Interstitial cystitis

Summary

Interstitial cystitis (MONDO:0018301) is a disease and 195 clinical trials. Top therapeutic interventions include amitriptyline, sodium chloride, and dexmedetomidine. A subtype of connective tissue disorder — broader associated-gene and molecular evidence is on the parent page (see Disease family below).

At a glance

• Prevalence: 1-5 / 10 000 (Finland) [Orphanet-validated]
• Phenotypes (HPO): 19
• Clinical trials: 195

Clinical features

Epidemiology

Prevalence records

4 prevalence record(s), Orphanet:

Type	Class	Value	Geography	Validation
Annual incidence	1-9 / 1 000 000	0.66	Finland	Validated
Point prevalence	1-5 / 10 000	10.6	Finland	Validated
Point prevalence	1-5 / 10 000	30	United States	Validated
Point prevalence	1-5 / 10 000		Europe	Not yet validated

Signs & symptoms

Clinical features (HPO)

19 HPO clinical features (Orphanet curated; top 19 by frequency):

HPO ID	Term	Frequency
HP:0000009	Functional abnormality of the bladder	Very frequent (80-99%)
HP:0000012	Urinary urgency	Very frequent (80-99%)
HP:0000014	Abnormality of the bladder	Very frequent (80-99%)
HP:0000017	Nocturia	Very frequent (80-99%)
HP:0000058	Abnormality of the labia	Very frequent (80-99%)
HP:0000078	Abnormality of the genital system	Very frequent (80-99%)
HP:0000140	Abnormality of the menstrual cycle	Very frequent (80-99%)
HP:0000795	Abnormality of the urethra	Very frequent (80-99%)
HP:0030016	Dyspareunia	Very frequent (80-99%)
HP:0034267	Pelvic pain	Very frequent (80-99%)
HP:0100515	Pollakisuria	Very frequent (80-99%)
HP:0100518	Dysuria	Very frequent (80-99%)
HP:0100577	Urinary bladder inflammation	Very frequent (80-99%)
HP:0000716	Depression	Frequent (30-79%)
HP:0002960	Autoimmunity	Frequent (30-79%)
HP:0011118	Abnormality of tumor necrosis factor secretion	Frequent (30-79%)
HP:0011227	Elevated circulating C-reactive protein concentration	Frequent (30-79%)
HP:0000142	Abnormality of the vagina	Occasional (5-29%)
HP:0500005	Anal pain	Occasional (5-29%)

Identifiers

Disease identifiers

Field	Value
Canonical name	interstitial cystitis
Mondo ID	MONDO:0018301
EFO	EFO:0008507
MeSH	D018856
Orphanet	37202
DOID	DOID:13949, DOID:1678
ICD-10-CM	N30.1
ICD-11	1650709285
NCIT	C27189
SNOMED CT	111409009, 197834003
UMLS	C0282488
MedGen	129176
GARD	0018825
MedDRA	10008927, 10011796
Is cancer (heuristic)	no

Also known as: bladder pain syndrome · chronic interstitial cystitis · IC/BPS · IC/PBS · interstitial cystitis, chronic · interstitial cystitis/bladder pain syndrome · interstitial cystitis/painful bladder syndrome · painful bladder syndrome

Disease family

This is a subtype of connective tissue disorder. Genetic, therapeutic, and trial evidence is largely curated at the broader-term level — see the parent page for the associated-gene cohort and molecular evidence.

Classification path: disease › human disease › disease by body system or component › connective tissue disorder › interstitial cystitis

Related subtypes (15): benign connective and soft tissue neoplasm, ochronosis disorder, enthesopathy, synovitis, collagenopathy, fasciitis, interstitial keratitis, periostitis, rheumatic disorder, panniculitis, ainhum, overlapping connective tissue disease, connective tissue neoplasm, hereditary disorder of connective tissue, disease of the tendon

Genetics & variants

GWAS landscape

No GWAS associations recorded — common-variant (GWAS) studies don’t cover this disease (typical for Mendelian / rare diseases). See the curated gene cohort and Mendelian overlap below.

Variant details and genetic-evidence tiers

No tiered GWAS variants or ClinVar records for this disease.

Genes & proteins

No associated-gene cohort resolved for this disease. Atlas builds the molecular and therapeutic sections — associated genes, protein families, druggability, pathways, interactions, and drug associations — by aggregating over a disease’s associated genes (resolved via GWAS / GenCC / ClinVar / CIViC), and none resolved here. This is expected for antibody-mediated, autoimmune, or otherwise non-gene-defined conditions; the curated evidence for this disease is its clinical features, GWAS susceptibility, and clinical trials (above).

