Clinical and Quality of Life Evaluation




INTRODUCTION



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Pelvic floor disorders, including urinary and anal incontinence, pelvic organ prolapse (POP), sexual dysfunction, and pelvic pain consist of an array of functional and anatomical diseases that significantly impact the quality of life (QOL) of women. Central to the diagnosis and treatment of these disorders is the amount of bother and impact on QOL women experience from their pelvic floor problems. For the majority of pelvic floor disorders, no universally accepted definition of the disease state on physical examination or on ancillary testing exists. For this reason, diagnosis of disorders must not only take into account anatomic and functional measures, but also must include evaluation of symptom severity and impact on QOL. This is not meant to trivialize the importance of the diagnosis and treatment of these problems, but rather to emphasize the need for pelvic floor disorders to be evaluated within the context of the patients’ personal experience. In this chapter, we review the clinical and QOL evaluation of the women with pelvic floor dysfunction; detailed descriptions of specific tests will not be presented here, but will be covered in more detail in chapters addressing specific pelvic floor dysfunctions.



Key Point




  • Central to the diagnosis and treatment pelvic floor disorders is the amount of bother and impact on quality of life women experience from their pelvic floor problems.





CLINICAL EVALUATION OF A PATIENT WITH PELVIC FLOOR DYSFUNCTION



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Pelvic floor disorders comprise a group of diseases that patients may find difficult to bring up during a medical interview. Although common, many patients are reluctant to discuss these problems with providers because of embarrassment or because women are unaware of treatment options. In addition, many providers are not familiar with the diagnosis and treatment of pelvic floor dysfunction or feel that these disease states can only be treated by a specialist. Family members may believe that the lack of urinary or bowel control is volitional. Challenges faced by families are underlined by the fact that incontinence is a major reason for nursing home admissions in the elderly.1



The National Center for Quality Assurance emphasized the importance of screening for pelvic floor problems by determining that a quality indicator for primary care provider is to identify individuals with urinary incontinence.2 In a busy primary care or obstetrics and gynecology practice, finding time to ask about incontinence or prolapse may be challenging. Many providers ask women general questions about whether or not they have bowel, bladder, or sexual complaints on their intake history. This simple intervention opens the door for women to feel more comfortable to seek treatment. Often patients have more than a single disorder; it is critical that women who present with a single disorder be screened for others as well. Because of their central importance in detection and evaluation of functional problems, following is a discussion of the psychometric properties of questionnaires in general and a brief discussion of questionnaires used to screen pelvic floor disorders, as well as questionnaires that evaluate a spectrum of pelvic floor dysfunction. Clinical and physical examination assessment of urinary and bowel complaints and POP will then be presented, with questionnaires specific to the particular dysfunction included in its respective section.



Key Point




  • Evaluation of pelvic floor dysfunction involves eliciting history, physical examination, and clinic-based tests and advanced studies.





QUESTIONNAIRES



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Although a complete discussion of the science behind questionnaire development is beyond the scope of this chapter, a general understanding of the central concepts of questionnaire development is important because pelvic floor disorders are largely functional problems that cannot be diagnosed by objective testing. Questionnaires transform “subjective” information into “objective” measures of the presence and severity of symptoms as well as their effect on QOL. Information should be collected in a nonbiased and reproducible fashion. Questionnaires range from measures that have not undergone rigorous analysis, referred to as an ad hoc questionnaire, to measures that have been extensively evaluated or validated questionnaires. Validated measures can be further divided into those that are condition-specific, or were designed to measure clinical problems in a specific group of individuals, or generic, meaning the questionnaire is best used to evaluate differences between a variety of disease states. Questionnaires used to evaluate pelvic floor dysfunction range in size from a single question to much longer questionnaires. Often, both long- and short-form versions of a questionnaire will be developed. Although the long-form version of a questionnaire will provide more detail than a shorter version, shorter forms reduce patient burden and are often the most appropriate for use in clinical practice. Some questionnaires have subsections, which focus on a particular aspect of QOL or symptoms; these are referred to as domains. Choosing which questionnaires to use depends on the goals of their use; although the International Continence Society (ICS) rates questionnaires based on their quality, no standard measures have been determined. Questionnaires are evaluated by their psychometric properties, including validity, reliability, and responsiveness, or ability to measure changes in clinical condition (Table 4-1). Questionnaires are rated by the ICS based on their validity, reliability, and responsiveness, and given a “Grade” of A, B, or C. Initial questionnaire validation is a process and not necessarily the endpoint of questionnaire assessment.




