Bulking Agent vs Sling for Stress Urinary Incontinence

(BASIS Trial)

Recruiting at 8 trial locations

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: NICHD Pelvic Floor Disorders Network

Must be taking: OAB/UUI medications

Must not be taking: Botox, SNS, PTNS

Disqualifiers: Prolapse, Pregnancy, Neurogenic bladder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: 12 months

358 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on stable medication for overactive bladder or urinary urgency incontinence, you should continue it without changes for at least 3 months before the trial and throughout the study period.

What data supports the effectiveness of the treatment Bulkamid Transurethral Bulking Agent for stress urinary incontinence?

Bulkamid, a gel used to treat stress urinary incontinence, has shown long-term effectiveness and safety, with studies reporting success rates between 64% and 74%. It is a minimally invasive option that creates a supportive mass in the urethra, and is often used when other treatments like midurethral slings are not suitable or have failed. ^{1 2 3 4 5}

Is Bulkamid safe for treating stress urinary incontinence?

Bulkamid, a bulking agent used for stress urinary incontinence, is considered safe and minimally invasive, with high tissue compatibility and fewer risks of complications like erosion or migration compared to other particulate agents. ^{1 4 5 6 7}

How is the Bulkamid Transurethral Bulking Agent and Solyx Single-incision Sling treatment different from other treatments for stress urinary incontinence?

The Bulkamid Transurethral Bulking Agent and Solyx Single-incision Sling treatment is unique because it combines a bulking agent, which is injected to add volume and support to the urethra, with a minimally invasive sling procedure that provides additional support to prevent urine leakage. This dual approach offers a less invasive alternative to traditional surgeries and may provide longer-lasting results compared to treatments that require frequent re-injections. ^{8 9 10 11 12}

What is the purpose of this trial?

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).

Research Team

Emily Lukacz, MD

Principal Investigator

University of California, San Diego

Marie Gantz, MD

Principal Investigator

RTI International

Eligibility Criteria

This trial is for women who have stress urinary incontinence (SUI) or mixed urinary incontinence with a stress component, and haven't found relief from conservative treatments. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and agree to follow the study procedures.

Inclusion Criteria

I have tried or cannot do basic treatments for urinary incontinence.

Available for up to 3 years

Agrees to randomization

Exclusion Criteria

My vaginal prolapse extends beyond the hymen.

Pregnant, breastfeeding, or plans for pregnancy within 1 year

Incomplete emptying (PVR greater than 150mL)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either transurethral bulking agent or single-incision sling as treatment for stress urinary incontinence

12 months

1 visit (in-person) for procedure, follow-up visits at 2-4 weeks, 3 months, and 12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

36 months

Follow-up visits at 6 months, 24 months, and 36 months (phone)

Treatment Details

Interventions

• Bulkamid Transurethral Bulking Agent
• Solyx Single-incision Sling

Trial Overview The trial is testing two different treatments for SUI: Bulkamid Transurethral Bulking Agent injections versus the Solyx Single-incision Sling procedure. It's designed to see which one is more effective at improving symptoms after 12 months.

Participant Groups

Group I: Solyx Single-incision Sling Active Control 1 Intervention

Solyx Single-incision Sling

Group II: Bulkamid Transurethral Bulking Agent Active Control 1 Intervention

Bulkamid Transurethral Bulking Agent

Bulkamid Transurethral Bulking Agent is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Bulkamid for:

• Stress urinary incontinence

Approved in United States as Bulkamid for:

• Stress urinary incontinence

Approved in Canada as Bulkamid for:

• Stress urinary incontinence

Who Is Running the Clinical Trial?

NICHD Pelvic Floor Disorders Network

Lead Sponsor

Trials

16

Recruited

4,900+

Kaiser Permanente

Collaborator

Trials

563

Recruited

27,400,000+

RTI International

Collaborator

Trials

201

Recruited

942,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Duke University

Collaborator

Trials

2,495

Recruited

5,912,000+

University of Texas Southwestern Medical Center

Collaborator

Trials

1,102

Recruited

1,077,000+

University of Chicago

Collaborator

Trials

1,086

Recruited

844,000+

University of California, San Diego

Collaborator

Trials

1,215

Recruited

1,593,000+

University of Pennsylvania

Collaborator

Trials

2,118

Recruited

45,270,000+

Women and Infants Hospital of Rhode Island

Collaborator

Trials

119

Recruited

59,200+

Findings from Research

In a study of 1,200 women treated with Bulkamid for stress urinary incontinence (SUI) or mixed urinary incontinence (MUI), 67.1% reported feeling cured or improved after 7 years, indicating long-term efficacy of this treatment.

