Study N Age, y Treatment Study design Study duration Efficacy measures Efficacy outcomes Glutaraldehyde cross-linked (GAX) collagen Bent et al. 2001 [50 ] 90 Mean, 60.9 Range, 35–86 Up to 3 injections, as needed, over 6 mos Open label, single arm 12 mos Continence grade; diaries; LPP testing, QOL questionnaire Dry: 21% Improved: 21% Improved LPP: 54% QOL improvement: 62% ≥1 continence grade improvement: 21%
Corcos and Fournier 1999 [19 ] 40 Mean, 2.3 Range, 38–82 Up to 5 injections, as needed Open label, single arm Mean follow-up, 50 mos Direct patient questioning; PVR test; stress pad weight test; Valsalva LPP Cured: 30% Improved: 40% All cured patients had PVR <10 mL and negative pad tests
Elsergany et al. 1998 [43 ] 33 Mean, 64 Range, 19–97 Up to 3 injections, as needed Open label, single arm Mean follow-up, 18.8 mos Stamey Urinary Incontinence Scale; daily pad usage; diaries Cured: 48.5% ≥1 Stamey Scale grade improvement: 33.3% Improved from baseline, all
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Herschorn et al. 1996 [44 ] 187 Mean, 62.9 Range, 15–94 Up to 3 injections Open label, single arm Mean follow-up, 22 mos Direct patient questioning Cured: 23% Improved: 52% Homma et al. 1996 [45 ] 78 Mean, 57.1–63.5 Injections as needed Open label, single arm 24 mos Patient-administered questionnaire No SUI leaks: 6.7% SUI episodes daily: 50% <1 SUI episode/wk: 16.7% <1 SUI episode/day: 26.7% Mean injections, 1.9 Monga et al. 1995 [53 ] 60 Mean, 64 Range, 20–90 Up to 3 injections Open label, single arm 24 mos Direct patient questioning; cystometry; stress pad weight test Patient-rated cured at 3, 12, 24 mos: 46%, 40%, 48%; improved: 40%, 37%, 20% Objective measures (cystometry/pad weight), cured at 3, 12, 24 mos: 61%, 54%, 48% Mean injections: 1.6 Richardson et al. 1995 [46 ] 42 Mean, 64 Range, 28–88 1–8 injections, as needed Open label, single arm Mean follow-up, 46 mos LPP testing; incontinence grades (0–3) Cured: 40% Greatly improved/improved: 43% Unchanged/worse: 17% LPP improvement in women cured/greatly improved: 65.4 cmH2 O Mean injections: 2.4 in those cured/greatly improved; 4.1 in those improved/unchanged/worse Smith et al. 1997 [47 ] 94 67 Injections as needed Open label, single arm ≥18 mos Patient self-report Initially dry/improved: 67% Of these, 66.7% still dry/improved at 18 mos; most continent with 1–3 injections, 7 required 4 or more Winters et al. 2000 [48 ] 58 Mean, 73.2 Range, 65–86 Injections as needed Open label, single arm 24 mos Telephone interview Maximal/moderate improvement: 62.5% Maximal/moderate QOL improvement: 45.0% Mean injections: 1.9 Mean time to SUI recurrence: 7.9 months Carbon-coated zirconium beads Chrouser et al. 2004 [51 ] 86 Mean, 67 Carbon-coated zirconium beads (
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Mean injections: N/A Lightner et al. 2001 [52 ] 235 Mean, 57.7 Mean, 57.0 Range, 26–84 Carbon-coated zirconium beads (
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) Maximum 5 injections, as needed Randomized, controlled, single blind versus GAX collagen (control) 12 mos Stamey Urinary Incontinence Scale; stress pad weight test ≥1 Stamey Scale grade improvement: Zirconium beads: 66.1% GAX collagen: 65.8%
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Mean change in pad weight: Zirconium beads: 27.9 g GAX collagen: 26.4
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Mean injections: 1.69 versus 1.55 Polydimethylsiloxane Ghoniem et al. 2009 [54 ] 247 Mean, 61 Polydimethylsiloxane (
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) Injections as needed Randomized, single blind versus GAX collagen 12 mos Stamey Urinary Incontinence Scale; stress pad weight test; I-QOL scores ≥1 Stamey Scale grade improvement: Polydimethylsiloxane: 61.5% GAX collagen: 48.0% I-QOL improvement: Polydimethylsiloxane: 28.7% GAX collagen: 26.4% Pad weight test,
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Koelbl et al. 1998 [55 ] 32 Mean, 64.3 Range, 39–85 Up to 2 injections Open label, single arm 12 mos Stamey Urinary Incontinence Scale; cough stress test; urethral pressure measurements Cured: 60% Increased maximal urethral pressure,
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Maher et al. 2005 [56 ] 45 Mean, 65 Range, 34–84 Mean, 63 Range, 43–81 Polydimethylsiloxane (
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) Randomized, controlled 60 months Patient questionnaire Response rate, 60% in both groups Cured/improved: Injection: 21% Sling: 69% Radley et al. 2001 [57 ] 56 Mean, 53 Range, 26–81 Up to 3 injections Open label, single arm Mean follow-up, 19 months Patient questionnaire Cured/improved: 19.6% Improved: 39.3% No longer using pads: 19.6% Tamanini et al. 2003 [58 ] 21 Median, 47.4 Range, 33–54 Injections as needed Open-label, single arm, interim results 12 mos Stamey Urinary Incontinence Scale; King’s Health Questionnaire; pad usage; LPP testing; stress pad weight test Cured: 76.2% Improved: 66.7% Mean decrease in daily pad usage: 3.1 Mean pad weight decrease: 45.7 g Tamanini et al. 2006 [59 ] 21a Median, 47.4 Range, 33–54 Injections as needed Open label, single arm 60 mos Stamey Urinary Incontinence Scale; King’s Health Questionnaire; pad usage; LPP testing; stress pad weight test Cured: 40.0% Improved: 33.3% Mean decrease in daily pad usage: 2.6 Mean pad weight decrease: 47.9 g ter Meulen et al. 2009 [60 ] 45 Mean, 55 Range, 40–76 Up to 2 injections, as needed (
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) Randomized, controlled, open label versus PFMT (control) 12 mos I-QOL scores; patient questionnaire; stress pad weight test Polydimethylsiloxane: Cured: 88.9% Improved: 82.4% PFMT: 12-mo results N/A Zullo et al. 2005 [61 ] 61 Mean, 69.7 Range, 55–82 One-time injection Observational, open-label, single arm 60 mos VAS scores; diaries, cough stress test; PVR; LPP Cured: 18% Improved: 39% Cough stress test: Cured patients: negative Improved patients: positive only when standing Mean decrease in daily SUI episodes: 3.8 Mean changes in PVR and LPP:
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versus baseline Calcium Hydroxylapatite Mayer et al. 2007 [62 ] 296 Mean, 61 Up to 5 injections, as needed Randomized, single blind versus GAX collagen 12 mos Stamey Urinary Incontinence Scale ≥1 Stamey Scale grade improvement: 63.4% (calcium Hydroxylapatite) versus 57.0% (GAX collagen);
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