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The Cochrane Database of Systematic... Jul 2017Urinary incontinence imposes a significant health and economic burden to society. Periurethral or transurethral injection of bulking agents is a minimally invasive... (Review)
Review
BACKGROUND
Urinary incontinence imposes a significant health and economic burden to society. Periurethral or transurethral injection of bulking agents is a minimally invasive surgical procedure used as one the surgical treatments of stress urinary incontinence (SUI) in adult women.
OBJECTIVES
To assess the effects of periurethral or transurethral injection therapy on the cure or improvement of urinary incontinence in women.
SEARCH METHODS
We searched the Cochrane Incontinence Group Specialised Trials Register (searched 8 November 2010) and the reference lists of relevant articles.
SELECTION CRITERIA
All randomised or quasi-randomised controlled trials of treatment for urinary incontinence in which at least one management arm involved periurethral or transurethral injection therapy.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed methodological quality of each study using explicit criteria. Data extraction was undertaken independently and clarification concerning possible unreported data sought directly from the investigators.
MAIN RESULTS
Excluding duplicate reports, we identified 14 trials (excluding one that was subsequently withdrawn from publication and not included in this analysis) including 2004 women that met the inclusion criteria. The limited data available were not suitable for meta-analysis because they all came from separate trials. Trials were small and generally of moderate quality.One trial of 45 women that compared injection therapy with conservative treatment showed early benefit for the injectable therapy with respect to continence grade (risk ratio (RR) 0.70, 95% confidence interval (CI) 0.52 to 0.94) and quality of life (mean difference (MD) 0.54, 95% CI 0.16 to 0.92). Another trial, comparing Injection of autologous fat with placebo, terminated early because of safety concerns. Two trials that compared injection with surgical management found significantly better objective cure in the surgical group (RR 4.77, 95% CI 1.96 to 11.64; and RR 1.69, 95% CI 1.02 to 2.79), although the latter trial data did not reach statistical significance if an intention-to-treat analysis was used.Eight trials compared different agents and all results had wide confidence intervals. Silicone particles, calcium hydroxylapatite, ethylene vinyl alcohol, carbon spheres and dextranomer hyaluronic acid combination gave improvements which were not shown to be more or less efficacious than collagen. Dextranomer hyaluronic acid compound treated patients appeared to have significantly higher rates of injection site complications (16% with the hyaluronic acid compound versus none with collagen; RR 37.78, 95% CI 2.34 to 610.12) and this product has now been withdrawn from the market.A comparison of periurethral and transurethral methods of injection found similar outcomes but a higher (though not statistically significant) rate of early complications in the periurethral group. One trial of 30 women showed a weak (but not clinically significant) advantage for patient satisfaction (data not suitable for analysis in RevMan) after mid-urethral injection in comparison to bladder neck injection but with no demonstrable difference in continence levels.
AUTHORS' CONCLUSIONS
The available evidence base remains insufficient to guide practice. In addition, the finding that placebo saline injection was followed by a similar symptomatic improvement to bulking agent injection raises questions about the mechanism of any beneficial effects. One small trial comparing silicone particles with pelvic floor muscle training was suggestive of benefit at three months but it is not known if this was sustained, and the treatment was associated with high levels of postoperative retention and dysuria. Greater symptomatic improvement was observed with surgical treatments, though the advantages need to be set against likely higher risks. No clear-cut conclusions could be drawn from trials comparing alternative agents, although dextranomer hyaluronic acid was associated with more local side effects and is no longer commercially available for this indication. There is insufficient evidence to show superiority of mid-urethral or bladder neck injection. The single trial of autologous fat provides a reminder that periurethral injections can occasionally cause serious side effects. Also, a Brief Economic Commentary (BEC) identified three studies suggesting that urethral bulking agent might be more cost-effective compared with retropubic mid-urethral slings, transobturator or traditional sling procedure when used as an initial treatment in women without hypermobility or as a follow-up to surgery failure provided injection is kept minimal. However, urethral bulking agent might not be cost-effective when compared with traditional sling as an initial treatment of SUI when a patient is followed up for a longer period (15 months post-surgery).
