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


Journal

Neurourology and urodynamics
ISSN: 1520-6777
Titre abrégé: Neurourol Urodyn
Pays: United States
ID NLM: 8303326

Informations de publication

Date de publication:
01 2021
Historique:
received: 28 06 2020
revised: 31 10 2020
accepted: 18 11 2020
pubmed: 8 1 2021
medline: 12 6 2021
entrez: 7 1 2021
Statut: ppublish

Résumé

Bulking agents are a minimally invasive treatment option for women with stress urinary incontinence (SUI) or stress-predominant mixed urinary incontinence (MUI). The aim of this study was to evaluate long-term efficacy and safety following treatment with Bulkamid as a primary procedure for SUI or stress-predominant MUI. This was an Institutional Review Board-approved single-center retrospective study of female patients with SUI or stress-predominant MUI who had undergone injection with Bulkamid since 2005 and had completed 7 years of follow up. The primary endpoint was patient satisfaction measured on a four-point scale as cured, improved, unchanged, or worse. Secondary outcomes included the number of incontinence pads used, International Consultation on Incontinence Questionnaire-Short Form (ICIQ-UI SF) scores, Visual Analog Scale Quality of Life (VAS QoL), reinjection rates, and perioperative and postoperative complications. A total of 1,200 patients were treated with Bulkamid since 2005 and of these, 388 (32.3%) had completed 7 years of follow-up. A total of 67.1% of the patients reported feeling cured or improved if Bulkamid was a primary procedure, 11.1% reported no change, and 2.3% reported worsening of incontinence. A total of 19.5% of patients received a subsequent other incontinence procedure. The ICIQ-UI SF was reduced by 8.6 points. VAS QoL improved by a mean of 4.3 points. Postoperative complications were transient. Prolonged bladder emptying time was reported in 15.3% of patients and urinary tract infection in 3.5%. Bulkamid injections are an effective and safe first-line treatment option for women with SUI or stress-predominant MUI providing durable outcomes at 7 years.

Identifiants

pubmed: 33410544
doi: 10.1002/nau.24589
pmc: PMC7839440
doi:

Substances chimiques

Acrylic Resins 0
Biocompatible Materials 0
Bulkamid 0
Hydrogels 0

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

502-508

Commentaires et corrections

Type : CommentIn

Informations de copyright

© 2021 The Authors. Neurourology and Urodynamics published by Wiley Periodicals LLC.

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Auteurs

Torsten Brosche (T)

Gyneacology - Pelvic Floor Center, Women's Hospital, DRK-Hospital Chemnitz-Rabenstein, Chemnitz, Germany.

Annette Kuhn (A)

Inselspital Bern, Women's Hospital, Switzerland and University of Bern, Bern, Switzerland.

Kurt Lobodasch (K)

Gyneacology - Pelvic Floor Center, Women's Hospital, DRK-Hospital Chemnitz-Rabenstein, Chemnitz, Germany.

Eric R Sokol (ER)

Section of Urogynecology and Pelvic Reconstructive Surgery, Stanford University School of Medicine, Stanford, California, USA.

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Classifications MeSH