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Urinary Incontinence, Stress

14
Pipeline Programs
11
Companies
17
Clinical Trials
1 recruiting
1
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
0
0
2
0
10
2
Early DiscoveryClinical DevelopmentMarket

On Market (1)

Approved therapies currently available

Eli Lilly and Company
CYMBALTAApproved
duloxetine hydrochloride
Eli Lilly and Company
oral2004

Competitive Landscape

9 companies ranked by most advanced pipeline stage

Prevail Therapeutics
7 programs
6
1
Duloxetine hydrochloridePhase 4
DuloxetinePhase 3
DuloxetinePhase 3
DuloxetinePhase 3
Duloxetine HydrochloridePhase 3
+2 more programs
Eli Lilly and Company
Eli Lilly and CompanyINDIANAPOLIS, IN
2 programs
1
DuloxetinePHASE_31 trial
Duloxetine HydrochloridePHASE_3
Active Trials
NCT00475358Completed120Est. Feb 2005
Human BioSciences
Human BioSciencesWV - Martinsburg
3 programs
3
Botox® injectionPhase 31 trial
Burch urethropexy at time of sacrocolpopexyPhase 31 trial
Miduretheral SlingPhase 31 trial
Active Trials
NCT04171531Completed150Est. Feb 2024
NCT00065845Completed322Est. Apr 2007
NCT01959347Completed480Est. Sep 2017
Cook MyoSite
Cook MyoSitePA - Pittsburgh
1 program
1
AMDC-USRPhase 31 trial
Active Trials
NCT01382602Completed150Est. Jan 2017
Pfizer
PfizerNEW YORK, NY
2 programs
2
SS-RBXPhase 21 trial
SS-RBXPhase 21 trial
Active Trials
NCT00138749Completed402Est. Aug 2006
NCT00141128Completed18Est. Jun 2006
Boehringer Ingelheim
Boehringer IngelheimINGELHEIM, Germany
5 programs
DuloxetinePHASE_31 trial
Duloxetine HydrochloridePHASE_31 trial
duloxetinePHASE_31 trial
duloxetinePHASE_31 trial
Duloxetine hydrochloridePHASE_41 trial
Active Trials
NCT00191087Completed458Est. May 2006
NCT00190996Completed2,765Est. Jun 2006
NCT00190814Completed600Est. May 2006
+2 more trials
Coloplast
ColoplastAustralia - Mulgrave
2 programs
Altis Single Incision SlingN/A1 trial
Virtue male slingN/A1 trial
Active Trials
NCT04115605Unknown599Est. Sep 2023
NCT04098822Recruiting130Est. Dec 2026
Medtronic
MedtronicNJ - Phillipsburg
1 program
Vaginal SlingN/A1 trial
Active Trials
NCT00223106Completed467Est. Sep 2007
Johnson & Johnson
Johnson & JohnsonNEW BRUNSWICK, NJ
1 program
TVT SecurPHASE_32 trials
Active Trials
NCT01029106Terminated125
NCT00685217Terminated74Est. Apr 2012

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
Boehringer IngelheimDuloxetine hydrochloride
Human BioSciencesBotox® injection
Human BioSciencesMiduretheral Sling
Cook MyoSiteAMDC-USR
Johnson & JohnsonTVT Secur
Boehringer Ingelheimduloxetine
Boehringer Ingelheimduloxetine
Eli Lilly and CompanyDuloxetine
Boehringer IngelheimDuloxetine Hydrochloride
Human BioSciencesBurch urethropexy at time of sacrocolpopexy
Boehringer IngelheimDuloxetine
PfizerSS-RBX
PfizerSS-RBX
ColoplastVirtue male sling
ColoplastAltis Single Incision Sling

Showing 15 of 17 trials with date data

Clinical Trials (17)

Total enrollment: 7,636 patients across 17 trials

NCT00244296Boehringer IngelheimDuloxetine hydrochloride

To Determine How Effective Duloxetine is in Treating Women 65 Years and Older With Symptoms of Stress Urinary Incontinence, or With a Combination of Stress Urinary Incontinence and Urge Urinary Incontinence Symptoms

