NCT06793046

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
290

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 17, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 14, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 27, 2025

Completed
Last Updated

February 10, 2025

Status Verified

July 1, 2024

Enrollment Period

2 months

First QC Date

January 14, 2025

Last Update Submit

February 5, 2025

Conditions

Keywords

Detrusor overactivity

Outcome Measures

Primary Outcomes (1)

  • Life quality

    Use King's health questionnaire Question 2 to evaluate the life quality of the 2 cohort (score 1-4, higher score indicates worse life quality)

    Between July 2009 and December 2023

Secondary Outcomes (1)

  • Strong-desire to void volume (mL) in urodynamic study

    Between July 2009 and December 2023

Study Arms (2)

Phasic DO

Detrusor involuntary contraction during filling cystometry before strong-desire to void volume

Terminal DO

Detrusor involuntary contraction at the end of filling cystometry

Eligibility Criteria

Age20 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women more than 20-year-old with lower urinary tract symptoms, received urodynamic study and was diagnosed with detrusor overactivity.

You may qualify if:

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

You may not qualify if:

  • Woman who was pregnant
  • Chronic pelvic inflammatory disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan, 100, Taiwan

Location

Related Publications (5)

  • 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.

    PMID: 30943696BACKGROUND
  • 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.

    PMID: 34762173BACKGROUND
  • 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.

    PMID: 12559262BACKGROUND
  • 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.

    PMID: 28681849BACKGROUND
  • 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.

    PMID: 19941278BACKGROUND

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ho-Hsiung Lin, M.D. Ph.D

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ho-Hsiung Lin, Department of Obstetrics and Gynecology, Principal Investigator, Professor

Study Record Dates

First Submitted

January 14, 2025

First Posted

January 27, 2025

Study Start

July 17, 2024

Primary Completion

August 31, 2024

Study Completion

September 30, 2024

Last Updated

February 10, 2025

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

The data will be provided under request.

Locations