Introduction

Pelvic floor disorders (PFD) are a conglomerate of conditions that affect a substantial portion of the female population. PFDs include female sexual dysfunction (FSD), urinary incontinence (UI), fecal incontinence (FI), and pelvic organ prolapse (POP). Prevalence of these conditions increases incrementally with age and weight. Research shows that 23.7% of women will report symptoms of at least one PFD [1]. PFDs can lead to functional and psychological burden on those affected. Therefore, many advances have been made in the management of such conditions ranging from conservative approaches such as lifestyle modifications, physiotherapy, and medications, to more invasive approaches.

Evaluation of patients with PFDs should include detailed history (medical and psychosocial), physical exam, and the diagnostics indicated for the specific chief complaint. Clinicians should also strive to assess the impact on the patient’s quality of life (QoL) [2].

As health care increasingly shifts toward evidence-based practices, more tools are emerging to allow practitioners to objectively measure the brunt of the symptoms and the outcome of the treatments. Patient-reported outcomes (PROs) is a term used to describe the patient’s perspective regarding his/her health, QoL, or functionality as it relates to a specific disease process or intervention. Patient-reported outcome measures (PROMs) are instruments used by the clinicians to measure PROs. The use of PROMs has become progressively more important with the transformation of health care toward a patient-centered holistic approach. PROMs also play an important role in clinical and pharmaceutical research to complement objective outcomes or serve as primary outcomes when objective outcomes cannot be measured [3].

In the pursuit of providing high-quality care and conducting robust research, many instruments have been developed to evaluate PROs. Some of these instruments are generic and applicable across multiple conditions such as the National Institute of Health (NIH) Patient-Reported Outcomes Measurement Information System (PROMIS®) which is derived from the World Health Organization (WHO) framework for self-reported health and evaluates pain, fatigue, emotional distress, physical functioning, social participation, and global health perception [4], while other instruments are condition-specific. In this article, we aim to examine the role of PROMs in the management of PFDs.

Material and Method

We conducted a Medline and PubMed search to identify all recent publications related to the use of PROMs in the management of PFDs from 2015 to 2018. Original studies and review articles were included. All articles related to male pelvic floor disorders were excluded. Keywords used for the search were “pelvic floor disorders,” “patient-reported outcomes measures,” “female sexual dysfunction,” “urinary incontinence,” “fecal incontinence,” and “pelvic organ prolapse.”

PROMs Development

Over the last decade, we have witnessed the development of hundreds of PROMs that are used by clinicians across different specialties. PROMs assist clinicians in providing personalized, effective, and compassionate care. They also serve a major role in clinical research trials [5].

PROMs generally fall into two major categories: generic and condition-specific. Generic PROMs are multidimensional, applicable across different specialties, and can assess wide range of populations. Condition-specific PROMs—on the other hand—are designed to assess the different aspects affected by a specific condition or a syndrome. Condition-specific PROMs can further be subdivided into screeners or in-depth questionnaires. Screeners allow the provider to determine if the patient is experiencing a specific problem. The multidimensional in-depth questionnaires allow further evaluation of the specific problem flagged by the screener. Figure 1 summarizes a stepwise approach for utility of PROMs with PFDs.

Fig. 1
figure 1

Approach to using PROMs in management of pelvic floor disorders

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The development of a new PROM is a complex, scientific, and time-consuming process. Coyne and Sexton describe the properties that PROMs need to demonstrate in order to be useful in practice or research: reliability, validity, and responsiveness. Reliability refers to the ability of producing similar results when repeated. Validity refers to the ability of measuring what is intended to be measured. Responsiveness is the ability to detect clinically meaningful change [6].

Urologists and urogynecologists have access to many generic and condition-specific PROMs that can be utilized in the clinical or research settings. Over the next sections, we will examine the most recent literature on the topic of PROMs utilization in females with sexual dysfunction (FSD), urinary incontinence (UI), fecal incontinence (FI), and pelvic organ prolapse (POP).