Topics: Adipose Tissue; Biocompatible Materials; Calcium Compounds; Collagen; Dextrans; Dimethylpolysiloxanes; Durapatite; Female; Glucans; Humans; Hyaluronic Acid; Injections; Polytetrafluoroethylene; Polyvinyls; Quality of Life; Randomized Controlled Trials as Topic; Urethra; Urinary Incontinence, Stress; Zirconium
PubMed: 28738443
DOI: 10.1002/14651858.CD003881.pub4 -
JPMA. the Journal of the Pakistan... Nov 2021To review different modes of application of hydroxyapatite for treatment of dentin hypersensitivity via dentinal tubule occlusion.
OBJECTIVE
To review different modes of application of hydroxyapatite for treatment of dentin hypersensitivity via dentinal tubule occlusion.
METHODS
Literature search for the systematic review was done using key words 'hydroxyapatite and dentin hypersensitivity', 'hydroxyapatite and dentinal tubule occlusion', 'hydroxyapatite and dentin permeability', and 'dentinal tubule occlusion' on Pubmed, Science Direct and Web of Science databases for articles published over 10 years, from 2009 to 2018.
RESULTS
Of the 132 research articles initially identified, 97(73.5%) related to the 10-year study period. After detailed screening, 16(16.5%) studies were included. The results of in vitro studies showed that application of hydroxyapatite caused dentinal tubule occlusion leading to reduction in dentin permeability and reduction in dentin hypersensitivity.
CONCLUSIONS
Hydroxyapatite has the potential to reduce dentin hypersensitivity via dentinal tubule occlusion within 2-8 weeks.
Topics: Dentin; Dentin Sensitivity; Durapatite; Humans; Microscopy, Electron, Scanning
PubMed: 34783744
DOI: 10.47391/JPMA.01175 -
The Cochrane Database of Systematic... Oct 2012It is not clear which fixation of total knee arthroplasty obtains the best clinical, functional and radiographic results in people with osteoarthritis and other... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
It is not clear which fixation of total knee arthroplasty obtains the best clinical, functional and radiographic results in people with osteoarthritis and other non-traumatic diseases, such as rheumatoid arthritis.
OBJECTIVES
To assess the benefits and harms of cemented, cementless and hybrid knee prostheses fixation techniques in participants with primary osteoarthritis (osteoarthritis following trauma was not included) and other non-traumatic diseases, such as rheumatoid arthritis.
SEARCH METHODS
We searched CENTRAL (2011, issue 10), MEDLINE via PubMed, EMBASE, Current Controlled Trials, LILACS, The Cumulative Index to Nursing and Allied Health Literature, SPORTDiscus, Health Technology Assessment Database and the Database of Abstracts of Reviews of Effectiveness, all from implementation to October 2011, along with handsearches of high-yield journals and reference lists of articles. No language restrictions were applied.
SELECTION CRITERIA
Randomized controlled trials (RCTs) evaluating cemented, cementless and hybrid fixation. Participants included patients that were 18 years or older with osteoarthritis and other non-traumatic diseases who were undergoing primary total knee arthroplasty.
DATA COLLECTION AND ANALYSIS
Three authors independently selected the eligible trials, assessed the trial quality, risk of bias and extracted data. Researchers were contacted to obtain missing information.
MAIN RESULTS
Five RCTs and 297 participants were included in this review. Using meta-analysis on roentgen stereophotogrammetric analysis (RSA) we observed that cemented fixation of the tibial components demonstrated smaller displacement in relation to cementless fixation (with and without hydroxyapatite) after a follow-up of two years (maximum total point-motion, N = 167, two RCTs, mean difference (MD) = 0.52 mm, 95% confidence interval (CI) 0.31 to 0.74). However, the risk of future aseptic loosening with uncemented fixation was approximately half that of cemented fixation according to the arthroplasty instability classification (moderate quality as assessed by GRADE) inferred from RSA (N = 216, three RCTs, risk ratio (RR) = 0.47, 95% CI 0.24 to 0.92) with a 16% absolute risk difference between groups. The number needed to treat for an additional beneficial outcome (NNTB) to prevent future aseptic loosening was 7 (95% CI 5 to 44). There was a low risk of bias for RSA among the studies included. It was not possible to perform meta-analysis on patient-important outcomes, such as the survival rate of the implant (any change of a component), patient global assessments, functional measures, pain, health-related quality of life measures and adverse events. Almost all included studies recorded functional measures of Knee Society and Hospital for Special Surgery knee scores, but the authors of each study found no significant difference between the groups.
AUTHORS' CONCLUSIONS
There was a smaller displacement of the cemented tibial component in relation to the cementless fixation in studies with osteoarthritis and rheumatoid arthritis participants who underwent primary total knee prosthesis with a follow-up of two years; however, the cemented fixation presented a greater risk of future aseptic loosening than cementless fixation.
Topics: Arthritis, Rheumatoid; Arthroplasty, Replacement, Knee; Biocompatible Materials; Bone Cements; Durapatite; Humans; Knee Prosthesis; Osteoarthritis, Knee; Prosthesis Failure; Radiostereometric Analysis; Randomized Controlled Trials as Topic; Time Factors; Treatment Outcome
PubMed: 23076921
DOI: 10.1002/14651858.CD006193.pub2 -
Stem Cell Research & Therapy Feb 2021To repair bone defects, a variety of bone substitution materials have been used, such as ceramics, metals, natural and synthetic polymers, and combinations thereof. In... (Review)
Review
INTRODUCTION
To repair bone defects, a variety of bone substitution materials have been used, such as ceramics, metals, natural and synthetic polymers, and combinations thereof. In recent decades, a wide range of synthetic polymers have been used for bone regeneration. These polymers have the advantages of biocompatibility, biodegradability, good mechanical properties, low toxicity, and ease of processing. However, when used alone, they are unable to achieve ideal bone formation. Incorporating zinc (Zn) into synthetic polymers has been considered, as previous studies have shown that Zn promotes stem cell osteogenesis and mineral deposition. The purpose of this systematic review was to provide an overview of the application and effectiveness of Zn in synthetic polymers for bone regeneration, whether used alone or in combination with other biomaterials. This study was performed according to the PRISMA guidelines.
MATERIALS AND METHODS
A search of the PubMed, Embase, and the Cochrane Library databases for articles published up to June 2020 revealed 153 relevant studies. After screening the titles, abstracts, and full texts, 13 articles were included in the review; 9 of these were in vitro, 3 were in vivo, and 1 included both in vitro and in vivo experiments.
RESULTS
At low concentrations, Zn promoted cell proliferation and osteogenic differentiation, while high-dose Zn resulted in cytotoxicity and inhibition of osteogenic differentiation. Additionally, one study showed that Zn reduced apatite formation in simulated body fluid. In all of the in vivo experiments, Zn-containing materials enhanced bone formation.
CONCLUSIONS
At appropriate concentrations, Zn-doped synthetic polymer materials are better able to promote bone regeneration than materials without Zn.
Topics: Biocompatible Materials; Bone Regeneration; Osteogenesis; Polymers; Zinc
PubMed: 33579372
DOI: 10.1186/s13287-021-02195-y -
The Cochrane Database of Systematic... Nov 2016Anophthalmia is the absence of one or both eyes, and it can be congenital (i.e. a birth defect) or acquired later in life. There are two main types of orbital implant:... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Anophthalmia is the absence of one or both eyes, and it can be congenital (i.e. a birth defect) or acquired later in life. There are two main types of orbital implant: integrated, whereby the implant receives a blood supply from the body that allows for the integration of the prosthesis within the tissue; and non-integrated, where the implant remains separate. Despite the remarkable progress in anophthalmic socket reconstruction and in the development of various types of implants, there are still uncertainties about the real roles of integrated (hydroxyapatite (HA), porous polyethylene (PP), composites) and non-integrated (polymethylmethacrylate (PMMA)/acrylic and silicone) orbital implants in anophthalmic socket treatment.
OBJECTIVES
To assess the effects of integrated versus non-integrated orbital implants for treating anophthalmic sockets.
SEARCH METHODS
We searched CENTRAL (which contains the Cochrane Eyes and Vision Trials Register) (2016, Issue 7), Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMEDLINE (January 1946 to August 2016), Embase (January 1980 to August 2016), Latin American and Caribbean Health Sciences Literature Database (LILACS) (1982 to August 2016), the ISRCTN registry (www.isrctn.com/editAdvancedSearch), ClinicalTrials.gov (www.clinicaltrials.gov), and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). We did not use any date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 8 August 2016.
SELECTION CRITERIA
Randomised controlled trials (RCTs) and quasi-RCTs of integrated and non-integrated orbital implants for treating anophthalmic sockets.
DATA COLLECTION AND ANALYSIS
Two authors independently selected relevant trials, assessed methodological quality and extracted data.
MAIN RESULTS
We included three studies with a total of 284 participants (250 included in analysis). The studies were conducted in India, Iran and the Netherlands. The three studies were clinically heterogenous, comparing different materials and using different surgical techniques. None of the included studies used a peg (i.e. a fixing pin used to connect the implant to the prosthesis). In general the trials were poorly reported, and we judged them to be at unclear risk of bias.One trial compared HA using traditional enucleation versus alloplastic implantation using evisceration (N = 100). This trial was probably not masked. The second trial compared PP with scleral cap enucleation versus PMMA with either myoconjunctival or traditional enucleation (N = 150). Although participants were not masked, outcome assessors were. The last trial compared HA and acrylic using the enucleation technique (N = 34) but did not report comparative effectiveness data.In the trial comparing HA versus alloplastic implantation, there was no evidence of any difference between the two groups with respect to the proportion of successful procedures at one year (risk ratio (RR) 1.02, 95% confidence interval (CI) 0.95 to 1.09, N = 100, low-certainty evidence). People receiving HA had slightly worse horizontal implant mobility compared to the alloplastic group (mean difference (MD) -3.35 mm, 95% CI -4.08 to -2.62, very low-certainty evidence) and slightly worse vertical implant motility (MD -2.76 mm, 95% CI -3.45 to -2.07, very low-certainty evidence). As different techniques were used - enucleation versus evisceration - it is not clear whether these differences in implant motility can be attributed solely to the type of material. Investigators did not report adverse events.In the trial comparing PP versus PMMA, there was no evidence of any difference between the two groups with respect to the proportion of successful procedures at one year (RR 0.92, 95% CI 0.84 to 1.01, N = 150, low-certainty evidence). There was very low-certainty evidence of a difference in horizontal implant motility depending on whether PP was compared to PMMA with traditional enucleation (MD 1.96 mm, 95% CI 1.01 to 2.91) or PMMA with myoconjunctival enucleation (-0.57 mm, 95% CI -1.63 to 0.49). Similarly, for vertical implant motility, there was very low-certainty evidence of a difference in the comparison of PP to PMMA traditional (MD 3.12 mm 95% CI 2.36 to 3.88) but no evidence of a difference when comparing PP to PMMA myoconjunctival (MD -0.20 mm 95% CI -1.28 to 0.88). Four people in the PP group (total N = 50) experienced adverse events (i.e. exposures) compared to 6/100 in the PMMA groups (RR 17.82, 95% CI 0.98 to 324.67, N = 150, very low-certainty evidence).None of the studies reported socket sphere size, cosmetic effect or quality of life measures.
AUTHORS' CONCLUSIONS
Current very low-certainty evidence from three small published randomised controlled trials did not provide sufficient evidence to assess the effect of integrated and non-integrated material orbital implants for treating anophthalmic sockets. This review underlines the need to conduct further well-designed trials in this field.
Topics: Anophthalmos; Durapatite; Eye Enucleation; Eye Evisceration; Humans; Orbital Implants; Polyethylene; Polymethyl Methacrylate; Prosthesis Design; Prosthesis Implantation; Randomized Controlled Trials as Topic
PubMed: 27820878
DOI: 10.1002/14651858.CD010293.pub2 -
Chemosphere Mar 2024Hydroxyapatite (HA) is a biomaterial widely used in clinical applications and pharmaceuticals. The literature on HA-based materials studies is focused on chemical... (Review)
Review
Hydroxyapatite (HA) is a biomaterial widely used in clinical applications and pharmaceuticals. The literature on HA-based materials studies is focused on chemical characterization and biocompatibility. Generally, biocompatibility is analyzed through adhesion, proliferation, and differentiation assays. Fewer studies are looking for genotoxic events. Thus, although HA-based biomaterials are widely used as biomedical devices, there is a lack of literature regarding their genotoxicity. This systematic review was carried out following the PRISMA statement. Specific search strategies were developed and performed in four electronic databases (PubMed, Science Direct, Scopus, and Web of Science). The search used "Hydroxyapatite OR Calcium Hydroxyapatite OR durapatite AND genotoxicity OR genotoxic OR DNA damage" and "Hydroxyapatite OR Calcium Hydroxyapatite OR durapatite AND mutagenicity OR mutagenic OR DNA damage" as keywords and articles published from 2000 to 2022, after removing duplicate studies and apply include and exclusion criteria, 53 articles were identified and submitted to a qualitative descriptive analysis. Most of the assays were in vitro and most of the studies did not show genotoxicity. In fact, a protective effect was observed for hydroxyapatites. Only 20 out of 71 tests performed were positive for genotoxicity. However, no point mutation-related mutagenicity was observed. As the genotoxicity of HA-based biomaterials observed was correlated with its nanostructured forms as needles or rods, it is important to follow their effect in chronic exposure to guarantee safe usage in humans.
Topics: Humans; Durapatite; Biocompatible Materials; Hydroxyapatites; DNA Damage; Mutagens
PubMed: 38360416
DOI: 10.1016/j.chemosphere.2024.141383 -
European Journal of Orthopaedic Surgery... Dec 2022Although various papers have reported on the clinical performance of cup retention with cementation of a new liner and bone grafting in the management of well-fixed cups... (Review)
Review
PURPOSE
Although various papers have reported on the clinical performance of cup retention with cementation of a new liner and bone grafting in the management of well-fixed cups with polyethylene wear and periacetabular osteolysis after total hip arthroplasty (THA), no systematic review of this topic has been published to date.
METHODS
Medline, EMBASE and Cochrane Library were searched for articles published from January 1999 to January 2019 using "osteolysis" AND "well-fixed", "osteolysis" AND "retro-acetabular", "bone graft" AND ("retention" OR "retained" OR "stable") AND "cup", and "cemented liner" AND "well-fixed".
RESULTS
Nine articles were selected for review (186 cases, 76.1 months mean follow-up). The overall revision rate was 11.3% (21 hips) most commonly due to aseptic loosening (9/186 hips), dislocation (8/186 hips), and liner wear progression (2/186 cases). The reported square size of osteolytic lesions ranged from a mean of 465.84 mm to a max of 4,770 mm. Almost all reported lesions treated with bone grafts resolved or did not progress 97% (72/74). All studies indicated improved pain and functional scores at follow-up.
CONCLUSION
Cementation of a new liner with periacetabular bone grafting provides an alternative option to isolated liner exchange and cup revision for the management of periacetabular osteolysis in well-fixed cups with a disrupted locking mechanism or unavailable exchange liner. Further higher quality studies are required in order to examine if the use of highly cross-linked polyethylene, highly porous-coated cups, hydroxyapatite-coated cups, and small-diameter cups influence the clinical outcome of liner cementation in well-fixed cups with periacetabular osteolysis.
Topics: Humans; Polyethylene; Cementation; Prosthesis Failure; Prosthesis Design; Reoperation; Hip Prosthesis; Osteolysis; Arthroplasty, Replacement, Hip; Acetabulum; Metals; Hydroxyapatites; Follow-Up Studies
PubMed: 34605989
DOI: 10.1007/s00590-021-03130-w -
Journal of Trace Elements in Medicine... Jul 2021The poor biological performance of zirconium implants in the human body resulting from their bio-inertness and vulnerability to corrosion and bacterial activity reflects...
BACKGROUND
The poor biological performance of zirconium implants in the human body resulting from their bio-inertness and vulnerability to corrosion and bacterial activity reflects the need for further studies on substitution or performing the surface modification. The suggestion of employing zirconia (ZrO) bioceramic coatings for surface modification seems beneficial.
OBJECTIVES
This systematic review aims to identify and summarize existing documents reporting the biological responses for ZrO coatings produced by the PEO process on zirconium implants.
