UROLOGIC CHRONIC PELVIC PAIN SYNDROME: A SCOPING REVIEW OF SYNDROME-SPECIFIC INSTRUMENTS

Abstract

Objective:

To facilitate research on interstitial cystitis/bladder pain syndrome (IC/BPS) and chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) symptom variability or flares, we reviewed the published literature to document existing data collection instruments (e.g., questionnaires and diaries), and to identify those relevant for flare research.

Methods:

Seven databases were searched systematically for articles describing the development of instruments: 1) specific for IC/BPS, CP/CPPS, or both; and 2) intended for use by investigators beyond the development team. 1,216 abstracts and 79 full-text articles were reviewed, and data were extracted in duplicate.

Results:

We identified 17 instruments, 11 for IC/BPS, five for CP/CPPS, and one for both. Thirteen instruments (12 questionnaires and one electronic diary) assessed symptoms for diagnostic, symptom evaluation, and/or symptom monitoring purposes, and included items assessing the presence, location, intensity (mostly typical intensity), and/or amount of time experienced pelvic pain and/or urinary symptoms. No instruments included items related to symptom variability or flares.

Conclusion:

In addition to describing existing instruments for future urologic chronic pelvic pain syndrome research, our review identified a lack of validated instruments for flares. Future studies should address this gap to facilitate rigorous research on this understudied topic.

INTRODUCTION

Interstitial cystitis/bladder pain syndrome (IC/BPS) and chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) are common, chronic, and debilitating conditions collectively referred to as urologic chronic pelvic pain syndrome (UCPPS).¹ Both conditions are characterized by persistent pelvic, bladder, or prostate pain and urinary symptoms, such as urgent and frequent urination. IC/BPS is also often accompanied by pain with bladder filling, painful urgency, pain relieved with voiding, and pain during and after sexual activity; whereas CP/CPPS is often accompanied by pain with ejaculation or during urination.¹ UCPPS affects 1.8-6.5% of Americans^2,3 and costs the healthcare system $3,000-7,000 per patient annually. It also exacts a large toll on patients, including reductions in physical functioning,^4,5 mental health,^4,5 sexual health,^5–7 and work productivity;^8,9 as well as increases in relationship strain, social isolation,^10,11 depressive symptoms, and suicidal ideation.^5,12

Similar to other chronic pain conditions, UCPPS symptoms can fluctuate over time. In our Multidisciplinary Approach to the Study of Chronic Pelvic Pain (MAPP) Research Network studies, most participants (95%) reported experiencing at least one symptom exacerbation or “flare” in their lifetime¹³ and approximately half reported a flare as recently as in the past week.¹⁴ Flare experiences varied, but most involved an acute worsening or recurrence of existing UCPPS symptoms lasting at least several hours to days.¹⁵ As a result, flares were disruptive to participants’ lives¹³ and contributed to decreased quality of life and increased health care seeking behavior and/or utilization, even over and above participants’ non-flare symptoms.¹⁴ These findings suggest that flares have an independent negative impact on patients’ lives. Despite this finding, little empirical evidence exists on the etiology or causes of flares or the best ways in which to prevent, manage, or treat them.¹⁵ This type of research would be facilitated by instruments designed specifically to measure UCPPS symptom variability or flares. Flare-specific instruments would also be useful to address the updated draft guidelines from the U.S. Federal Drug Association requiring documentation of flares in all IC/BPS drug- and device-related trials.¹⁶ To further this goal, we conducted a scoping review of the peer-reviewed literature to identify any validated flare-specific instruments and to describe the breadth of flare-related and other items included in existing instruments as a foundation for future flare and overall UCPPS research. This article extends two recent reviews summarizing and evaluating five commonly used BPS questionnaires¹⁷ and describing questionnaires used to measure quality of life in individuals with IC/BPS.¹⁸

MATERIALS AND METHODS

Search strategy

We searched the literature for records including the concepts of interstitial cystitis, bladder pain syndrome, chronic prostatitis, validating instruments, questionnaires, diaries, and ecological momentary assessment. A medical librarian created search strategies using a combination of keywords and controlled vocabulary in Embase.com 1947- , Ovid Medline 1946- , Scopus 1823- , Cochrane Central Register of Controlled Trials, The Cochrane Database of Systematic Reviews, APA PsycINFO 1600s-, and Clinicaltrials.gov 1997-. Our initial search was limited to questionnaires and was completed on August 11, 2023, with no added limits. In December 2024, we updated the search to add terms for diaries and ecological momentary assessment in addition to questionnaires. This expanded search was run from inception to December 17, 2024 (see Appendix for fully reproducible search strategies for each database). We also hand-searched the references of all identified articles.

Eligibility criteria

We limited our scoping review to English-language, full-text articles that described the development of an English-language instrument for IC/BPS, CP/CPPS, or both. Instruments could include either questionnaires or diaries. Articles were excluded if they developed: 1) instruments for chronic pelvic pain or chronic pain more broadly; 2) instruments for lower urinary tract symptoms more broadly; 3) single 10- or 11-point items (e.g., numeric pain ratings scales from 0-9 or -10); 4) instruments designed to address etiologic or other study-specific hypotheses that were not intended for use by investigators beyond the study team; and 5) self-management tools. Articles that described modification of a previously developed instrument or the development of shorter versions were retained in the review. Finally, articles that described the development of an instrument that was not publicly available—for example, because it was not published with the original or any subsequent articles, was not available on a website, or could not be obtained from the corresponding authors—were also excluded.

