Int Urogynecol J DOI 10.1007/s00192-015-2720-y

ORIGINAL ARTICLE

Heterogeneity in post-intervention prolapse and urinary outcome reporting: a one-year review of the International Urogynecology Journal Dobrochna Globerman 1 & Magali Robert 1

Received: 23 January 2015 / Accepted: 15 April 2015 # The International Urogynecological Association 2015

Abstract Introduction This review aimed to examine post-intervention prolapse, incontinence, and overactive bladder outcome measures published in the International Urogynecology Journal over the previous year and to report on the heterogeneity in outcome reporting. Methods All original article abstracts published in the print version of the International Urogynecology Journal in 2014 were reviewed for possible inclusion. Those reporting on prolapse and/or incontinence and/or overactive bladder outcomes following a urogynecological intervention were analyzed. Articles were reviewed for all reported outcomes. Outcomes were categorized as primary or secondary and objective or subjective. Results Of 117 original articles published, 45 were reviewed. Among primary outcomes, 9 different outcomes were reported for prolapse and 11 for incontinence and overactive bladder. For prolapse, 6 different objective and 13 subjective outcomes were reported. For incontinence, 21 objective and 36 subjective outcomes were reported. Three different definitions were used for the outcome of Bprolapse cure,^ 3 for Bprolapse recurrence,^ and 4 for Bstress incontinence cure.^ Several validated and non-validated questionnaires in addition to single unvalidated questions were used to measure subjective outcomes.

Conclusions This research highlights the diversity in outcome reporting for prolapse, incontinence, and overactive bladder after an intervention in the last year of publications alone. This can lead to serious challenges in the generation of higher order evidence, such as systematic reviews and meta-analyses. As a subspecialty, we need to aim for more cohesive reporting so as to allow for robust comparison and evidence dissemination. Keywords Prolapse . Incontinence . Overactive bladder . Outcomes

Abbreviations CROWN Core Outcomes in Women’s Health ICIQ International Consultation on Incontinence Modular Questionnaire ICS International Continence Society IIQ Incontinence Impact Questionnaire IUGA International Urogynecology Association IUJ International Urogynecology Journal PFDI Pelvic Floor Distress Inventory PISQ Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire POPDI Pelvic Organ Prolapse Distress Inventory POPQ Pelvic Organ Prolapse Quantification SUI Stress urinary incontinence UDI Urinary Distress Inventory

Introduction * Dobrochna Globerman [email protected] 1

Division of Urogynecology, Department of Obstetrics and Gynecology, 1403 29 St NW, Calgary, AB T2N 2T9, Canada

The CROWN (Core Outcomes in Women’s Health) Initiative was developed as a means of promoting cohesiveness in the collection and reporting of outcomes in our field [1]. In particular, it can be quite challenging for systematic reviews and

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meta-analyses to draw significant conclusions when there is wide heterogeneity among outcome variables. Clinicians must also evaluate the literature and wade through conflicting papers that report on different outcomes. The development of a Bcore outcome set^ is needed to provide consistent evidence from which to draw conclusions. Urogynecology is a rapidly expanding subspecialty with a growing amount of research and evidence. This evolution has therefore generated an increasing number of outcomes that are being collected and reported. It is therefore crucial for this subspecialty to be represented in the CROWN Initiative, and fortunately the International Urogynecology Journal (IUJ) has recognized this [2]. First, to develop a core set of outcomes for this field, we need a platform of knowledge of the existing outcomes. From there, we can construct the core outcome set. Furthermore, it is not enough to report on the same outcomes if the tools to measure them and their definitions are different; thus, we need consistency in this as well. The main question this review set out to answer was how many outcomes and what type of outcomes have been published in the IUJ over a 1-year span, with regard to prolapse and incontinence/overactive bladder. We hypothesized that heterogeneity would be found in the outcomes reported in the field of urogynecology.

Materials and methods This retrospective review assessed all original articles published in the print version of the IUJ from January 2014 through December 2014. Two reviewers (DG and MR) independently screened all titles and abstracts. An article was considered for inclusion if it reported on prolapse and/or incontinence and/or overactive bladder outcomes after a urogynecological intervention (conservative, medical or surgical). Any articles not pertaining to humans were excluded. The lists generated from each reviewer were then compared for concordance. Those articles that were independently chosen by both reviewers were included for analysis. Where there was a discrepancy, articles were read in full and we came to an agreement by discussion whether the article should be included. Data gathered from each article included: author, title, type of study, primary and secondary outcomes or an absence thereof, number of objective and subjective outcomes reported per paper, and details of objective and subjective outcomes. All reported outcome measures were extracted from the abstract, results, and discussion sections of each article. Data from the relevant papers were extracted and entered into an Excel database.

