SECTION IV. OTHER
IV. HEALTH-RELATED QUALITY-OF-LIFE INSTRUMENTS AVAILABLE FOR USE IN URINARY INCONTINENCE
A. General HRQOL Instruments
Although there are over 50 established and published instruments designed to measure general HRQOL, few have been used in the specific setting of primary urinary incontinence. These
include only the RAND 36-item Health Survey (SF-36), the Sickness Impact Profile (SIP), and the Nottingham Health Profile.
Many researchers feel that the SF-36 is the “gold standard” for measuring general HRQOL in medical research (6). Developed during the Medical Outcomes Study, a large study that examined health-related aspects of daily life in many different types of patients (13), it is a 36-item, self-administered instrument that takes,10 min to complete and quantifies HRQOL in eight multi-item scales that address different health concepts: physical function, social function, bodily pain, emotional well-being, energy/fatigue, general health perceptions, and role limitation due to physical or emotional problems. Two summary scales, a physical health composite and a mental health composite, may also be calculated (14). Each of the eight individual scales is scored from 0 to 100, with higher scores corresponding to better outcomes.
The composite scales are standardized to a population mean of 50 with a population standard deviation of 10. Importantly, the SF-36 has been used in prior studies of patients with urinary incontinence and has been shown to perform well in this patient group (15). There is also a shortened version of the SF-36, known as the SF-12, which can be used in place of the SF-36 if the researcher wishes to reduce the respondent burden. Although the results are not reported in eight distinct domains, as with the SF-36, the two summary domains generated in the SF-12 are still acceptable in many research settings.
The SIP is considerably longer (136 items) than the SF-36. However, the greater number of questions results in more domains—12—which may allow for a more comprehensive view of general HRQOL. Individual summary scores can be generated for each of these domains (16,17).
The Nottingham Health Profile contains six domains comprising a total 38 items that the subject responds to with binary (yes/no) answers (18). It has been used primarily in the United Kingdom to measure general HRQOL in a number of disease processes (19 – 21). While not as widely used in the general population as the SF-36, both of the Nottingham Health Profile and the SIP have been successfully utilized to measure general HRQOL in women with incontinence (22,23). In a recent review of HRQOL instruments for use in incontinence, Corcos and colleagues (24) concluded that these three generic HRQOL instruments were not responsive to change in incontinent patients. This observation underscores the need for valid, reliable, and responsive disease-specific HRQOL instruments in incontinence.
B. Disease-Specific HRQOL Instruments
There are now numerous HRQOL instruments designed specifically to look at the impact of both stress and urge incontinence on HRQOL. No one instrument has been demonstrated to be superior to another, and the choice of outcome measure should be based upon one’s particular clinical or research goals. Most of these questionnaires are available in the public domain.
Interested clinicians and researchers can therefore review the items in an instrument and select the established questionnaire that best suits their purposes.
The Incontinence Impact Questionnaire (IIQ) and the Urogenital Distress Inventory (UDI) are two of the most common questionnaires used to measure disease-specific HRQOL in urinary incontinence. Developed in the mid 1990s, the original versions of these questionnaires were relatively long (roughly 53 items combined) (25). The two questionnaires had the advantage of adequately capturing both dysfunction and bother due to urgency, frequency and incontinence, etc. The IIQ generates four domain subscores: physical activity, travel, social, and emotional.
The IIQ and UDI were specifically designed for females with urinary incontinence and have been extensively tested in this population and shown to be valid and reliable. The IIQ has been shown to perform well in both English- and French-speaking women (26). In clinical practice, however, the questionnaires were cumbersome to complete, which limited their utility. This was
remedied with the development of short-form versions of these questionnaires—the IIQ-7 and the UDI-6. Although the information obtained is not as detailed, it is adequate and still provides a relatively comprehensive measure of disease-specific HRQOL in women with urinary incontinence. In addition, the IIQ-7 and UDI-6 have been shown to be responsive to change. In a group of 55 women with pelvic organ prolapse, FitzGerald et al. (27) found that women who reported subjective continence following surgery for this condition also reported lower IIQ-7 and UDI-6 scores (better HRQOL) when compared to baseline. Finally, although not originally developed for men, the IIQ-7 and UDI-6 have since been used in a population of older men and have performed well (28,29).