Study selection and data extraction

We performed a title/abstract review, full-text review, and data extraction by two independent raters, and resolved discrepancies by group consensus. Extracted data included the instrument title, purpose, and the minimum and maximum number of items overall, by sex (if applicable), and by domain (pain, urinary symptoms, other symptoms, and overall condition-specific quality of life or impact/bother). Pain and urinary symptom-specific quality of life or impact/bother were grouped with pain and urinary symptoms. Additional extracted data included details of the development process, the recall period, and, for each symptom, whether the following were assessed: any presence of the symptom; the average/typical, worst, least, and current symptom intensity; amount of time symptoms experienced; variability in symptoms (including flares), and impact/bother of the symptom. These data were extracted for each pain location or type of pain and for each urinary symptom. For frequent daytime (i.e., urinary frequency) and nighttime urination (i.e., nocturia), items related to the number of times that individuals voided were classified as symptom intensity and items related to the amount of time that urinary frequency or nocturia were experienced were classified as the amount of time that symptoms were experienced. We complemented data extraction with a review of the literature for articles describing the validation of each instrument, assessment of its reproducibility and/or responsiveness to change, and translation into languages other than English. Together with details about the development process, these additional references were included to inform the quality of the instrument or ease of use in future multi-language studies.

RESULTS

We identified a total of 4,315 records (2,065 from the original and 2,250 from the updated search), 3,099 of which were removed as duplicates, for a total of 1,216 unique citations (1,092 from the original and 124 from the updated search, Figure 1). Of these, 1,137 (1,020 in the original and 117 in the updated search) did not meet eligibility criteria at the abstract stage and 63 (57 in the original and 6 in the updated search) at the full-text article stage, leaving 18 articles (17 in the original and 1 in the updated search). Two of these articles described questionnaires that were never published and could not be obtained from the corresponding authors.^19,20 One additional article was identified by hand-searches, leaving 17 articles in the scoping review (Table 1). Two of these articles described one instrument and one described two instruments, for a total of 17 instruments, including 16 questionnaires and one electronic diary.

Figure 1:

PRISMA flow diagram for the scoping review of urologic chronic pelvic pain syndrome-specific instruments

Table 1:

Summary of published instruments for urologic chronic pelvic pain syndrome, including interstitial cystitis/bladder pain syndrome and chronic prostatitis/chronic pelvic pain syndrome.

First author, year	Instrument title	Purpose	No. of itemsa	No. of itemsa related to:				Development process	Refinement Process	Psychometric properties	CIDc	Translations
				Painb	Urinary symptomsb	Other symptomsb	Overall QOL
Interstitial cystitis/bladder pain syndrome
Keller, 199433	University of Wisconsin Interstitial Cystitis Scale (UW-IC; embedded in a checklist with 18 control symptom items)	Diagnosis, symptom monitoring	7	3	3		1d	LR, CL, PF	FG	V33,39, Rep33		Italian40
O’Leary, 199724	Interstitial Cystitis Symptom Index (ICSI) and Problem Index (ICPI)	Symptom evaluation, management, and monitoring	8	2	6			LR, CL, FG	FG, I/COG, PsycA	V24,41, Rep24,41, Resp41	ICSI: 5.4 out of 2041	Italian42, Brazilian Portuguese,43 Turkish44, Chinese45, Japanese46, Korean47
Parsons, 200248	Pelvic Pain and Urgency/Frequency (PUF) Patient Symptom Scale	Diagnosis, screening	5-12	1-5	3-6			CL	NS	V48, Rep48		Italian49, Spanish50, Brazilian Portuguese43, Arabic51, Chinese52, Korean53
Berry, 201029	RAND Interstitial Cystitis Epidemiology (RICE) Case Definition Questionnaire	Case definition for screening and epidemiologic research	4-5	2-3	2-3			LR, CL, EP	PsycA	V29
Bogart, 201254	RAND Bladder Symptom Impact scale (RICE BSI-6)	Condition-specific QOL evaluation and monitoring					6e	LR, CL, FG	PsycA	V54		Brazilian Portuguese55
Humphrey, 201226	Bladder Pain/Interstitial Cystitis Symptom Score (BPIC-SS)	Identify patients with moderate-to-severe symptoms for trials	8	5	3			LR, CL, I/CE	I/COG, PsycA	V26, Rep26		34 languages,26 including Spanish56
	Bladder Pain/Interstitial Cystitis e-diary	Symptom monitoring	18f	10g	7		1	LR, CL, I/CE	I/COG
Shorter, 200727	Shorter-Moldwin Food Sensitivity Questionnaire	Determine whether specific comestibles affect symptoms.	182-191					CL	NS	V27
Shorter, 201425	Shorter-Moldwin Food Sensitivity Questionnaire (short form)	Determine whether specific comestibles affect symptoms.	50-53					CL, EP	I/COG, EP	V25, Rep25
Taneja, 201923	Apollo Clinical Scoring system (ACS system, including the ICSI with modified scoring)	Symptom evaluation and monitoring	6	2h	3		1i	LR, CL	NS	V, Rep57
Chen, 202228	Interstitial Cystitis Self-Help and Medical Resources Scale (ICSR)	Measure self-help and medical resource-seeking, diagnosis, treatment	19					LR, CL, I/CE	I/COG, EP	V28		Chinese28
Chronic prostatitis/chronic pelvic pain syndrome
Neal, Jr., 199458	Symptom Score Questionnaire/Index (can be administered with the Boyarsky symptom score59)	Symptom evaluation and monitoring	4	4				CL	NS	V58, Resp58	3.8 out of 1258
Krieger, 199630	University of Washington Symptom Score (including items from the American Urological Association Symptom Index24)	Symptom evaluation	21	8	7	6j		LR, CL	PF	V30
Nickel, 199660,61	Prostatitis Symptom Severity Index and Prostatitis Symptom Frequency Questionnaire	Diagnosis, symptom evaluation and monitoring	20	15	5			LR, CL	NS	V60, Resp60
Litwin, 199922	NIH Chronic Prostatitis Symptom Index (NIH-CPSI)	Symptom evaluation and monitoring	13	8	2		3	LR, CL, EP, FG	I/COG, EP, PsycA	V22,62, Rep22, Resp62,63	6 out of 4363	14 languages64
Tohi, 202331	Screening Tool for Chronic Prostatitis (S-CP)	Screening	16	8		4k		CL, EP	CL, EP	V31		Japanese31
Urologic chronic pelvic pain syndrome
Clemens, 200921	Genitourinary Pain Index (GUPI)	Symptom evaluation and monitoring	15	10	2		3	LR, CL	NS	V21, Resp21	7 out of 4521	Spanish65

