NCT06210477

Brief Summary

Hypothesis / aims of study The clinical and urodynamic features on the severity of low compliance bladder in neurologically intact women with lower urinary tract symptoms are indeterminate. Thus, this study aimed to elucidate the above association. Study design, materials and methods Between January 1996 and December 2021, the medical records of all consecutive women who underwent urodynamic studies for their lower urinary tract symptoms were reviewed to elucidate the clinical significance of low bladder compliance.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 22, 2023

Completed
27 days until next milestone

First Posted

Study publicly available on registry

January 18, 2024

Completed
13 days until next milestone

Study Start

First participant enrolled

January 31, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

February 19, 2025

Status Verified

February 1, 2025

Enrollment Period

11 months

First QC Date

December 22, 2023

Last Update Submit

February 17, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Bladder capacity (mL)

    To compare the bladder capacity (mL) between the groups with and without low bladder compliance. The bladder capacity will be derived from the filling cystometry of urodynamic studies.

    1996/1/1~2021/12/31

Secondary Outcomes (1)

  • Persistence rates of treatment (%)

    1996/1/1~2021/12/31

Study Arms (1)

Low compliance

Low urinary tract symptoms with low bladder compliance

Drug: medical treatment for lower urinary tract symptoms

Interventions

The clinical and urodynamic features on the severity of low compliance bladder in neurologically intact women with lower urinary tract symptoms are indeterminate. Thus, this study aimed to elucidate the above association.

Also known as: antimuscarinics
Low compliance

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailswomen who underwent urodynamic studies
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women with lower urinary tract symptoms

You may qualify if:

  • Urodynamic finding with low bladder compliance

You may not qualify if:

  • Nil.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Obstetrics and Gynecology, National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Urinary Bladder, OveractiveUrinary Bladder Neck ObstructionPelvic Organ ProlapseUrinary Incontinence

Interventions

Muscarinic Antagonists

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 SymptomsUrethral ObstructionUrethral DiseasesProlapsePathological Conditions, AnatomicalUrination Disorders

Intervention Hierarchy (Ancestors)

Cholinergic AntagonistsCholinergic AgentsNeurotransmitter AgentsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesPhysiological Effects of Drugs

Study Officials

  • Ho-Hsiung Lin, MD, PhD

    Department of Obstetrics and Gynecology, National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2023

First Posted

January 18, 2024

Study Start

January 31, 2024

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

February 19, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations