Recruiting

Bulking Agent vs. Sling

Sponsor:

NICHD Pelvic Floor Disorders Network

Code:

NCT06480227

Conditions

Stress Urinary Incontinence

Urinary Incontinence

Mixed Urinary Incontinence

Eligibility Criteria

Sex: Female

Age: 21+

Healthy Volunteers: Not accepted

Interventions

Solyx Single-incision Sling

Bulkamid Transurethral Bulking Agent

Study Details

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

Study ID

NCT06480227

Start date

Aug 28, 2024

Status verified date

Jun, 2026

Completion date

Dec 31, 2030

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 21+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

358 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Solyx Single-incision Sling

Solyx Single-incision Sling

active comparator: Bulkamid Transurethral Bulking Agent

Bulkamid Transurethral Bulking Agent

Interventions

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

Primary outcome measure

  • Subjective success measured by Patient Global Impression-Improvement [PGI-I] (>2) for TBA vs. SIS at 12 months. [ Time Frame: At 12 months post-intervention. ]

Central Contacts and Locations

Locations

University of California at San Diego

Recruiting

La Jolla, California, United States, 92037-0974

Contacts

Kyle Herrala

(858) 657-6827UrogynRSCH@ucsd.edu

Principal Investigator:

Emily Lukacz, MD

Kaiser Permanente -- San Diego

Recruiting

San Diego, California, United States, 92110

Contacts

Gisselle Zazueta-Damian

619-821-5717gisselle.zazueta-damian@kp.org

Linda Mackinnon

619-821-6009linda.m.mackinnon@kp.org

Principal Investigator:

Shawn A Menefee, MD

University of Chicago

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Jinxuan (Rowena) Shi

872-724-0774jinxuan.shi@bsd.uchicago.edu

Principal Investigator:

Kimberly Kenton, MD

Duke University, Duke Division of Urogynecology and Reconstructive Pelvic Surgery

Recruiting

Durham, North Carolina, United States, 27707

Contacts

Stephanie Yu

(919) 401-1016stephanie.yu@duke.edu

Principal Investigator:

Nazema Siddiqui, MD

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Zandra Kennedy

(215) 615-6569zandra.kennedy@pennmedicine.upenn.edu

Principal Investigator:

Heidi Harvie, MD

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

Recruiting

Providence, Rhode Island, United States, 02903

Contacts

Madeline Malloy

(401) 430-8228MMMalloy@wihri.org

Principal Investigator:

Vivian Sung, MD

University of Texas Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Contacts

Agnes Burris

(214) 645-3833Agnes.Burris@UTSouthwestern.edu

Principal Investigator:

David Rahn, MD

More Information

Sponsor

NICHD Pelvic Floor Disorders Network

Last update posted

Jun 8, 2026

Last verified

Jun, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by NICHD Pelvic Floor Disorders Network on 2026-06-08.