CL=clinical/content expertise; CID=clinically important difference; EP=expert panel; FG=focus group; I/CE=patient interviews for concept elicitation; I/COG=patient cognitive interviews; LR=literature review; NS=not stated; QOL=quality of life; PF=patient feedback; PsycA=psychometric analyses; Rep=test-retest reproducibility; Resp=responsiveness to change; V=validity.

^aRange includes the minimum and maximum number of items that patients can complete depending on their responses.

^bLimited to items that assess patients’ current, typical, or lifetime symptoms; not related to testing etiologic hypotheses (e.g., whether putative triggers exacerbate symptoms).

^cDefined as moderate or greater improvement for all studies, except for Neal Jr., 1994; this study assessed improvement versus no improvement.

^dIncludes one item related to difficulty sleeping because of symptoms.

^eIncludes interest in life, feelings of self-worth, social life, ability to carry out household responsibilities, energy level, and moods related to bladder symptoms.

^fExcludes items related to diary instructions and measuring voided urine volume.

^gIncludes an item related to tablets for pain relief.

^hIncludes one item that assesses sexual dysfunction, which was primarily pain with sexual activity. The following three response options: “aversion to sexual thoughts” (female) and “complete loss of erection” and “loss of libido with ED” (male), were inferred to be related to pain with sexual activity because they were the most extreme response options in a series that included increasing intensity of pain with sexual activity.

ⁱIncludes one item that assesses the degree of mental bother from symptoms.

^jIncludes six items that assess sexual dysfunction (aside from pain) and blood in semen.

^kIncludes four items that assess hematogenous semen or hematuria, discoloration of semen, premature ejaculation, and erectile dysfunction.

Of the 17 instruments, two were modifications of previous questionnaires (the Genitourinary Pain Index²¹ developed from the NIH Chronic Prostatitis Symptom Index²² and the Apollo Clinical Scoring (ACS) system²³ developed from the Interstitial Cystitis Symptom Index²⁴); one was a shorter version of a previous questionnaire (the Shorter-Moldwin Food Sensitivity Questionnaire [short form]²⁵); and two were questionnaire and electronic diary versions of a similar instrument.²⁶ Eleven instruments were developed for IC/BPS, five for CP/CPPS, and one for either IC/BPS or CP/CPPS. Seven instruments were designed, at least in part, to diagnose, screen, or identify individuals with IC/BPS or CP/CPPS or to evaluate their symptoms at one point in time, and eight were designed to monitor patients’ symptoms over time. Two instruments assessed patients’ reactions to food, one measured condition-specific quality of life, and one assessed self-management strategies. The majority of instruments were brief, including 4-21 items total. Exceptions were the original and short form versions of the Shorter-Moldwin Food Sensitivity Questionnaire (n=50-191 items).^25,27 Of the instruments designed to assess symptoms, most included items related to pain and urinary symptoms, with only two including items related to additional symptoms/signs and one including items related to pain medication use. Finally, six instruments assessed overall condition-related quality of life or bother.

With respect to the development process, almost all instruments (n=13 of 17) were developed in the U.S or Canada and in the English language. Exceptions were the Bladder Pain/Interstitial Cystitis Symptom Score and electronic diary,²⁶ which were developed in Germany, France, and the U.S.; the Apollo Clinical Scoring system²³ developed in India; and the Interstitial Cystitis Self-Help and Medical Resources Scale²⁸ developed in Taiwan. Seven instruments were informed by both clinical/content expertise and patient input (e.g., focus groups, concept elicitation interviews) and seven were refined with patient-reported data/input (e.g., focus groups, cognitive interviews). Most instruments (n=16) were validated. In addition, seven instruments were assessed for test-retest reproducibility and four for responsiveness to change, including estimation of clinically important differences. Finally, nine were developed or subsequently translated into languages other than English.

