Urinary Incontinence

15
Pipeline Programs
8
Companies
17
Clinical Trials
6
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
1
0
1
1
3
9
Early DiscoveryClinical DevelopmentMarket

On Market (6)

Approved therapies currently available

U
DARIFENACINApproved
darifenacin
Unknown Company
oral2017
U
DARIFENACIN HYDROBROMIDEApproved
darifenacin
Unknown Company
oral2017
Ipsen
DYSPORTApproved
botulinum toxin type a
Ipsen
Acetylcholine Release Inhibitor [EPC]injection2009
U
SOLIFENACIN SUCCINATEApproved
solifenacin succinate
Unknown Company
oral2023
Astellas
VESICAREApproved
solifenacin succinate
Astellas
oral2004
Astellas
VESICARE LSApproved
solifenacin succinate
Astellas
oral2020

Competitive Landscape

8 companies ranked by most advanced pipeline stage

C
ColoplastAustralia - Mulgrave
8 programs
1
1
Conveen Optima is a urisheath to be used together with a collecting bag for urinePhase 41 trial
Test Catheter - SpeediCath Compact MalePhase 2/31 trial
CLINY catheterN/A1 trial
Investigational deviceN/A1 trial
Investigational device - intermittent catheter with a micro-hole zoneN/A1 trial
+3 more programs
Active Trials
NCT05626686CompletedEst. Mar 2023
NCT05841004CompletedEst. Sep 2023
NCT05485922CompletedEst. Nov 2022
+5 more trials
Ipsen
IpsenChina - Tianjin
2 programs
2
1
Botulinum toxin type APhase 31 trial
Botulinum toxin type APhase 31 trial
Active Trials
NCT02660138Terminated227Est. Feb 2019
NCT02660359Terminated258Est. Jul 2019
Novartis
NovartisBASEL, Switzerland
1 program
1
DarifenacinPhase 41 trial
Active Trials
NCT00127270Completed395Est. Feb 2006
Astellas
AstellasChina - Shenyang
1 program
1
solifenacin succinatePhase 41 trial
Active Trials
NCT00333112Completed398Est. Jan 2007
Pfizer
PfizerNEW YORK, NY
2 programs
1
tolterodine extended release capsulePhase 31 trial
Screening for Urinary Incontinence by Primary Care ProvidersN/A1 trial
Active Trials
NCT00178334Completed554Est. Jul 2006
NCT00139724Completed260Est. Oct 2006
Teva
TevaIsrael - Petach Tikva
1 program
1
DR-3001aPhase 21 trial
Active Trials
NCT00196404Completed800Est. Dec 2006
Carbon Biosciences
Carbon BiosciencesMA - Waltham
1 program
1
Needle Guided Periurethral InjectionPhase 11 trial
Active Trials
NCT00763711TerminatedEst. Nov 2009
Amber Therapeutics
1 program
Amber UI systemN/A1 trial
Active Trials
NCT06597994Active Not RecruitingEst. Jan 2026

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
ColoplastConveen Optima is a urisheath to be used together with a collecting bag for urine
Astellassolifenacin succinate
NovartisDarifenacin
IpsenBotulinum toxin type A
IpsenBotulinum toxin type A
Pfizertolterodine extended release capsule
ColoplastTest Catheter - SpeediCath Compact Male
TevaDR-3001a
Carbon BiosciencesNeedle Guided Periurethral Injection
Amber TherapeuticsAmber UI system
ColoplastInvestigational device - newly developed intermittent catheter
ColoplastInvestigational device
ColoplastInvestigational device - intermittent catheter with a micro-hole zone
ColoplastCLINY catheter
ColoplastInvestigational prototype device

Showing 15 of 17 trials with date data

Clinical Trials (17)

Total enrollment: 2,892 patients across 17 trials

NCT01056666ColoplastConveen Optima is a urisheath to be used together with a collecting bag for urine

Conveen Optima Urisheaths With Collecting Bags Versus Absorbents

Start: Jun 2007Est. completion: Mar 2009
Phase 4Completed
NCT00333112Astellassolifenacin succinate

A Study to Evaluate Solifenacin Succinate in Combination With Tamsulosin for the Treatment of Residual Overactive Bladder Symptoms (OAB) in Men.

