My Reconstrutive Female Surgery Has Fallen Again
Obstet Gynecol. Author manuscript; available in PMC 2010 Jul xv.
Published in final edited form as:
PMCID: PMC2904469
NIHMSID: NIHMS205621
Defining Success Subsequently Surgery for Pelvic Organ Prolapse
Matthew D. Hairdresser, Medico, MHS, Linda Brubaker, MD, MS, Ingrid Nygaard, MD, Thomas L. Wheeler, II, Doctor, MSPH, Joeseph Schaffer, Dr., Zhen Chen, MS, and Cathie Spino, DSc, for the Pelvic Floor Disorders Network
Abstract
OBJECTIVES
To draw pelvic organ prolapse surgical success rates using a variety of definitions with differing requirements for anatomic, symptomatic, or re-treatment outcomes.
METHODS
18 unlike surgical success definitions were evaluated in participants who underwent abdominal sacrocolpopexy inside the Colpopexy and Urinary Reduction Efforts trial. The participants' assessments of overall improvement and rating of handling success were compared betwixt surgical success and failure for each of the definitions studied. The Wilcoxon rank sum test was used to identify meaning differences in outcomes between success and failure.
RESULTS
Treatment success varied widely depending on definition used (19.2–97.two%). Approximately 71% of the participants considered their surgery "very successful," and 85.2% considered themselves "much amend" than before surgery. Definitions of success requiring all anatomic support to be proximal to the hymen had the lowest handling success (19.ii–57.6%). Approximately 94% achieved surgical success when it was defined as the absence of prolapse beyond the hymen. Subjective cure (absence of bulge symptoms) occurred in 92.1% while absenteeism of re-treatment occurred in 97.2% of participants. Subjective cure was associated with significant improvements in the patient'due south assessment of both treatment success and overall improvement, more so than whatsoever other definition considered (P<.001 and <.001, respectively). Similarly, the greatest difference in symptom burden and health-related quality of life every bit measured by the Pelvic Organ Prolapse Distress Inventory and Pelvic Organ Prolapse Impact Questionnaire scores between treatment successes and failures was noted when success was defined equally subjective cure (P<.001).
CONCLUSION
The definition of success substantially affects handling success rates after pelvic organ pro-lapse surgery. The absence of vaginal burl symptoms postoperatively has a pregnant relationship with a patient's cess of overall improvement, while anatomic success alone does not.
The lack of standardized definitions for surgical success following pelvic organ prolapse (POP) surgery has resulted in highly variable estimates of success.1 , ii Equally an initial step frontwards, the 2001 National Institutes of Health (NIH) Workshop on Standardization of Terminology for Researchers in Pelvic Flooring Disorders recommended arbitrary definitions for treatment success.3 , 4 The definition of "optimal anatomic outcome," designated as "cure," requires perfect anatomic support (Pelvic Organ Prolapse Quantification System [Pop-Q] stage 0) and "satisfactory anatomic outcome" requires support higher than ane cm proximal to the hymen. However, information now advise that 75% of women presenting for annual gynecologic exams without symptoms of Popular would not meet the definition of "optimal anatomic outcome" and near 40% would not meet the definition of "satisfactory anatomic outcome."5 Since the NIH Standardization Workshop, considerable variability in the definition of treatment success after surgery for prolapse still persists, making it difficult to compare study results.one , six – ix
The objective of this study was to describe different definitions of surgical success later surgery for stages two to 4 Popular in women undergoing abdominal sacrocolpopexy with or without Burch colposuspension enrolled in the Colpopexy and Urinary Reduction Efforts (CARE) trial.10 , xi Specifically, our objectives were to 1) describe how using different definitions affect estimates of treatment success; 2) evaluate how using different definitions touch comparisons of anatomic success between those who received a Burch colposuspension and those who did not; three) compare different definitions of surgical success by examining their relationship to patients' subjective assessments of improvement, treatment success, and improvements in wellness-related quality of life; and iv) assess which definitions of treatment success upshot in the to the lowest degree corporeality of missing data 2 years afterward surgery. Information from this study should aid in planning future trials of prolapse surgery including sample size estimates and hopefully will ultimately contribute toward the development of a consensus definition of success afterward surgical treatment of prolapse.
