Urodynamics: Prone Vs. Seated Position

NCT06864117 | Not Yet Recruiting

• 1 other identifier: 2024-01522
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

To demonstrate the feasibility of a pressure-flow study using a urinary condom with drainage tube in the sitting and lying position in everyday clinical practice and the comparability of the measured values with the "conventional" pressure-flow studies according to the ICS standard with regard to the diagnosis of outlet obstruction in men.

Conditions

Urodynamic Studies; Urodynamics; Outlet Obstruction

Keywords

obstruction; urodynamics

Outcome Measures

Primary Outcomes (13)

• First sensation of filling, FSF [mL]

  measured during storage phase

  Periprocedural

• First desire to void, FDV [mL]

  measured during storage phase

  Periprocedural

• Strong desire to void, SDV [mL]

  measured during storage phase

  Periprocedural

• Pdet(S) [cmH2O]

  Maximum detrusor pressure, measured during storage phase

  Periprocedural

• Electromyography pelvic floor EMG [μV] during storage phase

  Periprocedural

• Filling volume [mL] during storage phase

  Periprocedural

• Compl [mL/cmH2O]

  Compliance, measured during storage phase

  Periprocedural

• Maximum detrusor pressure during the voiding phase (Pdet(E) [cmH2O])

  Periprocedural

• Detrusor pressure at maximum flow rate (PdetQmax [cmH2O])

  measured during voiding phase

  Periprocedural

• Maximum flow rate (Qmax [mL/s]) during voiding phase

  Periprocedural

• Electromyography pelvic floor (EMG [μV]) during voiding phase

  Periprocedural

• Flow volume [mL] during voiding phase

  Periprocedural

• Residual urine volume (post void residual, PVR [mL])

  Periprocedural

Study Arms (2)

Group A: sitting, lying down(s/l)

OTHER

Other: Body position during urodynamics

Goup B: lying down, sitting (l/s)

OTHER

Other: Body position during urodynamics

Interventions

Body position during urodynamics OTHER

The group defines the body position in which the first and second measurements are taken. Group A: sitting, lying down (s/l). Group B: lying down, sitting (l/s). According to the ICS standard, the third measurement is always taken in a sitting position.

Goup B: lying down, sitting (l/s); Group A: sitting, lying down(s/l)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Genotype and phenotype XY
• Age between 18 and 90 years
• Signed informed consent form
• Ability to understand and follow the study procedures and understand the consent form
• possibility ti carry out out the necessary urodynamics as part of the regular clinical examination
• assessment of neurogenic and/or non-neurogenic (idiopathic) bladder dysfunction
• Spontaneous micturition in a sitting position is possible

You may not qualify if:

• Patients with assistance/patients under guardianship
• Patients with latex allergy or cross-allergy (banana, kiwi, fig, avocado)
• No spontaneous movement possible in a sitting position
• Sitting position not possible due to lack of trunk stability/circulatory problems
• Intravesical Botox injection during the last 9 months

Sponsors & Collaborators

• Kantonsspital Winterthur KSW: lead

MeSH Terms

Conditions

Bites and Stings

Condition Hierarchy (Ancestors)

Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2025
• First Posted: March 7, 2025
• Study Start: February 28, 2025
• Primary Completion (Estimated): February 28, 2028
• Study Completion (Estimated): February 28, 2028
• Last Updated: March 7, 2025

Record last verified: 2025-03