State of The Evidence Blog – Botox for Overactive Bladders

Critical Appraisal of “Polyacrylamide Hydrogel (Bulkamid®) for Stress Urinary Incontinence in Women: A Systematic Review of the Literature”

Citation:

Kasi AD, Pergialiotis V, Perrea DN, Khunda A, Doumouchtsis SK. Polyacrylamide hydrogel (Bulkamid®) for stress urinary incontinence in women: a systematic review of the literature. Int Urogynecol J. 2016 Mar;27(3):367-75. doi: 10.1007/s00192-015-2781-y. Epub 2015 Jul 26. PMID: 26209952.

Take-Home Message:

1. Bulkamid: A Safe, Minimally Invasive Option: PAHG offers a favorable safety profile, making it an attractive option for patients seeking less invasive treatments for SUI.
2. Reinjections May Be Needed: Up to 1 in 4 women may require additional treatments, which is important for patient counseling.
3. Quality of Life Improvements: Significant QoL gains post-treatment highlight its potential beyond symptom control.
4. Ideal for Select Patient Groups: Particularly beneficial for women contraindicated for more invasive surgeries.
5. Call for More Research: Long-term RCTs comparing PAHG to other bulking agents and surgical interventions are needed.

Introduction:

This systematic review by Kasi et al. (2017) examines the efficacy and safety of polyacrylamide hydrogel (PAHG, Bulkamid®) for treating stress urinary incontinence (SUI) in women. Given the growing preference for minimally invasive treatments, understanding Bulkamid®’s clinical performance is essential.

Study Design and Methodology:

• Design: Systematic review following PRISMA guidelines.
• Data Sources: Comprehensive search of MEDLINE, Scopus, POPLINE, ClinicalTrials.gov, and reference lists (1966–2015).
• Inclusion Criteria: Observational studies (prospective, retrospective) and randomized controlled trials (RCTs) assessing PAHG in women with SUI.
• Quality Assessment: Utilized Oxford Level of Evidence and GRADE criteria.

Results:

• Studies Included: 8 studies with 767 participants.
• Efficacy: Significant reduction in incontinence episodes and improved quality of life (QoL). However, 24.3% required reinjection.
• Safety: Most common adverse effects were injection site pain (4–14%) and urinary tract infections (3–7%). Rare complications included transient/chronic urinary retention and periurethral abscess.

Strengths:

1. Comprehensive Literature Search: Wide database range with no language restrictions.
2. Standardized Quality Assessment: Use of PRISMA, Oxford, and GRADE improves methodological rigor.
3. Detailed Adverse Events Reporting: Provides a nuanced understanding of PAHG’s safety profile.

Limitations:

1. Heterogeneity of Included Studies: Variability in study design, patient populations, and outcome measures limits generalizability.
2. Lack of Control Groups: Few RCTs comparing PAHG to standard treatments, such as midurethral slings.
3. Short Follow-Up Periods: Most studies assessed outcomes only up to 1–2 years, limiting insights into long-term efficacy and safety.
4. Inconsistent Outcome Measures: Both subjective (patient-reported) and objective (urodynamic) outcomes varied across studies.