TheraRadar
Landscape / Urology
Page updated Sep 30, 2026 · using data updated on Nov 12, 2026

Stress Urinary Incontinence Clinical Trial Landscape

Stress Urinary Incontinence is being studied across 74 clinical trials registered since 2008, with 11 programs currently active. The competitive pipeline includes 4 active Phase 3 trials, 4 active Phase 2 trials, and 0 active Phase 1 trials.

Top industry sponsors include Levee Medical, Inc., Cook MyoSite, TBF Genie Tissulaire.

Trial activity

11 active / 74 total since 2008
Active by phase 4 Ph3 / 28 4 Ph2 / 23 0 Ph1 / 8 3 Ph4 / 15

Competitive Intelligence

This Stress Urinary Incontinence competitive landscape maps 0 companies against 0 mechanisms of action (MOA) across 0 active drug-development programs. Each cell is the lead program for a company–mechanism pair — its trial phase, modality, combination, and nearest readout. Read down a column to see who is competing on the same mechanism in Stress Urinary Incontinence, across a row to see one company's mechanistic spread, and click any cell for the full program list and trial links.

Beta 0 companies 0 mechanisms 0 programs mapped all shown mechanisms rule/db-classified click any cell → asset tearsheet
The competitive read

Stress urinary incontinence has no approved drug in the US, and the industry pipeline is small and split across unrelated approaches. Cook MyoSite's iltamiocel, an injection of the patient's own muscle-derived cells into the urethral sphincter, is in Phase 3 (CELLEBRATE) in women whose SUI persists after surgery. Eli Lilly is testing the oral GLP-1 drug orforglipron in women with overweight or obesity. Device makers are working on men having prostate surgery (Levee's Voro scaffold) and on sling materials (TBF's umbilical-vein allograft). No two companies share a mechanism, so each program appears in the single-program list rather than the grid.

Key findings
  • Cook MyoSite runs 1 programs — the deepest pipeline in this view.
  • Eli Lilly has the highest composite score (70) — most-imminent / most-advanced asset weighted higher than program count.
  • 2 single-program mechanisms in the long tail — 1 are Ph2+ first-in-class first-mover bets.
  • 1 NME candidates in the long tail.
  • Most-novel-of-novel: Cook MyoSite Autologous muscle-cell therapy (Ph3) — first-in-class within scope + NME candidate.

Forward catalysts next 18 months

Nearest first. ⚖ Confirmed FDA PDUFA dates (curated calendar, primary sources) and 📅 estimated readouts (ClinicalTrials.gov primaryCompletionDate — a timing proxy, not a confirmed action date). Red = due within 6 months.
No PDUFA decisions or estimated readouts in this window for this view.

Company × Mechanism

Each cell = a company’s most-advanced program in that mechanism. Click for the asset tearsheet.
Unverified (lowTrust) cells:
Ph1 Ph2 Ph3 Ph4 ⚠ lowTrust +combo
Select & Focus Pro → 🔒 Transpose, filtering, selection & export are Pro (search & sort are free) — start a free trial, or try them free on our showcase →

Phase 3 leaders · most advanced

  1. active Levee Medical, Inc. NCT06873581
  2. recruiting Eli Lilly and Company NCT07202884
  3. active Cook MyoSite NCT03104517
  4. recruiting TBF Genie Tissulaire NCT06678984
  5. done Kafrelsheikh University NCT07366762

Beyond the grid Beta

What the matrix leaves out — rare mechanisms with only one player, small & emerging sponsors, and programs we haven’t classified yet.
⚡ first-in-class · 🌱 first-in-indication · 🆕 NME candidate · ✅ AI-classified + verified · ⚙️ AI-classified, unverified · first-in-class computed across 63 mapped landscapes
Single-program mechanisms (2) — one program each — earliest-stage, sorted by phase
PhaseMechanismCompanyModalityReadoutTrial
Ph3 Autologous muscle-cell therapy ⚡ 🌱 🆕 Cook MyoSite ⏰ 3Q26 NCT03104517
Ph3 GLP1R 🌱 Eli Lilly 1Q28 NCT07202884
Unclassified programs (3) — mechanism not captured yet
PhaseMechanismCompanyModalityReadoutTrial
Ph3 Pivotal Study of Voro Urologic Scaffoldunclassified Levee Medical, Inc. NCT06873581
Ph3 Treated Umbilical Vein Allograft (UVT) Versus Autologous Fascia…unclassified TBF Genie Tissulaire NCT06678984
Ph2 Feasibility Study of A VoRo UrologIc ScaffolD (ARID)unclassified Levee Medical, Inc. NCT06275945

Sponsor activity

Who is running trials now — green active, blue completed, red failed/terminated.

