Objective
We sought to identify and summarize definitions of apical support loss utilized for inclusion, success, and failure in surgical trials for treatment of apical vaginal prolapse.
Background
Pelvic organ prolapse is a common condition affecting more than 3 million women in the US, and the prevalence is increasing. Prolapse may occur in the anterior compartment, posterior compartment or at the apex. Apical support is considered paramount to overall female pelvic organ support, yet apical support loss is often underrecognized and there are no guidelines for when an apical support procedure should be performed or incorporated into a procedure designed to address prolapse.
Study Design
A systematic literature search was performed in 8 search engines: PubMed 1946-, Embase 1947-, Cochrane Database of Systematic Reviews, Cochrane Database of Abstracts of Review Effects, Cochrane Central Register of Controlled Trials, ClinicalTrials.gov , Proquest Dissertations and Theses, and FirstSearch Proceedings, using key words for apical pelvic organ prolapse and apical suspension procedures through April 2016. Searches were limited to human beings using human filters and articles published in English. Study authors (M.R.L.M., J.L.L.) independently reviewed publications for inclusion based on predefined variables. Articles were eligible for inclusion if they satisfied any of the following criteria: (1) apical support loss was an inclusion criterion in the original study, (2) apical support loss was a surgical indication, or (3) an apical support procedure was performed as part of the primary surgery.
Results
A total of 4469 publications were identified. After review, 35 articles were included in the analysis. Prolapse-related inclusion criteria were: (1) apical prolapse (n = 20, 57.1%); (2) overall prolapse (n = 8, 22.8%); or (3) both (n = 6, 17.1%). Definitions of apical prolapse (relative to the hymen) included: (1) apical prolapse >–1 cm (n = 13, 50.0%); (2) apical prolapse >+1 cm (n = 7, 26.9%); (3) apical prolapse >50% of total vaginal length (–[total vaginal length/2]) (n = 4, 15.4%); and (4) cervix/apex >0 cm (n = 2, 7.7%). Sixteen of the 35 studies (45.7%) required the presence of symptoms for inclusion. A measurement of the apical compartment (relative to the hymen) was used as a measure of surgical success or failure in 17 (48.6%) studies. Definitions for surgical success included: (1) prolapse stage >2 in each compartment (n = 5, 29.4%); (2) prolapse >–[total vaginal length/2] (n = 2, 11.8%); (3) apical support >–[total vaginal length/3] (n = 1, 5.9%); (4) absence of prolapse beyond the hymen (n = 1, 5.9%); and (5) point C at ≥–5 cm (n = 2, 11.8%). Surgical failure was defined as: (1) apical prolapse ≥0 cm (n = 2, 11.8%); (2) apical prolapse ≥–1 cm (n = 2, 11.8%); (3) apical prolapse >–[total vaginal length/2] (n = 3, 17.6%); and (4) recurrent apical prolapse surgery (n = 1, 5.9%). Ten (28.6%) of the 35 studies also included symptomatic outcomes in the definition of success or failure.
Conclusion
Among randomized, controlled surgical trials designed to address apical vaginal support loss, definitions of clinically significant apical prolapse for study inclusion and surgical success or failure are either highly variable or absent. These findings provide limited evidence of consensus and little insight into current expert opinion.
Introduction
Pelvic organ prolapse (POP) is a common condition affecting >3 million women in the United States, and the prevalence is increasing. Over 300,000 women undergo surgery for POP annually, and the lifetime risk of surgery for POP or urinary incontinence is 11%. While 40-75% of parous women demonstrate some degree of prolapse on physical examination, symptoms are variable and many women are asymptomatic until the leading edge of the prolapse is at or beyond the hymen. In fact, given the relative paucity of symptoms for many women with POP Quantification (POP-Q) examination stage I through early stage II prolapse, some authors argue that prolapse is not clinically significant until the leading edge is at or beyond the hymen.
POP is measured and described in the literature using both validated and nonvalidated methods. The POP-Q examination and the Baden-Walker halfway system are the most frequently utilized validated staging systems. In the POP-Q system, an overall stage of prolapse is defined by the leading edge of prolapse. In the Baden-Walker system, the stage of prolapse for each vaginal compartment is assigned. The key advancement of both systems is the individual assessment of each vaginal compartment (anterior, posterior, and apical). Prolapse may occur in the anterior vaginal wall, posterior vaginal wall, or at the apex, and apical support is considered the keystone of female pelvic organ support. Unfortunately, apical vaginal support loss is often underrecognized.
