Table 3.
Outcomes and Adherence at Six and Twelve Months
| Behavior | Behavior Plus | P value | |
|---|---|---|---|
|
| |||
| Percent Improvement in Incontinence Episodes on 7-Day Bladder Diary, mean (95% CI*) | |||
| 6 Months Post-Treatment, n = 91 | 55.9% (46.1–65.7%) | 52.8% (36.4–69.1%) | .74 |
| Mean episodes per week (95% CI) | 12.6 (8.7–16.6) | 14.6 (7.0–22.1) | |
| 12 Months Post-Treatment, n = 81 | 50.4% (39.8–61.1%) | 59.0% (45.0–73.1%) | .32 |
| Mean episodes per week (95% CI) | 13.5 (9.5–17.5) | 9.1 (4.6–13.6) | |
|
| |||
| Change in EPIC,‡ mean (95% CI) | |||
| Urinary Domain | |||
| 6 Months Post-Treatment, n = 98 | 12.2 (9.5–14.9) | 7.2 (4.0–10.4) | .10 |
| 12 Months Post-Treatment, n = 82 | 12.0 (8.2–15.7) | 9.9 (6.2–13.7) | .49 |
| Incontinence Subscale | |||
| 6 Months Post-Treatment, n = 98 | 14.7 (9.7–19.6) | 10.1 (6.4–13.8) | .19 |
| 12 Months Post-Treatment, n = 82 | 14.4 (8.9–19.8) | 13.3 (7.7–18.8) | .97 |
|
| |||
| Change in IIQ, ‡‡ median (range) | |||
| Physical Activity subscale | |||
| 6 Months Post-Treatment, n = 97 | −.5.6 (−72.2–61.1) | −5.6 (−83.3–61.1) | .71 |
| 12 Months Post-Treatment, n = 82 | −5.6 (−77.8–50.0) | −5.6 (−83.3–77.8) | .06 |
| Travel subscale | |||
| 6 Months Post-Treatment, n = 97 | −5.6 (−80.0–22.2) | −5.6 (−61.1–77.8) | .99 |
| 12 Months Post-Treatment, n = 82 | −2.8 (−72.2–22.2) | −7.8 (−72.2–22.2) | .03 |
| Social Relationships subscale | |||
| 6 Months Post-Treatment, n = 97 | −3.3 (−63.3–26.7) | −4.2 (−64.8–50.0) | .87 |
| 12 Months Post-Treatment, n = 81 | −3.3 (−56.7–30.0) | −3.3 (−68.1–22.6) | .06 |
| Emotional subscale | |||
| 6 Months Post-Treatment, n = 97 | −6.7 (−66.7–25.0) | −4.2 (−83.3–62.5) | .93 |
| 12 Months Post-Treatment, n = 81 | 0.0 (−66.7–33.3) | −4.2 (−66.7–54.2) | .10 |
| Total Score | |||
| 6 Months Post-Treatment, n = 97 | −16.9 (−242.2–95.6) | −12.2 (−214.8–188.9) | .92 |
| 12 Months Post-Treatment, n = 81 | −14.6 (−256.7–99.4) | −19.2 (−238.9–176.8) | .04 |
|
| |||
| Change in SF-36, ‡‡‡ mean (95% CI) | |||
| Physical Component Summary | |||
| 6 Months Post-Treatment, n = 97 | 1.3 (−0.3–2.9) | 1.8 (−0.0–3.7) | .38 |
| 12 Months Post-Treatment, n = 81 | 0.5 (−1.4–2.3) | 1.1 (−0.7–3.0) | .51 |
| Mental Component Summary | |||
| 6 Months Post-Treatment, n = 97 | −0.8 (−3.5–1.9) | 0.5 (−1.4–2.4) | .18 |
| 12 Months Post-Treatment, n = 81 | 0.2 (−2.6–3.1) | 0.2 (−1.7–2.2) | .64 |
|
| |||
| Change in AUA-SI§ scores, mean (95% CI) | |||
| Total Score | |||
| 6 Months Post-Treatment, n = 98 | −3.9 (−5.3 – −2.6) | −2.5 (−3.8 – −1.2) | .53 |
| 12 Months Post-Treatment, n = 84 | −3.4 (−4.9 – −1.9) | −2.1 (−3.2 – −1.1) | .94 |
| Voiding Subscale | |||
| 6 Months Post-Treatment, n = 98 | −1.6 (−2.3 – −0.9) | −0.6 (−1.2–0.1) | .26 |
| 12 Months Post-Treatment, n = 84 | −1.3 (−2.1 – −0.5) | −0.2 (−0.8–0.4) | .42 |
| Storage Subscale | |||
| 6 Months Post-Treatment, n = 98 | −2.3 (−3.1 – −1.5) | −1.9 (−2.8 – −1.0) | .90 |
