Table 2. Outcomes evaluated in Phase II compared to Phase I study (unpublished data).

Outcomes		Phase I Study (Hypospadias)		Phase II Study (Hypospadias, Epispadias, Phymosis and Peyronie's Disease)
		Polyurethane	BC	BC	p-value	RR	IC 95%
	N° of patients	30	30	141	-	-	-
SAFETY	Adverse events:
	Hyperemia	0	1 (3.3%)	5 (3.6%)	0.6120a	1.556	0.8304–2.914
	Hyperemia/Edema	2 (6.7%)	0	0	0.1471b	2.264	0.8678–5.906
	Edema	1 (3.3%)	0	0	1.0000c	0.9483	0.1537–5.852
EFFICACY	Adherence degree:
	Fully adhered	30 (100%)	28 (93.3%)	137 (97.2%)	-	-	-
	Partially detached	0	2 (6.7%)	2 (1.4%)	0.4915a	-	-
					1.0000b	-	-
					0.1453c	0.3394	0.1204–0.9571
	Difficulty removed	3 (10%)	0	0	0.2373a	2.111	1.606–2.776
					0.0050b *	6.222	4.404–8.791
	Early dressing fall	0	2 (6.7%)	4 (2.8%)	0.4915a	-	-
					1.0000b	-	-
					0.3105c	0.5419	0.1664–1.765
	Pain and discomfort:
	Uncomfortable	23 (76.7%)	24 (80%)	88 (62.4%)	1.0000a	0.9088	0.5078–1.626
	Not a problem	7 (23.3%)	6 (20%)	53 (37.6%)	0.2054b	1.776	0.8095–3.897
					0.0898c	2.107	0.9120–4.868
	Use of analgesic:
	In the 1st p.o.	20 (66.7%)	21 (70%)	70 (49.6%)	1.0000a	0.9268	0.5458–1.574
					0.1086b	1.800	0.8962–3.615
					0.0463c *	2.051	0.9975–4.218
	After 1st p.o.	8 (26.7%)	6 (20%)	20 (14.2%)	0.7611a	1.195	0.6928–2.061
					0.1062b	1.857	0.9216–3.742
					0.4095c	1.394	0.6319–3.076
	At dressing removal	3 (10%)	0	0	0.2373a	2.111	1.606–2.776
					0.0050b *	6.222	4.404–8.791
	Healing (time)
	8th-10th	9 (30%)	22 (73.3%)	84 (59.6%)	0.0017a *	0.4009	0.2212–0.7266
	11th-14th	21 (70%)	8	33 (23.4%)	<0.0001b*	0.2488	0.1229–0.5038
			(26.7%)		1.0000c	1.064	0.5153–2.195

Notes: p.o = postoperative; BC = Bacterial Cellulose; RR = Relative Risk; IC = confidence interval. Values are total number or percentage (%).

^*Statistical significance if p<0.05, to a: Polyurethane≠BC phase I; b: Polyurethane≠BC phase II; c: BC phase I≠BC phase II, by the Fisher's exact test.