Overactive bladder

Summary

Overactive bladder (MONDO:0006624) is a disease and 552 clinical trials. Top therapeutic interventions include solifenacin, tolterodine, and fesoterodine. A subtype of urinary bladder disorder — broader associated-gene and molecular evidence is on the parent page (see Disease family below).

At a glance

• Clinical trials: 552

Clinical features

No curated clinical features (Orphanet) for this disease.

Identifiers

Disease identifiers

Field	Value
Canonical name	overactive bladder
Mondo ID	MONDO:0006624
EFO	EFO:1000781
MeSH	D053201
DOID	DOID:0070355
ICD-10-CM	N32.81
ICD-11	1118102209
SNOMED CT	236633002
UMLS	C0878773
MedGen	168058
MedDRA	10020853
Is cancer (heuristic)	no

Also known as: overactive bladder · overactive bladder (disease)

Data availability: 1 HPO phenotype.

Disease family

This is a subtype of urinary bladder 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 › urinary system disorder › urinary bladder disorder › overactive bladder

Related subtypes (16): low compliance bladder, detrusor sphincter dyssynergia, female stress incontinence, urinary bladder tuberculosis, urinary bladder neoplasm, urinary schistosomiasis, vesicoureteral reflux, cystitis, bladder calculus, bladder neck obstruction, postcholecystectomy syndrome, ureterolithiasis, bladder diverticulum, ureterocele, Hinman syndrome, disorder of neck of urinary bladder

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

4 approved, 12 in late-stage (phase 3) trials. Disease-direct ChEMBL indications, not inferred from the associated-gene cohort below.

Drug	Development status
Botulinum Toxin Type A	Approved (phase 4)
Mirabegron	Approved (phase 4)
Oxybutynin	Approved (phase 4)
Vibegron	Approved (phase 4)
Darifenacin	Phase 3 (in late-stage trials)
Dimethyl Sulfoxide	Phase 3 (in late-stage trials)
Fesoterodine	Phase 3 (in late-stage trials)
Imidafenacin	Phase 3 (in late-stage trials)
Incobotulinumtoxina	Phase 3 (in late-stage trials)
Lidocaine	Phase 3 (in late-stage trials)
Onabotulinumtoxina	Phase 3 (in late-stage trials)
Propiverine	Phase 3 (in late-stage trials)
Ritobegron	Phase 3 (in late-stage trials)
Sodium Chloride	Phase 3 (in late-stage trials)
Solifenacin	Phase 3 (in late-stage trials)
Tolterodine	Phase 3 (in late-stage trials)

Earlier-phase candidates (phase 2, investigational — efficacy not yet established): Casopitant, Desmopressin, Dexmecamylamine, Estrogens, Conjugated, Lactose, Anhydrous, Pregabalin, Vardenafil.

Clinical trials & evidence

Clinical trials

Clinical trials: 552.

Phase distribution (across all retrieved trials)

Phase	Trials
Not specified	294
PHASE4	98
PHASE3	59
PHASE2	50
PHASE1	34
PHASE1/PHASE2	7
PHASE2/PHASE3	5
EARLY_PHASE1	5