PROMs in Female Sexual Dysfunction

The Diagnostic and Statistical Manual of Mental Disorders

DSM V has reclassified the different disorders constituting FSD into three categories: sexual interest/arousal order, orgasmic disorder, and genitopelvic pain/penetration disorder. To be dysfunctional, these disorders must cause distress and occur over 75% of time over a 6-month period [7]. According to the literature, FSD affects roughly 40% of US women with 12–22% of all women reporting associated stress. Of the affected women, 64% will experience desire difficulties, 31% arousal difficulties, 35% orgasmic difficulties, and 26% sexual pain [8, 9]. Despite the prevalence of FSD, most health care providers fail to question their patients about their sexual health. This is in large part due to clinicians’ busy schedules, inadequate training in discussing the topic, and limited treatment options [10]. Sexual function questionnaires have provided a way for providers to breach this gap.

In 2016, Hatzichristou et al. highlighted the role of symptoms’ scales and questionnaires in the diagnosis of sexual dysfunction in males and females. In their review, the authors list over twenty questionnaires targeting the general population, specific groups (multiple sclerosis, prolapse, spine cord injury, etc.), treatment outcome, and sexual QoL [11]. Most FSD-PROMs address some but not all of the following domains: desire, arousal, frequency of sexual activity, receptivity, pleasure, satisfaction, orgasm, lubrication, pain, concerns, behaviors, and partner-related problems [12•]. Therefore, a detailed diagnostic interview including medical, sexual, psychosocial history, and a physical exam are imperative to choosing the appropriate questionnaires that will home in on the patient’s sexual problem(s). Selecting the appropriate measures lessens the burden on the patient and yields the most valuable results for the clinician making the time spent worthwhile.

In a study to develop a PROM to assess individual and relationship distress within the context of sexual dysfunction, Frost et al. utilized a revised version of female sexual distress scale (FSDS) [13]. The FSDS was developed in 2002 (20 items) and revised in 2008 (13 items) to measure stress related to sexual dysfunction in women. A score of 15 or greater on the FSDS is associated with sexual distress [14].

In another study, Li-Yun-Fong et al. investigated the association of sexual dysfunction with PFDs. Seven hundred and fifty-five women referred for PFDs were included in the study. The authors used the Short Personal Experiences Questionnaire (SPEQ) to assess the sexual function of the subjects. In this study, PFDs were associated with large burden of sexual dysfunction. However, factors not specific to PFDs (e.g., atrophy and partner issues) were more likely to be the larger contributor to sexual dysfunction [15]. The SPEQ is a 9-item measure that assesses: feelings for partner, sexual responsivity, sexual frequency, libido, dyspareunia, and partner problems. A cutoff score of 7 or below distinguishes with 79% specificity and sensitivity those with sexual dysfunction [16].

Finally, a large study of over 3500 US adults—utilizing the PROMIS® Sexual Function and Satisfaction measure (SexFS) version 2.0—found 62% of men and 43% of women believed sexual health is of high importance to their QoL [17]. The PROMIS® SexFS is a sophisticated measure developed by the NIH with 11 scored domains (interest in sexual activity, lubrication, vaginal discomfort, clitoral discomfort, labial discomfort, erectile function, orgasm ability, orgasm pleasure, oral dryness, oral discomfort, satisfaction) and six unscored item pools (screeners, sexual activities, anal discomfort, therapeutic aids, factors interfering with sexual satisfaction, bother). Respondents’ scores are rescaled to a T-score and compared to the mean scores of the US population with the higher score representing more of the scored domain (e.g., vaginal discomfort, lubrication). Researchers can customize the PROMIS® SexFS to select domains that are relevant to their studies to decrease the burden on the study subjects [18].

PROMs in Urinary Incontinence

According to the International Continence Society (ICS), UI is defined as the complaint of any involuntary leakage of urine. UI can be further subcategorized based on symptoms. Most common types of UI include: stress urinary incontinence (SUI), urge urinary incontinence (UUI), mixed urinary incontinence (MUI), postural urinary incontinence, continuous urinary incontinence, and unconscious (insensible) urinary incontinence [19].