METHODS
PubMed, Scopus, and Web of Science international databases were searched for the original and English-language studies published between 2000 and 2021. All publications reported at least one study about in-vitro (cellular and immersion studies), in-vivo (animal studies), and antibacterial topics for ZrO-PEO coated zirconium implants.
RESULTS
Throughout the initial search, 496 publications were found, and 296 papers remained following the elimination of duplicates. Finally, after multiple screening and eligibility assessments, 25 publications were qualified and included in the review. Among them, 25 in-vitro (cellular and immersion in SBF and Hanks' solutions studies), one in-vivo (animal studies), and eight antibacterial studies were found.
CONCLUSION
The ZrO coated samples demonstrate no cytotoxicity, high cell viability rate, and excellent biocompatibility. However, changing the solution composition and electrical parameters during the PEO procedures result in significant changes to in-vitro responses. As an instance, the ZrO coating surface demonstrates greater biocompatibility after irradiated by UV, which makes the surface more suitable for cell growth. Due to weak apatite-forming ability, the zirconium sample shows low bioactivity in SBF. However, most cases (13 out of 16) show that the specific morphology and chemical composition of the ZrO coating promote apatite-forming ability with good bioactivity in SBF. Nevertheless, few papers (three out of 16) showed that the ZrO coatings immersed in SBF had no apatite precipitates and so no bioactivity. These cases limit the bioactivity enhancement to treatment by UV-light irradiation, hydrothermal and chemical treatment, thermal evaporation, and cathodic polarization post-treatment on ZrO coatings. Both zirconium and ZrO coated samples do not show apatite-forming ability in Hanks' solution. The ZrO coated implant with the bone together indicates a greater shear strength and rapid new bone formation ability during 12 weeks because of containing Ca-P compounds and porous structure. The UV post-treated ZrO coating induces faster new bone formation and firmer connection of bond with bone than those of untreated ZrO coatings. A stronger antibacterial activity of ZrO coatings is confirmed in half of the selected papers (four out of eight studies) compared to the bare zirconium samples. The antibacterial protection of ZrO coatings can be influenced by the PEO procedure variables, i.e., solution composition, electrical parameters, and treatment time. In three cases, the antibacterial activity of ZrO coatings is enhanced by deposition of Zn, Ag, or Cu antibacterial layers through thermal evaporation post-treatment.
Topics: Anti-Bacterial Agents; Bacteria; Cell Survival; Coated Materials, Biocompatible; Electrochemical Techniques; Humans; Materials Testing; Microbial Sensitivity Tests; Oxidation-Reduction; Zirconium
PubMed: 33831798
DOI: 10.1016/j.jtemb.2021.126756 -
Regenerative Medicine Dec 2020To ascertain clinical effectiveness of anorganic bovine-derived hydroxyapatite matrix/cell-binding peptide (ABM/P-15) for regeneration of periodontal defects.... (Meta-Analysis)
Meta-Analysis
Clinical effectiveness of anorganic bovine-derived hydroxyapatite matrix/cell-binding peptide grafts for regeneration of periodontal defects: a systematic review and meta-analysis.
To ascertain clinical effectiveness of anorganic bovine-derived hydroxyapatite matrix/cell-binding peptide (ABM/P-15) for regeneration of periodontal defects. Electronic databases (National Library of Medicine [Medline by PubMed], Cochrane Library [Wiley], CINAHL [EBSCO] and Medline [EBSCO]) were systematically searched up to December 2019. Randomized controlled clinical trials comparing ABM/P-15 grafts to conventional surgery for intrabony and gingival recession defects were included and evaluated intrabony defects including clinical attachment level (CAL), probing depth and gingival recession. A significant gain in CAL (1.37 mm), and reduction in probing depth (1.22 mm) were shown by ABM/P-15 grafts than open flap debridement (p < 0.00001). The subgroup analysis also showed better results for ABM/P-15 grafts in CAL gain for intrabony defects. For furcation and gingival recession defects, no significant difference was seen. The adjunct use of ABM/P-15 grafts in conventional periodontal surgery is useful for periodontal regeneration of intrabony defects.