MATERIALS AND METHODS
We analyzed information from 322 women who completed 2-year follow-upwards in the Care trial, a randomized trial designed to evaluate whether a standardized modified Burch colposuspension, when added to abdominal sacrocolpopexy to care for Pop, improves urinary stress continence in women without preoperative symptoms of stress urinary incontinence.10 , 11 Each clinical site and the information analogous center received institutional review board approval for this trial, and all participants provided written informed consent.
The methods and main outcomes of this trial have been previously reported.10 , 11 Colpopexy and Urinary Reduction Efforts trial participants were assessed before surgery and at ii-year follow-upwardly for pelvic organ back up using the Pop-Q.iv In addition, pelvic symptoms and severity (Pelvic Floor Distress Inventory) forth with status-specific life impact (Pelvic Floor Touch Questionnaire) were measured via validated instruments.12 Two years afterward surgery, women rated the overall success of their treatment ("In your stance, has the treatment of your pelvic floor status been _______?") on a 4-point scale (very successful, moderately successful, somewhat successful, non at all successful) and similarly a global assessment of improvement ("Compared with how you lot were doing before your contempo pelvic floor operation, would you say that at present you are _______?") on a v-point calibration (much better, a picayune better, about the same, a little worse, much worse).
We created xviii unlike definitions of surgical success by using POP-Q assessments, responses to Pelvic Floor Distress Inventory questions regarding vaginal bulging, data on re-treatment (surgery or pessary), and participant'due south subjective ratings of overall treatment success and global improvement as listed in Table i. The proposed definitions of treatment success consist of those recommended in the NIH Standardization Workshop and several used past clinical trials or prospective cohorts evaluating treatment success subsequently prolapse surgery including one from an ongoing clinical trial being conducted by the Pelvic Flooring Disorders Network (the OPTIMAL Trial).1 , 2 , 7 – 9 , 13
Tabular array 1
Cure Rates and Rates of Missing Data for Different Definitions of Treatment Success ii Years Later Surgery
| Description | Criteria for Success | Cure Rate (%) | Missing Information (%) | |||
|---|---|---|---|---|---|---|
| Anterior and Posterior | Upmost | No Symptoms of Vaginal Bulge | No Re- handling (%) | |||
| Anatomic-based definitions | ||||||
| NIH "optimal" (Popular-Q phase 0) | Ba and Bp at −3 | C ≤ − (TVL-2) | 19.2 | 23.9 | ||
| NIH "optimal" noon and no anterior/posterior segment descent across the hymen | Ba and Bp ≤ 0 | C ≤ − (TVL-2) | 90.6 | 23.9 | ||
| NIH "satisfactory" (POP-Q phase 0 or 1) | Ba and Bp < −1 | C < −1 | 57.vi | 23.ix | ||
| "Optimal" noon but | NA | C ≤ − (TVL-2) | 95.five | 23.9 | ||
| "No descent beyond half-mode betoken of vagina" (Baden-Walker course 0 or 1) | Ba and Bp < −1 | C ≤ −1/ii * TVL | 57.6 | 23.9 | ||
| "No descent beyond the hymen" (Baden-Walker grade 0, 1, or 2) | Ba and Bp ≤ 0 | C ≤ 0 | 94.3 | 23.ix | ||
| NIH hybrid:"optimal" apex and "satisfactory" inductive/posterior segments | Ba and Bp < −ane | C ≤ − (TVL-two) | 56.three | 23.9 | ||
| Anatomic plus symptom based definitions | ||||||
| NIH "satisfactory" and no bulge symptoms | Ba and Bp < −1 | C < −i | Yeah | 53.3 | 23.six | |
| "No descent beyond the hymen" and no bulge symptoms | Ba and Bp ≤ 0 | C ≤ 0 | Yeah | 87.3 | 24.ii | |
| Failure=symptoms and Popular-Q phase 2 or greater | Ba and Bp < −1 or Ba and Bp < −i if no burl symptoms | C < −1 or C < +1 if no bulge symptoms | Yes* | 92.6 | 24.v | |
| "Optimal" apex simply plus no symptoms | NA | C ≤ − (TVL-2) | Yes | 87.three | 23.nine | |
| Beefcake plus symptom plus re-handling based definitions | ||||||
| NIH "satisfactory," no bulge symptoms, and no re-treatment | Ba and Bp < −1 | C < −i | Yes | Yes | 52.0 | 23.6 |
| "No descent beyond the hymen," no bulge symptoms, and no re-treatment | Ba and Bp ≤ 0 | C ≤ 0 | Yes | Aye | 84.9 | 23.9 |
| OPTIMAL Trial definition13 | Ba and Bp ≤ 0 | C ≤ −2/3 * TVL | Yeah† | Yeah | 83.6 | 24.two |