The use of PROMs in UI is perhaps the most standardized among PFDs. In 1998, the ICS recognized the need for a simple universal questionnaire to measure PROMs across populations with different PFDs. The International Consultation on Incontinence Modular Questionnaire (ICIQ) is a multi-module instrument that contains different core and supplemental questionnaires. The ICIQ, is used to assess different PFDs’ impact on continence in different populations. The core modules include instruments for assessment of lower urinary tract symptoms (LUTS), diary of urinary events, vaginal symptoms, bowel symptoms, and UI.

Other core instruments target populations with specific symptoms such as nocturia, overactive bladder, spinal cord disease (in development), long-term catheters, and LUTS in children (in development). Supplemental QoL instruments can be used alone or as an “add-on” to the core questionnaires. They assess QoL and sexual problems as they relate to a specific dysfunction. QoL is assessed in relation to LUTS, vaginal symptoms (in development), bowel symptoms (in development), and pad use (validated in 2018) in separate questionnaires. Sexual problems in relation to LUTS are assessed in separate questionnaire. However, sexual problems assessment in relation to vaginal symptoms and bowel symptoms are included in the main core ICIQ module for the respective disorder [20•, 21].

The multifaceted ICIQ highlights the complexity of PFDs and their overlapping nature. Many instruments provide the clinician and the researcher with tools to personalize their care and narrow their research. Nystrom et al. compared the results of ICIQ instruments (UI-SF and LUTSqol) scores to Patient Global Impression of Improvement (PGI-I) after pelvic floor muscle training for SUI. Reduction in symptoms severity on the ICIQ-UI SF (4 items/0–21 total score) and ICIQ-LUTSqol (22 items/0–76 total score) correlated with improved PGI-I (single item/very much improved to very much worse) scores [22]. Karmakar also demonstrated a similar relationship between the ICIQ-SF and PGI-I in women who underwent mid-urethral slings for SUI or MUI. Lower ICIQ-UI SF symptoms scores (6/21 or lower) was likely to be associated with patient-reported successful surgical outcome on follow-up from 1 to 8 years [23].

PROMs in Bowel Dysfunction

It is not surprising that genitourinary dysfunction is often accompanied by bowel dysfunction given the interconnectedness of the pelvic organs anatomically and neurologically. High prevalence of bowel and anorectal disorders were reported in women with UI and POP. In a study of 300 women with UI or POP prevalence of constipation was 36%, anorectal pain disorder 25%, fecal incontinence (FI) 19%, irritable bowel syndrome (IBS) 19%, and diarrhea 6% [24]. The assessment of bowel function is a challenge for clinicians given the wide range of normal bowel functions among different individuals. This is evident by the obvious advances made in development of PROMs for urinary and sexual function when compared to bowel function.

Mohamed et al. examined many of the currently available PROMs for assessment of patients with FI and bowel evacuation difficulties [25•]. At the time of this review, PROMs available for assessment of bowel function fall under the recommendation of grade B or C (recommended or with potential respectively). There is an obvious lack of rigorously validated grade A (highly recommended) PROMs.

Like other pelvic disorders, the frequency of symptoms or severity of anatomical abnormality do not always correlate to the impact on the patient’s QoL. Therefore, most bowel function PROMs assess QoL. The ICIQ Bowel (ICIQ-B) is currently the most psychometrically robust instrument evaluating FI and its impact on the QoL. It is a 17-item questionnaire arranged in three domains: bowel pattern, bowel control, and QoL with 4 unscored items to evaluate issues important to the patient [26]. For constipation, the Patient Assessment of Constipation Quality of Life (PAC-QoL) questionnaire has demonstrated internal consistently, reproducibility, and responsiveness in multinational studies. It’s a 28-item instrument with four subscales (worries, physical discomfort, psychosocial discomfort, and satisfaction) [27].