Function

No pathway enrichment — requires an associated-gene cohort.

Therapeutics

Drugs indicated for this disease

1 approved, 11 in late-stage (phase 3) trials. Disease-direct ChEMBL indications, not inferred from the associated-gene cohort below.

Drug	Development status
Pentosan Polysulfate Sodium	Approved (phase 4)
Adalimumab	Phase 3 (in late-stage trials)
Amitriptyline	Phase 3 (in late-stage trials)
Certolizumab Pegol	Phase 3 (in late-stage trials)
Estrogens, Conjugated	Phase 3 (in late-stage trials)
Gabapentin	Phase 3 (in late-stage trials)
Methenamine	Phase 3 (in late-stage trials)
Mirabegron	Phase 3 (in late-stage trials)
Mycophenolate Mofetil	Phase 3 (in late-stage trials)
Omalizumab	Phase 3 (in late-stage trials)
Rosiptor	Phase 3 (in late-stage trials)
Triamcinolone Acetonide	Phase 3 (in late-stage trials)

Earlier-phase candidates (phase 2, investigational — efficacy not yet established): Chondroitin Sulfate Sodium, Cyclosporine, Dimethyl Sulfoxide, Fremanezumab, Gefapixant, Heparin, Interferon, Lidocaine, Naltrexone, Onabotulinumtoxina, Ozone, Sodium Chloride, Tanezumab.

Clinical trials & evidence

Clinical trials

Clinical trials: 195.

Phase distribution (across all retrieved trials)

Phase	Trials
Not specified	109
PHASE2	36
PHASE4	18
PHASE3	10
PHASE1	8
PHASE1/PHASE2	5
EARLY_PHASE1	5
PHASE2/PHASE3	4

