Trial of Transurethral Bulking Agent Injection Versus Single-Incision Sling for Stress Urinary Incontinence

NCT06480227 | Recruiting DMC FDA Device

• 8 other identifiers: PFDN-33P01UG1HD069013UG1HD054214UG1HD041267UG1HD054241UG1HD110057UG1HD069010U24HD069031
• Study Type: interventional
• Target: 358
• Locations: 1 country
• Sites: 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).

Conditions

Stress Urinary Incontinence; Urinary Incontinence; Mixed Urinary Incontinence

Keywords

Urinary Incontinence; Pelvic Floor Disorders; Single Incision Sling; Transurethral Bulking Agent

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.

Study Arms (2)

Solyx Single-incision Sling

ACTIVE COMPARATOR

Solyx Single-incision Sling

Device: Solyx Single-incision Sling

Bulkamid Transurethral Bulking Agent

ACTIVE COMPARATOR

Bulkamid Transurethral Bulking Agent

Device: Bulkamid Transurethral Bulking Agent

Interventions

Solyx Single-incision Sling DEVICE

Minimally invasive mesh device placed to treat stress urinary incontinence.

Solyx Single-incision Sling

Bulkamid Transurethral Bulking Agent DEVICE

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

Bulkamid Transurethral Bulking Agent

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women ≥ 21 years
• 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.

You may not qualify if:

• Anterior/apical vaginal prolapse beyond the hymen (\>0 on POPQ) - Advanced prolapse may require additional surgery or potentially increase the risk of postoperative urinary obstruction and confound the results of the study.
• 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.

Sponsors & Collaborators

• NICHD Pelvic Floor Disorders Network: lead
• Duke University: collaborator
• Kaiser Permanente: collaborator
• University of Chicago: collaborator
• University of Pennsylvania: collaborator
• University of Texas Southwestern Medical Center: collaborator
• Women and Infants Hospital of Rhode Island: collaborator
• RTI International: collaborator
• University of California, San Diego: collaborator
• 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

RECRUITING

Kaiser Permanente -- San Diego

San Diego, California, 92110, United States

RECRUITING

University of Chicago

Chicago, Illinois, 60637, United States

RECRUITING

Duke University, Duke Division of Urogynecology and Reconstructive Pelvic Surgery

Durham, North Carolina, 27707, United States

RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Brown/ Women and Infants Hospital of Rhode Island, Division of Urogynecology and Reconstructive Pelvic Surgery

Providence, Rhode Island, 02903, United States

RECRUITING

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

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: 41428458 DERIVED

MeSH Terms

Conditions

Urinary Incontinence, Stress; Urinary Incontinence; Pelvic Floor Disorders

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pregnancy Complications

Study Officials

• Emily Lukacz, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

• Marie Gantz, MD

  RTI International

  PRINCIPAL INVESTIGATOR

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: April 30, 2026

Record last verified: 2025-12

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.

Locations

US (7)