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Contigen (Contigen)

✓ Approved

AbbVie, Inc. · therapeutic agent

What is Contigen?

Contigen is a therapeutic agent developed by AbbVie, Inc.. It is approved for therapeutic indications via unknown.

Drug Profile

Brand NamesContigen
CompanyAbbVie, Inc.
RouteUnknown
StatusApproved
Sources: ClinicalTrials.gov, AbbVie, Inc.

Therapeutic Indications

Contigen is developed for 1 unique indication across 1 therapeutic area.

Therapeutic AreaConditionPhase
Renal and urinary disordersUrinary incontinence✓ Approved

Related Research Articles

PubMedNeurourology and urodynamics2021-05-21

Urethral bulking agents for the treatment of stress urinary incontinence in women: A systematic review.

Hoe Venetia V, Haller Britt B, Yao Henry H HH, O'Connell Helen E HE

To perform a systematic review to assess and compare the efficacy and safety of all urethral bulking agents (UBAs) available for the treatment of stress urinary incontinence (SUI) in women. This systematic review was conducted in accordance with the PRISMA guideline. A systematic search was conducted using the Ovid Medline, Embase and PubMed databases. Studies were included if they involved women who underwent either Bulkamid®, Macroplastique®, Durasphere®, Coaptite®, or Urolastic® injections for the treatment of SUI. A total of 583 articles were screened with 56 articles included. A qualitative analysis was performed. The newer synthetic UBAs are not inferior to Contigen®, with variable mean success rates of 30%-80% in the short-term. Better long-term success rates were found with Bulkamid® (42%-70%), Coaptite® (60%-75%), and Macroplastique® (21%-80%) on qualitative review. Urinary tract infection rates were similar between bulking agents (4%-10.6%) although temporary acute urinary retention was more commonly associated with Coaptite® (mean: 34.2%), and de novo urgency in Durasphere® (mean: 24.7%). Significant complications such as migration into lymph nodes was reported with Durasphere®. Erosion was reported with Macroplastique®, Coaptite®, and Urolastic®, with a rate as high as 24.6% in one study of Urolastic®. Available data support the use of Bulkamid® and Macroplastique®, which has shown a short-term efficacy of 30%-90% and 40%-85% respectively, and long-term efficacy of 42%-70%, and 21%-80%, respectively. Bulkamid® appears to have a more favorable safety profile, with no cases of erosion or migration of product associated with its use. Direct comparisons of UBAs have not been performed.

PMID 34015151
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PubMedNature reviews. Urology2020-01-25

Regenerative medicine and injection therapies in stress urinary incontinence.

Hillary Christopher J CJ, Roman Sabiniano S, MacNeil Sheila S, Aicher Wilhelm K WK et al.

Stress urinary incontinence (SUI) is a common and bothersome condition. Anti-incontinence surgery has high cure rates, but concerns about mesh tapes have resulted in the resurgence of surgical procedures that involve increased abdominopelvic dissection and morbidity. Injection therapy with urethral bulking agents or stem cell formulations have been developed as minimally invasive alternatives. Many synthetic and biological bulking agents have been trialled, but several have been discontinued owing to safety concerns. The use of Macroplastique and Contigen has the largest evidence base, but, overall, success rates seem to be similar between the various agents and positive outcomes are poorly sustained for more than 6 months. Furthermore, subjective cure rates, although initially high, also deteriorate over time. The available data consistently demonstrate manifestly poorer outcomes for injection therapies than for surgery. Stem cell treatments are thought to functionally regenerate the urethral sphincter in patients with suspected intrinsic sphincter deficiency. Autologous adipose and muscle-derived stem cells seem to be the intuitive cell source, as they are comparatively abundant, can be harvested and cause minimal donor site morbidity. To date, only a few small clinical studies have been reported and most data are derived from animal models. The success rates of stem cell injection therapies seem to be comparable with those of bulking agents.

PMID 31974507
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PubMedThe Journal of urology2019-02-28

Patient Characteristics that May Influence the Effect of Urethral Injection Therapy for Female Stress Urinary Incontinence.

Elmelund Marlene M, Sokol Eric R ER, Karram Mickey M MM, Dmochowski Roger R et al.

Urethral injection therapy is a well-known treatment of female stress urinary incontinence but to our knowledge the optimal group of recipients has not been established. In this study we examined which patient characteristics are associated with success after urethral injection therapy. This study is a post hoc analysis of a previously published, randomized, 33-center study of the hydrogel bulking agent Bulkamid® vs the collagen gel Contigen®. Regardless of the treatment women were considered cured if there were no stress incontinence episodes in the bladder diary and no stress incontinence symptoms on the ICIQ-UI-SF (International Consultation on Incontinence Questionnaire-Urinary Incontinence-Short Form), improved if there was a 50% or greater reduction in stress incontinence episodes and no effect if there was less than a 50% reduction in stress incontinence episodes 1 year after treatment. Of the 345 women who were initially randomized 291 were included in this study. A total of 191 women received hydrogel and 100 received collagen. At 1 year 74 women (25%) were cured, 164 (56%) were improved and 53 (18%) showed no effect. On multivariate logistic regression analysis age 60 years or greater and fewer than 2.5 daily stress incontinence episodes were associated with cure. In this group 90% of women experienced a treatment effect and 38% were cured compared with a 13% cure rate in those younger than 60 years with 2.5 or more daily stress incontinence episodes. Urethral injection therapy was more effective to treat stress urinary incontinence in women 60 years old or older with fewer than 2.5 daily stress incontinence episodes. It had a 90% success rate in these women.