Topics: Alveolar Bone Loss; Animals; Cattle; Follow-Up Studies; Guided Tissue Regeneration, Periodontal; Hydroxyapatites; Peptides; Regeneration; Treatment Outcome
PubMed: 33356535
DOI: 10.2217/rme-2020-0113 -
The Cochrane Database of Systematic... Feb 2012Periurethral or transurethral injection of bulking agents is a minimally invasive surgical procedure used for the treatment of stress urinary incontinence in adult women. (Review)
Review
BACKGROUND
Periurethral or transurethral injection of bulking agents is a minimally invasive surgical procedure used for the treatment of stress urinary incontinence in adult women.
OBJECTIVES
To assess the effects of periurethral or transurethral injection therapy on the cure or improvement of urinary incontinence in women.
SEARCH METHODS
We searched the Cochrane Incontinence Group Specialised Trials Register (searched 8 November 2010) and the reference lists of relevant articles.
SELECTION CRITERIA
All randomised or quasi-randomised controlled trials of treatment for urinary incontinence in which at least one management arm involved periurethral or transurethral injection therapy.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed methodological quality of each study using explicit criteria. Data extraction was undertaken independently and clarification concerning possible unreported data sought directly from the investigators.
MAIN RESULTS
Excluding duplicate reports, we identified 14 trials (excluding one that was subsequently withdrawn from publication and not included in this analysis) including 2004 women that met the inclusion criteria. The limited data available were not suitable for meta-analysis because they all came from separate trials. Trials were small and generally of moderate quality.One trial of 45 women that compared injection therapy with conservative treatment showed early benefit for the injectable with respect to continence grade (risk ratio (RR) 0.7, 95% confidence interval (CI) 0.52 to 0.94) and quality of life (RR 0.54, 95% CI 0.16 to 0.92). Another, comparing Injection of autologous fat with placebo, terminated early because of safety concerns. Two trials that compared injection with surgical management found significantly better objective cure in the surgical group (RR 4.77, 95% CI 1.96 to 11.64; and RR 1.69, 95% CI 1.02 to 2.79), although the latter trial data did not reach statistical significance if an intention-to-treat analysis was used.Eight trials compared different agents and all results had wide confidence intervals. Silicone particles, calcium hydroxylapatite, ethylene vinyl alcohol, carbon spheres and dextranomer hyaluronic acid combination gave improvements which were not shown to be more or less efficacious than collagen. Dextranomer hyaluronic acid compound treated patients appeared to have significantly higher rates of injection site complications (16% with the hyaluronic acid compound versus none with collagen; RR 37.78, 95% CI 2.34 to 610) and this product has now been withdrawn from the market.A comparison of periurethral and transurethral methods of injection found similar outcomes but a higher (though not statistically significant) rate of early complications in the periurethral group. One trial of 30 women showed a weak (but not clinically significant) advantage for patient satisfaction (data not suitable for analysis in Revman) after mid-urethral injection in comparison to bladder neck injection but with no demonstrable difference in continence levels.
AUTHORS' CONCLUSIONS
The available evidence base remains insufficient to guide practice. In addition, the finding that placebo saline injection was followed by a similar symptomatic improvement to bulking agent injection raises questions about the mechanism of any beneficial effects. One small trial comparing silicone particles with pelvic floor muscle training was suggestive of benefit at three months but it is not known if this was sustained, and the treatment was associated with high levels of postoperative retention and dysuria. Greater symptomatic improvement was observed with surgical treatments, though the advantages need to be set against likely higher risks. No clear-cut conclusions could be drawn from trials comparing alternative agents, although dextranomer hyaluronic acid was associated with more local side effects and is no longer commercially available for this indication. There is insufficient evidence to show superiority of mid-urethral or bladder neck injection. The single trial of autologous fat provides a reminder that periurethral injections can occasionally cause serious side effects.
Topics: Biocompatible Materials; Collagen; Dimethylpolysiloxanes; Durapatite; Female; Glucans; Humans; Injections; Polytetrafluoroethylene; Polyvinyls; Quality of Life; Randomized Controlled Trials as Topic; Urethra; Urinary Incontinence, Stress; Zirconium
PubMed: 22336797
DOI: 10.1002/14651858.CD003881.pub3