The procedure was found to be safe, with only transient postoperative complications, and significant improvements in quality of life and incontinence symptoms, as evidenced by a reduction in ICIQ-UI SF scores and a mean increase in VAS QoL scores.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Seven-year efficacy and safety outcomes of Bulkamid for the treatment of stress urinary incontinence. Brosche, T., Kuhn, A., Lobodasch, K., et al.[2023]

Bulkamid® is a nonbiodegradable urethral bulking agent that can be injected in an office setting under local anesthesia, making it a minimally invasive treatment for women with recurrent stress urinary incontinence (SUI).

The procedure has minimal downtime and only minor potential complications, positioning Bulkamid® as a valid treatment option for patients who have not found success with midurethral sling (MUS) surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Urethral Bulkamid® injection after failed midurethral sling: a step-by-step video. Lukanović, D., Blaganje, M., Rhazi, I., et al.[2023]

Midurethral slings are highly effective for treating stress urinary incontinence (SUI), with success rates up to 80%, while bulking agents have a lower efficacy of 64% to 74% but are associated with fewer complications.

This study will assess patient satisfaction and preferences between midurethral slings and bulking agents in a non-randomized trial involving 266 patients, aiming to provide insights into the role of bulking agents as a first-choice treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing Single-Incision Midurethral Sling with Bulking Agents for Female Stress Urinary Incontinence: Rationale for a Non-Randomized Controlled Trial. Osse, NJE., Schonewille, MEA., Engberts, MK., et al.[2023]

Bulking agents, such as particulate and non-particulate types, are low-risk alternatives for treating stress urinary incontinence (SUI) in women, with particulate agents like Polydimethylsiloxane® and Bulkamid® offering different mechanisms for achieving continence.

While particulate agents can lead to complications like granulomas and erosion, Bulkamid® may have a lower risk of these issues due to its gel-based composition, although more direct comparisons between the two types are needed to assess their long-term durability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Particulate Versus Non-Particulate Bulking Agents In The Treatment Of Stress Urinary Incontinence. Chapple, C., Dmochowski, R.[2023]

In a study involving 345 women, Bulkamid® hydrogel was found to be as effective as Contigen® collagen gel for treating stress urinary incontinence, with similar rates of improvement in leakage and incontinence episodes after 12 months.

Both treatments had a low risk of serious adverse events, making Bulkamid a promising alternative, especially since Contigen is no longer available.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of polyacrylamide hydrogel for the treatment of female stress incontinence: a randomized, prospective, multicenter North American study. Sokol, ER., Karram, MM., Dmochowski, R.[2015]

Bulkamid, a new urethral bulking agent for managing female stress urinary incontinence, can be difficult to distinguish from a periurethral cyst on MRI, leading to diagnostic challenges.

A combination of limited noncontrast CT and voiding cystometrogram (VCMG) is more effective than MRI in differentiating Bulkamid from true periurethral diverticula, potentially saving time and costs in patient management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A diagnostic conundrum: Is it a periurethral diverticulum/cyst or a bulking agent (Bulkamid)? Akinjise-Ferdinand, O., Hubbard, R., Osman, NI., et al.[2023]

In a study of 154 women with mixed urinary incontinence (MUI), treatment with the bulking agent Bulkamid resulted in significant improvements in both subjective and objective measures of incontinence, including all domains of the King's Health Questionnaire and the standardized pad weight test.

The overall complication rate from the bulking therapy was relatively low at 13%, suggesting that Bulkamid is a safe and effective option for treating MUI, although long-term results are still pending.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bulkamid (PAHG) in mixed urinary incontinence: What is the outcome? Mohr, S., Marthaler, C., Imboden, S., et al.[2018]

Incorporating Bioglass 45S5® (BG) into silicone implants significantly enhances their bioactivity and tissue integration, with porous silicone composites showing a 72% improvement and nanoparticle composites achieving a 94% improvement in integration compared to pure silicone.