| Symptoms/subjective outcomes based definitions | ||||||
| Subjective cure (no bulge symptoms) | NA | NA | Yep | NA | 92.1 | nine.iii |
| Overall improvement="much better"‡ | NA | NA | NA | NA | 85.2 | 9.6 |
| Treatment considered "very successful"§ | NA | NA | NA | NA | 71.4 | 9.9 |
| Re-treatment only definition | ||||||
| No re-treatment|| | NA | NA | NA | 97.two | 0.0 | |
Definitions assessing anatomic outcomes used POP-Q measurements at ii-year follow-upwardly to define treatment success or failure. To evaluate definitions that used the Baden-Walker system,14 POP-Q measurements were used to approximate Baden-Walker grades 0–iii. For instance, handling success divers as Baden-Walker form 0, 1, or 2 translates into "no descent of the vaginal walls beyond the hymen" or POP-Q measurements Ba, Bp, and C less than or equal to 0. Treatment success defined equally Baden-Walker course 0 or 1 corresponds to "no vaginal descent beyond the half-way point of the vagina." For the noon, this translates into a POP-Q measurement of point C that does non descend more ane-half the full vaginal length (Indicate C less than or equal to 1/2 total vaginal length). For the anterior and posterior vaginal segments, there is no obvious directly translation to Pop-Q measurements, so we assigned the criteria for success for the inductive/posterior segments as Bp and Ba less than −1 for this definition of treatment success to all-time approximate the Baden-Walker arrangement.
Subjective cure was defined equally the absenteeism of vaginal bulge symptoms as indicated by a negative response at 2-yr follow-upward to the questions "Do you ordinarily have a sensation of bulging or protrusion from the vaginal area?" and "Do you usually have a bulge or something falling out that you can see or experience in the vaginal area?" from the Pelvic Floor Distress Inventory.12 We chose this definition of subjective cure as the patient's ability to see or feel a vaginal burl every bit the symptom about consistently related to the presence or absence of Popular.15
Re-treatment for Pop was defined as any reoperation or use of pessary for recurrent Pop over the 2-year follow-up period. Definitions of treatment success compositing anatomic outcomes, subjective cure, and/or re-treatment were also considered.
For each of 18 dichotomous definitions of handling success, the proportion of women who had a successful outcome was reported for all analyzed Intendance women. This cure rate was farther compared between the women who received a Burch colposuspension and those who did non for each proposed definition by using χ 2 or Fisher exact test. Additionally, the proportion of women with missing data that precluded a decision of success or failure for each definition was too determined. To evaluate the clinical relevance of each definition from a patient'south perspective, we examined the relationship of subjective assessment of treatment success and the global impression of comeback to unlike definitions of surgical treatment success by comparing the assessments between those who met the criteria of treatment success to those who did non. Likewise, the comparisons between surgical success and failure groups were performed on the scores of the prolapse scales of the Pelvic Flooring Distress Inventory and Pelvic Floor Touch Questionnaire (Pelvic Organ Prolapse Distress Inventory and Pelvic Organ Prolapse Impact Questionnaire). A clinically relevant definition of surgical success should demonstrate significantly better global impression of improvement, lower symptom carp (lower Pelvic Floor Distress Inventory scores), and higher health-related quality of life (lower Pelvic Floor Touch on Questionnaire scores) in handling successes than in failures. Mean and standard deviation were reported for the ordinal outcomes of subjective assessments and Pelvic Organ Prolapse Distress Inventory and Pelvic Organ Prolapse Impact Questionnaire scores, and the Wilcoxon rank sum test was used to place whatever pregnant difference in outcomes between success and failure. All reported P values were based on the two-sided statistical tests and intended to exist interpreted from a hypothesis-generating framework. The analyses were performed in SAS ix.i.3 for Windows (SAS Inc., Cary, NC).
