With the most recently established definition of OABS in 2011, urgency is now regarded as the most pivotal symptom of OABS and, therefore, is essential to evaluate and often the focus of further physician investigations [2, 3, 10, 12]. Possible etiologies for urgency include spontaneous smooth muscle cell contractions, structural changes in the bladder wall, altered release of neurotransmitters acting on smooth muscle or nerves, and altered central nervous system communication with the bladder [18]. Like all symptoms that may be present in OABS, however, urgency poses a challenge for physicians due to its subjective nature and the difficulties associated with ensuring that patients understand what it really means [2, 3, 9–12]. While the exact mechanisms of how urgency is perceived remain unclear, it is critical to differentiate between pathological “urgency” and the physiological “desire to void” that occurs during normal bladder filling [2, 3]. As the bladder fills with volume, an appropriate physiological response (urge) takes place as individuals without symptoms are able to tolerate increases of intensity in their desire to void and defer voiding up to a certain point [3]. At maximal bladder volume, and thus maximal intensity to void, voiding will take place and the regular cycle continues [3]. However, once a sudden, compelling desire to void occurs, which is difficult to defer, patients are experiencing urgency, begin to urinate more frequently (with smaller volumes and at nighttime) and may do so involuntarily [3]. Thus, it is essential to evaluate urgency appropriately so that effective treatment methods can relieve patients of these bothersome symptoms.

The first two subjective tools developed were the Indevis Urgency Severity Scale (IUSS) and the Urgency Perception Scale [10]. Based on the perception that urgency can be perceived differently amongst patients, efforts were made via the IUSS to help distinguish how severe the urgency was on a 4-point qualitative scale. During a clinical trial performed in 2003 [19], patients were asked to rate the severity of their urgency before voiding on a scale from 0 to 4 where 0 represented no urgency, 1 represented mild severity with awareness of urgency but easily tolerated and interruption of daily activities, 2 represented moderate severity with enough urgency/discomfort to interfere with daily activities, and 3 represented the most severe with extreme urgency discomfort that stops the ability to perform all activities [19]. Inclusion criteria for the trial included patients who voided greater than ten times per day and had greater than one urgency incontinence episode per day [19]. The IUSS was later validated in a 12-week randomized controlled clinical trial of trospium chloride in 658 patients with overactive bladder symptoms [20].

The Urgency Perception Scale, which must not be confused with the Urgency Perception Score, represents a subjective assessment of a patient’s perception of urgency (with or without incontinence) using a 3-point scale [21]. Patients are asked to describe what they feel when they experience the desire to pass urine [10]. The three responses can be described either as (1) where the patient reports they are usually not able to hold urine (urgency incontinence), (2) where the patient reports they usually able to hold their urine until they reach the toilet if they go immediately (urgency), and (3) where the patient reports they are usually able to finish what they are doing before going to the toilet (first desire to void) [10]. Although not validated in patients with urinary symptoms, construct validity of the Urgency Perception Scale was established by correlating scores with clinical and patient assessment data from three different clinical trials assessing efficacy of tolterodine in patients with overactive bladder symptoms [21–23].

More recently, other subjective tools have been developed. The Urgency Perception Score is a single-item questionnaire developed to grade urgency based on determining why individual patients choose to void as opposed to use as an index of severity and frequency of urgency episodes [10]. Patents are asked “What is the reason that you usually urinate?” and each response represents a 5-point grading scale that includes 0, which represents voiding out of convenience (no urgency), 1, which represents voiding with delay of an hour (mild urgency), 2, which represents voiding with delay of 10–60 min (moderate urgency), 3, which represents voiding with delay no longer than 10 min (severe urgency), and 4, which represents voiding because of desperate urgency (must stop and go void immediately) [10]. The UPS has been validated in asymptomatic volunteers, patients with lower urinary tract symptoms and patients with OABS through clinical trials evaluating the efficacy of tolterodine extended-release capsules and tolterodine with tamsulosin [24]. With proven test–retest reliability, the UPS represents a clinically useful measure of grading urgency [10].