Results From January 2014 until December 2014, 117 original articles were published in the print version of the IUJ. A total of 53 were screened as potentially appropriate for review. Fortythree of these articles were independently chosen by both reviewers (κ=0.81). From the total of 53, 7 were excluded (2 did not report prolapse or incontinence outcomes, 5 did not involve a urogynecological intervention). Thus, 46 original articles were included for analysis. During analysis, it became apparent that one article did not report prolapse or incontinence outcomes and was excluded. Therefore, we report the outcome results of 45 published articles [3–47]. Four articles involved a conservative urogynecological intervention, 3 involved a medical intervention, and 38 included surgical intervention. With regard to the primary aim of the studies, 18 examined prolapse outcomes primarily, 16 examined incontinence outcomes, and 6 looked at overactive bladder outcomes. Five articles looked at both prolapse and urinary outcomes as the primary goal. Out of 45 articles, 28 and 25 stated primary and secondary outcomes respectively. Thus, in 17 published papers, no primary outcome was identified. Primary outcomes for prolapse were published in 12 articles, and among these, 9 different outcomes were reported (Table 1). Ten different primary outcomes for incontinence were published in 16 articles (Table 1). Outcomes gathered from validated and nonvalidated questionnaires, patient interviews, and clinical history were considered subjective outcomes. The following were considered objective outcomes: re-operation rates, cough stress test, pad use, pad weight test, urodynamic findings, information from voiding diary, Pelvic Organ Prolapse Quantification (POP-Q) measurements, Baden–Walker grading, Bobjective cure,^ Bobjective recurrence,^ the need for medication, and treatment interval. Of 45 articles, 37 and 38 articles reported on objective and subjective outcomes respectively. Four articles reported on Bde novo stress urinary incontinence (SUI)^ or Brecurrent prolapse,^ where it was unclear how these were measured [3–6]. Three papers reported on outcomes that were a composite of objective and subjective measurements (de novo SUI, presence of SUI, prolapse cure) [7–9]. The average number of reported objective outcomes per paper was 1.8 (range 0–7) and the average number of subjective outcomes was 4.1 (range 0–21). Twenty different objective outcomes for incontinence were published in 23 articles and 6 objective prolapse outcomes were reported among 19 articles (Table 2). Three different objective definitions were used for Bprolapse cure,^ 3 for Bprolapse recurrence,^ and 4 for BSUI cure.^ For subjective outcomes, 36 urinary outcomes were published in 33 papers. Among the outcomes, 16 were the scores obtained from 16 different validated questionnaires. The most

Int Urogynecol J Table 1 Primary outcomes reported for prolapse and incontinence/ overactive bladder

Table 2 Reported objective outcomes for prolapse and incontinence/ overactive bladder

Condition

Number of articles reporting this outcome

Condition

Outcome

Number of articles reporting this outcome

1 3 2 1

Prolapse (19 papers)

POP-Q stage POP-Q in cm Baden–Walker grade Re-operation for prolapse Prolapse cure Prolapse recurrence Re-operation for SUI

5 7 1 9

Urodynamic stress incontinence CST Pad weight test Pad use/day SUI episodes/24 h SUI episodes/3 days UPR values SUI cure Frequency/24 h Nocturia/24 h

2

Prolapse (10 papers)

Outcome

Objective cure Objective recurrence/failure Subjective symptom cure Presence of prolapse symptoms Combined subjective/ objective cure Re-operation for prolapse POP-Q measurements PGI-I score POP-SS score Incontinence/ Objective cure overactive bladder Subjective cure (16 papers) Subjective improvement Re-operation for SUI Treatment failure Combined subjective and objective cure ICIQ-SF scores OLS questionnaire score OABq-SS score Change in opening urethral pressure

1 1 1 1 1 5 4 2 2 1 3

Incontinence/ overactive bladder (23 papers)

1 1 1 1

UUI episodes/24 h UUI episodes/3 days UUI episodes/7 days Mean cystometric capacity Maximum cystometric capacity Detrusor overactivity OAB cure Need for anticholinergics Botox interinjection interval

POP-Q Pelvic Organ Prolapse Quantification, PGI-I Patient Global Impression of Improvement, POP-SS Pelvic Organ Prolapse Symptom Score, SUI stress urinary incontinence, ICIQ-SF International Consultation on Incontinence Modular Questionnaire-Short Form, OLS O’Leary Sant, OABq-SS Overactive Bladder Questionnaire Symptom Severity

common questionnaires used were the Urinary Distress Inventory (UDI-6), the International Consultation on Incontinence Modular Questionnaire Short Form (ICIQ-SF), and the Incontinence Impact Questionnaire (IIQ-7). These scores were reported as outcomes among 12, 8 and 7 papers respectively. The remaining 20 outcomes published among 21 papers are represented in Table 3. In total, 64 different sources (validated and unvalidated questionnaires, clinical history, single unvalidated questions from questionnaires) were used to gather the data on the 36 incontinence outcomes. Thirteen subjective prolapse outcomes were reported among 18 papers. Ten of these outcomes were the scores from 10 different validated questionnaires. The Pelvic Organ Prolapse Distress Inventory (POPDI-6) was the most frequently used questionnaire (5 papers), followed by the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ12) and Pelvic Floor Distress Inventory (PFDI-20), which

3 3 12

8 1 3 1 1 1 7 3 3 2 1 1 2 2 1 1 2 1

POP-Q Pelvic Organ Prolapse Quantification, SUI stress urinary incontinence, CST cough stress test, UPR urethral pressure reflectometry, UUI urge urinary incontinence, OAB overactive bladder

were each used by 4 papers. The remaining 3 subjective prolapse outcomes are found in Table 3 and were published among 9 papers.