RESULTS
3 hundred xx-two women were enrolled in Intendance with 157 women assigned to Burch colposuspension and 165 to the control grouping. All enrolled participants completed at least a portion of the 2-yr follow-up that allowed assessment of at least one definition of treatment success considered in this analysis; 53 women (16.v%) completed only questionnaire data at year ii, and 24 women (7.4%) simply provided data on re-handling. At baseline, thirteen.7% had stage 2 POP, 67.four% at phase 3, and 18.nine% at stage 4. One hundred twenty-six women (39.1%) had a history of surgery for Popular before enrollment in CARE. Further demographic information tin be establish elsewhere.10
Handling success varied widely depending on definition used (19.ii–97.ii%) (Table 1). Definitions of success requiring anatomic back up proximal to the hymen had the lowest treatment success (xix.two–57.six%). In contrast, 94.three% achieved surgical success when it was defined every bit the absenteeism of prolapse beyond the hymen. Subjective cure (absence of bulge symptoms) occurred in 92.i% while absenteeism of re-handling occurred in 97.2% of participants. Surgery was considered "very successful" by 71.4% of women, and 85.two% of women considered themselves "much better" than before surgery on the global impression of comeback. The distributions of maximum descent of the inductive, posterior, and upmost vaginal segments are displayed in Figure 1.
Distribution of the maximum descent of the anterior (A), apical (B), and posterior (C) vaginal segments 2 years after surgery. Pelvic organ prolapse quantification (Pop-Q) measurements are fabricated in 1-cm increments with descent to the hymen equal to 0, with negative numbers indicating back up proximal to the hymen, and positive numbers indicating prolapse beyond the hymen. Indicate Ba, maximum descent of inductive vaginal wall; point C, maximum descent of the cervix or vaginal cuff; point Bp, maximum posterior vaginal wall. Perfect anterior and posterior vaginal wall support corresponds to a value of -three for Ba and Bp, respectively. Corresponding Popular-Q stages are listed beyond the top.
Barber. Defining Success After Prolapse Surgery. Obstet Gynecol 2009.
Missing data were more frequent for definitions requiring Popular-Q values (24–25%) than for those requiring data from patient interview lonely (0–10%). No significant difference in successful treatment of Pop was institute in those women who received a Burch compared with those who did non for each of the 18 definitions considered (information not shown).
Figure ii demonstrates the relative size and overlap of the failures between 2 anatomic definitions of success (NIH satisfactory issue, "no prolapse beyond the hymen"), subjective cure, and the proportion requiring no re-treatment 2 years later on surgery in the 240 women who could provide data for all of these definitions. In this group, 45% failed to meet the NIH satisfactory anatomic criteria while 9% had prolapse beyond the hymen, ten% had symptoms of vaginal bulging, and four% required re-treatment for prolapse recurrence. Vaginal bulging symptoms were noted in 18.5% (twenty of 108) of those who did not run into the NIH satisfactory anatomic criteria and 64% (14 of 22) of those with prolapse beyond the hymen. Seventeen percent (four of 24) of participants with vaginal bulge symptoms had stage 0 or 1 pelvic organ support.
Venn diagram of failures rates (in parentheses) using 4 definitions of success: two anatomic definitions (National Institutes of Health [NIH] "satisfactory" anatomic result [pelvic organ prolapse quantification (POP-Q) stage 0 or 1] and "no descent beyond the hymen"), subjective cure, and no re-treatment. Universe marriage of N=240 represents the participants who have data on all four definitions of success in the diagram. In the Venn diagram, we assume whatever re-handling over the two-year follow-up also fails by every other definition every bit well.
Hairdresser. Defining Success Afterward Prolapse Surgery. Obstet Gynecol 2009.