Top trials by phase / activity

NCT	Phase	Status	Title
NCT06387329	PHASE4	RECRUITING	Bladder Botox UTI Antibiotic Prophylaxis
NCT00086684	PHASE4	TERMINATED	Effectiveness and Safety Study of Pentosan Polysulfate Sodium for the Treatment of Interstitial Cystitis
NCT00194610	PHASE4	COMPLETED	Botox as a Treatment for Interstitial Cystitis in Women
NCT00919802	PHASE4	COMPLETED	Intranasal Oxytocin for the Treatment of Pain Associated With Interstitial Cystitis
NCT01157507	PHASE4	UNKNOWN	Botulinum A Toxin in the Treatment of Patients With Painful Bladder Syndrome
NCT01195116	PHASE4	COMPLETED	Usefulness of Dexmedetomidine on Post-operative Pain Management in Patients With Interstitial Cystitis
NCT01312259	PHASE4	UNKNOWN	Clinical Efficacy of Changing the InterStim® Parameters in Patients With Interstitial Cystitis/Painful Bladder Syndrome
NCT01678911	PHASE4	TERMINATED	Efficacy of Gralise® for Chronic Pelvic Pain
NCT01879930	PHASE4	TERMINATED	Chronic Bladder Pain Syndrome in Women: Can Doxycycline Help? A Prospective Study
NCT02000401	PHASE4	COMPLETED	Intranasal Ketorolac Tromethamine (Sprix) for Acute Pain of Interstitial Cystitis Flare of Pain
NCT02297100	PHASE4	COMPLETED	Intravesicular Onabotulinumtoxin A in Interstitial Cystitis
NCT02600715	PHASE4	COMPLETED	Reduction of Bladder Injection Pain With Belladonna Opiate Suppository
NCT02981459	PHASE4	WITHDRAWN	Mirabegron for the Treatment of Pain Motivated Urinary Frequency and Urgency in Women
NCT03008382	PHASE4	COMPLETED	Interstitial Cystitis: Examination of the Central Autonomic Network
NCT04268810	PHASE4	TERMINATED	Prospective Trial Comparing Intravesical Chondroitin Sulphate 2% and DMSO in the Treatment of PBS/Interstitial Cystitis
NCT04313972	PHASE4	TERMINATED	IC PaIN Trial: Interstitial Cystitis Pain Improvement With Naltrexone
NCT05223244	PHASE4	COMPLETED	Bladder Capacity as Objective Measure of Intravesical Treatment of Newly Diagnosed IC
NCT05518864	PHASE4	UNKNOWN	GAG-therapy Efficacy Trial Solution for Bladder Pain Syndrome/ Interstitial Cystitis (GETSBI Study)
NCT05726786	PHASE3	RECRUITING	The Role of Preoperative Immunonutrition on Morbidity and Immune Response After Cystectomy (INCyst Trial)
NCT06096597	PHASE2/PHASE3	RECRUITING	Amniotic Membrane Therapy for Interstitial Cystitis/Painful Bladder Syndrome
NCT07391306	PHASE2/PHASE3	RECRUITING	The Study is Being Conducted to Find a New Treatment for Patients Suffering From Interstitial Cystitis Without Hunner’s Lesions.
NCT07459790	PHASE2/PHASE3	RECRUITING	The Study is Being Conducted to Find a New Treatment for Patients Suffering From Interstitial Cystitis With Hunner’s Lesions
NCT00094874	PHASE3	UNKNOWN	Acupuncture for the Treatment of Interstitial Cystitis (IC) Symptoms
NCT00124306	PHASE3	COMPLETED	Efficacy of Amitriptyline for Painful Bladder Syndrome (PBS)
NCT00451867	PHASE3	TERMINATED	A Randomized Multicenter Double-Blind CT to Evaluate the Efficacy and Safety of Mycophenolate Mofetil . . .
NCT01294878	PHASE3	COMPLETED	Omalizumab in Interstitial Cystitis/Bladder Pain Syndrome
NCT01295814	PHASE3	COMPLETED	Efficacy Study of Adalimumab to Treat Interstitial Cystitis
NCT02858453	PHASE3	UNKNOWN	Efficacy and Safety of 2 Doses of AQX-1125 in Subjects With Interstitial Cystitis / Bladder Pain Syndrome
NCT03463915	PHASE3	COMPLETED	Clinical Trial Comparing Two Bladder Instillations for IC/BPS
NCT05658874	PHASE3	TERMINATED	A Multidisciplinary, Multimodal Bundled Care Approach to Chronic Pelvic Pain
NCT05912946	PHASE2/PHASE3	UNKNOWN	Assessing the Effectiveness and Safety of Interferon Bladder Infusion for the Treatment of Interstitial Cystitis
NCT06209008	PHASE3	COMPLETED	Submucosal Intravesical Injection of Platelet-rich Plasma in the Treatment of Painful Bladder Syndrome
NCT02870738	PHASE2	ACTIVE_NOT_RECRUITING	Bladder Directed vs. Pelvic Floor Therapy in IC/BPS
NCT04845217	PHASE1/PHASE2	RECRUITING	Peppermint Oil for the Treatment of Interstitial Cystitis / Bladder Pain Syndrome
NCT05737121	PHASE2	RECRUITING	Safety and Efficacy Study of VNX001 Compared to Its Individual Components (Lidocaine and Heparin) or Placebo in Subjects With IC/BPS
NCT06394830	PHASE2	RECRUITING	Safety, Efficacy, and Frequency of Administration of VNX001 in the Treatment of Interstitial Cystitis / Bladder Pain Syndrome (IC/BPS)
NCT00004316	PHASE1/PHASE2	COMPLETED	Phase I/II Randomized, Placebo-Controlled Study of Capsaicin for Interstitial Cystitis and Vulvar Vestibulitis
NCT00056251	PHASE2	COMPLETED	Interstitial Cystitis
NCT00256542	PHASE2	COMPLETED	Study of U101 for Bladder Pain and/or Urgency
NCT00295854	PHASE2	COMPLETED	Phase II Study Efficacy and Safety of Two Dosing Regimens of MN-001 in Patients With Interstitial Cystitis

Drugs tested across these trials (top 30)

Molecule	Max phase	Trials referencing
AMITRIPTYLINE	4	9
SODIUM CHLORIDE	4	5
DEXMEDETOMIDINE	4	3
DIMETHYL SULFOXIDE	4	3
DOXYCYCLINE ANHYDROUS	4	3
NALTREXONE	4	3
FREMANEZUMAB	4	2
CAPSAICIN	4	1
GABAPENTIN	4	1
GEFAPIXANT	4	1
HYALURONIC ACID	4	1
KETOROLAC TROMETHAMINE	4	1
METHENAMINE	4	1
MIRABEGRON	4	1
NITROFURANTOIN	4	1
NORTRIPTYLINE	4	1
OMALIZUMAB	4	1
OXYTOCIN	4	1
CHONDROITIN SULFATE SODIUM	3	2
ROSIPTOR	3	2
BELLADONNA	3	1
ESTROGEN	3	1
INTERFERON	3	1
MEDETOMIDINE	3	1
OZONE	3	1
PEPPERMINT OIL	3	1
WAX, EMULSIFYING	3	1
ZUCAPSAICIN	3	1
SUNOBINOP	2	1
TIPELUKAST	2	1