Perhaps the most used and validated subjective tool for assessing urgency in drug development programs has been the Patient Perception of Intensity of Urgency Scale (PPIUS). The PPIUS asks patients to rate the level of urinary urgency for each void using a 5-point scale [10]. With each void recorded, patients rate the degree of associated urgency ranging from 0, described as no urgency—no feeling of need to empty bladder, but did for other reasons, to 3, described as severe urgency—could not postpone voiding, but had to rush to the toilet in order to avoid wetting oneself, or 4, described as urge incontinence—leakage before arriving to toilet [10]. The content validity and test–retest reliability of PPIUS has been tested in both non-interventional [25] and interventional [26–28] studies including healthy volunteers and patients with urinary symptoms/overactive bladder. Clinical trials assessing the efficacy of solifenacin, mirabegron, and the oxybutynin patch have used the PPIUS and indicated it shows good test–retest reliability and responsiveness [26–28]. Also it was demonstrated to have good value in assessing improvements in major OAB symptoms through correlated changes in PPIUS scores related to patients’ perception of bladder condition [26–28]. A recent group from the United Kingdom has worked on incorporating the PPIUS with frequency in efforts to assess two of the major storage symptoms as a single measure [29]. This combination of a subjective urgency assessment with the objective count of urinary voids, termed a Total Urgency and Frequency Score (TUFS) , has been tested and validated in patients with OAB [10]. Patients report urgency intensity using the PPIUS with every void and record the number of voids per day in their urinary diary [10]. The PPIUS scores are added to every void and then divided by the total number of days recorded in their diary [10]. While relying on patients to complete their diaries accurately, TUFS has produced favorable results in ongoing clinical trials. Through use in the BLOSSOM [27], SUNRISE [29], SATURN [30], and NEPTUNE [31] trials, TUFS has been shown to have good psychometric properties with high responsiveness and is a useful tool for assessing improvements in major OAB symptoms [10].

Lastly, a unique questionnaire has been developed that couples the assessment of severity of urgency with its impact on quality of life, regardless of the patient’s continence status [2]. The Urgency Severity and Life Impact Questionnaire (USIQ) is a 13-question instrument that is divided into a 5-question part examining symptom severity and another 8 question part evaluating the impact of urgency of quality of life (see Fig. 10.2). For both assessments, scores range from 0 to 100 where higher scores correlate with more severe urgency symptoms and a greater impact of such symptoms on quality of life [2]. Validation studies have shown that the USIQ has excellent internal consistency as well as good construct, face, and discriminatory validity [2]. Also, after testing the questionnaire in a controlled trial of symptomatic patients receiving treatment with tolterodine, it was found that the USIQ had excellent test–retest reliability and demonstrated responsiveness following OAB treatment [2].

The effect of OABS on quality of life is significant. Over the past 20+ years, there have been several questionnaires developed and targeted towards assessing the impact of disease on quality of life. Many are used across a wide variety of disease spectrums while others are tailored specifically to urinary tract symptoms. This assessment is essential for physicians to help identify patients in need of immediate therapy, improve their symptoms with various treatment methods, and follow how successful their course of therapy is.

The Urogenital Distress Inventory (UDI), one of the first significant questionnaires developed in the United States in the early 1990s, assesses the amount of distress associated with incontinence and other urinary symptoms [32]. The subjective tool asks about 19 urinary symptoms and patients rate the degree to which these symptoms are troubling to them [32]. The UDI is highly recommended and has been shown to have high validity, reliability, and responsiveness in various populations of women with bladder symptoms before and after treatment [32–34]. A shorter form, UDI-6, has also been developed and has shown equal efficacy in trials [35, 36]. Continued improvements to the UDI are ongoing, and it is now being tested in the male population.

The King’s Health Questionnaire (KHQ), available in 26 languages, is another tool that was first developed in London and consists of three major parts [37]. The first part tests the patient’s general health and health related to urinary symptoms [37]. The second part includes 19 questions divided into seven domains of quality of life: incontinence impact, role limitations, physical limitations, social limitations, personal relationships, emotions, sleep and energy, severity of coping measures, and symptom severity [37]. The third part includes 11 questions assessing the impact/severity of such symptoms [37]. Similar to the UDI, the KHQ is highly recommended and has been shown to have excellent reliability and validity for women [38–40]. The KHQ also has proven reliability and validity for use in assessing lower urinary tract symptoms in men.

A questionnaire targeted towards the psychosocial impact of urinary symptoms in women was developed and named the Incontinence Impact Questionnaire (IIQ) [32, 41]. The tool consists of 30 questions, 24 related to the degree to which the symptoms affect regular activities and 6 related to feelings caused by them. Scores are added and divided into clusters pertaining to effect on physical activity, travel, social relationships, and emotional health [32]. The IIQ has been tested in several studies including use in incontinent women treated with oxybutynin, tolterodine, or behavioral interventions and has been shown to have good levels of reliability and validity [42, 43].

