Trial of Transurethral Bulking Agent Injection Versus Single-Incision Sling for Stress Urinary Incontinence
BASIS
A Randomized Trial of Transurethral Bulking Agent Injection Versus Single-Incision Sling for Stress Urinary Incontinence
8 other identifiers
interventional
358
1 country
7
Brief Summary
This is a multicentered, double-blind, randomized controlled, surgical trial of 358 women with inadequate symptom relief of stress urinary incontinence (SUI) or stress predominant mixed urinary incontinence (MUI) after conservative care. The Primary Aim is to determine the comparative effectiveness (as defined by "much" or "very much" better on PGI-I) of transurethral bulking agent (TBA) \[for 1 or 2 injections in 12 months\] vs. single-incision sling (SIS) 12 months after treatment intervention in women with predominant stress urinary incontinence (SUI).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2024
Longer than P75 for not_applicable
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 14, 2024
CompletedFirst Posted
Study publicly available on registry
June 28, 2024
CompletedStudy Start
First participant enrolled
August 28, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2030
June 8, 2026
June 1, 2026
4.3 years
June 14, 2024
June 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Subjective success measured by Patient Global Impression-Improvement [PGI-I] (>2) for TBA vs. SIS at 12 months.
The PGI-I is used to compare condition improvement, defined as (1) = very much better, (2) = much better, (3) = a little better, (4) = no change, (5) = a little worse, (6) much worse, (7) very much worse. Determine the comparative effectiveness (as defined by "much" or "very much" improved on PGI-I) of transurethral bulking agent \[for 1 or 2 injections in 12 months\] vs. single-incision sling 12 months after treatment intervention in women with predominant stress urinary incontinence.
At 12 months post-intervention.
Secondary Outcomes (21)
Rates of retreatment
From intervention to 12 months post-intervention.
Change in Incontinence Questionnaire-Urinary Incontinence Short Form [ICIQ-SF] score
From intervention to 36 months post-intervention.
Subjective success measured by Patient Global Impression-Improvement [PGI-I] (>2) for TBA vs. SIS
From 3 months to 36 months post-intervention.
Condition improvement measured by Patient Global Symptom Control [PGSC] for TBA vs. SIS
From interventions to 36 months post-intervention.
Condition improvement measured by Patient Global Impression of Severity [PGI-S] for TBA vs. SIS
From intervention to 36 months post-intervention.
- +16 more secondary outcomes
Study Arms (2)
Solyx Single-incision Sling
ACTIVE COMPARATORSolyx Single-incision Sling
Bulkamid Transurethral Bulking Agent
ACTIVE COMPARATORBulkamid Transurethral Bulking Agent
Interventions
Minimally invasive mesh device placed to treat stress urinary incontinence.
Minimally invasive bulking agent injections used to bulk up the tissue surrounding the urethra to treat stress urinary incontinence. Up to 2 treatments within 12 months are allowed
Eligibility Criteria
You may qualify if:
- Women ≥ 21 years
- For \> 3 months, bothersome SUI (response of somewhat, moderately, or quite a bit) without UUI or stress-predominant MUI. For those with equal bother of UUI and SUI, clinician determination that SUI is more severe/significant than UUI is required.
- A positive cough stress test on standardized non-invasive testing or urodynamic SUI within the past 18 months.
- Normal PVR \< 150 mL
- Candidate for either study procedure as determined by treating surgeon
- Available for up to 3 years.
- Agrees to randomization.
You may not qualify if:
- Anterior/apical vaginal prolapse beyond the hymen (\>0 on POPQ)
- Urge-predominant mixed UI despite stable therapy
- Advanced UUI/OAB 3rd line therapy treatment within 1 year of enrollment.
- Planned hysterectomy, urethral or anterior/apical surgeries s requiring general anesthesia at the time of SUI treatment, during the last 6 months, or planned within the next 12 months.
- Malignancy or history of radiation of the pelvis
- Pregnant, post-partum, breast feeding or plans for pregnancy within 1 year
- Incomplete emptying (PVR \> 150mL)
- Prior anti-incontinence procedure
- Neurogenic bladder
- Unwilling to continue current UUI treatment until completion of primary outcome at 12 months
- Prior adverse reaction to synthetic mesh or urethral bulking material
- Chronic bladder or pelvic pain conditions (e.g., Interstitial cystitis, painful bladder syndrome, fibromyalgia, chronic pelvic pain, etc.)
- Active treatment for SUI with a pessary. For those using a pessary or other SUI support device, a 3-week washout period should occur prior to assessing baseline measures.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NICHD Pelvic Floor Disorders Networklead
- Duke Universitycollaborator
- Kaiser Permanentecollaborator
- University of Chicagocollaborator
- University of Pennsylvaniacollaborator
- University of Texas Southwestern Medical Centercollaborator
- Women and Infants Hospital of Rhode Islandcollaborator
- RTI Internationalcollaborator
- University of California, San Diegocollaborator
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)collaborator
Study Sites (7)
University of California at San Diego
La Jolla, California, 92037-0974, United States
Kaiser Permanente -- San Diego
San Diego, California, 92110, United States
University of Chicago
Chicago, Illinois, 60637, United States
Duke University, Duke Division of Urogynecology and Reconstructive Pelvic Surgery
Durham, North Carolina, 27707, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Brown/ Women and Infants Hospital of Rhode Island, Division of Urogynecology and Reconstructive Pelvic Surgery
Providence, Rhode Island, 02903, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
Related Publications (1)
Lukacz ES, Menefee SA, Carper B, Collins S, McMillian K, Florian-Rodriguez M, Rardin C, Weidner AC, Harvie HS, Alexander B, Mazloomdoost D; NICHD Pelvic Floor Disorders Network. Design of Transurethral Bulking Agent Injection Versus Single-Incision Sling Trial. Urogynecology (Phila). 2026 Feb 1;32(2):131-141. doi: 10.1097/SPV.0000000000001702.
PMID: 41428458DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Emily Lukacz, MD
University of California, San Diego
- PRINCIPAL INVESTIGATOR
Marie Gantz, MD
RTI International
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 14, 2024
First Posted
June 28, 2024
Study Start
August 28, 2024
Primary Completion (Estimated)
December 31, 2028
Study Completion (Estimated)
December 31, 2030
Last Updated
June 8, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- Plan to submit full study dataset before the end of the award period.
- Access Criteria
- Access is managed by DASH.
Study data will be made available through DASH