Discussion This review has provided insight into the number and types of outcomes reported within the last year of this journal as they pertain to prolapse and/or incontinence and/or overactive bladder.

Int Urogynecol J Table 3 Reported subjective outcomes for prolapse and incontinence/ overactive bladder (excluding outcomes represented by validated questionnaires) Condition

Outcome

Prolapse (9 papers)

Symptoms of prolapse Subjective prolapse cure QOL affected by prolapse Incontinence/ UI cure overactive UUI cure bladder SUI cure (21 Urgency cure papers) Urgency/OAB present UI present UUI present SUI present MUI present De novo urgency/OAB De novo UI Improved urgency/OAB Improved SUI Improved UI Frequency Nocturia Satisfaction Regret surgery for SUI UUI bother Frequency bother

Number articles Number tools used reporting to measure* 9

8

1

1

1

1

1 2 3 2 8

3 2 3 2 7

1 5 9 2 5

1 4 7 2 4

2

2

2

2

2 1 1 1 1 1

2 1 1 1 1 1

1 1

1 1

*Measured by clinical history, unvalidated questionnaire or unvalidated single question from validated questionnaire QOL quality of life, UI urinary incontinence, UUI urge urinary incontinence, SUI stress urinary incontinence, MUI mixed urinary incontinence, OAB overactive bladder

It is evident from this review that many different outcomes have been reported among different articles. In particular, there is a very wide range in the outcomes obtained for incontinence. Although not as drastic, there is also heterogeneity in published prolapse outcomes. For both, this is seen in the primary, objective, and subjective outcomes that have been chosen to represent the studies’ endpoints. It makes sense, therefore, that this could be a potential hindrance to comparison. Fortunately, the subspecialty of Urogynecology has the International Urogynecology Association (IUGA) and the International Continence Society (ICS), both of which have already defined and standardized several objective and

subjective outcomes for prolapse and incontinence/ overactive bladder [48–50]. Despite this, many other valid outcomes are outside the scope of the IUGA and ICS definitions. One of the most common outcomes, for example, is Bcure^ after an intervention. Diversity in this exists depending on its definition. Barber et al. pointed this out when they published a comparison of 18 different definitions to define the outcome of Bsuccess^ after prolapse surgery [51]. Depending on the definition used, success was achieved in 19.2– 97.2 %. This was also seen in our review, where many reported outcomes, although labeled the same (such as Bcure^) had several different definitions. In addition to the definitions that are used to describe an outcome, the tools used to measure the outcome are also a source of heterogeneity. For example, many subjective outcomes are reported from different validated and unvalidated questionnaires. In 2006, the authors of a systematic review found 8 validated quality of life questionnaires for incontinence [52]. In their paper, they discourage the development of new incontinence measures as it makes evidence synthesis impossible because of the lack of standardization. More recently in 2014, the European Urology Association reported that 21 such validated questionnaires now exist for incontinence symptom and quality of life measures [53]. Although many questions are similar among the questionnaires, not all are interchangeable for the purposes of a larger analysis. This creates further heterogeneity among the evidence. The fact that 17 of the papers evaluated in this review did not identify a primary objective for their studies is of concern. It is difficult to speculate why this may be the case, but perhaps this reflects a flaw in the original study methodology where the studies were not designed around a primary goal or question. It must be kept in mind that in order for outcomes and conclusions to be considered sound, we need to adhere to strict and proper study design. This problem could be remedied by requesting that trials be registered before being undertaken. A weakness of our review is that we only analyzed articles published in print in the IUJ and not all published research in the field of urogynecology. Thus, potentially more outcome variables could have been reported had we included all published articles in 2014. Despite this, we were able to demonstrate that much diversity exists in outcome variables, just within the last year. In addition, the IUJ should be representative of the field as it has an international Bvoice.^ Our goal was to report on the outcome variables and thus did not explore the definitions of outcomes in further detail. In order to publish robust systematic reviews and metaanalyses in this subspecialty, we need an international agreement among researchers to gather and report on a Bcore outcome set^. These outcomes should ideally bear in mind what is most important in the end, and that is the clinical reflection of the urogynecologic patient. This should perhaps include a

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minimum of a validated objective and subjective outcome. This is not to say that other interesting and valid outcomes cannot be generated and reported. Furthermore, as pointed out by Dwyer et al., the core set should evolve over time with the rapidly expanding nature of this subspecialty [2]. Lastly, core outcomes should be consistent in their measurement and definition. By highlighting that much heterogeneity exists among the reported urogynecologic outcomes for the two most common conditions, this review lends full support to the stand that the IUJ is taking by joining the CROWN Initiative. Financial disclaimer None. Conflicts of interest None. Authors’ contributions D. Globerman: data collection, data analysis, manuscript writing; M. Robert: project development, manuscript editing.

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