Sorted by active Active Done Failed
Levee Medical, Inc. 2 0 0
Cook MyoSite 1 4 1
TBF Genie Tissulaire 1 1 0
Eli Lilly 1 0 0
GTx 0 2 2
Taiho Pharmaceutical Co., Ltd. 0 3 0

How the field has grown

New-trial starts peaked in 2016 (7 registered); 2025 saw 7. The right-hand chart shows median Phase 3 enrollment by start year — the number in parentheses is that year's Phase 3 trial count (14 in total), so single-trial years (and years with no Phase 3 starts) are obvious. Both are by trial start date; the current year is partial.

New trials started by year

2016
7
2017
3
2018
4
2019
4
2020
5
2021
2
2022
4
2023
2
2024
5
2025
7
2026
2

TheraRadar.com

Median Phase 3 enrollment by start year

2016 (3)
100
2017 (1)
210
2018 (1)
132
2019 (1)
96
2020 (1)
150
2021 (0)
0
2022 (2)
58
2023 (1)
148
2024 (1)
40
2025 (3)
266
2026 (0)
0

TheraRadar.com

Full trial pipeline

Every active and completed trial across Phase 1–4, with enrollment analytics. Sortable, filterable, exportable with Pro.

NCT06873581 ACTIVE NOT RECRUITING
Pivotal Study of Voro Urologic Scaffold
Levee Medical, Inc. n=266
NCT07202884 RECRUITING
A Study of Orforglipron in Female Participants With Stress Urinary Incontinence Who Have Obesity or Overweight
Eli Lilly and Company n=1,000
NCT03104517 ACTIVE NOT RECRUITING
Autologous Muscle Derived Cells Compared to Placebo for Urinary Sphincter Repair in Post-surgical Female Stress Incontinence
Cook MyoSite n=96
NCT06678984 RECRUITING
Treated Umbilical Vein Allograft (UVT) Versus Autologous Fascial Pubovaginal Sling in the Treatment of Female Stress Urinary Incontinence
TBF Genie Tissulaire n=96
NCT07366762 COMPLETED
Comparison Between Two Techniques in Treatment of Female Stress Urinary Incontinence
Kafrelsheikh University n=40
NCT04171531 COMPLETED
Sling vs Botox for Mixed Incontinence
NICHD Pelvic Floor Disorders Network n=150
NCT05702827 COMPLETED
Use of a Dual-agent Local Analgesic (Bupivacaine-meloxicam) for Abdominal Incisions in Patients Undergoing Retropubic Mid-urethral Sling Surgery
TriHealth Inc. n=148
NCT05390970 COMPLETED
Platelet-Rich Plasma for Stress Urinary Incontinence
Annah J. Vollstedt n=50
NCT03997318 WITHDRAWN
Japanese Bridging Study of Autologous Muscle Derived Cells Compared to Placebo for Female Urinary Sphincter Repair(JPN1)
Cook MyoSite
NCT05493735 COMPLETED
Lidocaine for Pessary Check Pain Reduction
University of South Florida n=66
NCT01893138 COMPLETED
Autologous Muscle Derived Cells for Female Urinary Sphincter Repair
Cook MyoSite n=311
NCT03295487 COMPLETED
ToT and Estrogen in Postmenopausal Females
Kasr El Aini Hospital n=210
NCT04412876 WITHDRAWN
Comparisons of the Impact of Duloxetine Versus Imipramine on Therapeutic Efficacy, Psychological Distress, Sexual Function, Urethral and Bladder Wall Structure and Blood Flow in Women With Stress Urinary Incontinence: a Randomized Controlled Study
Far Eastern Memorial Hospital
NCT03524339 COMPLETED
Tamsulosin vs Placebo to Prevent Postoperative Urinary Retention in Female Pelvic Reconstructive Surgery
University Hospitals Cleveland Medical Center n=132
NCT04812574 COMPLETED
Hypertonic Saline Injection For Urinary Incontinence
Turgut Ozal University n=65
NCT04571346 COMPLETED
Female Sling Procedure
Ain Shams University n=100
NCT01959347 COMPLETED
Combined Treatment for Mixed Incontinence
NICHD Pelvic Floor Disorders Network n=480
NCT02263534 COMPLETED
Comparing Minisling to Tension Free Vaginal Tape in Mangement of Stress Urinary Incontinence
Ain Shams University n=48
NCT01382602 COMPLETED
Autologous Muscle Derived Cells Female Stress Urinary Incontinence Clinical Study
Cook MyoSite n=150
NCT03463863 COMPLETED
Midurethral Sling With Autologus Rectus Sheath
sarah mohamed hassan n=70
NCT03296748 COMPLETED
Correction of Asymptomatic 2nd Degree Cystocele in Patient With Stress Incontinence
Kasr El Aini Hospital n=123
NCT02334878 COMPLETED
Stem Cell Therapy for Treatment of Female Stress Urinary Incontinence
Ain Shams Maternity Hospital n=50
NCT00685217 TERMINATED
Transvaginal Tape (TVT) Secur Versus TVT Randomised Controlled Trial (RCT)
University of Calgary n=74
NCT00527696 TERMINATED
Trial Comparing TVT SECUR System and Trans Vaginal Obturator Tape for Surgical Management of Stress Urinary Incontinence
University of Manitoba n=106
NCT01366066 TERMINATED
Transcutaneous Mechanical Nerve Stimulation in the Treatment of Incontinence
Copenhagen University Hospital at Herlev n=4
NCT01148290 COMPLETED
Tension-free Vaginal Tape (TVT) Versus Bulking Agent for the Treatment of Post Vulvectomy Urinary Incontinence
University Magna Graecia n=40
NCT01628991 COMPLETED
Behavioral Intervention Program and Vaginal Cones on SUI
Mashhad University of Medical Sciences n=60
NCT00801203 COMPLETED
A Study to Evaluate the Effectiveness of the Induced Reflex Cough Test Plus Urodynamics to Identify Stress Urinary Incontinence in Female Subjects With a History of Stress Urinary Incontinence
Pneumoflex Systems, LLC n=180