A comparison of the subjective cess of treatment success and the global impression of improvement between treatment successes and failures for each definition considered is shown in Table 2. For each definition that was based solely on anatomic outcomes, we did not notice a significant departure in the patients' subjective assessment of treatment success or overall comeback betwixt those who were considered a surgical success and those considered failures (P=.09 –.99). In contrast, subjective cure (absenteeism of vaginal bulging symptoms) was associated with pregnant improvements in the patient'south assessment of both handling success and overall improvement, more than so than whatsoever other definition considered (P<.001 and<.001, respectively) When the absenteeism of bulge symptoms was combined with the NIH satisfactory anatomic outcome criteria (Popular-Q stage 0 and 1) to define treatment success, no significant relationship was noted between the patients' assessments of treatment success and overall comeback. In contrast, when the absence of bulge symptoms was combined with less strict anatomic criteria, significant relationships were noted (P≤.05 for each).
Table two
Relationship of Subjective Cess of Treatment Success and Global Impression of Improvement to Different Definitions of Surgical Treatment Success
| Cursory Description* | Subjective Assessment of Handling Success† | Global Impression of Improvement‡ | ||||
|---|---|---|---|---|---|---|
| Success | Failure | P | Success | Failure | P | |
| Anatomic-based definitions | ||||||
| NIH "optimal" (Popular-Q phase 0) | 1.39±0.69 | one.41±0.74 | .99 | ane.36±1.03 | i.25±0.69 | .xc |
| NIH "optimal" apex and no anterior/posterior segment descent across the hymen | 1.39±0.72 | 1.57±0.81 | .26 | one.28±0.79 | 1.24±0.44 | .32 |
| NIH "satisfactory" (Pop-Q stage 0 or 1) | 1.twoscore±0.72 | one.42±0.74 | .99 | i.31±0.86 | ane.23±0.sixty | .82 |
| "Optimal" apex only | i.41±0.73 | i.50±0.71 | .48 | ane.27±0.77 | i.30±0.48 | .24 |
| "No descent across one-half-way point of vagina" (Baden-Walker grade 0 or ane) | 1.twoscore±0.72 | 1.42±0.74 | .99 | i.31±0.86 | i.23±0.sixty | .82 |
| "No descent beyond the hymen" (Baden-Walker grade 0, 1, or 2) | i.39±0.71 | ane.77±0.93 | .09 | i.27±0.77 | ane.31±0.48 | .15 |
| NIH hybrid:" optimal"apex and "satisfactory"anterior/posterior segments | 1.40±0.73 | ane.42±0.73 | .eighty | i.31±0.87 | 1.23±0.59 | .68 |
| Anatomic plus symptom based definitions | ||||||
| NIH "satisfactory" and no bulge symptoms | 1.39±0.71 | ane.50±0.83 | .48 | ane.27±0.83 | 1.32±0.76 | .sixteen |
| "No descent beyond the hymen" and no bulge symptoms | 1.38±0.70 | 1.xc±1.05 | .004 | one.23±0.73 | ane.73±1.08 | <.001 |
| Failure=symptoms and POP-Q phase 2 or greater | ane.38±0.71 | 1.76±0.xc | .05 | ane.25±0.76 | ane.53±0.80 | .004 |
| "Optimal"apex only plus no symptoms | 1.38±0.71 | one.xc±1.01 | .002 | 1.23±0.73 | 1.77±ane.07 | <.001 |
| Beefcake plus symptom plus re-treatment based definitions | ||||||
| NIH "satisfactory," no bulge symptoms, and no re-treatment | i.39±0.71 | 1.49±0.82 | .48 | 1.25±0.77 | 1.35±0.83 | .10 |
| "No descent beyond the hymen," no burl symptoms, and no re-handling | 1.38±0.71 | 1.79±1.01 | .01 | 1.22±0.69 | 1.74±1.17 | <.001 |
| OPTIMAL Trial definitionthirteen | 1.38±0.71 | ane.73±0.96 | .02 | 1.23±0.lxx | i.68±ane.14 | <.001 |
| Symptoms only definition | ||||||
| Subjective cure (no bulge symptoms) | 1.37±0.69 | 2.09±one.06 | <.001 | ane.22±0.70 | 1.96±ane.15 | <.001 |
| Re-treatment only definition | ||||||