Start: Oct 2005Est. completion: Jan 2007276 patients
Phase 4Completed
NCT04171531Human BioSciencesBotox® injection

Sling vs Botox for Mixed Incontinence

Start: Jun 2020Est. completion: Feb 2024150 patients
Phase 3Completed
NCT01959347Human BioSciencesMiduretheral Sling

Combined Treatment for Mixed Incontinence

Start: Oct 2013Est. completion: Sep 2017480 patients
Phase 3Completed
NCT01382602Cook MyoSiteAMDC-USR

Autologous Muscle Derived Cells Female Stress Urinary Incontinence Clinical Study

Start: Nov 2011Est. completion: Jan 2017150 patients
Phase 3Completed
NCT00685217Johnson & JohnsonTVT Secur

Transvaginal Tape (TVT) Secur Versus TVT Randomised Controlled Trial (RCT)

Start: May 2008Est. completion: Apr 201274 patients
Phase 3Terminated
NCT00190814Boehringer Ingelheimduloxetine

Effectiveness and Safety of Duloxetine in Women Experiencing Urinary Leakage Due to Physical Stress and Urge.

Start: Sep 2003Est. completion: May 2006600 patients
Phase 3Completed
NCT00190827Boehringer Ingelheimduloxetine

Effectiveness of Duloxetine in the Treatment of Stress Urinary Incontinence(Uncontrolled Leakage of Urine)

Start: Sep 2003Est. completion: May 2006500 patients
Phase 3Completed
NCT00475358Eli Lilly and CompanyDuloxetine

Efficacy and Safety Stress Urinary Incontinence Study

Start: Apr 2003Est. completion: Feb 2005120 patients
Phase 3Completed
NCT00190996Boehringer IngelheimDuloxetine Hydrochloride

Evaluate Safety and Efficacy of Duloxetine in Predominant Stress Urinary Incontinence

Start: Jan 2003Est. completion: Jun 20062,765 patients
Phase 3Completed
NCT00065845Human BioSciencesBurch urethropexy at time of sacrocolpopexy

Colpopexy and Urinary Reduction Efforts (CARE) Protocol

Start: Apr 2002Est. completion: Apr 2007322 patients
Phase 3Completed
NCT00191087Boehringer IngelheimDuloxetine

Duloxetine in the Treatment of Stress Urinary Incontinence.

Start: Apr 2001Est. completion: May 2006458 patients
Phase 3Completed
NCT00141128PfizerSS-RBX

Evaluation Of A Novel Methodology In The Assessment Of Urethral Function Using SS-RBX.

Start: Dec 2005Est. completion: Jun 200618 patients
Phase 2Completed
NCT00138749PfizerSS-RBX

An 8 Week Study Looking At The Efficacy, Toleration And Safety Of SS-RBX For Stress Urinary Incontinence.

Start: Nov 2004Est. completion: Aug 2006402 patients
Phase 2Completed
NCT04098822ColoplastVirtue male sling

A 3 Years Naturalistic Cohort Survey Of Virtue® Male Sling System For Male Stress Urinary Incontinence

Start: Jun 2017Est. completion: Dec 2026130 patients
N/ARecruiting
NCT04115605ColoplastAltis Single Incision Sling

A 3 Years Naturalistic Cohort Survey of Altis Single Incision Sling System For Female Stress Urinary Incontinence

Start: Apr 2015Est. completion: Sep 2023599 patients
N/AUnknown
NCT01029106Johnson & JohnsonTVT Secur

Gynecare TVT Secur for the Management of Stress Urinary Incontinence (SUI)

Start: Sep 2009125 patients
N/ATerminated
NCT00223106MedtronicVaginal Sling

Treatment for Stress and Mixed Urinary Incontinence and Vaginal Vault Prolapse

Start: Mar 2004Est. completion: Sep 2007467 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

10 late-stage (Phase 3) programs, potential near-term approvals
1 actively recruiting trials targeting 7,636 patients
11 companies competing in this space

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.