Table 4-1

Properties of Questionnaires





Key Points




  • Questionnaires help in detection and evaluation of functional problems and transform “subjective” information into “objective” measures of the presence and severity of symptoms as well as their effect on quality of life.



  • Questionnaires can be generic or condition-specific and are rated by the International Continence Society based on their validity, reliability, and responsiveness and given a “Grade” of A, B, or C.




Screening Questionnaires for Pelvic Floor Dysfunction



To overcome screening barriers, several screening questionnaires for pelvic floor dysfunction have been developed. The most extensive of these is the Epidemiology of Prolapse and Incontinence Questionnaire (EPIQ), which consists of 49 questions that evaluate urinary and anal incontinence, POP, and sexual health. On this measure, for items with a positive response, bother/satisfaction measures are reported on a 0 to 100 visual analog scale. Question no. 35, which asks the patient “Do you have a sensation that there is a bulge in your vagina or that something is falling out from your vagina?” has been used as a screening question for POP in epidemiologic studies.3,4 Because of its length, the EPIQ questionnaire is not well suited for most clinical settings.



To identify women with incontinence, the 3IQ consists of three questions that screen for incontinence symptoms and determines the type of incontinence.5 Using an extended evaluation as a gold standard, the sensitivity of the 3IQ for urgency incontinence was 0.75 (95% CI, 0.68–0.81) and a specificity of 0.77 (95% CI, 0.69–0.84); for stress incontinence, the sensitivity was higher at 0.86 (95% CI, 0.79–0.90) and the specificity lower at 0.60 (95% CI, 0.51–0.68). The 3IQ can easily be incorporated into intake questionnaires in a clinical setting.



Other screening questionnaires include the Simple Questionnaire for sexual function.6 This questionnaire consists of three questions that ask whether or not a patient is sexually active, if active, whether they have any sexual problems and whether or not they have pain with sexual activity. This simple questionnaire was able to identify women with sexual dysfunction as well as those who underwent detailed analysis with a psychologist. Although these validated questionnaires are available for use in the clinical setting, many providers have incorporated ad hoc screening questions that they develop themselves into their intake history.



Questionnaires that Evaluate a Range of Pelvic Floor Dysfunction


Although many measures focus on a specific aspect of pelvic floor function, such as urinary incontinence or POP, a number of questionnaires have been developed to assess an array of disorders. Two commonly used measures include the Pelvic Floor Distress Inventory (PFDI)7 and the Pelvic Floor Impact Questionnaire (PFIQ).7



Pelvic Floor Distress Inventory (PFDI) (Grade A)7


This 46-item (long-form) questionnaire was developed for use in women with all major pelvic floor disorders. Both long (46 questions) and short forms (20 questions) consist of three scales, individually focused on urinary symptoms, bowel symptoms, and prolapse symptoms. Patients are asked if they have a particular symptom and asked to rate the level of bother of that symptom, if present, on a four-point scale. The measure has undergone extensive psychometric testing, which has established its reliability, validity, and responsiveness.



Pelvic Floor Impact Questionnaire (PFIQ) (Grade A)7


This measure assesses QOL impact of urinary and/or anal incontinence and/or prolapse. The long-form version of the PFIQ has three scales and a total of 92 items, whereas the short-form version consists of 21 questions, also divided in three scales. These include the Incontinence Impact Questionnaire (IIQ), Colorectal-anal impact Questionnaire, and Pelvic Organ Prolapse Impact Questionnaire. Each scale consists of four domains that include physical activity, social, emotional, and travel. Again, the PFIQ has been extensively validated and has proved responsiveness.