Pelvic pain and urinary symptom assessment

Of the instruments designed to assess symptoms, all assessed at least one aspect of pain, consistent with the definitions of IC/BPS and CP/CPPS, and most assessed at least one aspect of urinary symptoms (Tables 2–4); however, none assessed symptom flares or variability.

Table 2:

Summary of symptoms assessed in instruments for interstitial cystitis/bladder pain syndrome

Questionnaire title	Pain, burning, pressure, or discomfort assessment											Urinary symptom assessment
	Recall period	Bodily area or function		Any	Intensity				Amount of time	Variability/Flares	Bother/Impact of symptoms	Type of symptom	Any	Intensity				Amount of time	Variability/flares	Bother/Impact of symptoms
					Average or typical	Worst	Least	Current						Average or typical	Worst	Least	Current
University of Wisconsin Interstitial Cystitis Scale (UW-IC)	Past day (completed at night)	Burning sensation in bladder			✓a				✓a			Urgency to urinate		✓a				✓a
		Bladder discomfort			✓a				✓a			Going to the bathroom frequently during the day		✓a				✓a
		Bladder pain			✓a				✓a			Getting up at night to go to the bathroom		✓a				✓a
Interstitial Cystitis Symptom Index (ICSI) and Problem Index (ICPI)	Past month	Bladder							✓		✓	Strong need to urinate with little or no warning						✓		✓
												Urinate less than two hours after finishing urinating						✓		✓
												Get up at night to urinate		✓						✓
Pelvic Pain and Urgency/Frequency (PUF) Patient Symptom Scale	Unclearb	Bladder or in pelvis (vagina, lower abdomen, urethra, perineum, testes, scrotum)			✓				✓		✓	Urgency after going to the bathroom		✓				✓		✓
		During or after sexual intercourse							✓		✓	Frequency of going to the bathroom during the day		✓
												Frequency of going to the bathroom at night		✓						✓
RAND Interstitial Cystitis Epidemiology (RICE) Case Definition Questionnaire	Past 3 months	Lower abdomen or pelvic area		✓								Strong urge or feeling that you had to urinate that made it difficult to wait to go to the bathroom	✓
		Urge to urinate because of pain		✓								Urge to urinate because of fear of wettingc	✓
		As bladder starts to fill		✓								Go to the bathroom to urinate during the day when awake	✓
Bladder Pain/Interstitial Cystitis Symptom Score (BPIC-SS)	Past 7 days	Bladder pain				✓			✓			Need to urinate just after urinating						✓
		Bladder pressure							✓			Frequent urination during the daytime								✓
		Need to urinate because of bladder pain							✓			Having to get up during the night to urinate								✓
		Need to urinate to avoid worsening bladder pain							✓
Bladder Pain/Interstitial Cystitis e-diary	Last time urinated	Forced to urinate because of bladder pain		✓								Rushed to get to the bathroom	✓
		Urinated due to bladder pain		✓								Urinated due to fear of urine leakage	✓
		Urinated to avoid worsening bladder pain		✓								Urinated due to normal feeling of needing to urinate	✓
	Past 24 hours	Bladder pain			✓	✓						Rush to get to the bathroom						✓
		Forced to urinate due to bladder pain							✓			Feel the need to urinate						✓
		Forced to urinate due to bladder discomfort							✓			Constant need to urinate						✓
		Forced to urinate due to bladder pressure							✓			Need to urinate just after urinating						✓
		Urinated to avoid worsening bladder pain							✓
Apollo Clinical Scoring System (ACS system, including ICSI)	Past monthd	Bladder							✓			Strong need to urinate with little or no warning						✓
		F	With genital contact/sexual activity		✓							Urinate less than two hours after finishing urinating						✓
		M	With erection and post ejaculation		✓							Get up at night to urinate		✓

F=female; M=male.

^aResponse options may refer to intensity or amount of time experienced. They range from 0 = not at all to 6 = a lot to indicate the extent to which individuals experience each symptom on a given day.

^bInferred to be “typical” for all symptoms except for pain during or after sexual intercourse. This item asks about lifetime history of symptoms.

^cAssessed to distinguish IC/BPS from other urologic conditions.

^dStated as “past month” for all items except sexual pain. Assumed to be “past month” for sexual pain.

Table 4:

Summary of symptoms assessed in instruments for urologic chronic pelvic pain syndrome

Questionnaire title	Pain, burning, pressure, or discomfort assessment											Urinary symptom assessment
	Recall period	Bodily area or function		Any	Intensity				Amount of time	Variability/Flares	Bother/Impact of symptoms	Type of symptom	Any	Intensity				Amount of time	Variability/Flares	Bother/Impact of symptoms
					Average or typical	Worst	Least	Current						Average or typical	Worst	Least	Current
Genitourinary Pain Index (GUPI)	Past week	Pelvic or genital pain			✓				✓			Urinate again <2 hours after finishing to urinate						✓
		F	Entrance to vagina	✓								Sensation of not emptying bladder completing after finishing to urinate						✓
			Vagina	✓
			Urethra	✓
		M	Area between rectum and testicles (perineum)	✓
			Testicles	✓
			Tip of penis (not related to urination)	✓
		Below waist, in pubic or bladder area		✓
		During urination		✓
		F	During or after sexual intercourse	✓
		M	During or after sexual climax (ejaculation)	✓
		As your bladder fills		✓
		Relieved by voiding		✓

F=female; M=male.