Top trials by phase / activity

NCT	Phase	Status	Title
NCT04020510	PHASE4	RECRUITING	Standard Injections Versus Reduced Injections for Intravesical onabotulinumtoxinA Treatment of Overactive Bladder
NCT04444440	PHASE4	RECRUITING	Antibiotic Prophylaxis for Bladder Botox
NCT05362292	PHASE4	RECRUITING	TReating Incontinence for Underlying Mental and Physical Health
NCT05557279	PHASE4	RECRUITING	Urinary Microbiome Changes Following Administration of 500 mg of NDS-446 in Women With Dry OAB at 12 Weeks
NCT06387329	PHASE4	RECRUITING	Bladder Botox UTI Antibiotic Prophylaxis
NCT06695585	PHASE4	NOT_YET_RECRUITING	Optimal Intravesical Lidocaine Volume for Pain Relief During Office Intra-detrusor Onabotulinum Toxin a Injections
NCT06769854	PHASE4	NOT_YET_RECRUITING	Defining the Safety and Efficacy of POSterIor Tibial NeRve StimulatiON in Children
NCT06953271	PHASE4	NOT_YET_RECRUITING	Methenamine Hippurate Following Intradetrusor OnabotulinumtoxinA Injection
NCT07187466	PHASE4	NOT_YET_RECRUITING	Behavioral and/or Mirabegron to Treat Urinary Symptoms in Parkinson Disease
NCT07387315	PHASE4	NOT_YET_RECRUITING	A Randomized, Placebo-controlled Trial of Nitrous Oxide During In-office Bladder Botox Injections
NCT07416968	PHASE4	RECRUITING	Randomized Controlled Trial Comparing Low Dose Tadalafil Versus Solifenacin For Management of Overactive Bladder in Women: Multicenter Egyptian National Study
NCT07473310	PHASE4	RECRUITING	Low-intensity Shockwave Therapy Versus Solifenacin for the Treatment of Overactive Bladder in Women
NCT00171184	PHASE4	COMPLETED	Efficacy, Safety, and Tolerability of Darifenacin in Patients Aged > 65 Years With Overactive Bladder
NCT00224146	PHASE4	COMPLETED	Transdermal (TDS) Oxybutynin (Oxytrol(r)) in Overactive Bladder
NCT00282932	PHASE4	COMPLETED	Detrol LA In Men With Overactive Bladder.
NCT00313924	PHASE4	UNKNOWN	Assessing the OAB-8 Questionnaire as a Tool to Measure Treatment Outcome
NCT00337558	PHASE4	COMPLETED	A Study of Solifenacin With Bladder Training Versus Solifenacin Alone in Patients With Overactive Bladder (SOLAR)
NCT00366002	PHASE4	COMPLETED	Patient’s Perception of Treatment Outcome With Darifenacin by Patients With Overactive Bladder
NCT00431041	PHASE4	COMPLETED	Study to Compare the Safety and Efficacy of Solifenacin With Oxybutynin for the Treatment of Overactive Bladder (VECTOR)
NCT00448175	PHASE4	COMPLETED	Overactive Bladder Innovative Therapy Trial (OrBIT)
NCT00547378	PHASE4	COMPLETED	InSite for Over Active Bladder
NCT00730535	PHASE4	COMPLETED	Exploring Predictors of Symptoms Relapse After Discontinuation of Treatment in Overactive Bladder (OAB) Patients
NCT00759577	PHASE4	TERMINATED	Feasibility of At-home Titration of Solifenacin
NCT00771264	PHASE4	COMPLETED	Study of Urgent PC Versus Sham Effectiveness in Treatment of Overactive Bladder Symptoms
NCT00771394	PHASE4	COMPLETED	Solifenacin as Add-on Therapy for Overactive Bladder Symptoms in Men Treated for Benign Prostatic Hyperplasia
NCT00773552	PHASE4	WITHDRAWN	Solifenacin Succinate Versus Placebo in Inner City Women Ages 20-45 With Overactive Bladder
NCT00836381	PHASE4	COMPLETED	Assessment of Patient-reported Goal Attainment in the Treatment of Female Overactive Bladder
NCT00862745	PHASE4	COMPLETED	Bringing Simple Urge Incontinence Diagnosis & Treatment to Providers (BRIDGES)
NCT00863551	PHASE4	COMPLETED	Sanctura Muscarinic Receptor Antagonist Resists Transport (SMART) Trial
NCT00871975	PHASE4	TERMINATED	Tetra-NIRS Clinical Study
NCT00883818	PHASE4	COMPLETED	Microorganism in Overactive Bladder Patients
NCT00884104	PHASE4	COMPLETED	A Study to Evaluate Add on Effect of Solifenacin in Men With Overactive Bladder Symptoms After Tamsulosin Monotherapy for 4 Weeks
NCT00902421	PHASE4	COMPLETED	Efficacy and Safety of Selective Serotonin Reuptake Inhibitor (SSRI) in Overactive Bladder Patients
NCT00903045	PHASE4	COMPLETED	Urinary Urgency Outcomes Following Propiverine Treatment for an Overactive Bladder
NCT00911937	PHASE4	COMPLETED	A Trial To Evaluate The Efficacy And Safety Of Fesoterodine In Patients With Symptoms Of Overactive Bladder Including Nocturnal Urinary Urgency
NCT00922506	PHASE4	COMPLETED	Combination Treatment With Doxazosin Plus TolterodineSR 2 mg Versus 4mg in Men With an Overactive Bladder (OAB) and Benign Prostatic Hyperplasia (BPH)
NCT00928070	PHASE4	COMPLETED	A Study Of Efficacy And Safety Of Fesoterodine In Vulnerable Elderly Subjects With Overactive Bladder
NCT00932022	PHASE4	COMPLETED	Trospium Chloride XR in Obese Female Patients With Overactive Bladder
NCT00979472	PHASE4	COMPLETED	Solifenacin Flexible Dosing Study in Frequent Micturition Patients With and Without Urgency
NCT01003249	PHASE4	TERMINATED	Dysfunctional Voiding and Lower Urinary Tract Symptoms With Baclofen

Drugs tested across these trials (top 30)

Molecule	Max phase	Trials referencing
SOLIFENACIN	4	136
TOLTERODINE	4	71
FESOTERODINE	4	34
OXYBUTYNIN	4	33
MIRABEGRON	4	28
DARIFENACIN	4	24
TAMSULOSIN	4	17
TROSPIUM	4	12
PROPIVERINE	4	10
ONABOTULINUMTOXINA	4	8
VIBEGRON	4	8
BOTULINUM TOXIN TYPE A	4	6
DOXYCYCLINE ANHYDROUS	4	3
ESTRADIOL	4	2
TADALAFIL	4	2
ABOBOTULINUMTOXINA	4	1
ATOGEPANT	4	1
AZITHROMYCIN	4	1
BACLOFEN	4	1
CIPROFLOXACIN	4	1
DIMETHYL SULFOXIDE	4	1
EPTINEZUMAB	4	1
ERENUMAB	4	1
ESTROGENS, CONJUGATED	4	1
FREMANEZUMAB	4	1
GALCANEZUMAB	4	1
INCOBOTULINUMTOXINA	4	1
LIDOCAINE HYDROCHLORIDE	4	1
METHENAMINE HIPPURATE	4	1
NITROFURANTOIN	4	1