Trial of Transurethral Bulking Agent Injection Versus Single-Incision Sling for Stress Urinary Incontinence
NCT ID: NCT06480227
Last Updated: 2025-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
358 participants
INTERVENTIONAL
2024-08-28
2030-01-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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).
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
All participants will have data including demographics, medical history, and quality of life assessments as they relate to urinary incontinence collected at baseline. After undergoing treatment (either transurethral bulking agent or single-incision sling), participants will be asked to return to the clinic at 2-4 weeks, 3 months, and 12 months with additional follow-ups at 6 months, 24 months, and 36 months done over the phone.
The primary outcome of the BASIS trial is subjective success measured by PGI-I for TBA vs. SIS at 12 months.
Secondary outcomes include assessments of 1) retreatment rates within 12 months; 2) validated, objective measures of condition improvement through 36 months; 3) objective success at 3 and 12 months as measured by standardized cough stress test; 4) functional outcomes (activity level, perceived recover, sexual function, etc.); 5) quality of life assessments; 6) operative procedure data and adverse events; 7) pain and functional activity, need for sedation and anesthesia, de novo or worsening symptoms; 8) medical resource use (additional medications, procedures, or therapies); and 9) healthy utility measures.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Solyx Single-incision Sling
Solyx Single-incision Sling
Solyx Single-incision Sling
Minimally invasive mesh device placed to treat stress urinary incontinence.
Bulkamid Transurethral Bulking Agent
Bulkamid Transurethral Bulking Agent
Bulkamid Transurethral Bulking Agent
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Solyx Single-incision Sling
Minimally invasive mesh device placed to treat stress urinary incontinence.
Bulkamid Transurethral Bulking Agent
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
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Bothersome SUI (PFDI-20 Q:#17 of somewhat, moderately or quite a bit) or stress predominant MUI (PFDI-20 Q:#16 \< Q:#17)50 for \> 3 months with well-controlled UUI on stable medication treatment through baseline and follow-up.
* A positive cough stress test or urodynamic SUI within the past 18 months.
* Normal voiding function as demonstrated by PVR \< 150 mL
* Candidate for either study procedure as determined by treating surgeon (i.e., failed or unable to perform conservative management for SUI including pelvic floor strengthening and failed or declines pessary option for SUI)
* Available for up to 3 years.
* Agrees to randomization.
Exclusion Criteria
* Urge-predominant mixed UI by UDI-6 despite stable therapy - Urge predominant UI would not be expected to improve after TBA or SIS and may bias results of interventions designed specifically for stress urinary incontinence.
* Planned hysterectomy, urethral or anterior/apical surgeries - additional surgery beyond TBA or SIS has potential to confound the results. Additionally, these procedures generally require general anesthesia and indwelling catheterization immediately post operatively. The impact of urethral instrumentation after TBA is unknown and could impact the efficacy of the urethral coaptation.
* Malignancy or history of radiation of the pelvis - The risk of foreign material rejection and mesh complications may be higher in women with pelvic radiation and other treatment for pelvic malignancy may impact primary outcomes.
* Pregnant, breast feeding or plans for pregnancy within 1 year - subsequent vaginal delivery and hormonal changes of breast feeding prior to primary outcome could impact the efficacy of either treatment.
* Incomplete emptying (PVR \> 150mL) - SUI surgery may increase the risk of urinary retention.
* Prior anti-incontinence procedure - the aim of the study is to identify the role of TBA and SIS in primary, uncomplicated SUI or stress predominant MUI management.
* Neurogenic bladder - the aim of the study is to identify the role of TBA and SIS in primary, uncomplicated SUI or stress predominant MUI management.
* Prior adverse reaction to synthetic mesh or polyacrylamide - to minimize risk of post procedure complications.
* Chronic bladder or pelvic pain conditions (e.g., Interstitial cystitis, painful bladder syndrome, fibromyalgia, chronic pelvic pain, etc.) - given the known risks of postoperative pain with SIS and higher risks of pain in those with baseline chronic pain, we aim to minimize post operative complications.
* Active 3rd line treatment for OAB/UUI with botulinum toxin, sacral neuromodulation stimulation (SNS) or percutaneous tibial nerve stimulation (PTNS) within 12 months or plan for 3rd line or new OAB/UUI treatment within 1 year of SUI surgery. For those on stable medication OAB/UUI treatment, participants should be on stable treatment for 3 months with adequate symptom control prior to baseline measures and plan to remain on stable therapy without 3rd line treatment plans within 1 year of SUI surgery. Those who have received 3rd line treatment (Botox. PTNS or SNS) should have a washout of 1yr from and no plans for restarting within the primary outcome timeframe of 1 year post procedure. Those using SNS for bowel leakage only and no UUI symptoms do not require minimum 3 months. Participants with MUI on OAB/UUI medication therapy will still need to have SUI worse than UUI at baseline. Randomization will be stratified based on presence of UUI treatment component.
* 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.
21 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Duke University
OTHER
Kaiser Permanente
OTHER
University of Chicago
OTHER
University of Pennsylvania
OTHER
University of Texas Southwestern Medical Center
OTHER
Women and Infants Hospital of Rhode Island
OTHER
RTI International
OTHER
University of California, San Diego
OTHER
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
NICHD Pelvic Floor Disorders Network
NETWORK
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Emily Lukacz, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Diego
Marie Gantz, MD
Role: PRINCIPAL_INVESTIGATOR
RTI International
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of California at San Diego
La Jolla, California, United States
Kaiser Permanente -- San Diego
San Diego, California, United States
University of Chicago
Chicago, Illinois, United States
Duke University, Duke Division of Urogynecology and Reconstructive Pelvic Surgery
Durham, North Carolina, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Brown/ Women and Infants Hospital of Rhode Island, Division of Urogynecology and Reconstructive Pelvic Surgery
Providence, Rhode Island, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Kyle Herrala
Role: primary
Gisselle Zazueta-Damian
Role: primary
Linda Mackinnon
Role: backup
Jinxuan (Rowena) Shi
Role: primary
Stephanie Yu
Role: primary
Zandra Kennedy
Role: primary
Madeline Malloy
Role: primary
Agnes Burris
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
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 SlingTrial. Urogynecology (Phila). 2025 Dec 17:10.1097/SPV.0000000000001702. doi: 10.1097/SPV.0000000000001702. Online ahead of print.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PFDN-33P01
Identifier Type: -
Identifier Source: org_study_id