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 Up to 3 injections, as needed, over 6 mos Open label, single arm 12 mos Continence grade; diaries; LPP testing, QOL questionnaire Dry: 21%
Corcos and Fournier 1999 [19 ] 40 Mean, 2.3 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%
Elsergany et al. 1998 [43 ] 33 Mean, 64 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%
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Herschorn et al. 1996 [44 ] 187 Mean, 62.9 Up to 3 injections Open label, single arm Mean follow-up, 22 mos Direct patient questioning Cured: 23% 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% Monga et al. 1995 [53 ] 60 Mean, 64 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% Richardson et al. 1995 [46 ] 42 Mean, 64 1–8 injections, as needed Open label, single arm Mean follow-up, 46 mos LPP testing; incontinence grades (0–3) Cured: 40% 2 O Smith et al. 1997 [47 ] 94 67 Injections as needed Open label, single arm ≥18 mos Patient self-report Initially dry/improved: 67% Winters et al. 2000 [48 ] 58 Mean, 73.2 Injections as needed Open label, single arm 24 mos Telephone interview Maximal/moderate improvement: 62.5% Carbon-coated zirconium beads Chrouser et al. 2004 [51 ] 86 Mean, 67 Carbon-coated zirconium beads (
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) Post hoc, open label versus GAX collagen (control) 36 mos Patient questionnaire SUI improvement at 12, 24, 26 mos:
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Lightner et al. 2001 [52 ] 235 Mean, 57.7 Carbon-coated zirconium beads (
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) Randomized, controlled, single blind versus GAX collagen (control) 12 mos Stamey Urinary Incontinence Scale; stress pad weight test ≥1 Stamey Scale grade improvement:
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Polydimethylsiloxane Ghoniem et al. 2009 [54 ] 247 Mean, 61 Polydimethylsiloxane (
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) 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%
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Koelbl et al. 1998 [55 ] 32 Mean, 64.3 Up to 2 injections Open label, single arm 12 mos Stamey Urinary Incontinence Scale; cough stress test; urethral pressure measurements Cured: 60%
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Maher et al. 2005 [56 ] 45 Mean, 65 Range, 34–84 Polydimethylsiloxane (
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) Randomized, controlled 60 months Patient questionnaire Response rate, 60% in both groups Radley et al. 2001 [57 ] 56 Mean, 53 Up to 3 injections Open label, single arm Mean follow-up, 19 months Patient questionnaire Cured/improved: 19.6% Tamanini et al. 2003 [58 ] 21 Median, 47.4 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% Tamanini et al. 2006 [59 ] 21a Median, 47.4 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% ter Meulen et al. 2009 [60 ] 45 Mean, 55 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: Zullo et al. 2005 [61 ] 61 Mean, 69.7 One-time injection Observational, open-label, single arm 60 mos VAS scores; diaries, cough stress test; PVR; LPP Cured: 18%
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N
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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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