Clinical trial NCT06793046: Comparisons of Phasic and Terminal DO
Official title: Comparisons of Phasic and Terminal Detrusor Overactivity in Women with Lower Urinary Tract Dysfunction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Detrusor Overacitivity
Keywords: Detrusor overactivity
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2025-01-27
Enrollment: 290
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women more than 20-year-old with lower urinary tract symptoms, received urodynamic study and was diagnosed with detrusor overactivity.

Brief summary: Overactive bladder is a common issue among women of childbearing age, regardless of their childbirth experience. Some of these women may exhibit detrusor overactivity in urodynamic studies. Excluding detrusor overactivity caused by neurogenic bladder, the International Continence Society defines two types of idiopathic detrusor overactivity: phasic and terminal. Although many studies have explored overactive bladder and detrusor overactivity under different conditions, no literature directly compares these two types of detrusor contractions. Therefore, we aim to compare phasic and terminal detrusor overactivity in women with lower urinary tract dysfunction. Between July 2009 and December 2023, medical records of all women with lower urinary tract symptoms who underwent urodynamic studies in the urogynecological department of a medical center were reviewed. The medical records of phasic or terminal detrusor overactivity were selected for comparison (N=290). Those with phasic and terminal detrusor overactivity were excluded (N=21).

Detailed description: Hypothesis / aims of study Detrusor overactivity (DO) can be classified into phasic or terminal ones. However, to our knowledge, clinical and urodynamic differences between phasic or terminal DO have never been reported. Therefore, the objective of this study is to elucidate the above differences.

Study design, materials and methods Between July 2009 and December 2023, medical records, including urodynamic data, bladder dairy data, and questionnaires, including patient perception of bladder condition, urgency severity scale, overactive bladder symptom score, urogenital distress inventory, incontinence impact questionnaire and King's health questionnaire, of all women with lower urinary tract symptoms who underwent urodynamic studies in the urogynecological department of a medical center were reviewed. The medical records of phasic or terminal DO were selected for comparison. Those with phasic and terminal DO were excluded.

STATA software was used for statistical analysis. Wilcoxon rank sum test or chi-square test were used for statistical analysis, as appropriate. A p \< 0.05 was considered statistically significant.

Eligibility criteria: Inclusion Criteria:

* \> 20 y/o
* Women with lower urinary tract symptoms
* Complete urodynamic study with a diagnosis of detrusor overactivity
* Complete the questionnaires

Exclusion Criteria:

* Woman who was pregnant
* Chronic pelvic inflammatory disease

Primary outcomes:
measure: Life quality
timeFrame: Between July 2009 and December 2023
Secondary outcomes:
measure: Strong-desire to void volume (mL) in urodynamic study
timeFrame: Between July 2009 and December 2023
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Ho-Hsiung Lin, M.D. Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hsiao SM, Wu PC, Chang TC, Chen CH, Lin HH. Urodynamic and Bladder Diary Factors Predict Overactive Bladder-wet in Women: A Comparison With Overactive Bladder-dry. Int Neurourol J. 2019 Mar;23(1):69-74. doi: 10.5213/inj.1836212.106. Epub 2019 Mar 31.
citation: Wu PC, Hsiao SM, Lin HH. Prevalence and predictors of nocturnal polyuria in females with overactive bladder syndrome. World J Urol. 2022 Feb;40(2):519-527. doi: 10.1007/s00345-021-03865-5. Epub 2021 Nov 11.
citation: Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, Van Kerrebroeck P, Victor A, Wein A; Standardisation Sub-Committee of the International Continence Society. The standardisation of terminology in lower urinary tract function: report from the standardisation sub-committee of the International Continence Society. Urology. 2003 Jan;61(1):37-49. doi: 10.1016/s0090-4295(02)02243-4. No abstract available.
citation: Aoki Y, Brown HW, Brubaker L, Cornu JN, Daly JO, Cartwright R. Urinary incontinence in women. Nat Rev Dis Primers. 2017 Jul 6;3:17042. doi: 10.1038/nrdp.2017.42.
citation: Haylen BT, de Ridder D, Freeman RM, Swift SE, Berghmans B, Lee J, Monga A, Petri E, Rizk DE, Sand PK, Schaer GN; International Urogynecological Association; International Continence Society. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Neurourol Urodyn. 2010;29(1):4-20. doi: 10.1002/nau.20798.