| No re-handling | i.42±0.75 | 1.43±0.79 | .98 | 1.26±0.73 | 2.00±1.60 | .05 |
A comparison of the Pelvic Organ Prolapse Distress Inventory and Pelvic Organ Prolapse Impact Questionnaire scores between those who met the criteria for treatment success and those who did non for each definition considered is shown in Table 3. The greatest difference in symptom brunt and health-related quality of life every bit measured by the Pelvic Organ Prolapse Distress Inventory and Pelvic Organ Prolapse Impact Questionnaire scores between treatment successes and failures was noted when success was defined every bit subjective cure (−55 and −29 points, respectively, P<.001). Each of the 7 definitions that combined anatomic criteria with absenteeism of vaginal burl symptoms to define success demonstrated significantly less symptom burden in treatment successes than in failures compared with only ii of the seven definitions that used anatomic criteria alone. Health-related quality of life every bit measured by Pelvic Organ Prolapse Impact Questionnaire was significantly improve in treatment successes than failures in four of seven definitions that combined subjective cure with anatomic criteria but in none of the definitions that used anatomic criteria alone. When the NIH optimal anatomic outcome was used, health-related quality of life was significantly worse in treatment successes than in failures (difference in Pelvic Organ Prolapse Impact Questionnaire: +10.5, P=.02).
Table 3
Relationship of Pelvic Organ Prolapse Distress Inventory and Pelvic Organ Prolapse Impact Questionnaire Scores to Dissimilar Definitions of Surgical Treatment Success
| Brief Clarification* | Pelvic Organ Prolapse Distress Inventory | Pelvic Organ Prolapse Impact Questionnaire | ||||||
|---|---|---|---|---|---|---|---|---|
| Success | Failure | Mean Difference | P | Success | Failure | Mean Difference | P | |
| Anatomic-based definitions | ||||||||
| NIH "optimal" (POP-Q phase 0) | 29.8±42.7 | 30.three±39.8 | −0.4 | .5 | 17.35±44.18 | 6.89±xix.73 | 10.46 | .02 |
| NIH "optimal" apex and no anterior/posterior segment descent beyond the hymen | 29.76±40.61 | 34.55±37.16 | −4.79 | .4 | ix.37±27.40 | 3.61±8.13 | v.75 | 1.0 |
| NIH "satisfactory" (Pop-Q phase 0 or 1) | 28.78±42.66 | 32.12±36.90 | −three.34 | .03 | 11.38±31.64 | 5.38±15.84 | half dozen.01 | .7 |
| "Optimal" apex only | xxx.31±forty.64 | 27.74±31.57 | ii.57 | .8 | 8.99±26.72 | 5.fifty±xi.59 | 3.48 | .7 |
| "No descent beyond half-fashion bespeak of vagina" (Baden-Walker grade 0 or 1) | 28.78±42.66 | 32.12±36.90 | −three.34 | .03 | eleven.38±31.64 | 5.38±fifteen.84 | 6.01 | .7 |
| "No descent beyond the hymen" (Baden-Walker grade 0, ane, or 2) | 29.52±xl.28 | 41.16±39.68 | −11.64 | .2 | ix.09±27.00 | v.06±9.65 | 4.03 | .5 |
| NIH hybrid: "optimal" apex and "satisfactory" anterior/posterior segments | 29.34±42.96 | 31.30±36.69 | −i.96 | .07 | xi.64±31.95 | 5.22±15.63 | vi.42 | .six |
| Anatomic plus symptom-based definitions | ||||||||
| NIH "satisfactory" and no bulge symptoms | 25.80±38.89 | 38.37±46.47 | −12.57 | .001 | viii.90±27.57 | 11.76±35.24 | −2.86 | .2 |
| "No descent beyond the hymen" and no bulge symptoms | 26.65±37.68 | 65.78±59.32 | −39.14 | <.001 | seven.59±24.20 | 27.87±58.01 | −20.27 | <.001 |
| Failure=symptoms and Popular-Q phase 2 or greater | 28.23±forty.08 | 54.43±35.07 | −26.20 | <.001 | 9.12±27.24 | 5.67±viii.87 | iii.45 | .06 |
| "Optimal" apex only plus no symptoms | 26.84±37.74 | 65.67±lx.16 | −38.83 | <.001 | seven.58±24.x | 29.34±59.74 | −21.75 | <.001 |
| Anatomy plus symptom plus re-treatment-based definitions | ||||||||
