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CompletedNCT06210477Updated Feb 19, 2025

Association With Low Compliance Bladder in Women With LUTS

An observational study in Urinary Bladder, Overactive, Urinary Bladder Neck Obstruction and Pelvic Organ Prolapse, sponsored by National Taiwan University Hospital. Completed at 1 site in Taiwan. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-19.

Sponsored by National Taiwan University Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
200
Ages
18 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Urinary Bladder, Overactive
  • Urinary Bladder Neck Obstruction
  • Pelvic Organ Prolapse
  • Urinary Incontinence
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Women with lower urinary tract symptoms

Inclusion criteria

  • Urodynamic finding with low bladder compliance

Exclusion criteria

Exclusion Criteria:

  • Nil.
04

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
200 participants (actual)
Patient registry
No

Groups and cohorts

  • Low compliance

    Low urinary tract symptoms with low bladder compliance

    Drug: medical treatment for lower urinary tract symptoms

Interventions

  • Drugmedical treatment for lower urinary tract symptoms

    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

05

What researchers measure

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.

    Time frame: 1996/1/1~2021/12/31

Secondary outcomes

  1. Persistence rates of treatment (%)

    To compare the persistence rates of treatment (%) between the groups with and without low bladder compliance. The persistent rate of treatment will be checked from outpatient medical records about prescription.

    Time frame: 1996/1/1~2021/12/31

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Study locations

1 site
  • Department of Obstetrics and Gynecology, National Taiwan University Hospital
    Taipei, 100, Taiwan
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06210477
Lead sponsor
National Taiwan University Hospital
Responsible party
Sponsor
First posted
Jan 18, 2024
Start date
Jan 31, 2024
Primary completion
Dec 31, 2024
Completion
Dec 31, 2024
Last update
Feb 19, 2025

Study contacts

Ho-Hsiung Lin, MD, PhD
principal investigator · Department of Obstetrics and Gynecology, National Taiwan University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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