While prolapse in the anterior vaginal compartment appears to be the most frequent and recognized, the majority of women who present with anterior prolapse at or beyond the hymen typically also manifest a component of apical support loss. Restoration of apical support is thought to be paramount for adequately treating prolapse. This hypothesis is supported by recent findings from a Medicare database study that found that women who had an apical procedure coincident with an anterior or posterior colporrhaphy had significantly lower reoperation rates for prolapse than those who only had an isolated anterior or posterior repair.
Despite this growing recognition that apical support is critical to overall vaginal support, there are no guidelines for when an apical support procedure should be performed and/or incorporated into a procedure designed to address prolapse. Additionally, little evidence exists to guide surgeons on the degree of restoration of apical vaginal support that defines surgical success or failure, or to improve symptomatic outcomes, as these do not always correlate. Therefore, to begin to address this question, we systematically reviewed the existing clinical trial literature to capture, summarize, and compare the range of: (1) indications for apical support procedures (ie, inclusion criteria); and (2) definitions of success and failure used in previous apical support trials. The objective of our study was to determine if the surgical literature utilized clinically meaningful definitions of apical support and loss, and if there was consensus among reported surgical trials.
Materials and Methods
The published literature was searched using strategies created for the concepts of POP (specifically apical prolapse) and apical suspension surgical procedures using the following search terms for prolapse: “pelvic organ prolapse,” “uterine prolapse,” “urogenital prolapse,” “vaginal vault prolapse,” “vaginal prolapse,” “apical vaginal prolapse,” “apical prolapse,” “pelvic organ prolapse quantification,” “POP-Q,” “genital prolapse,” “pelvic organ descent,” “pelvic prolapse,” “genitourinary prolapse,” “uterus prolapse,” “decensus uteri,” “prolapses uteri,” “uterovaginal prolapse,” and “posthysterectomy prolapse”; and the following terms for apical support procedure: “sacral colpopexy,” “sacrocolpopexy,” “sacrospinous fixation,” “uterosacral ligament suspension,” “ULS,” “apical vaginal suspension,” “culdoplasty,” “iliococcygeus colpopexy,” “uterosacral colpopexy,” “abdominal uterosacral suspension,” “AUSS,” “hysteropexy,” “sacrocervicopexy,” “sacrospinous ligament suspension,” “SSLS,” and “USLS.” Studies containing any of these terms (either term for prolapse or term for prolapse procedure) were captured and reviewed for eligibility. These strategies were implemented in PubMed 1946-, Embase 1947-, Cochrane Database of Systematic Reviews, Cochrane Database of Abstracts of Review Effects, Cochrane Central Register of Controlled Trials, clinicaltrials.gov , Proquest Dissertations and Theses, and FirstSearch Proceedings. Searches were limited to English using database-supplied limits. Searches were also limited to human beings using the human filter for PubMed recommended in Cochrane Handbook for Systematic Reviews of Interventions. This was then used as a model to create similar human filters for the other databases searched.
All searches were initially completed in April 2014 for articles published through March 2014. All results were exported to EndNote (Version X7.5.3; Thomson Reuters, Philadelphia, PA). There were 1329 duplicates removed, for a total of 2331 unique citations. The full strategies for PubMed and Embase are available in the Appendix. We reviewed the references of the included studies to identify additional studies. The literature search was executed again in May 2016 in PubMed, Embase, Scopus, Cochrane Library, and ClinicalTrials.gov for articles published through April 2016, and 809 new citations were found and added to the pool of citation results.
The results of the systematic search were screened, and studies had to satisfy at least 1 of the following criteria to qualify for inclusion: (1) apical support loss was an inclusion criterion in the original study; (2) apical support loss was a surgical indication in the original study; or (3) an apical support procedure was performed as part of the primary surgery, even if the primary compartment of prolapse was not specifically defined. Initially, all randomized trials as well as prospective and retrospective studies were included. Studies were excluded from analysis if preoperative assessment/staging of prolapse was not reported. Case reports and surgical case series were also excluded.