| NIH "satisfactory," no bulge symptoms, and no re-treatment | 25.88±39.x | 37.95±46.16 | −12.06 | .002 | 8.49±27.17 | 12.xv±35.37 | −three.66 | .2 |
| "No descent beyond the hymen," no bulge symptoms, and no re-treatment | 26.93±37.91 | 58.71±58.44 | −31.78 | <.001 | vii.39±23.96 | 26.19±55.eighteen | −18.79 | <.001 |
| OPTIMAL Trial definition | 27.72±38.36 | 52.72±58.05 | −24.99 | .007 | 7.53±24.eighteen | 24.24±53.twoscore | −16.71 | .002 |
| Symptoms/Subjective outcomes-based definitions | ||||||||
| Subjective cure (no bulge symptoms) | 25.79±36.ninety | 81.75±59.70 | −55.96 | <.001 | 7.12±22.75 | 36.77±65.28 | −29.66 | <.001 |
| Overall comeback= "much better" | 25.27±38.85 | 57.60±47.90 | −32.33 | <.001 | half-dozen.forty±21.87 | 28.07±53.68 | −21.67 | <.001 |
| Treatment considered "very successful" | 20.72±33.xiii | 52.82±51.66 | −32.10 | <.001 | 4.38±16.71 | 20.l±43.16 | −16.12 | <.001 |
| Re-handling simply definition | ||||||||
| No re-treatment | 29.52±40.77 | 54.39±70.04 | −24.87 | .4 | eight.66±27.63 | 38.47±64.78 | −29.81 | .three |
Word
In this study, nosotros demonstrated that cure rates 2 years after abdominal sacrocolpopexy vary dramatically depending on the definition of treatment success used. Almost three-fourths of participants considered their surgery "very successful," re-treatment was uncommon (2.eight%), and less than x% of participants complained of symptomatic vaginal bulging postoperatively, yet cure rates using strict anatomic criteria such every bit those found in the NIH Workshop definitions of optimal and satisfactory anatomic outcome were only 19% and 57%, respectively. Cure rates using definitions with less stringent anatomic criteria for all segments or that considered just support of the vaginal noon were appreciably college (xc.vi–95.5%) and more than consequent with subjective cure rates. This is consistent with a contempo systematic review of sacrocolpopexy in which the success rates ranged from 58% to 100%; studies with the lowest success rates divers success using more than stringent anatomic support while those with the highest success rates generally used subjective outcomes such as satisfaction and resolution of POP symptoms.7 , 20 – 22
The NIH Workshop recommended that, until more data became available, merely the consummate absence of prolapse should be considered "normal"; hence their recommendation for the optimal anatomic outcome.three More data is at present available, about the relationship between pelvic organ back up and symptoms. Most symptoms often attributing to Pop accept at best weak-to-moderate correlations with worsening pelvic organ support; nonetheless, the one symptom that is near consistently acknowledged by patients with advanced POP is the presence of a vaginal bulge that can be seen or felt.xv , 23 – 26 Additionally, the hymen seems to be an important "cut-off signal" as women with prolapse beyond the hymen have more pelvic flooring symptoms and are more than likely to report a vaginal burl than women with prolapse at or to a higher place the hymen.5 , 15 , 23 – 26
In addition, we now know that the bulk of women presenting for routine care or evaluated in population-based research demonstrate some loss of vaginal or uterine support on pelvic exam and iii–half dozen% have descent of the prolapse beyond the hymen.5 , 27 Given this, the NIH Workshop definitions of optimal (POP-Q stage 0) and satisfactory anatomic issue (Pop-Q stage ane) no longer seem appropriate because a substantial proportion of women in the general population without symptoms of Popular would non meet these criteria.