CLINICAL ASSESSMENT OF URINARY INCONTINENCE



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History



A history of urinary incontinence should document both the presence of incontinence as well as delineate the major types of incontinence, including stress, urgency, and mixed urinary incontinence. The precise nature of leakage should be queried. Patients may complain of leakage of urine with stress such as coughing, laughing or sneezing or exertion, Valsalva maneuvers during exercise, or sexual intercourse, all of which are associated with an increase in abdominal pressure and the diagnosis of stress incontinence. Patients with urgency incontinence have loss of urine after a sensation of urgency and often report failing to make it to the bathroom in time. These patients typically practice “toilet-mapping” and are aware of restrooms in the vicinity of all the places they usually visit. Women with urgency incontinence also report urgency “triggers” or association of having urgency when they hear the sound of running water. Patients may have a combination of these symptoms and are diagnosed with mixed urinary incontinence.



The severity of the incontinence must be ascertained, as well as the bother that the patient experiences. Surrogate markers for bother include frequency of leakage, pad use, type of pads, degree of pad saturation and number of voids during the day and night. Documentation of symptom onset and past medical history is important as well as any precipitating events including recent medication changes (Table 4-2). Patients with rare leakage may not be bothered by their symptoms.




Table 4-2

History Related to Urinary Incontinence, Anal Incontinence, and/or Pelvic Organ Prolapse,*





Not all lower urinary tract problems are associated with incontinence; patients may have difficulty voiding or more commonly, complain of overactive bladder (OAB). OAB, an umbrella term that encompasses urgency urinary incontinence, is defined as urinary urgency, usually accompanied by frequency and nocturia, with or without urgency urinary incontinence, which occurs in the absence of urinary tract infection or other obvious pathology. Although not all women with OAB are incontinent, the condition is associated with significant bother and decreased QOL. Risk factors for urinary incontinence and relevant past medical history should be ascertained as outlined in Table 4-2.



Voiding dysfunction, although relatively uncommon in women, may occur in patients with severe POP or after pelvic surgery or complicated vaginal birth. Although some patients may develop overflow incontinence as a result of voiding dysfunction, others will report a slow stream or having to perform maneuvers in order to empty their bladders.



Bladder Diaries


Bladder diaries are central to the evaluation of women with urinary incontinence and OAB. On a bladder diary, patients prospectively record the number of voluntary voids and volumes, incontinent episodes, and fluid intake. The National Institutes of Health recommends a three-day bladder diary that records at least urinary incontinence episodes, voiding frequency, and pad usage8 (Figure 4-1). Bladder diaries are both diagnostic and therapeutic, as women who complete them can identify patterns of fluid intake and voiding that may lead to simple interventions, such as modifying excessive fluid intake or if voiding very infrequently, planned voids to avoid overflow incontinence.




FIGURE 4-1


Bladder diary.





Physical Examination



After taking a history, a physical examination, including pelvic examination, is performed. A neurological examination should be performed to assess perineal sensation and cutaneous nerve reflexes (Figure 4-2). An abdominal examination should be performed with attention to masses and previous surgical scars. Perineal and genital inspection should include attention to markers of incontinence such as erythema and excoriation due to incontinence and the wearing of pads. An assessment of prolapse, described in more detail below, is included.




FIGURE 4-2


Dermatomes of perineal body.





Direct observation of incontinence on physical examination can often confirm the diagnosis. One such test is the empty supine cough test. This is performed while the patient lies in a supine position, immediately after voiding. The patient is asked to cough with subsequent observation of involuntary loss of urine on examination. Stress incontinence can sometimes be only observed after the reduction of coexistent prolapse. Urgency urinary incontinence may also be observed; the patient has loss of urine synchronous with the sensation of a sudden, compelling desire to void that is difficult to defer. Typically, urgency losses are larger than urine loss associated with stress incontinence.




CLINIC-BASED TESTS



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Other clinically based tests performed on physical examination include assessment of the ability of the patient to completely empty her bladder, and whether or not she has a urinary tract infection.