The resulting studies were then reviewed thoroughly and independently by 2 authors (M.R.L.M., J.L.L.). In the event of a disagreement on study inclusion, the authors reviewed the study together and came to a consensus regarding whether it satisfied criteria for inclusion. Data from included studies were extracted for study design, study location, and year of publication. Study characteristics including inclusion criteria, exclusion criteria, POP staging system used, operative intervention(s), and outcome(s) were recorded. Characteristics of each intervention, specifically success rate, criteria for success and/or failure (if defined), duration of follow-up, and rates of anatomic and symptomatic recurrence, were also extracted. Statistical analysis was performed using software (SPSS, Version 21; IBM Corp, Armonk, NY). The conduct and reporting of this systematic review closely adhered to guidelines of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.
Materials and Methods
The published literature was searched using strategies created for the concepts of POP (specifically apical prolapse) and apical suspension surgical procedures using the following search terms for prolapse: “pelvic organ prolapse,” “uterine prolapse,” “urogenital prolapse,” “vaginal vault prolapse,” “vaginal prolapse,” “apical vaginal prolapse,” “apical prolapse,” “pelvic organ prolapse quantification,” “POP-Q,” “genital prolapse,” “pelvic organ descent,” “pelvic prolapse,” “genitourinary prolapse,” “uterus prolapse,” “decensus uteri,” “prolapses uteri,” “uterovaginal prolapse,” and “posthysterectomy prolapse”; and the following terms for apical support procedure: “sacral colpopexy,” “sacrocolpopexy,” “sacrospinous fixation,” “uterosacral ligament suspension,” “ULS,” “apical vaginal suspension,” “culdoplasty,” “iliococcygeus colpopexy,” “uterosacral colpopexy,” “abdominal uterosacral suspension,” “AUSS,” “hysteropexy,” “sacrocervicopexy,” “sacrospinous ligament suspension,” “SSLS,” and “USLS.” Studies containing any of these terms (either term for prolapse or term for prolapse procedure) were captured and reviewed for eligibility. These strategies were implemented in PubMed 1946-, Embase 1947-, Cochrane Database of Systematic Reviews, Cochrane Database of Abstracts of Review Effects, Cochrane Central Register of Controlled Trials, clinicaltrials.gov , Proquest Dissertations and Theses, and FirstSearch Proceedings. Searches were limited to English using database-supplied limits. Searches were also limited to human beings using the human filter for PubMed recommended in Cochrane Handbook for Systematic Reviews of Interventions. This was then used as a model to create similar human filters for the other databases searched.
All searches were initially completed in April 2014 for articles published through March 2014. All results were exported to EndNote (Version X7.5.3; Thomson Reuters, Philadelphia, PA). There were 1329 duplicates removed, for a total of 2331 unique citations. The full strategies for PubMed and Embase are available in the Appendix. We reviewed the references of the included studies to identify additional studies. The literature search was executed again in May 2016 in PubMed, Embase, Scopus, Cochrane Library, and ClinicalTrials.gov for articles published through April 2016, and 809 new citations were found and added to the pool of citation results.
The results of the systematic search were screened, and studies had to satisfy at least 1 of the following criteria to qualify for inclusion: (1) apical support loss was an inclusion criterion in the original study; (2) apical support loss was a surgical indication in the original study; or (3) an apical support procedure was performed as part of the primary surgery, even if the primary compartment of prolapse was not specifically defined. Initially, all randomized trials as well as prospective and retrospective studies were included. Studies were excluded from analysis if preoperative assessment/staging of prolapse was not reported. Case reports and surgical case series were also excluded.
The resulting studies were then reviewed thoroughly and independently by 2 authors (M.R.L.M., J.L.L.). In the event of a disagreement on study inclusion, the authors reviewed the study together and came to a consensus regarding whether it satisfied criteria for inclusion. Data from included studies were extracted for study design, study location, and year of publication. Study characteristics including inclusion criteria, exclusion criteria, POP staging system used, operative intervention(s), and outcome(s) were recorded. Characteristics of each intervention, specifically success rate, criteria for success and/or failure (if defined), duration of follow-up, and rates of anatomic and symptomatic recurrence, were also extracted. Statistical analysis was performed using software (SPSS, Version 21; IBM Corp, Armonk, NY). The conduct and reporting of this systematic review closely adhered to guidelines of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.