CPP is defined by the American College of Obstetricians and Gynecologists (ACOG) as localized, noncyclic, pain that persists for 6 months or more and causes a loss of function [44]. CPP affects up to 24 % of women who are of reproductive age and often requires pharmacologic or surgical intervention, which may not ultimately treat the patient’s complaints as pain recurrence is likely [45–47]. The etiology of CPP is unclear as it is thought to result from a complex interplay between gynecologic, urinary, gastrointestinal, neurological, musculoskeletal, and psychological systems [45]. What is certain, however, is the negative effect of CPP on quality of life. Patients with CPP suffer tremendously and have associated stress that affects their marital, social, professional, and sexual lives [45, 46, 48]. Thus, improvement of quality of life is the primary goal in treating patients with CPP [48]. With the aid of subjective instruments such as questionnaires, physicians can appropriately assess the impact of CPP in patients and manage outcomes of their therapeutic interventions. The most recent systematic review of quality of life instruments used in studies of CPP identified a need for the development and evaluation of more specific instruments to assess pelvic pain [48]. Only 19 eligible articles studying use of questionnaires were identified from the 187 articles retrieved after a thorough electronic database search. Of those identified, three of the reports had been studying disease-specific instruments, which were not patient generated and instead developed based on reports from other health professionals [48]. It was determined that, in general, the quality of life instruments reviewed have poor clinical face validity [48]. With regard to the disease-specific questionnaires, compliance with matters of importance to patients varied and only one demonstrated reasonable compliance with quality criteria [48, 49].

Painful bladder syndrome (PBS)/interstitial cystitis (IC ) was initially defined by the International Society of Bladder Pain Syndrome in 2005 as “the complaint of suprapubic pain related to bladder filling, accompanied by other symptoms, such as increased daytime and night-time frequency, in the absence of proven urinary infection or other obvious pathology” [50]. Currently, the European Society for the Study of Bladder Pain Syndrome favors the use of the term “Bladder Pain Syndrome” instead of PBS or IC [51]. This syndrome may be included as a form of CPP in patients and differs from OABS such that pain is the predominant symptom and is occurring in association with bladder symptoms. Parsons and colleagues [52] surveyed several studies in 2007 and reported that BPS has a prevalence of 197 for every 100,000 women over the last 10 years, which was deemed a substantial underestimation of its true prevalence, and affects women more often than men. However, the specific etiology is still uncertain as there is still no absolute definition on how to classify BPS. Genetics, prior pelvic surgery, glycosaminoglycan layer defects, nitrogen oxide metabolism, and autoimmunity have all been linked as possible causes [50].

Various subjective tools have been used and evaluated in the assessment of patients complaining of symptoms of BPS. In efforts to address the initial need for developing broad symptom indexes specifically for BPS, O’Leary and colleagues [53] developed the Interstitial Cystitis Symptoms Index (ICSI) and Interstitial Cystitis Problem Index (ICPI) (see Fig. 10.2). Based off of a 10-year clinical experience with over 400 patients at a New England IC clinic and after statistical validation, these tools were believed to be beneficial in IC management and facilitate clinical research [53, 54]. Both indexes contain questions that address each of the symptoms of frequency, urgency, nocturia, and bladder pain. The two indexes differ, however, in that the ICSI assesses the level of severity of symptoms directly while the ICPI assesses the degree of problem caused by each symptom [53, 54]. Questions such as “have you experienced pain or burning in your bladder” versus how much has “burning, pain, discomfort or pressure in your bladder” been a problem for you, are answered based on a scale of 0–4 where 0 represents either “not at all” or “no problem at all” and 4 represents “almost always” or “big problem,” respectively [53, 54]. Both the ICSI and ICPI have been shown to demonstrate excellent ability to differentiate characteristics between patients and controls [54]. The ICSI has also been shown to be responsive to changes in patient condition after use in a clinical trial with pentosan polysulfate sodium [55].

While condition-specific tools such as the ICSI or ICPI exist, few address additional associated symptoms such as dyspareunia or pelvic pain other than bladder pain [56]. In 2009, a single instrument was developed and reported by Clemens and colleagues [56] in Michigan that assessed genitourinary pain symptoms in women using symptom-based criteria. Referred to as the Genitourinary Pain Index (GPI), the 9-question tool initially asks patients to report if they experience pain or discomfort in pelvic areas or in association with bladder activities and sexual intercourse [56]. The GPI also asks patient to quantify how often such symptoms occur (including a scale from never to always) and also challenges patients to assess the average pain on a scale from 1 to 10, 10 being as bad a pain as imaginable [56]. Lastly, the GPI assesses the impact of symptoms on quality of life: how much do patients think about their symptoms, whether it interferes with their daily routine and how patients would feel if they experienced symptoms for the rest of their life [56]. A total score of 0–45 is determined based on each patient’s scores from the pain, urinary, and quality of life questions. After a thorough evaluation, the GPI was determined to be a valid and reliable instrument that can be used to assess symptom severity and impact in women, demonstrating excellent internal consistency and responsiveness to change [56]. Similar positive results were found with a gender-specific GPI used when assessing pain and symptoms in males [56].