Full Stress Urinary Incontinence Pipeline

Every trial across Phase 1–4, plus enrollment analytics. Sortable, filterable, exportable.

Unlock with Pro
How this is built — methodology & limits

These grids are only as good as the data and the classification behind them — so here is exactly what goes in, what stays out, how every assignment is made, and where the limits are.

Where the data comes from

Every heatmap is built from the public ClinicalTrials.gov registry, via its official API — interventional drug and biologic trials with a start date of 2008 or later. The master index holds over 145,000 trials and is refreshed weekly (see the “updated” date on this page). A disease landscape draws only from the active, Phase 1–3, industry-sponsored slice of that index.

  • In scope: industry-sponsored trials in Phase 1, 2, or 3, with an active status (recruiting, active-not-recruiting, not-yet-recruiting, or enrolling by invitation). Phase 4 sits in the index but is left out of the landscapes.
  • Filtered out: deeply stale programs (a primary completion date more than two years past with no update to completed or terminated); basket trials and incidental mentions (a trial counts toward a disease only when that disease is genuinely the subject of study — not a secondary cohort, an organ-of-origin overlap, or a passing mention); and healthy-volunteer studies.

We do not exclude trials by sponsor geography. Where a sponsor is based in China, the program is flagged on the page rather than hidden, so you can weigh it yourself. An automated test fails the weekly refresh if the underlying index is more than 14 days old, so a published grid is never built on a stale index.

How a trial is matched to a disease

Matching uses a structured medical ontology, not keyword guessing, and is designed so that no trial is ever silently dropped — every trial that clears the filters gets a classification, even if that is just “Other.” It runs as an ordered sequence of steps, stopping at the first that applies:

  1. Healthy-volunteer studies are set aside as non-disease trials.
  2. Ontology match — each tracked disease is linked to its official identifiers in the standard medical taxonomy (MeSH), so a trial can be matched even when its text uses a synonym.
  3. Curated disease patterns — a hand-maintained library of over 150 disease-name patterns covers the more granular indications across oncology, hematology, infectious disease, cardiometabolic, immunology, and neuropsychiatry.
  4. Basket guard — a trial matching four or more distinct diseases, or carrying explicit basket language (“tumor-agnostic,” “all solid tumors,” “pan-cancer”), is grouped into a single advanced-solid-tumor category rather than over-counted across every cancer it touches.
  5. Therapeutic-area roll-up — a trial with no specific match, but which the taxonomy still places under a broad area, is assigned to that area (“Oncology — other,” “Immunology — other,” …), checking cancers first so a site-specific tumor isn’t filed under its anatomical system.

A “drop-if-parent-present” rule keeps a generic name from drowning out a subtype: a trial matching both lupus and lupus nephritis is reported only as lupus nephritis. Internal abbreviations are translated to the plain disease names used across the site (for example, “CRC” becomes “Colorectal Cancer”), and the same classifier is shared by every heatmap, so the same trial always maps to the same disease wherever it appears.

How a drug is matched to its mechanism

Mechanism of action is the hardest part to get right, so it is assigned in layers — leaning on curated and public data first, with AI as a last resort:

  1. Curated rulebook (first). A rulebook we maintain — over 600 drug-to-mechanism rules — is checked first, matching on drug names, trial acronyms, sponsor trial identifiers, and intervention lists. First match wins, which stops a combination trial from being counted several times.
  2. Public molecular-target data. Where no rule applies, each intervention’s target is looked up in a public target database, with verbose or gene-symbol labels normalized into consistent short forms so one target isn’t split across several columns.
  3. Standard-of-care backbones. A small set of rules recognizes common combination scaffolds (checkpoint-inhibitor monotherapy, standard chemotherapy regimens, established standard-of-care agents) so they aren’t mistaken for the experimental arm.
  4. AI as a last resort, then cross-checked. Only for genuinely opaque sponsor code-names that none of the first three steps can resolve do we ask an AI model to propose a mechanism — applied only above a fixed confidence bar, then automatically cross-checked against the sponsor’s own pipeline page. Where AI and the sponsor agree, the program is marked sponsor-verified. Where they contradict, the label is discarded entirely — not shown, not counted.

