Comparisons of Phasic and Terminal DO

NCT ID: NCT06793046

Last Updated: 2025-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

290 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-17

Study Completion Date

2024-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Detrusor Overacitivity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Phasic DO

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

No interventions assigned to this group

Terminal DO

Detrusor involuntary contraction at the end of filling cystometry

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

National Taiwan University Clinical Trial Center

Ho-Hsiung Lin, Department of Obstetrics and Gynecology, Principal Investigator, Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ho-Hsiung Lin, M.D. Ph.D

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

National Taiwan University Hospital

Taipei, Taiwan, Taiwan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Taiwan

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 30943696 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34762173 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12559262 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28681849 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19941278 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

202406143RINE

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.