Results
The initial search identified 3660 publications, 1329 of which were duplicates. The subsequent search identified an additional 809 articles. We screened the resulting 3140 publications and excluded 2741 based on predefined inclusion and exclusion criteria, resulting in 399 full-text articles reviewed. Due to study quality and reporting issues, and to enhance the quality of the results from this systematic review, we limited our analysis to randomized controlled trials (RCTs). This resulted in 35 studies for analysis ( Figure and Table 1 ). Two studies identified on the subsequent search reported additional outcome data from a study captured in the initial search. The more recently published studies replaced the parent studies originally included in the initial analysis as study criteria (inclusion, exclusion, success, and failure) were unchanged.
| Reference | Intervention | Comparator | ||
|---|---|---|---|---|
| Surgery | N | Surgery | N | |
| Qatawneh et al, 2013 | Anterior vaginal wall mesh augmentation, sacrospinous colpopexy and posterior fascial plication | 53 | Native tissue anterior colporrhaphy, sacrospinous colpopexy, and posterior fascial plication | 63 |
| Rane et al, 2004 | Sacrospinous fixation | 7 | Posterior Intravaginal slingplasty, sacrocolpopexy a | 7, 7 |
| Maher et al, 2004 | Sacral colpopexy | 47 | Sacrospinous colpopexy | 48 |
| Maher et al, 2011 | Laparoscopic sacral colpopexy | 53 | Prolift (Ethicon, Somerville, NJ) total vaginal mesh | 55 |
| Freeman et al, 2013 | Abdominal sacrocolpopexy | 27 | Laparoscopic sacrocolpopexy | 26 |
| Costantini et al, 2008 | Abdominal sacrocolpopexy plus Burch colposuspension | 24 | Abdominal sacrocolpopexy | 23 |
| Lopes et al, 2010 | Posterior vaginal wall mesh augmentation | 14 | Sacrospinous ligament fixation | 16 |
| Natale et al, 2010 | High levator myorrhaphy | 116 | Uterosacral ligament suspension | 113 |
| Roovers et al, 2004 | Vaginal hysterectomy with uterosacral ligament suspension | 41 | Sacrocolpopexy with uterine preservation | 41 |
| Anger et al, 2014 | Robotic sacrocolpopexy | 40 | Laparoscopic sacrocolpopexy | 38 |
| Svabik et al, 2014 | Prolift total vaginal mesh | 36 | Unilateral vaginal sacrospinous colpopexy (sacrospinous fixation) | 34 |
| Alperin et al, 2013 | Hysterectomy plus uterosacral ligament suspension | N/A | Hysterectomy alone without uterosacral ligament suspension | N/A |
| Doganay and Aksakal, 2013 | Sacrospinous ligament suspension via Deschamps ligature carrier | 762 | Sacrospinous ligament suspension via automatic suturing instrument | 702 |
| Paraiso et al, 2011 | Laparoscopic sacrocolpopexy | 33 | Robotic sacrocolpopexy | 35 |
| Halaska et al, 2012 | Sacrospinous fixation | 83 | Prolift total vaginal mesh | 85 |
| Withagen et al, 2011 | Conventional vaginal prolapse surgery b | 97 | Prolift total vaginal mesh | 93 |
| Culligan et al, 2013 | Laparoscopic sacrocolpopexy with porcine dermis graft | 58 | Laparoscopic sacrocolpopexy with synthetic mesh | 62 |
| de Tayrac et al, 2008 | Infracoccygeal sacropexy | 24 | Sacrospinous suspension | 25 |
| Lo and Wang, 1998 | Abdominal colposacropexy | 66 | Sacrospinous ligament fixation | 72 |
| Dietz et al, 2010 | Vaginal hysterectomy | 31 | Sacrospinous hysteropexy | 35 |
| Benson et al, 1996 | Vaginal approach c | 48 | Abdominal approach d | 40 |
| Barber et al, 2014 | Sacrospinous ligament fixation | 186 | Uterosacral ligament suspension | 188 |
| Brubaker et al, 2006 | Abdominal sacrocolpopexy with Burch colposuspension | 157 | Abdominal sacrocolpopexy without Burch colposuspension | 165 |