New mechanism rules are independently double-verified before they’re trusted — a second, adversarial pass set up to disprove the first — and each is checked so it can’t mislabel an unrelated trial. Drugs whose mechanism isn’t publicly disclosed are shown openly as “Emerging — not yet disclosed” rather than guessed at: for a tool meant to support real decisions, “we don’t yet know” is a more trustworthy answer than a confident guess.

Where AI is used — and where it isn’t

The disease and mechanism matching above is driven first by deterministic rules and public ontologies, not AI. AI plays three bounded, disclosed roles: (1) an optional extra check that a trial genuinely studies the disease, on top of the ontology match; (2) inferring a trial’s treatment setting on the competitive grids when the rules don’t cover it, only above a fixed confidence bar; and (3) the last-resort mechanism step above, always cross-checked against the sponsor’s disclosures. Wherever an AI label reaches a cell, the page marks it (⚙️ or ✅) — AI is never the silent, sole source of what you see.

What the on-page markers mean

  • ✅ Sponsor-verified — AI proposed the mechanism and it matched the sponsor’s own pipeline page. High-trust.
  • ⚙️ AI-classified — AI proposed it above the confidence bar but it has not yet been cross-checked against the sponsor. Useful; verify before citing. It never means a person reviewed it.
  • ⚡ First-in-class — the mechanism hasn’t appeared in any other disease landscape we’ve built. This reflects the scope of landscapes published so far (the tooltip lists exactly which were scanned), not an absolute claim about the whole market.
  • 🌱 First-in-indication — the only program competing on that mechanism within this disease.
  • 🆕 NME candidate — the interventions match no drug in our approved-drug index, suggesting a new molecular entity. The index is incomplete — a signal, not a regulatory fact.
  • 🔗 Combination · 👶 Pediatric · 🔥 Hot (readout within six months) · ⏳ Stale (completion date passed but still marked active — often a stalled program).

Sponsor names are resolved through a curated parent/subsidiary map; unrecognized sponsors appear under their raw registry name. The registry records the sponsor at a trial’s inception, so names are as originally filed and may not reflect later acquisitions. To keep large grids legible, mechanisms with a single program are listed separately rather than crowding the main grid, and very small players are listed below it — presentation choices only; nothing is removed from the underlying counts.

How we score programs — “what’s about to move”

Each program carries a 0–100 score that deliberately ranks imminence over raw stage — the most decision-relevant signal on a competitive grid. It is the sum of:

  • Clinical phase — up to 40 points (Phase 3 = 40, Phase 2 = 25, Phase 1 = 10).
  • Readout proximity — up to 60 points (next readout <6 months = 60, 6–12 months = 45, 1–2 years = 30, distant = 5).
  • Stale penalty — the score is halved if a trial is past its expected readout but still listed as active.

Cell colour on the grid is driven by this score, so a Phase 2 program about to read out can — correctly — outrank a dormant Phase 3 one. It answers “what’s about to move,” not just “what’s furthest along.”

What each grid plots

  • Indication landscape (this page) — one disease — companies (rows) × mechanism of action (columns): who is competing, and on what mechanism.
  • Company portfolio — one company — diseases (rows) × mechanism (columns): where it is active, and what it is betting on.
  • MOA platform — one mechanism family — drugs (rows) × diseases (columns): who is working on this class, and where.
  • Competitive landscape — one disease — mechanism (rows) × clinical setting (columns), aggregated across companies; setting columns are tailored per disease (e.g. lines of therapy in oncology; biologic-naïve vs. biologic-experienced in IBD).

What we don’t claim

  • First-in-class is editorial, not absolute — “not seen in the landscapes we’ve built,” not “novel across the industry.”
  • NME candidate is a signal, not a filing — absent from our (incomplete) approved-drug index.
  • Disease matching is automated and not exhaustively validated per disease — ontology and pattern matching can occasionally include or miss a trial.
  • AI-classified mechanisms are machine-proposed — unconfirmed unless they also carry ✅.
  • Sponsor names are as-filed and may lag current ownership.
  • Grids are as fresh as their last rebuild from the weekly index — no faster continuous refresh is claimed.

Data: ClinicalTrials.gov v2 API + FDA Drugs@FDA (approved-drug index). Spot an error? hello@theraradar.com.

Data: ClinicalTrials.gov · Trials registered 2008 onwards · Industry sponsors only