Ane of the most important findings in our study is that definitions that included the absence of vaginal bulge symptoms had the strongest relationships with the patients' assessment of overall improvement and treatment success as well equally improvements in symptom bother and wellness-related quality of life. Few of the definitions using anatomic criteria lone to define treatment success demonstrated any such relationships, and when they did they were relatively weak. Thus, every bit a full general rule, definitions of treatment success that require patients be gratuitous of vaginal bulging symptoms postoperatively are more clinically relevant and meaningful to the patient than those that include only anatomic criteria to define success. This, in our stance, is a strong argument for including the absence of vaginal burl symptoms in any consensus definition of success after treatment of Pop. Notwithstanding, paradoxically, 17% of participants in our population who reported vaginal bulge symptoms demonstrated good anatomic support (stages 0 or 1). Further enquiry is necessary to sympathize the origin and clinical significance of these symptoms.
The clinical relevance of stage 2 prolapse that is asymptomatic is unclear. If a loftier proportion of women with phase 2 Popular postoperatively progress over time and require further surgery and if the same is non true for women with stages 0 or one prolapse, then early on anatomic differences proceeds greater clinical significance; if the rate of symptomatic progression in this group is depression and then the differences seen are less clinically meaningful. Surgical trials with long-term follow-up are disquisitional to determine the clinical relevance of this group.
In conclusion, an ideal result measure out should be valid, reliable, responsive, easily assessed, easily interpreted, and clinically relevant. Good outcome measures are essential to compare one handling with another, to compare our own results with those of some other and, perhaps about chiefly, to counsel our patients finer, realistically, and honestly using outcomes that are relevant to the individual patient.16 The results of this study along with the emerging literature on the distribution of pelvic support loss in the general population and information on the relationship between pelvic organ support loss and symptom development atomic number 82 us to make the post-obit recommendations: 1) whatsoever definition of success after POP surgery should include the absence of burl symptoms in improver to anatomic criteria and the absence of re-handling and 2) using the hymen as a threshold for anatomic success seems a reasonable and defensible arroyo. However, this approach should be revisited when we take an agreement, based on a larger body of long-term information, of the significance, or lack thereof, of asymptomatic phase ii POP 1–2 years after surgery. Farther studies are likewise needed to sympathise the significance of recurrent apical compared to anterior or posterior vaginal support defects. An anterior vaginal wall supported 2 cm above the hymen has dropped i cm from "perfect," while an apex supported ii cm above the hymen has dropped 5 cm or more, yet both are currently categorized as phase one Pop. Equally more information get available well-nigh the issues discussed above, surgeons will exist able to improve on definitions of success to create a valid and reproducible surgical outcome measure. In the meantime, when counseling women nearly surgical success rates for a given process, surgeons should describe "success" using a patient perspective to ensure a mutually agreeable definition of an acceptable issue before the intervention. Perioperative goal setting and achievement may augment this patient-surgeon communication.
Acknowledgments
Supported by grants from the Eunice Kennedy Shriver National Found of Child Health and Human being Development; National Institute of Diabetes, Digestive and Kidney Diseases; and the National Institutes of Health Part of Inquiry on Women's Health (U01 HD41249, U10 HD41250, U10 HD41261, U10 HD41267, U10 HD54136, U10 HD54214, U10 HD54215, and U10 HD54241).
Footnotes
Presented at the 2009 Annual Coming together of the Society for Gynecologic Surgeons in New Orleans, Louisiana, March 30 to April one, 2009, and at the 2009 Annual Coming together of the American Urological Association in Chicago, Illinois, April 25–xxx, 2009. To be presented the 2009 International Continence Society Annual Meeting in San Francisco, California, September 29 to Oct 3, 2009.
Financial Disclosure
Dr. Brubaker is a consultant and study investigator for Pfizer (New York, NY). Dr. Schaffer has served on the speaker's bureau and national advisory board for Astellas (Toyko, Japan) and GlaxoSmithKline (Philadelphia, PA). The other authors did not report any potential conflicts of interest.
CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, {"type":"clinical-trial","attrs":{"text":"NCT00065845","term_id":"NCT00065845"}}NCT00065845.
LEVEL OF EVIDENCE: 2
References
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