Evidence map›Paper›PMID 20645077›Full record

ArticleInternational urogynecology journal2010

An open multicenter study of polyacrylamide hydrogel (Bulkamid®) for female stress and mixed urinary incontinence.

Gunnar Lose, Helle Christina Sørensen, Susanne M Axelsen, Christian Falconer, Kurt Lobodasch, Tosson Safwat

Registry-linked trialAbstract readMulticenter Study
In one paragraph

Article in International urogynecology journal, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02538991 (TVT Versus Bulkamid®-Injections in Treatment of Stress Urinary Incontinence - Patient Satisfaction and Complications of the Treatment), which is not on this map. Cited by 31 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed, 3 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02538991 naunknown statusnot on this mapstarted 2015, after this paper: background citation

TVT Versus Bulkamid®-Injections in Treatment of Stress Urinary Incontinence - Patient Satisfaction and Complications of the Treatment

TypeinterventionalSponsorHelsinki University Central HospitalRan2015 to 2024Enrolled224ConditionsUrinary Stress IncontinenceArmsBulkamid, Tension-free Vaginal Tape
3 · Its place in the literature

Who cites it

31 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
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  7. Article
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  11. The Impact of Treatment Setting on Periurethral Bulking.International urogynecology journal · 2026
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Gunnar LoseDepartment of Obstetrics and Gynaecology, Herlev County Hospital, University of Copenhagen, Herlev, Denmark. gulo@heh.regionh.dk
Helle Christina Sørensen
Susanne M Axelsen
Christian Falconer
Kurt Lobodasch
Tosson Safwat

Funding

STUDIES OF REGIONAL FAT DISTRIBUTION AND ENERGY BALANCEK24DK002860 · NIDDK · UNIVERSITY OF WASHINGTON · PI WEIGLE, DAVID S · 2001 to 2005
$486k
NIDDK NIH HHS K24 DK002860
6 · The paper itself

Abstract

introductionPolyacrylamide hydrogel (PAHG, Bulkamid®) is a promising urethral bulking agent. This multicenter study was carried out to evaluate safety and efficacy of Bulkamid® for female stress and mixed urinary incontinence.

methodsSubmucosal injection of Bulkamid® was performed in 135 women with urinary incontinence (stress, 67; mixed, 68) followed for 12 months. Forty-seven had a reinjection (35%).

resultsAt 12 months, the subjective response rate was 66%. Incontinence episodes/24 h and urine leakage g/24 h decreased significantly (from 3.0 to 0.7 and 29 g to 4 g, respectively). Additionally, the median International Consultation on Incontinence Questionnaire score was reduced to approximately 50%, and the overall quality of life visual analogue scale score was decreased significantly (from 72 to 20). Efficacy was very similar between patients with stress and mixed incontinence. Thirty treatment-related adverse events were registered. The most frequent was urinary tract infection (n = 10). No polyacrylamide hydrogel-specific adverse events were seen.

conclusionsBulkamid® is an effective and safe bulking agent in women with stress or mixed incontinence.

Indexed as

Acrylic ResinsAdultAgedAged, 80 and overCohort StudiesDenmarkFemaleFinlandFollow-Up StudiesGermanyHumansHydrogelsMiddle AgedSwedenTreatment OutcomeUnited KingdomAcrylic ResinsBulkamidHydrogelspolyacrylamide gels

Identifiers

PMID20645077
PMCPMC2977052

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.