explanation] htfo ©r 20wo Vaginalprocedureversussacralcolpopexyfortherepairofapicalprolapse. 1m 6e Tn hw eCith Population:Womenwithapicalcompartmentpelvicorganprolapse ochraapica SInettetrinvegn:tIniopna:tVieangtinalprocedures nl eCvag Comparison:Sacralcolpopexy ollaboration.Publishinalprolapse(Review Outcomes IAllsussutmraetidverisckomparativerisksC*o(r9re5s%pConI)dingrisk R(9e5la%tiCveI)effect N(sotuodfiePsa)rticipants Q(GuRaAlitDyEo)ftheevidence ed) Sacralcolpopexy Vaginalsurgery b y Jo hn Awarenessofprolapse 65per1000 137per1000 RR2.11 277 ⊕⊕⊕(cid:13) W (2years) (69to274) (1.06to4.21) (3studies) moderate1 ile y & S Repeat surgery for pro- 41per1000 93per1000 RR2.28 383 ⊕⊕⊕(cid:13) o ns lapse (49to177) (1.20to4.32) (4studies) moderate1 , Ltd (2to4years) . Repeat surgery for stress 32per1000 61per1000 RR1.87 395 ⊕⊕⊕(cid:13) urinaryincontinence (23to157) (0.72to4.86) (4studies) moderate1 (2years) Recurrent prolapse on ex- 232per1000 438per1000 RR1.89 390 ⊕⊕⊕(cid:13) amination(1to2years) (309to626) (1.33to2.70) (4studies) moderate2 Bladderinjury 16per1000 9per1000 RR0.57 511 ⊕⊕⊕(cid:13) (2to39) (0.14to2.36) (5studies) moderate1 Stressurinaryincontinence 139per1000 259per1000 RR1.86 263 ⊕⊕⊕(cid:13) (2years) (163to409) (1.17to2.94) (3studies) moderate2 4 CS opyrigurgery ht©for Dyspareunia 91per1000 230per1000 RR2.53 106 ⊕⊕(cid:13)(cid:13) 20wo (2years) (106to501) (1.17to5.50) (3studies) low1,2 1m 6e Tn heCochrwithapic *cCToI:hmCepobanarfissidiosennfogcrerotihunepteaarsvnsadul;tmhReeRd:reRrliiassktkivirseattehiofef;emctedoifatnhecoinntterorvlegnrotiuopnr(iasnkdaictsro9s5s%stCuId)i.es.Thecorrespondingrisk(andits95%confidenceinterval)isbasedontheassumedriskinthe aa nl ev Cag ollaboration.Publishedinalprolapse(Review) 1GVHMLIomReiogwrAdphyDerqleqEroucauwaWitasleliqioitoqtyurynku:a::iaFlnFwilutgiuytirdryt:Gthe:hWreFoecreuurorrparnetehrsfgseieedreraaveaerdrnrcereccyhssheeuiosiainsnfrcvtcveeeehevrrrvrytiidyasaleiliulnskninkecaaleliebynklyodetoultoyothrtthoahloavecwveheeaaesannvtniegmimneimatpotrpeouao.rrttrecatsaonnsnttufimiigdmgeppenaascctcetitnoiognnnitomhouepurrrecescoctoniimsnfiifodaidneteen:ndcoceofeweinifnnfgtehtrcheated.eeesdstitmoimnaeatetleeovofefelefffefeccttaannddismlaikyeclyhtaongcehatnhgeeetshtiemeastteim. ate. b 2Unclearmanagement of detection biasin3of 4studies andoutcomedependent uponreviewerassessment:downgraded y Jo onelevelforseriousriskof bias h n W ile y & S o n s , L td . 5

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Copyright © 2016 The Cochrane Collaboration. Published by John Comparison 1 Vaginal procedure versus sacral colpopexy, Outcome 1 Awareness of prolapse (2 years) 96 review, taking account of legitimate differences.

Surgery for women with apical vaginal prolapse PDF

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