App-Based Treatment in Primary Care for Urinary Incontinence: A Pragmatic, Randomized Controlled Trial

Article Figures & Data

Table 1

Baseline Characteristics of Study Participants (N = 262)

Characteristic	App-Treatment (n = 131)^{^a}	Usual Care (n = 131)^{^a}
Age, mean (SD), y	53.2 (12.8)	51.3 (10.3)
Body mass index, mean (SD), kg/m²	27.6 (5.5)	28.0 (5.2)
Higher educational level, No. (%)^{^b}	53 (52.0)	48 (51.6)
≥1 Vaginal births, No. (%)	111 (85.4)	105 (80.2)
Postmenopausal, No. (%)	64 (49.2)	59 (45.0)
Recruitment type, No. (%)
General practitioner	76 (58.0)	76 (58.0)
Lay press or social media	55 (42.0)	55 (42.0)
Duration of UI, median (IQR), y	7 (4-14)	8 (4-13)
Type of UI, No. (%)
Stress	50 (38.2)	60 (45.8)
Mixed, stress predominant	37 (28.2)	33 (25.2)
Urgency	12 (9.2)	10 (7.6)
Mixed, urgency predominant	32 (24.4)	28 (21.4)
Previous treatment for UI, No. (%)
None	99 (76.2)	95 (72.5)
Pessary	0 (0)	1 (0.8)
Physical therapist	31 (23.8)	35 (26.7)
Incontinence severity
ICIQ-UI-SF score, mean (SD)^{^c}	9.5 (3.2)	10.3 (3.4)
ICIQ-LUTS-QoL score, mean (SD)^{^d}	33.9 (8.3)	33.4 (7.8)
UI episodes per day, median (IQR)	1.0 (0.33-2.33)	1.0 (0.33-2.33)

app = application; ICIQ-LUTS-QoL = International Consultation on Incontinence Modular Questionnaire lower urinary tract symptoms quality of life; ICIQ-UI-SF = ICIQ Urinary Incontinence Short Form; IQR = interquartile range; UI = urinary incontinence.
↵^aNumber for analysis ranged from 102 to 131 for the app-treatment group and from 93 to 131 for the usual care group. Some data were missing for the baseline assessment (1 patient) and the baseline questionnaires (3 patients).
↵^bAssessed at follow-up. Higher: third-level education (vs lower: high school or less).
↵^cPossible range of scores: 0-21. Higher scores correlate with worse incontinence.
↵^dPossible range of scores: 19-76. Higher scores correlate with a greater impact of incontinence on quality of life.

Table 2

Change in Outcomes From Baseline to Follow-Up

	Change From Baseline
Outcome	App-Treatment (n = 102)^{^a}	Care as Usual (n = 93)	Adjusted Difference (95% CI) or P Value
ICIQ-UI-SF score, mean (SD)	-2.16 (2.56)	-2.56 (3.51)	0.058 (-0.776 to 0.891)
ICIQ-LUTS-QoL score, mean (SD)	-4.34 (5.44)	-3.78 (5.90)	-0.566 (-2.035 to 0.902)
PGI-I, No. (%)			P = .35^{^b}
Very much better	2 (2.0)	11 (11.8)
Much better	25 (24.5)	20 (21.5)
A little better	40 (39.2)	31 (33.3)
No change	30 (29.4)	26 (28.0)
A little worse	3 (2.9)	2 (2.2)
Much worse	2 (2.0)	3 (3.2)
Very much worse	…	…
UI episodes per day	-0.61 ± 2.02	-0.48 ± 1.20	P = .71^{^b}

app = application; ICIQ-LUTS-QoL = International Consultation on Incontinence Modular Questionnaire lower urinary tract symptoms quality of life; ICIQ-UI-SF = ICIQ Urinary Incontinence Short Form; PGI-I = patient global impression of improvement; UI = urinary incontinence.
Notes: Number for analysis ranged from 83 to 102 for the app-treatment group and from 74 to 93 for the care as usual group. Analyses performed on an intention-to-treat basis. ICIQ-UI-SF score and ICIQ-LUTS-QoL score are adjusted for baseline. PGI-I and UI (per day) are unadjusted scores.
↵^aA baseline questionnaire was missing for 1 patient in the app-treatment group for the outcomes of ICIQ-UI-SF score and ICIQ-LUTS-QoL score.
↵^bAssessed with the U statistic.

Table 3

Treatment Effect Within Subgroups

Subgroup	No.	Treatment Effect, ICIQ-UI-SF Score (95% CI)
Recruitment type
General practitioner	107	-0.592 (-1.74 to 0.557)
Lay press or social media	87	0.598 (-0.634 to 1.831)
Type of UI
Stress	76	-0.154 (-1.337 to 1.029)
Mixed, stress predominant	56	-0.230 (-1.780 to 1.740)
Mixed, urgency predominant	42	-0.345 (-1.972 to 1.281)
Urgency	20	0.401 (-3.910 to 4.710)
Previous physical therapy for UI
No	137	-1.460 (-1.081 to 0.789)
Yes	57	0.149 (-1.701 to 1.999)

ICIQ-UI-SF = International Consultation on Incontinence Modular Questionnaire Urinary Incontinence Short Form; UI = urinary incontinence.
Notes: Linear regression analysis of the treatment effect testing superiority of the difference in change of ICIQ-UI-SF score at 4 months. Analysis was performed on an intention-to-treat basis.