Description

The National Institute of Arthritis, Diabetes, Digestive and Kidney Disease, or NIADDK (formerly the National Institute of Diabetes, Digestive and Kidney Disease, or NIDDK) developed criteria for interstitial cystitis that could be used for clinical trials.


 

Automatic exclusion criteria:

(1) age < 18 years of age

(2) benign or malignant bladder tumor

(3) radiation cystitis

(4) tuberculous cystitis

(5) bacterial cystitis or prostatitis within 3 month period

(6) vaginitis

(7) cyclophosphamide or any other type of chemical cystitis

(8) symptomatic urethral diverticulum

(9) uterine, cervical, vaginal or urethral carcinoma

(10) active herpes simplex

(11) bladder or lower ureteral calculi

(12) waking frequency < 5 times in 12 hours (some use < 8 times while awake)

(13) nocturia < 2 times

(14) symptoms relieved by antibiotics, urinary antiseptics, or urinary analgesics

(15) duration < 12 months (some use < 9 months)

(16) involuntary urinary contractions demonstrated on urodynamics

(17) urinary bladder capacity > 400 mL with absence of sensory urgency

 

Automatic inclusion:

(1) Hunner's ulcer (small brownish red mucosal patch seen on cystoscopy)

 

Positive factors (>= 2 required for inclusion):

(1) pain on bladder filling, relieved by emptying

(2) pain, either suprapubic, pelvic, urethral, vaginal and/or perineal

(3) glomerulations (pinpoint petechial hemorrhages) seen during endoscopic bladder distension under anesthesia

(4) decreased compliance demonstrated on cystometrogram

 

Substratification based on bladder capacity under anesthesia:

(1) bladder capacity <= 350 mL

(2) bladder capacity > 350 mL (some exclude patients if bladder capacity is > 350 mL)

 

where:

• Hunner's ulcers are found only infrequently.

• Bladder distension is arbitrarily defined as 80 cm water pressure for 1 minute (others use 80-120 cm water for 1-2 minutes).

• Glomerulations must be (a) diffuse (present in at least 3 bladder quadrants); (b) have at least 10 in each quadrant; (c) must not be along the path of the cystoscope.

• One of the exclusion criteria does not mean that the person cannot have interstitial cystitis. It just means that the patient cannot be included in research studies to determine the effectiveness of interventions.

• Prostate cancer was not listed as an exclusion criteria, but would make sense to me.

• Schistosomiasis would be exclusionary in those parts of the world with that disease.

 


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