Prospective randomized study of multimodal self-treatment of men with voiding dysfunction (LUTS) with a digital health application

Prospective randomized study of multimodal self-treatment of men with voiding dysfunction (LUTS) with a digital health application - BEST (Bladder emptying disorder-therapy)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00030935

Enrollment

230

Registered

2023-03-14

Start date

2023-04-12

Completion date

Unknown

Last updated

2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

N40 N32.8

Interventions

Group 1: Intervention (multimodal self-treatment of LUTS). Group 2: Delayed intervention after 12 weeks (control group

wait-group design).

Eligibility

Sex/Gender

Male

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Males with LUTS, OAB-q-SF Part 1 =11, or IPSS =4 Mastery of the German language Internet access Tablet or smartphone access Informed Consent

Exclusion criteria

Exclusion criteria: Recurrent urinary retention Recurrent urinary tract infections bladder stones Recurrent gross hematuria that cannot be controlled conservatively Dilatation of the upper urinary tract, impaired renal function or renal insufficiency due to obstructive bladder emptying disorders Newly started BPH drug therapy for the micturition symptoms (a-blockers, 5-a-reductase inhibitors, phytopharmaceuticals) in the last 4 weeks Inability to physically participate in the program

Design outcomes

Primary

Measure	Time frame
1. Change in IPSS from baseline to week 12	—

Secondary

Measure	Time frame
change in OAB-q-SF part 1 from baseline to week 12 change in OAB-q-SF part 2 from baseline to week 12change in micturition frequency during the day, change in micturition frequency at night, change in urge incontinence episode, change in the imperative urge to urinate, Change in functional bladder capacity IPSS question 8, Likert scale 1-5 Reduction in the proportion of patients with treatment failure within the study period. Treatment failure is defined as an increase in IPSS = 3 points and/or OAB-q = 11 points, urinary retention, or the start of a new LUTS-specific medication or surgery. Overall improvement after treatment (Likert scale of 1-7)	—

Measure

Time frame

change in OAB-q-SF part 1 from baseline to week 12 change in OAB-q-SF part 2 from baseline to week 12change in micturition frequency during the day, change in micturition frequency at night, change in urge incontinence episode, change in the imperative urge to urinate, Change in functional bladder capacity IPSS question 8, Likert scale 1-5 Reduction in the proportion of patients with treatment failure within the study period. Treatment failure is defined as an increase in IPSS = 3 points and/or OAB-q = 11 points, urinary retention, or the start of a new LUTS-specific medication or surgery. Overall improvement after treatment (Likert scale of 1-7)

—

Countries

Germany

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026