Assessing PFDs often requires multiple PROMs to evaluate bowel, bladder, and sexual symptoms. Bordeianou et al. used the Fecal Incontinence Severity Index and Fecal Incontinence Quality of Life Scale, the Constipation Severity Instrument, Pelvic Floor Impact Questionnaire, Pelvic Organ Distress Inventory, and Urinary Distress Inventory to evaluate QoL of patients with FI and other PFDs. The study concluded that QoL correlates strongly with both fecal and urinary incontinence [28].

PROMs in Pelvic Organ Prolapse

POP is defined as the descent of one or more of the anterior vaginal wall, the posterior vaginal wall, the apex of the vagina (cervix/uterus), or vaginal cuff (after hysterectomy) [19]. POP correlates with increasing age and parity, and is often accompanied by bladder, bowel, and sexual dysfunction [1]. POP Quantification (POP-Q) system is an objective grading (0 to 4) system which clinicians use to communicate and document the degree of the anatomical deformity [29]. When symptomatic, incidence of POP ranges from 3 to 6%. When measured objectively using the POP-Q, incidence can reach 50% [30]. POP is typically under-reported due to its non-life-threatening course; however, it can significantly limit patients’ physical, social, and sexual lives. Evaluation of patients with prolapse should include a medical history and pelvic exam. Asymptomatic women do not require treatment. Those who have symptoms are offered intervention in a step-wise fashion from least to most invasive starting with observation, then pessary use, then surgical treatment [31].

Alex Digesu reviewed the several PROMs currently available for assessment of POP and its impact on QoL [32•]. The use of PROMs is essential in management of POP as the severity of prolapse does not always correlate with symptomology or the degree of impact on QoL [33]. The clinician must decide on the appropriate PROM based on their patient’s presentation and goals for seeking care. For example, a patient with additional bowel and bladder symptoms might benefit from a global questionnaire like the pelvic floor distress inventory (PFDI), the pelvic floor impact questionnaire (PFIQ), or pelvic organ prolapse/urinary incontinence and sexual function questionnaire (PISQ) which assess the impact of all pelvic floor disorders rather than a symptoms-specific questionnaire like prolapse questionnaire (P-QoL).

Balchandra and colleagues utilized the ICIQ-vaginal symptoms (ICIQ-VS) to study patient-reported outcomes following transvaginal mesh surgery for POP from 2009 to 2012 [34]. All 51 patients who complete the postoperative ICIQ-VS noted statistically significant improvement in most arms of the questionnaire. The ICIQ-VS is a 14-item instrument that evaluates the severity of POP symptoms (vaginal and sexual), measures their impact on the QoL, and evaluates treatment outcomes [35].

The use of PROMs will continue to play a larger role in research and clinical practice as the population of older women and prevalence of PFDs increase. In fact, the American Urogynecologic Society (AUGS) has initiated a large project in collaboration with industry manufacturers, the Food and Drug Administration (FDA), and other professional organizations to establish the Pelvic Floor Disorders Registry (PFDR). The aim of the volunteer registry is to collect, store, and analyze data related to POP treatment as well as provide a framework for research and quality improvement. PROs would be collected for 36 months for the PFDR protocols to determine treatment efficacy from the patient’s perspective [36, 37].

Conclusion

PROMs provide clinicians with an objective way to assess patients’ symptoms and QoL. They also provide researchers with objective research tools that are more informative and easier to analyze. For PROMs to be useful, they must provide an adequate amount of information to the clinicians or researchers without an unreasonable burden to the patient. Therefore, PROMs must be succinct while maintaining their psychometric properties (reliability, validity, and responsiveness to change).

In the realm of female PFDs, tens of PROMs exist to assess different aspects of the diseases. The decision of choosing the appropriate PROMs should depend on the patient’s symptoms and underlying pathology. The goals of care should always be reducing the symptoms and improving the QoL. As such, providers can utilize instruments to help them home in on the problem and track progress after intervention.