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:
- 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.
- Reinjections May Be Needed: Up to 1 in 4 women may require additional treatments, which is important for patient counseling.
- Quality of Life Improvements: Significant QoL gains post-treatment highlight its potential beyond symptom control.
- Ideal for Select Patient Groups: Particularly beneficial for women contraindicated for more invasive surgeries.
- 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:
- Comprehensive Literature Search: Wide database range with no language restrictions.
- Standardized Quality Assessment: Use of PRISMA, Oxford, and GRADE improves methodological rigor.
- Detailed Adverse Events Reporting: Provides a nuanced understanding of PAHG’s safety profile.
Limitations:
- Heterogeneity of Included Studies: Variability in study design, patient populations, and outcome measures limits generalizability.
- Lack of Control Groups: Few RCTs comparing PAHG to standard treatments, such as midurethral slings.
- Short Follow-Up Periods: Most studies assessed outcomes only up to 1–2 years, limiting insights into long-term efficacy and safety.
- Inconsistent Outcome Measures: Both subjective (patient-reported) and objective (urodynamic) outcomes varied across studies.
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Dr. Darren Lazare
Restorative Gynecology Surgeon | BLOG
Dr. Darren Lazare received his residency training in Obstetrics and Gynaecology at the University of British Columbia. He successfully completed his subspecialty fellowship training in female pelvic medicine and reconstructive surgery at the University of Alberta. Dr. Lazare has been appointed as a Clinical Associate Professor at the University of British Columbia where he is the residency supervisor for the urogynecology program. He is a Surgeon Champion for the American College of Surgeon’s National Surgical Quality Improvement Program (NSQIP). He is a committed advocate for women’s health, medical education and quality improvement initiatives while maintaining a full clinical, reconstructive and cosmetic practice. Dr. Lazare’s professional memberships include the Royal College of Physicians and Surgeons, the Canadian Society of Pelvic Medicine, the International Urogynecology Association, the International Continence Society and the American Urogynecology Society.