Table 3.

Summary of outcomes by treatment group and time period.

	Intention-to-Treat			Per Protocol
Outcome	Combined N=150	Behavioral N=149	Pessary N=146	Combined	Behavioral	Pessary
“Much better” or “very much better” on PGI-I1
3 month	80 (53.3%)2	72 (49.3%)	59 (39.6%)2	47/69 (68.1%)	69/112 (61.6%)	53/99 (53.5%)
12 month	49 (32.7%)	48 (32.9%)	47 (31.5%)	12/27 (44.4%)	44/83 (53.0%)	39/67 (58.2%)
No bothersome stress incontinence symptoms3
3 month	66 (44.0%)4	71 (48.6%)5	49 (32.9%)4,5	38/69 (55.1%)	66/112 (58.9%)	45/99 (45.5%)
12 month	49 (32.7%)	59 (40.4%)	52 (34.9%)	11/27 (40.7%)	52/83 (62.7%)	41/67 (61.2%)
> 75% reduction in weekly urinary Incontinence episodes6
3 month	80 (53.3%)	68 (46.7%)	69 (46.3%)	42/69 (60.9%)	61/112 (54.5%)	64/99 (64.7%)
12 month	52 (34.7%)	54 (37.0%)	51 (34.2%)	14/27 (51.9%)	47/82 (56.6%)	39/67 (58.2%)
Satisfaction with treatment
3 month	118 (78.7%)7	110 (75.3%)8	94 (63.1%)7,8	63/69 (91.3%)	104/112(92.9%)	87/99 (87.9%)
12 month	81 (54.0%)	79 (54.1%)	75 (50.3%)	23/27 (85.2%)	72/83 (86.7%)	61/67 (91.0%)

¹PGI-I, Patient Global Impression ofI mprovement.

²Combined group is different from pessary group (p=0.02), but not different from behavioral group (p=0.49).

³Defined as an answer of either “no” or “yes” with a bother component of “not at all” or “somewhat” to all of the seven Urogenital Distress Inventory-Stress Incontinence Subscale items of the Pelvic Floor Distress Inventory;

⁴Combined group is different from pessary group (p=0.05), but not different from behavioral group (p=0.42).

⁵Pessary group is different from behavioral group (p=0.006).

⁶On the 7-day bladder diary

⁷Combined group is different from pessary group (p=0.003), but not different from behavioral group (p=0.50).

⁸Pessarygroup is different from behavioral therapy group (p=0.03).

All other results in tabledo not differ (p> 0.05).