With respect to pain location and/or type, all IC/BPS instruments assessed bladder or pelvic/lower abdominal pain, which also included burning, pressure, or discomfort (hereafter summarized as “pain;” Table 2). Additional pain-related items included pain with various activities (e.g., during or after sexual intercourse), urinary urgency because of pain, pain with bladder filling, and needing to urinate because of bladder pain or to avoid worsening bladder pain. In contrast to IC/BPS instruments, CP/CPPS instruments tended to include more items related to pain location, such as the perineum, testes, urethra, penis, bladder, abdomen, upper thigh, and lower back (Table 3). A few instruments also assessed pain with urination, ejaculation, or rectal examination. Finally, for UCPPS, female-specific anatomic locations were added to the Genitourinary Pain Index:²¹ pain in the vagina, at the entrance to the vagina, and the urethra (Table 4).

Table 3:

Summary of symptoms assessed in instruments for chronic prostatitis/chronic pelvic pain syndrome

Questionnaire title	Pain, burning, pressure, or discomfort assessment										Urinary symptom assessment
	Recall period	Bodily area or function	Any	Intensity				Amount of time	Variability/Flares	Bother/Impact of symptoms	Type of symptom	Any	Intensity				Amount of time	Variability/Flares	Bother/Impact of symptoms
				Average or typical	Worst	Least	Current						Average or typical	Worst	Least	Current
Symptom Score Questionnaire/Index	“Current”	Perineum/thigh: in or between legs					✓a	✓a		✓a
		Orchialgia: testicles or scrotal sac					✓a	✓a		✓a
		Urethral: penis					✓a	✓a		✓a
		Abdominal/inguinal: pain or full feeling in the abdomen					✓a	✓a		✓a
University of Washington Symptom Score	“Current”	Between testicles and anus								✓b	Difficulty postponing urination, hard to hold it								✓b
		Testicles								✓b	Need to urinate again <2 hours after urinating								✓b
		Penis								✓b	Getting up to urinate at night								✓b
		Rectal area								✓b	Bladder does not feel completely empty right after urinating								✓b
		Lower abdomen								✓b	Intermittency								✓b
		Lower back								✓b	Weak urinary stream								✓b
		During urination								✓b	Difficulty getting stream started								✓b
		With ejaculation								✓b
Prostatitis Symptom Severity Index and Prostatitis Symptom Frequency Questionnaire	Not stated for severity (intensity)c “Last week or so” for frequency	Perineum (area where you sit between testicles and anus)		✓c				✓			Difficulty postponing urination					✓c	✓
		Testicles or scrotum		✓c				✓			Voiding too often					✓c
		Penis						✓			Number of times urinate during waking hours		✓
		Suprapubic or bladder area		✓c				✓			Number of times get up to urinate at night		✓
		Low back		✓c				✓
		Upper leg or groin area
		Uncomfortable or difficult urination		✓c
		Painful or burning feeling during urination		✓c				✓
		During ejaculation		✓c				✓
		During the rectal examination		✓c
NIH Chronic Prostatitis Symptom Index (NIH-CPSI)	Past week	Area between rectum and testicles (perineum)	✓	✓				✓			Urinate again <2 hours after finishing to urinate						✓
		Testicles	✓
		Tip of penis (not related to urination)	✓
		Below waist, in pubic or bladder area	✓								Sensation of not emptying bladder completing after finishing to urinate						✓
		During urination	✓
		During or after sexual climax (ejaculation)	✓
Screening Tool for Chronic Prostatitis (S-CP)	Past year	Area between rectum and testicles (perineum)	✓
		Testicles	✓
		Tip of penis (not related to urination	✓
		Urethra of the penis	✓
		Below the waist in the pubic or bladder area	✓
		Groin area	✓
		During urination	✓
		During or after sexual climax (ejaculation)	✓

^aResponse options may refer to intensity, amount of time experienced, or bother. They include: 0 = no pain, 1 = occurs occasionally (not every day), 2 = usual but does not stop activity, and 3 = incapacitating.

^bAssumed to assess bother based on the modeling of the questionnaire on the Symptom Check List-90 Revised⁶⁶ that includes five response options related to bother: “not at all,” “a little bit,” “moderately,” “quite a bit,” and “extremely.”

^cRecall time period was assumed to refer to typical symptoms based on the following instruction: “Please position a “|” through each line on the place where you consider most appropriate. “0” means the symptom is absent and “10” means the symptom causes you maximal pain.

Irrespective of the condition, almost all instruments assessed urinary symptoms. The most common were urinary urgency, daytime urinary frequency, and nighttime urinary frequency or nocturia. Additional urinary symptoms were urgency because of fear of wetting, an item added to the RICE Case Definition Questionnaire²⁹ to distinguish IC/BPS from incontinence; needing to urinate just after urinating; and on some CP/CPPS questionnaires, symptoms related to voiding difficulties (incomplete emptying, intermittency, weak urinary stream, and hesitancy; Tables 2–4).