Start: May 2006Est. completion: Jan 2007398 patients
Phase 4Completed
NCT00127270NovartisDarifenacin

Using Behavioral Therapy in Combination With Darifenacin for Symptoms of Overactive Bladder

Start: May 2005Est. completion: Feb 2006395 patients
Phase 4Completed
NCT02660359IpsenBotulinum toxin type A

Dysport® Treatment of Urinary Incontinence in Adults Subjects With Neurogenic Detrusor Overactivity (NDO) Due to Spinal Cord Injury or Multiple Sclerosis - Study 2

Start: Jul 2016Est. completion: Jul 2019258 patients
Phase 3Terminated
NCT02660138IpsenBotulinum toxin type A

Dysport® Treatment of Urinary Incontinence in Adults Subjects With Neurogenic Detrusor Overactivity (NDO) Due to Spinal Cord Injury or Multiple Sclerosis - Study 1

Start: Mar 2016Est. completion: Feb 2019227 patients
Phase 3Terminated
NCT00139724Pfizertolterodine extended release capsule

Evaluate Efficacy and Safety Of Tolterodine Extended Release Capsule Compared With Tolterodine Immediate Release Tablet

Start: May 2005Est. completion: Oct 2006260 patients
Phase 3Completed
NCT01048541ColoplastTest Catheter - SpeediCath Compact Male

Bladder Scan of Residual Urine With New Catheter

Start: Jan 2010Est. completion: Jun 2010
Phase 2/3Completed
NCT00196404TevaDR-3001a

Study to Evaluate the Safety and Efficacy of DR-3001 Versus Placebo in Women With Overactive Bladder

Start: Oct 2004Est. completion: Dec 2006800 patients
Phase 2Completed
NCT00763711Carbon BiosciencesNeedle Guided Periurethral Injection

Injectable Bulking Agent Needle Guide

Start: Jun 2008Est. completion: Nov 2009
Phase 1Terminated
NCT06597994Amber TherapeuticsAmber UI system

Augmenting Urinary Reflex Activity: Study 3

Start: Jan 2025Est. completion: Jan 2026
N/AActive Not Recruiting
NCT05814211ColoplastInvestigational device - newly developed intermittent catheter

Clinical Trial of New Intermittent Single-use Catheter

Start: Aug 2023Est. completion: Nov 2023
N/ACompleted
NCT05841004ColoplastInvestigational device

Clinical Trial of New Single-use Compact Intermittent Catheter

Start: Jun 2023Est. completion: Sep 2023
N/ACompleted
NCT05485922ColoplastInvestigational device - intermittent catheter with a micro-hole zone

Performance of a Single-use Intermittent Micro-hole Zone Catheter

Start: Sep 2022Est. completion: Nov 2022
N/ACompleted
NCT05626686ColoplastCLINY catheter

An Exploratory Investigation of the Effects of Single Use vs. Reuse Catheters in Intermittent Catheterization

Start: Aug 2022Est. completion: Mar 2023
N/ACompleted
NCT05224544ColoplastInvestigational prototype device

Intermittent Catheterisation on the Bladder Mucosa of Healthy Volunteers With a Prototype Micro Hole Zone Catheter

Start: Jan 2022Est. completion: Mar 2022
N/ACompleted
NCT04672993ColoplastUrine collection device for men

Exploratory Study of a New Urine Collection Device for Men

Start: Nov 2020Est. completion: Dec 2020
N/ACompleted
NCT00178334PfizerScreening for Urinary Incontinence by Primary Care Providers

Screening for Urinary Incontinence by Primary Care Providers

Start: Mar 2006Est. completion: Jul 2006554 patients
N/ACompleted

Phase Legend

Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available

Key Insights

3 late-stage (Phase 3) programs — potential near-term approvals
8 companies competing in this space