Particularly in women with complaints of incomplete emptying, a postvoid measure of urine volume should be obtained, either by catheterization or by bladder scan. Although the exact definition of an elevated postvoid residual has not been ascertained, less than one-third of the voided volume or less than 100 to 150 mLs is often considered “normal.” If it is unclear as to how much is left in the bladder on bladder scan, straight catheterization is performed to determine the exact volume. A urine sample should be obtained to assess for hematuria, as well as markers for urinary infection. Although rare, hematuria may be an indication of underlying bladder pathology such as transitional cell carcinoma, or stone disease, and urinary tract infection can be associated with stress incontinence or OAB symptoms that resolve with treatment of the infection.



Assessment of urethral mobility is of limited clinical value for patients not undergoing surgical intervention. To assess mobility, a cotton-tipped swab is placed in the urethra and withdrawn until it is at the urethrovesical junction (Figure 4-3). The patient is then asked to cough or Valsalva and the mobility of the urethra is noted. A mobile urethra is defined as one that moves greater than 30 degrees on cotton swab testing, or greater than 10 degrees of movement on ultrasound. Women with immobile urethras who continue to leak urine are less likely to respond to surgical therapy than women with mobile urethras.9




FIGURE 4-3


‘Q-tip’ or cotton-swab test.





Pelvic muscle strength is then assessed. It is important to assess whether or not the patient is able to volitionally contract their pelvic floor muscles, as many initial therapies for pelvic floor dysfunction hinge on the performance of pelvic floor exercises. Women unable to volitionally contract their pelvic floor musculature are unlikely to benefit from these interventions without the aid of a physiotherapist. The ICS recommends assessment of pelvic floor strength to include notation of the ability to both volitionally contract and relax the pelvic floor muscles, and the use of “absent,” “weak,” “normal,” and “strong” to assess the strength of pelvic floor contraction.10 Two other measures are commonly used to assess pelvic floor muscle strength; the Brink scale, and the Oxford grading scale. For the Brink scale, pelvic floor strength is assessed after inserting two lubricated fingers into the vagina. The examiner then asks subjects to “squeeze and hold their pelvic muscles.” The Brink scale assesses three aspects of pelvic floor muscle contraction, including vaginal pressure, displacement of the examiner’s fingers, and duration of contraction. Each subscale is a four-point scale with a minimum score of one and maximum of four. The scores are added to provide a total score ranging from 3 to 12.11 The Oxford grading scale12 is a scale that quantifies pelvic floor muscle strength as no contraction (0), flicker (1), weak (2), moderate (3), good (4), and strong (5).



Pad Testing



Pad testing quantifies the amount of urine lost over the duration of testing, by measuring the increase in the weight of the perineal pads (weighed pre- and posttesting) used. This may give a guide to the severity of incontinence. Testing duration varies and ranges from a short (one hour) test in a clinical setting to a 24- and 48-hour test. Provocation during the test likewise varies from normal everyday activities to defined regimens. The regimen recommended for a one-hour test includes the patient drinking 500-mL fluid within a short period. After 15 minutes, the patient then walks or climbs stairs for half an hour and during the remainder of the time patient stands up from sitting position, coughs vigorously, runs in place, bends to pick up small object, and washes their hands in running water. At the end of one hour, the pad is removed and weighed.13,14 According to the ICS, women leaking less than 1 g during the one-hour pad test can be considered dry. Pad weight gains above these levels should indicate that incontinence occurred. Long-term tests are done for 24 or 48 hours of normal activities while wearing pads and then brought in by the patient for weighing. The upper limit of the 95% confidence interval is between 5.5- and 8-g gain in pad weight for the 24-hour home pad test.15,16



In addition to screening for the severity of incontinence, in patients where the diagnosis of incontinence is not clear, a test using an agent, such as phenazopyridine, that dyes the urine can be used. The patient is asked to take the phenazopyridine and engage in activities that are thought to cause incontinence. During the activity, the patient observes whether their pad is stained yellow. This test can aid in sorting out whether or not the patients’ “wetness” is from urine or is from another source, such as sweat or vaginal discharge.