With respect to the recall period, three of the older questionnaires assessed symptoms in the past day or “current” symptoms. However, given the response options, “current” most likely referred to “typical” symptoms in two of these questionnaires. The Bladder Pain/Interstitial Cystitis electronic diary²⁶ also assessed symptoms at last urination and in the past day. The remaining instruments used recall periods ranging from the past week to the past three months. The RICE Case Definition Questionnaire²⁹ assessed the presence of symptoms only, whereas most other instruments assessed the symptom intensity, amount of time that symptoms were experienced, or both. Most instruments assessed average or typical intensity of symptoms, whereas only two assessed worst intensity of symptom(s). None of the instruments assessed least symptom intensity for comparison. In addition, none assessed symptom flares or variability. Finally, five instruments assessed individual symptom-specific bother (Tables 2–4).

Assessment of additional symptoms and other items

In addition to pain with or following sexual activity, two CP/CPPS instruments assessed other aspects of sexual dysfunction. The University of Washington Symptom Score³⁰ assessed lack of interest in sexual activity, difficulty getting and maintaining an erection, difficulty reaching ejaculation, and premature ejaculation; and the Screening Tool for Chronic Prostatitis³¹ assessed erectile dysfunction and premature ejaculation. Both also included items on semen or urinary abnormalities. Finally, the Bladder Pain/Interstitial Cystitis electronic diary²⁶ included an item related to use of pain medications.

DISCUSSION

Given the negative impact of flares and/or variability on patient quality of life,^10,11,13,14 a major goal of our scoping review was to identify validated instruments to measure flares for future etiologic, preventive, and therapeutic research. However, despite reviewing over 1,200 abstracts and 17 chronic urological pain syndrome-specific instruments (11 for IC/BPS, five for CP/CPPS, and one for UCPPS), we did not identify any that assessed symptom flares, highlighting an important gap for urologic research.

In addition to reviewing the literature for flare instruments and/or items, we also considered whether any existing instruments or items could be re-purposed for flare assessment. For instance, some instruments assessed the amount of time that patients experienced symptoms, which could potentially capture symptom flares or at least symptom variability if patients’ non-flare symptom intensity were zero. However, it would not capture flares for patients who always have at least some intensity of symptoms. For example, a patient who experiences a symptom level of two most of the time and a symptom level of five during weekly flares, might report symptoms “all of the time,” obscuring flare identification. This type of scenario—i.e., symptom fluctuations above a non-zero typical symptom intensity—is common among UCPPS patients.^14,32 In addition, even in the smaller proportion of patients with a non-flare symptom intensity of zero, items on amount of time that symptoms were experienced would not be able to assess flare frequency. For example, if patients’ non-flare symptom intensity were zero and they reported experiencing symptoms “some of the time,” this could potentially capture one, two, or multiple flares. Finally, items on both worst and least symptom intensity could potentially be used to identify flares if patients’ difference in symptom intensity were above a certain threshold (mean of 2.6-5.8 points¹⁵). However, only two instruments—the Bladder Pain/Interstitial Cystitis Symptom Score and electronic diary²⁶—assessed worst pain intensity and none assessed least pain intensity for comparison.

We also considered whether repeated assessment of existing validated instruments could facilitate prospective flare assessment over time. Two instruments—the University of Wisconsin Interstitial Cystitis Scale³³ and the Bladder Pain/Interstitial Cystitis electronic diary²⁶—assessed symptoms over the past day; therefore, it is possible that they could be used to detect flares of at least several hours’ duration if they were administered daily. In this case, flares could potentially be inferred by comparing daily symptom values. Other instruments that assessed “current” symptoms would most likely not be useful for this purpose because they did not define “current” and appeared to assess “typical” symptoms rather than those experienced at the time of instrument completion. Finally, the recall time period for most other instruments was likely not narrow enough to document flares prospectively over time. For example, instruments that assessed average symptoms over the past week—a relatively short recall time period—would still not be able to detect flares lasting less than one week. Together, these findings suggest that current measures are inadequate to assess symptom variability or flares, supporting the need for new instruments dedicated specifically to flare measurement.

In addition to existing validated instruments, another possible source of potential flare items is existing non-validated questionnaires and diaries. By design, we limited our scoping review to instruments intended for use beyond the study team to avoid documenting numerous questionnaires and diaries developed for individual study-specific purposes—for example, a questionnaire designed to study smoking as a possible risk factor for IC/BPS. We were also not able to include instruments that were never published or disseminated. As a result, our scoping review did not include a small number of non-validated instruments that assessed flare incidence and characteristics,¹⁵ most notably two questionnaires and one electronic diary or app developed by the MAPP Research Network. These three instruments were developed to study flare triggers (MAPP-1),^34,35 document changes in flare burden over time (MAPP-2),^14,36 and describe symptom variability.^37,38 Although the two MAPP questionnaires were found to capture participants’ flare experiences accurately in subsequent focus group studies^10,11 and demonstrated convergent validity based on correlations with expected constructs (e.g., condition-specific quality of life and health care seeking behavior¹⁴), they were never formally validated or intended for use beyond MAPP studies. For this reason, we did not include them in our scoping review. They do, however, provide a useful starting point for future, validated flare instruments. Based on previous flare research, flares of greatest concern for patients (and thus of greatest importance to document and study) were those that lasted at least several hours and involved large increases in pelvic pain,¹⁵ although flares involving large increases in urinary symptoms alone have also been observed (5.8% of all flares)³² and reported to be bothersome.¹⁰