| 12 Months Post-Treatment, n = 84 | −2.1 (−3.0 – −1.2) | −1.9 (−2.7 – −1.1) | .50 |
|
| |||
| IPSS QOL§§ “If you were to spend the rest of your life with your urinary problem the way it is now, how would you feel about that?” n (%) | .95 | ||
| 6 Months Post-Treatment, n = 98 | 2 (4.0%) | 2 (4.2%) | |
| Delighted | 9 (18.0%) | 8 (16.7%) | |
| Pleased | 12 (24.0%) | 12 (25.0%) | |
| Mostly satisfied | 15 (30.0%) | 13 (27.1%) | |
| Mixed | 7 (14.0%) | 10 (20.8%) | |
| Mostly dissatisfied | 3 (6.0%) | 1 (2.1%) | |
| Unhappy | 2 (4.0%) | 2 (4.2%) | |
| Terrible | .13 | ||
| 12 Months Post-Treatment, n = 84 | 2 (4.4%) | 3 (7.9%) | |
| Delighted | 12 (26.1%) | 8 (21.1%) | |
| Delighted | 8 (17.4%) | 17 (44.7%) | |
| Mostly satisfied | 13 (28.3%) | 5 (13.2%) | |
| Mixed | 7 (15.2%) | 4 (10.5%) | |
| Mostly dissatisfied | 3 (6.5%) | 1 (2.6%) | |
| Unhappy | 1 (2.2%) | 0 (0.0%) | |
| Terrible | |||
|
| |||
| Global Perception of Improvement: (GPI) n (%) | |||
| “Better” or “much better” vs. “same”, “worse” or “much worse” | |||
| 6 Months Post-Treatment, n = 94 | 39 (84.8%) | 34 (70.8%) | .11 |
| 12 Months Post-Treatment, n = 82 | 42 (91.3%) | 30 (83.3%) | .27 |
|
| |||
| Able to Wear Less Protection Now than Before Treatment | |||
| 6 Months Post-Treatment, n = 95 | .853 | ||
| Yes | 26 (55.3%) | 24 (50.0%) | |
| No | 18 (38.3%) | 20 (41.7%) | |
| Never used protection | 3 (6.4%) | 4 (8.3%) | |
| 12 Months Post-Treatment, n = 84 | .913 | ||
| Yes | 25 (54.4%) | 19 (50.0%) | |
| No | 17 (37.0%) | 15 (39.5%) | |
| Never used protection | 4 (8.7%) | 4 (10.5%) | |
|
| |||
| Activity Restriction due to Incontinence, n (%) | |||
| 6 Months Post-Treatment, n = 95 | .05 | ||
| Not at All | 26 (55.3%) | 36 (75.0%) | |
| Some of the time | 20 (42.6%) | 10 (20.8%) | |
| Most of the time | 0 (0.0%) | 2 (4.2%) | |
| All of the time | 1 (2.1%) | 0 (0.0%) | |
| 12 Months Post-Treatment, n = 84 | .002 | ||
| Not at All | 24 (52.2%) | 32 (84.2%) | |
| Some of the time | 22 (47.8%) | 5 (13.2%) | |
| Most of the time | 0 (0.0%) | 1 (2.6%) | |
| All of the time | 0 (0.0%) | 0 (0.0%) | |
|
| |||
| How Disturbing is the Leakage of Urine? n (%) | |||
| 6 Months Post-Treatment, n = 95 | .89 | ||
| Not at all (including not leaking now) | 14 (29.8%) | 13 (27.1%) | |
| Somewhat disturbing | 31 (66.0%) | 32 (66.7%) | |
| Extremely disturbing | 2 (4.3%) | 3 (6.3%) | |
| 12 Months Post-Treatment, n = 82 | .15 | ||
| Not at all (including not leaking now) | 13 (29.6%) | 19 (50.0%) | |
| Somewhat disturbing | 29 (65.9%) | 17 (44.7%) | |
| Extremely disturbing | 2 (4.6%) | 2 (5.3%) | |
*
CI = Confidence Intervals
‡
EPIC = Expanded Prostate Cancer Index Composite
‡‡
IIQ = Incontinence Impact Questionnaire
‡‡‡
SF-36 = Medical Outcomes Study 36-Item Short-Form Health Survey
§
AUA-7 = American Urological Association Symptom Index
§§
IPSS QOL = International Prostate Symptom Scale Quality of Life question
§§§
PSQ = Patient Satisfaction Question