The IIQ and UDI instruments have also been modified for use in various subsets of patients with specific forms of urinary dysfunction. Lubeck et al. (30) developed and validated modified versions of the IIQ and UDI specifically for use in patients with urge incontinence and overactive bladder, known as the Urge-Incontinence Impact Questionnaire (U-IIQ) and the Urge-Urinary Distress Inventory (U-UDI). The U-IIQ and the U-UDI are longer (42 items) than the IIQ-7 and UDI-6, but have the advantage of measuring the impact of urgency, frequency, and urge incontinence on HRQOL in much greater detail. HRQOL is measured in seven domains: severity of urge symptoms, and impact on travel, activities, feelings, physical activities, relationships, and sexual function. The instrument has good psychometric properties and appears to capture most of the psychosocial concerns of patients with overactive bladder. Similarly, Barber and colleagues (31) modified the IIQ and UDI instruments for use in women with pelvic floor disorders. The new instruments, known as the Pelvic Floor Distress Inventory (PFDI) and the Pelvic Floor Impact Questionnaire (PFIQ), contain six scales. The PFDI consists of 61 items and generates scores in three domains: distress due to urinary incontinence, distress due to colorectal-anal dysfunction; and distress due to pelvic organ prolapse. The PFIQ includes 93 items and measures life impact in the same three domains. While the new scales have been shown to have acceptable criterion validity, further use in the clinical and research setting is needed to determine if the total number of items on the PFIQ and PFDI will affect subject’s willingness to complete the questionnaire.
The Bristol Female Lower Urinary Tract Symptoms (BFLUTS) instrument is a modified version of the ICSmalesurvey questionnaire that was developed to measure lower urinary tract symptoms (LUTS) in males (32). To develop the BFLUTS, the majority of the items on voiding symptoms in theICSmalequestionnaire were replaced with items quantifying the frequency and extent of urinary incontinence. The new questionnaire contains 20 items that address urinary incontinence, voiding symptoms in the voiding and storage phase, sexual function, and other aspects of quality of life. The BFLUTS was shown to be valid and reliable in a population of 85 incontinent women from the United Kingdom. It has the advantage of capturing both function and bother in the urinary domains, which are both important components of HRQOL. Although the BFLUTS has not been formally validated in men, a modified version of the questionnaire has been administered to males and was shown to perform well (33).
Kelleher et al. developed a 21-item survey, known as the King’s Health Questionnaire, to assess HRQOL in incontinent women (34). This questionnaire measures the domains of general health perception, incontinence impact, urinary symptoms, severity of disease, role limitations, physical limitations, social limitations, personal limitations, emotional problems, and sleep disturbances. It has been shown to be valid and reliable and correlates well with outcomes from the SF-36.
Black and colleagues (35) developed two instruments, a Symptom Severity Index (SSI) and a Symptom Impact Index (SII), to assess the impact of incontinence on women’s HRQOL.
They developed their instruments in a population of 442 women undergoing surgery for stress urinary incontinence. The new questionnaires have the advantage of being brief (eight items
total), yet able to generate to distinct summary scores that show acceptable validity and reliability. Research is ongoing to assess the responsiveness of these instruments to change.
Patrick et al. (36) have developed the I-QOL, a 22-item questionnaire, that specifically examines HRQOL in three domains, avoidance and limiting behavior due to incontinence, social embarrassment, and psychosocial impact of incontinence. This instrument has the advantage of being developed and test in both sexes and has been cross-culturally adapted for use in numerous countries in various languages (37). As it does not capture urinary function well, it should be used with a functional scale, such as a voiding diary or the SSI.
The York Incontinence Perceptions Scale (YIPS) is a simple eight-item questionnaire that is specifically designed to capture a subject’s psychosocial adjustments to urinary incontinence (38). This instrument, like most of the others described so far, tends to focus on stress incontinence, and is therefore of less utility when studying urge incontinence or overactive bladder. If the YIPS were to be used in this setting, it would need to be accompanied by other instruments that capture the impact of urgency and frequency on HRQOL. The 24-item Urge Impact Scale (URIS) (39) has the added advantage of examining urge incontinence in particular, although it doesn’t specifically capture the impact of urgency or overactive bladder on HRQOL.
V. IMPACT OF URINARY INCONTINENCE ON GENERAL