Finally, in addition to identifying flare-related instruments or items, a further goal of our scoping review was to describe existing chronic urological pain instruments and catalog their items for future research. Consistent with the definitions of IC/BPS and CP/CPPS, all instruments included items related to pelvic pain and almost all included items related to urinary symptoms. Our review catalogs these items, including their assessments of symptom type, presence, intensity, and amount of time experienced. It also describes other details of the development, refinement, validation, and translation process for each instrument to allow investigators to make informed choices about their selection of instruments in future studies.

Strengths of the current scoping review include its systematic and rigorous methodology (duplicate abstract review, full-text article review, and data extraction) and inclusion of questionnaires related to IC/BPS, CP/CPPS, and UCPPS. Limitations of our review include its reliance on the existing literature, which highlighted the lack of instruments that measure flares or symptom variability and, in some instances, the minimal or ambiguous detail related to the development, refinement, or validation process for some questionnaires, or related to the questionnaire instructions or items themselves.

In summary, of the 17 syndrome-specific instruments identified in our scoping review of the literature, none assessed flares and none could easily for re-purposed or used to measure flares longitudinally over time. New standardized and validated tools are therefore needed to facilitate flare research and address the negative impact that these symptom exacerbations have on patient quality of life.

APPENDIX

Full Search Strategies

Embase

Date Searched: 8/11/2023

Applied Database Supplied Limits: none

Number of Results: 800

*Search updated: 12/17/2024 (added terms relating to diaries and ecological momentary assessment)

Results: 877

Full Search Strategy:

(‘bladder pain syndrome’/exp OR ‘chronic prostatitis’/exp OR ‘interstitial cystitis’/exp OR (‘bladder pain syndrome*’ OR ‘chronic prostatitis’ OR ‘painful bladder syndrome’ OR ‘Bladder Pain Syndrome’ OR ‘panmural cystitis’ OR ‘interstitial cystitis’ OR ‘interstitial cystitides’):ti,ab,kw OR ((bladder OR hunner OR hunneri OR submucosal OR submucous) NEAR/3 (ulcer OR ulcus OR cystitis)):ti,ab,kw) AND (‘genitourinary pain index’/exp OR ‘National Institutes of Health-chronic prostatitis symptom index’/exp OR ‘index’/exp OR ‘instruments’/exp OR ‘interstitial cystitis symptom index’/exp OR ‘questionnaire’/exp OR ‘reliability’/exp OR ‘reproducibility’/exp OR ‘scale’/exp OR ‘consistency’/exp OR ‘symptom index’/exp OR ‘validity’/exp OR ‘ecological momentary assessment’/exp OR (‘Health-Chronic Prostatitis Symptom*’ OR ‘chronic prostatitis symptom index’ OR ‘NIH-CPSI’ OR ‘CPSI’ OR index* OR indices OR instrument* OR ‘Interstitial Cystitis Symptom Index’ OR questionnaire* OR survey* OR reliability OR reproductivity OR reproducibility OR scale OR validat* OR validity OR consistency OR diary OR diaries OR ‘ecological momentary assessment*’ OR ‘ecologic momentary assessment*’):ti,ab,kw) AND ((develop* OR new):ti,ab,kw)

Ovid Medline

Date Searched: 8/11/2023

Applied Database Supplied Limits: none

Number of Results: 490

*Search updated: 12/17/2024 (added terms relating to diaries and ecological momentary assessment)

Results: 536

Full Search Strategy:

(exp Cystitis, Interstitial/ OR exp Prostatitis/ OR (bladder pain syndrome* OR chronic prostatitis OR painful bladder syndrome OR Bladder Pain Syndrome OR panmural cystitis OR interstitial cystitis OR interstitial cystitides).ti,ab,kf. OR ((bladder OR hunner OR hunneri OR submucosal OR submucous) ADJ3 (ulcer OR ulcus OR cystitis)).ti,ab,kf.) AND (exp “Surveys and Questionnaires”/ OR exp “Reproducibility of Results”/ OR exp Ecological Momentary Assessment/ OR (Health-Chronic Prostatitis Symptom* OR chronic prostatitis symptom index OR NIH-CPSI OR CPSI OR index* OR indices OR instrument* OR Interstitial Cystitis Symptom Index OR questionnaire* OR survey* OR reliability OR reproductivity OR reproducibility OR scale OR validat* OR validity OR consistency OR diary OR diaries OR ecological momentary assessment* OR ecologic momentary assessment*).ti,ab,kf.) AND ((develop* OR new).ti,ab,kf.)