| Iglesia et al, 2010 | Vaginal colpopexy repair with Prolift mesh | 32 | Traditional vaginal colpopexy without mesh e | 33 |
| Campagna et al, 2016 | Laparoscopic sacral colpopexy f | 50 | Laparoscopic sacral colpopexy g | 50 |
| Costantini et al, 2016 | Laparoscopic sacrocolpopexy | 61 | Abdominal sacrocolpopexy | 60 |
| Detollenaere et al, 2015 | Sacrospinous hysteropexy | 103 | Vaginal hysterectomy with uterosacral ligament suspension | 105 |
| El-agwany et al, 2015 | Abdominal sacral colpopexy | 15 | Laparoscopic sacral colpopexy | 15 |
| Nager et al, 2016 | Vaginal hysterectomy with native tissue vault suspension | N/A | Mesh hysteropexy suspension | N/A |
| Noe et al, 2015 | Laparoscopic pectopexy | 44 | Laparoscopic sacral colpocervicopexy | 41 |
| Rahmanou et al, 2015 | Laparoscopic hysteropexy | 37 | Vaginal hysterectomy | 35 |
| Rondini et al, 2015 | Abdominal sacrocolpopexy | 54 | High uterosacral vault suspension | 56 |
| dos Reis Brandao da Silveira et al, 2015 | Native tissue repair h | 90 | Prolift total vaginal mesh | 94 |
| Tan-Kim et al, 2015 | Minimally invasive sacrocolpopexy i with barbed suture | 32 | Minimally invasive sacrocolpopexy i with nonbarbed suture | 32 |
| van Ijsselmuiden et al, 2014 | Laparoscopic sacrohysteropexy | N/A | Vaginal sacrospinous hysteropexy | N/A |
a Two comparators were used in this study, which evaluated referent procedure (sacrospinous fixation) to posterior intravaginal slingplasty or sacrocolpopexy with 7 patients in each treatment arm
b Anterior colporrhaphy was performed by midline anterior vaginal incision, dissection of vaginal epithelial layer from fibromuscular layer, midline plication of fibromuscular layer with delayed absorbable material, optional excision of excess vaginal mucosa, and incision closure with delayed absorbable material–apical compartment prolapse (uterus, vaginal vault, or cervix) was treated according to surgeon preference–vaginal hysterectomy, modified Manchester Fothergill procedure, uterosacral vaginal suspension (McCall procedure), and sacrospinous ligament fixation techniques were all allowed–posterior colporrhaphy was performed through posterior midline vaginal incision, dissection of vaginal epithelial layer from fibromuscular layer, midline plication of fibromuscular layer with delayed absorbable material, optional excision of excess vaginal mucosa, and incision closure with delayed absorbable material–reconstruction of perineum was left to each surgeon’s discretion– mesh was not allowed
c Vaginal approach consisted of bilateral sacrospinous ligament vault suspension and vaginal paravaginal repair with permanent monofilament suture–vaginal hysterectomy, modified Pereyra urethropexy or autologous sling, McCall culdoplasty, and standard anterior colporrhaphy were performed as indicated
d Abdominal approach consisted of colposacral suspension and abdominal paravaginal repair with permanent monofilament suture–abdominal hysterectomy, Burch procedure or autologous sling, Halban culdoplasty, and Macer wedge-type anterior colporrhaphy were performed as indicated
e Uterosacral ligament suspension or sacrospinous fixation
f Laparoscopic sacral colpopexy using monopolar hook and conventional mechanical morcellation
g Laparoscopic sacral colpopexy using bipolar loop and bipolar morcellator
h Native tissue repair involved site-specific prolapse repair using nonabsorbable suture–right sacrospinous ligament fixation was used for apical prolapse
i Patients underwent either laparoscopic or robotic sacrocolpopexy based on clinical location.
