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Optimizing Treatment in Female Urgency Urinary Incontinence: Predictive Urodynamic Parameters for Conservative versus Botulinum Toxin Therapy

Optimizing Treatment in Female Urgency Urinary Incontinence: Predictive Urodynamic Parameters for Conservative versus Botulinum Toxin Therapy - GUIDE

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00037571
Enrollment
90
Registered
2025-12-16
Start date
2025-11-17
Completion date
Unknown
Last updated
2026-06-22

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

Conditions

Overactive Bladder

Interventions

Group 1: Female patients with urgency or mixed urinary incontinence who, at the time of data collection, had undergone conservative pharmacological treatment and had not received any botulinum toxin t

Sponsors

Uniklinik RWTH Aachen
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: female, = 18 years, diagnosed with urge incontinence or mixed incontinence, has undergone urodynamic testing, has received pharmacological therapy and/or botulinum toxin injections into the bladder

Exclusion criteria

Exclusion criteria: Known urological pre-existing conditions such as bladder carcinoma, urethral stricture, bladder stones; spinal cord syndrome

Design outcomes

Primary

MeasureTime frame
Urodynamic parameters: first desire to void (ml), maximum desire to void (ml), bladder capacity (ml), post-void residual volume (ml), presence of detrusor instability (yes/no), result of the stress test (positive/negative). ? The primary endpoint is the comparison of the above-mentioned pre-therapeutic urodynamic parameters between patients who respond to a standardized conservative first-line therapy and those who subsequently received botulinum toxin. These parameters are collected as part of guideline-based diagnostic evaluation using urodynamic testing at the time of diagnosis and are therefore usually obtained shortly after the patients’ initial presentation to our urogynecological outpatient clinic.

Secondary

MeasureTime frame
Time interval between therapy initiation and therapy change (delay due to unsuccessful conservative treatment) Correlation of clinical parameters (age, BMI, parity, comorbidities, etc.) with therapy response

Countries

Germany

Contacts

Public ContactKaroline Eisfeld

Uniklinik RWTH Aachen

keisfeld@ukaachen.de0241800

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 29, 2026