Scopus

Date Searched: 8/11/2023

Applied Database Supplied Limits: none

Number of Results: 621

*Search updated: 12/17/2024 (added terms relating to diaries and ecological momentary assessment)

Results: 691

Full Search Strategy:

((TITLE-ABS-KEY(“bladder pain syndrome*” OR “chronic prostatitis” OR “painful bladder syndrome” OR “Bladder Pain Syndrome” OR “panmural cystitis” OR “interstitial cystitis” OR “interstitial cystitides”)) OR (TITLE-ABS-KEY((bladder OR hunner OR hunneri OR submucosal OR submucous) W/3 (ulcer OR ulcus OR cystitis)))) AND ((TITLE-ABS-KEY(“Health-Chronic Prostatitis Symptom*” OR “chronic prostatitis symptom index” OR “NIH-CPSI” OR “CPSI” OR index* OR indices OR instrument* OR “Interstitial Cystitis Symptom Index” OR questionnaire* OR survey* OR reliability OR reproductivity OR reproducibility OR scale OR validat* OR validity OR consistency OR diary OR diaries OR “ecological momentary assessment*” OR “ecologic momentary assessment*”))) AND ((TITLE-ABS-KEY(develop* OR new)))

The Cochrane Library

Date Searched: 8/11/2023

Applied Database Supplied Limits: none

Number of Results

CENTRAL: 97

CDSR: 1

*Search updated: 12/17/2024 (added terms relating to diaries and ecological momentary assessment)

Results

CENTRAL: 106

CDSR: 1

Full Search Strategy:

([mh “Cystitis, Interstitial”] OR [mh “Prostatitis”] OR (“bladder pain syndrome*” OR “chronic prostatitis” OR “painful bladder syndrome” OR “Bladder Pain Syndrome” OR “panmural cystitis” OR “interstitial cystitis” OR “interstitial cystitides”):ti,ab,kw OR ((bladder OR hunner OR hunneri OR submucosal OR submucous) NEAR/3 (ulcer OR ulcus OR cystitis)):ti,ab,kw) AND ([mh “Surveys and Questionnaires”] OR [mh “Reproducibility of Results”] OR [mh “Ecological Momentary Assessment”] OR (“Health Chronic Prostatitis Symptom*” OR “chronic prostatitis symptom index” OR “NIH CPSI” OR “CPSI” OR index* OR indices OR instrument* OR “Interstitial Cystitis Symptom Index” OR questionnaire* OR survey* OR reliability OR reproductivity OR reproducibility OR scale OR validat* OR validity OR consistency OR diary OR diaries OR “ecological momentary assessment*” OR “ecologic momentary assessment*”):ti,ab,kw) AND ((develop* OR new):ti,ab,kw)

APA PsycINFO

Date Searched: 8/11/2023

Applied Database Supplied Limits: none

Number of Results: 26

Search updated: 12/17/2024 (added terms relating to diaries and ecological momentary assessment)

Results 27

Full Search Strategy:

1. TI (“bladder pain syndrome*” OR “chronic prostatitis” OR “painful bladder syndrome” OR “Bladder Pain Syndrome” OR “panmural cystitis” OR “interstitial cystitis” OR “interstitial cystitides”) OR AB (“bladder pain syndrome*” OR “chronic prostatitis” OR “painful bladder syndrome” OR “Bladder Pain Syndrome” OR “panmural cystitis” OR “interstitial cystitis” OR “interstitial cystitides”) OR TI ((bladder OR hunner OR hunneri OR submucosal OR submucous) N3 (ulcer OR ulcus OR cystitis)) OR AB ((bladder OR hunner OR hunneri OR submucosal OR submucous) N3 (ulcer OR ulcus OR cystitis))

2. (((DE “Index (Testing)”) OR (DE “Questionnaires”)) OR (DE “Test Reliability” OR DE “Statistical Reliability”)) OR (DE “Consistency (Measurement)”) OR DE “Ecological Momentary Assessment” OR (TI (“Health-Chronic Prostatitis Symptom*” OR “chronic prostatitis symptom index” OR “NIH-CPSI” OR “CPSI” OR index* OR indices OR instrument* OR “Interstitial Cystitis Symptom Index” OR questionnaire* OR survey* OR reliability OR reproductivity OR reproducibility OR scale OR validat* OR validity OR consistency OR diary OR diaries OR “ecological momentary assessment*” OR “ecologic momentary assessment*”) OR AB (“Health-Chronic Prostatitis Symptom*” OR “chronic prostatitis symptom index” OR “NIH-CPSI” OR “CPSI” OR index* OR indices OR instrument* OR “Interstitial Cystitis Symptom Index” OR questionnaire* OR survey* OR reliability OR reproductivity OR reproducibility OR scale OR validat* OR validity OR consistency OR diary OR diaries OR “ecological momentary assessment*” OR “ecologic momentary assessment*”))

3. TI (develop* OR new) OR AB (develop* OR new)

4. #1 AND #2 AND #3

ClinicalTrials.gov

Date Searched: 8/11/2023

Number of Results: 30

Search updated: 12/17/2024 (added terms relating to diaries and ecological momentary assessment)

Results 39

Full Search Strategy:

Disease or condition: (“interstitial cystitis” OR “bladder pain syndrome” OR “chronic prostatitis”)

Other terms: ((validat* OR questionnaire* OR diary) AND (Developing OR new))

Data availability:

All extracted data are presented in Tables 1–4.