Advanced Studies



Simple Cystometry


Also referred to as “bedside” urodynamics, simple cystometry utilizes a catheter inserted into the urethra to check the postvoid residual volume of urine after voiding. The bladder is then retrograde-filled, with confirmation of when the patient experiences sensation of first fill, initial desire to void, strong desire to void, and maximum capacity. The bladder is filled via an open syringe attached to the catheter. Before maximum capacity, the catheter is removed and the patient asked to perform provocative maneuvers including coughing and Valsalva. Loss of urine with stress maneuvers indicates the diagnosis of stress incontinence, whereas a sudden loss of a large volume of urine with a rise in the meniscus in the syringe indicates urgency incontinence.



Urodynamics


Urodynamics is the functional study of the lower urinary tract, and will be further addressed in Chapter 7. The sequence of testing involves testing with a comfortably full bladder for free (no catheter) uroflowmetry and postvoid residual urine volume (PVR) measurement prior to filling and voiding (with catheter) cystometry. Uninstrumented uroflowmetry measures the rate, time, and volume of urine voiding. Filling cystometry is the pressure/volume relationship of the bladder during bladder filling. It begins with the commencement of filling and ends when a “permission to void” is given by the urodynamicist. Aims of filling cystometry are to assess bladder sensation, bladder capacity, detrusor activity, and bladder compliance. Stress incontinence is evaluated by asking patient to cough when supine, Valsalva when supine, and then cough when standing up. Urethral pressure profiles can also be performed, which indicate intraluminal pressure along the length of the urethra. At the conclusion of the testing, women typically perform a second instrumented uroflowmetry, which not only measures the rate, time, and volume of the void, but also the pressures in the urethra, bladder, and rectum, as a proxy for abdominal pressures.



Intravenous Urography



Intravenous urography provides an anatomical outline of the urinary tract including the calyces, renal pelvis, ureter, and bladder. An injection of x-ray contrast media is given to the patient intravenously. The contrast media becomes visible on x-rays after injection because it is excreted by the kidneys. x-rays are taken at specific time intervals to capture the contrast as it travels through the different parts of the urinary system. This gives a comprehensive view of the patient’s anatomy and some information on the functioning of the renal system.



Micturating Cystourethrogram



Micturating cystourethrogram is used in the detection of vesicoureteric reflux, stress incontinence, urethral stricture, some fistulae, and diverticula. A micturating cystourethrogram is a specific radiological procedure that is performed under fluoroscopic screening to visualize the bladder by filling it with contrast material asking the patient to void, in order to evaluate the anatomy of the urethra, bladder and distal ureters.



Magnetic Resonance Imaging



Magnetic resonance imaging (MRI) in urogynecology provides the opportunity to examine the soft tissue structures of the pelvic support. It is noninvasive, has excellent soft tissue contrast resolution without exposure to ionizing radiation, and allows the study of function of pelvic floor structures under different dynamic conditions such as increased abdominal pressure during Valsalva. Several anatomical landmarks used for pelvic measurements are also easily identified in MRI, and most measurements are thus highly reproducible. Currently, the clinical value of these examinations is still under investigation with its impact on therapeutic decisions not yet fully evaluated; MRI is not commonly used for the diagnosis of urinary incontinence.



Ultrasound



Ultrasound is commonly used to assess postvoid residual volumes. “Bladder scanners” give a volumetric assessment of residual urine volumes and are less invasive but more inaccurate than postvoid residual testing with a catheter. In addition to postvoid residual testing, ultrasound is most commonly used for assessment of the urethra for diagnosis of anatomic abnormalities, such as urethral diverticula.




URINARY INCONTINENCE/OVERACTIVE BLADDER QUESTIONNAIRES



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In addition to the questionnaire that assesses a variety of pelvic floor disorders in a single questionnaire, such as the PFDI and the PFIQ, a variety of validated questionnaires specifically focus on the evaluation of urinary incontinence and OAB. A sample of both symptom severity and QOL measures for urinary incontinence with their rating by the ICS is outlined in Table 4-3. Questionnaires are rated by the ICS based on their validity, reliability and responsiveness and given a “Grade” (Table 4-4).

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Dec 27, 2018 | Posted by in OBSTETRICS | Comments Off on Clinical and Quality of Life Evaluation

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