PMID 30810462
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PubMedThe Journal of urology2014-04-08

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

Sokol Eric R ER, Karram Mickey M MM, Dmochowski Roger R

Bulkamid® is a new polyacrylamide hydrogel bulking agent for stress urinary incontinence that is injected in the urethral submucosa using a specifically designed device. We evaluated the safety and efficacy of Bulkamid vs Contigen® collagen gel for stress urinary incontinence or stress predominant mixed urinary incontinence. This was a single-blind, randomized, prospective, 33-center, 2-arm parallel study of hydrogel vs collagen gel with followup to 1 year. At baseline patients underwent physical examination and bladder testing, and completed quality of life questionnaires and bladder diaries. After randomization patients could receive up to 3 injections at 1-month intervals. Patients were assessed 3, 6, 9 and 12 months after bulking. They completed bladder diaries and quality of life questionnaires, and pad weight was tested. At the last visit Valsalva leak point pressure was measured. Subjective and objective incontinence outcomes and adverse events were compared. Of the 345 women 229 were randomized to hydrogel and 116 were randomized to collagen gel. At 12 months a 50% or greater decrease in leakage and incontinence episodes was seen in 53.2% and 55.4% of patients who received hydrogel and collagen gel, respectively. At 12 months 47.2% of patients with hydrogel and 50% with collagen gel reported zero stress incontinence episodes, and 77.1% and 70%, respectively, considered themselves cured or improved. Major adverse events were rare in each group. Bulkamid is not inferior to Contigen. It has a favorable, persistent effect on stress urinary incontinence with a low risk of serious adverse events. Bulkamid is a new, simple, office based bulking system that shows promise as a treatment in women with stress urinary incontinence, particularly since Contigen is no longer commercially available.

PMID 24704117
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PubMedInternational urogynecology journal2012-06-19

Bulking agents: an analysis of 500 cases and review of the literature.

Mohr Stefan S, Siegenthaler Martine M, Mueller Michael D MD, Kuhn Annette A

Stress urinary incontinence (SUI) is common, impacts women's quality of life, and generates high costs. Physiotherapy is the first-line therapy, and if it fails, suburethral slings are the gold standard in SUI surgery. Bulking agents injected periurethrally might be a beneficial alternative, but there is a paucity of data on bulking therapy. The aim of this study was to prospectively analyze the efficacy and safety of bulking agents in the setting of a tertiary referral center. In the last 13 years, 514 elderly women with SUI were treated by injection therapy with either collagen (Contigen), hyaluronic acid (Zuidex), ethylene vinyl alcohol (Tegress), or polyacrylamide hydrogel (Bulkamid). Subjective and objective outcome was recorded at the 12-month postoperative appointment using the King's Health Questionnaire, visual analogue scale (VAS) describing their incontinence severity, standardized pad test, and urethral pressure profile. Demographic data were equally distributed in all four groups of agents used. Sixty-one patients were lost to follow-up (10.6 %). Statistically significant changes were found for maximum urethral closure pressure (MUCP), pad weight, and VAS before and after bulking for the four agents used. Pad test was negative in 73.2 % of patients after bulking therapy. Subjective assessment showed improvements in general health and role limitations. The overall complication rate was low for all agents. This study shows improvement in incontinence after bulking therapy according to subjective and objective outcomes in an elderly population. In contrast to earlier reports, side effects due to injections were few and mild. We can advocate bulking therapy for treating SUI, as it is simple, safe, and shows both objective and subjective improvement and relief.

PMID 22707004
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PubMedUrology2009-08-08

Randomized controlled multisite trial of injected bulking agents for women with intrinsic sphincter deficiency: mid-urethral injection of Zuidex via the Implacer versus proximal urethral injection of Contigen cystoscopically.

Lightner Deborah D, Rovner Eric E, Corcos Jacques J, Payne Christopher C et al.

To determine whether Zuidex using a non-cystoscopy mid-urethral injection technique produces as good a result (i.e. was not inferior) as Contigen injected endoscopically at the bladder neck in the treatment of urinary stress incontinence secondary to intrinsic sphincter deficiency in adult women. A prospective 2:1 randomized trial of mid-urethral injections of Zuidex-Implacer vs proximal urethral cystoscopic injections of Contigen was performed in 344 women with intrinsic sphincter deficiency at 23 North American sites, and followed up for >1 year from last treatment. Outcomes at 12 months from last treatment failed to demonstrate that mid-urethral injected Zuidex was equivalent to cystoscopically injected Contigen in primary and secondary outcome variables. The primary outcome, the proportion of women who achieved a 50% reduction in urinary leakage on provocation testing, was achieved in 84% of Contigen-treated women vs 65% of Zuidex-treated women. Confounding multiple variables inherent in the study design make a detailed analysis of study outcomes difficult.

PMID 19660800
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