Inclusion criteria
Apical prolapse was the primary inclusion criterion in the majority of studies (n = 26, 74.3%) ( Table 2 ). Anatomic definitions of clinically significant apical prolapse relative to the hymen used in these studies were: (1) apical prolapse >–1 cm (n = 13, 50.0%); (2) apical prolapse >+1 cm (n = 7, 26.9%); (3) apical prolapse (point C or D) >50% of total vaginal length (TVL) (–[TVL/2]) (n = 4, 15.4%); and (4) cervix/apex >0 cm (n = 2, 7.7%). Sixteen (45.7%) studies also required the presence of symptoms for inclusion.
| Reference | Anatomic inclusion criteria | Additional symptomatic inclusion criteria |
|---|---|---|
| Studies with apical support loss as inclusion criteria | ||
| Doganay and Aksakal, 2013 | Total uterine or cuff prolapse | None listed |
| Lopes et al, 2010 | Apical prolapse at stage ≥III | None listed |
| Qatawneh et al, 2013 | Apical prolapse at stage ≥III | Symptoms (not further described) |
| El-agwany et al, 2015 | Apical prolapse at stage ≥III | None listed |
| Lo and Wang, 1998 | Apical prolapse at stage ≥III | None listed |
| Campagna et al, 2016 | Anterior/apical prolapse at stage ≥III | None listed |
| Rondini et al, 2015 | POP-Q point C at ≥+1 cm | Symptoms (not further described) |
| Rane et al, 2004 | Apical prolapse at hymen or beyond | None listed |
| Maher et al, 2004 | Posthysterectomy apical prolapse to or beyond introitus | Symptoms (not further described) |
| Benson et al, 1996 | Cervical prolapse to or beyond hymen or vaginal vault inversion >50% of its length with anterior prolapse to or beyond hymen with paravaginal defect present | None listed |
| Nager et al, 2016 | POP-Q points Ba, Bp, or C >0 cm; uterine descent at least C >–[TVL/2] | Positive response to question 3 on PFDI-20 |
| Barber et al, 2014 | Prolapse at stage ≥II; or apical prolapse >–[TVL/2] | Symptoms (not further described) |
| Anger et al, 2014 | Prolapse at stage ≥II with apical prolapse to –[TVL/2] | Symptoms (not further described) |
| Culligan et al, 2013 | Apical prolapse at stage ≥II | None listed |
| Paraiso et al, 2011 | Posthysterectomy apical prolapse at stage ≥II | None listed |
| Roovers et al, 2004 | Apical prolapse at stage ≥II | None listed |
| Svabik et al, 2014 | Posthysterectomy, at least 2 compartment prolapse and apical prolapse at stage ≥II | Symptoms (not further described) |
| Maher et al, 2011 | Apical prolapse at stage ≥II | Symptoms (not further described) |
| Freeman et al, 2013 | Apical prolapse at stage ≥II | Symptoms (not further described) |
| Natale et al, 2010 | Apical prolapse at stage ≥II | Symptoms (not further described) |
| de Tayrac et al, 2008 | Apical prolapse at stage ≥II | Symptoms (not further described) |
| Dietz et al, 2010 | Apical prolapse at stage ≥II | Symptoms (not further described) |
| Detollenaere et al, 2015 | Apical prolapse at stage ≥II | Symptoms (not further described) |
| Rahmanou et al, 2015 | Apical prolapse at stage ≥II | Objectively verified on ICIQ-VS |
| van Ijsselmuiden et al, 2014 | Apical prolapse at stage ≥II | Symptoms (not further described) |
| Noe et al, 2015 | Prolapse at stage ≥II with apical defect a | Symptoms (not further described) |
| Studies without apical support loss as inclusion criteria | ||
| Alperin et al, 2013 | Leading edge above hymen | No prolapse symptoms based on validated questionnaires b |
| Costantini et al, 2008 | Prolapse at stage >II | None listed |
| Costantini et al, 2016 | Prolapse at stage >II | Symptoms (not further described) |
| dos Reis Brandao da Silveira et al, 2015 | Prolapse at stage >II | None listed |
| Brubaker et al, 2006 | Prolapse at stage ≥II | None listed |
| Iglesia et al, 2010 | Prolapse at stage ≥II | None listed |
| Withagen et al, 2011 | Recurrent prolapse at stage ≥II | None listed |
| Halaska et al, 2012 | Prolapse at stage ≥II | Objectively verified on validated questionnaires b |
| Tan-Kim et al, 2015 | None listed c | None listed |
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