The addition of BG also increases the stiffness of silicone composites while maintaining their elasticity, making them more suitable for medical applications without compromising comfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modification of silicone elastomers with Bioglass 45S5® increases in ovo tissue biointegration. Cohrs, NH., Schulz-Schönhagen, K., Mohn, D., et al.[2020]

Poly (caprolactone) microparticles loaded in a chitosan gel (CICGs) effectively deliver the COX-2 inhibitor Etoricoxib directly into the joint, potentially reducing cardiovascular toxicity associated with oral administration.

CICGs demonstrated superior drug retention and controlled release compared to bare chitosan gels and microparticles, indicating their potential as a dual-purpose treatment for osteoarthritis with good biocompatibility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Poly (caprolactone) microparticles and chitosan thermogels based injectable formulation of etoricoxib for the potential treatment of osteoarthritis. Arunkumar, P., Indulekha, S., Vijayalakshmi, S., et al.[2018]

In a study involving 56 male Wistar rats, the bone morphogenetic protein type 2 (rhBMP-2) effectively induced bone regeneration, demonstrating its potential as a treatment for bone healing.

The combination of rhBMP-2 with poloxamer gel and collagen sponge improved the healing process, indicating that these carriers can enhance the efficacy of rhBMP-2 in promoting bone repair over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bone healing process in critical-sized defects by rhBMP-2 using poloxamer gel and collagen sponge as carriers. Issa, JP., do Nascimento, C., Iyomasa, MM., et al.[2008]

The study evaluated three different controlled-release glass granule compositions for treating vesicoureteral reflux and urinary incontinence, showing that larger, slower-degrading particles stimulate a beneficial inflammatory response in soft tissue over a period of up to 6 months.

Smaller, fast-degrading glass particles caused tissue necrosis, indicating they are unsuitable for these medical applications, while the larger particles show promise for effectively treating stress incontinence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Soft tissue response to glycerol-suspended controlled-release glass particulate. Cartmell, SH., Doherty, PJ., Hunt, JA., et al.[2019]

The study developed a novel injectable biomaterial, AT-CS/teOCP-BG, which showed promising physicochemical properties and biological performance for treating bone defects in osteoporosis patients.

In an experiment with ovariectomized rats, the biomaterial led to significantly greater new bone growth compared to sham-operated controls within 8 weeks, indicating its potential for fast bone regeneration in minimally invasive treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preparation and characterization of trace elements-multidoped injectable biomimetic materials for minimally invasive treatment of osteoporotic bone trauma. Yang, X., Gan, Y., Gao, X., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Seven-year efficacy and safety outcomes of Bulkamid for the treatment of stress urinary incontinence. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Urethral Bulkamid® injection after failed midurethral sling: a step-by-step video. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Comparing Single-Incision Midurethral Sling with Bulking Agents for Female Stress Urinary Incontinence: Rationale for a Non-Randomized Controlled Trial. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Particulate Versus Non-Particulate Bulking Agents In The Treatment Of Stress Urinary Incontinence. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Efficacy and safety of polyacrylamide hydrogel for the treatment of female stress incontinence: a randomized, prospective, multicenter North American study. [2015]

6. United States pubmed.ncbi.nlm.nih.gov

A diagnostic conundrum: Is it a periurethral diverticulum/cyst or a bulking agent (Bulkamid)? [2023]

7. England pubmed.ncbi.nlm.nih.gov

Bulkamid (PAHG) in mixed urinary incontinence: What is the outcome? [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Modification of silicone elastomers with Bioglass 45S5® increases in ovo tissue biointegration. [2020]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Poly (caprolactone) microparticles and chitosan thermogels based injectable formulation of etoricoxib for the potential treatment of osteoarthritis. [2018]

10. England pubmed.ncbi.nlm.nih.gov

Bone healing process in critical-sized defects by rhBMP-2 using poloxamer gel and collagen sponge as carriers. [2008]

11. United States pubmed.ncbi.nlm.nih.gov

Soft tissue response to glycerol-suspended controlled-release glass particulate. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

Preparation and characterization of trace elements-multidoped injectable biomimetic materials for minimally invasive treatment of osteoporotic bone trauma. [2021]