Urinary Incontinence, Stress

11
Pipeline Programs
5
Companies
12
Clinical Trials
1 recruiting
2
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
0
0
1
0
7
3
Early DiscoveryClinical DevelopmentMarket

On Market (2)

Approved therapies currently available

Eli Lilly and Company
CYMBALTAApproved
duloxetine hydrochloride
Eli Lilly and Company
oral2004
U
DULOXETINE HYDROCHLORIDEApproved
duloxetine hydrochloride
Unknown Company
oral2013

Competitive Landscape

5 companies ranked by most advanced pipeline stage

Boehringer Ingelheim
Boehringer IngelheimINGELHEIM, Germany
5 programs
4
1
Duloxetine hydrochloridePhase 41 trial
DuloxetinePhase 31 trial
Duloxetine HydrochloridePhase 31 trial
duloxetinePhase 31 trial
duloxetinePhase 31 trial
Active Trials
NCT00191087Completed458Est. May 2006
NCT00190996Completed2,765Est. Jun 2006
NCT00190827Completed500Est. May 2006
+2 more trials
Eli Lilly and Company
Eli Lilly and CompanyINDIANAPOLIS, IN
2 programs
2
1
DuloxetinePhase 31 trial
Duloxetine HydrochloridePhase 3
Active Trials
NCT00475358Completed120Est. Feb 2005
J&
Johnson & JohnsonNEW BRUNSWICK, NJ
1 program
1
TVT SecurPhase 32 trials
Active Trials
NCT01029106Terminated125
NCT00685217Terminated74Est. Apr 2012
Pfizer
PfizerNEW YORK, NY
1 program
1
SS-RBXPhase 22 trials
Active Trials
NCT00141128Completed18Est. Jun 2006
NCT00138749Completed402Est. Aug 2006
C
ColoplastAustralia - Mulgrave
2 programs
Altis Single Incision SlingN/A1 trial
Virtue male slingN/A1 trial
Active Trials
NCT04115605UnknownEst. Sep 2023
NCT04098822RecruitingEst. Dec 2026

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
Boehringer IngelheimDuloxetine hydrochloride
Johnson & JohnsonTVT Secur
Boehringer Ingelheimduloxetine
Boehringer Ingelheimduloxetine
Eli Lilly and CompanyDuloxetine
Boehringer IngelheimDuloxetine Hydrochloride
Boehringer IngelheimDuloxetine
PfizerSS-RBX
PfizerSS-RBX
ColoplastVirtue male sling
ColoplastAltis Single Incision Sling
Johnson & JohnsonTVT Secur

Clinical Trials (12)

Total enrollment: 5,338 patients across 12 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

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

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

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

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

Start: Sep 2003Est. completion: May 2006500 patients
Phase 3Completed

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

Duloxetine in the Treatment of Stress Urinary Incontinence.

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

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

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

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 2026
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 2023
N/AUnknown

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

Start: Sep 2009125 patients
N/ATerminated

Phase Legend

PreclinicalLab & animal studies
Phase 1Safety & dosing
Phase 2Efficacy testing
Phase 3Large-scale trials
On MarketApproved & available

Key Insights

7 late-stage (Phase 3) programs — potential near-term approvals
1 actively recruiting trials targeting 5,338 patients
5 companies competing in this space