Association With Low Compliance Bladder in Women With LUTS

Urinary Incontinence Clinical Trial

Official title:

Comparisons of Clinical and Urodynamic Parameters and Persistence in the Treatment for Women With Different Types of Low Bladder Compliance

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06210477
• Other study ID #: 202303086RINC
• Status: Not yet recruiting
• Start date: January 31, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: National Taiwan University Hospital
• Contact: Ho-Hsiung Lin, MD, PhD
• Phone: +886-2-23123456
• Email: hhlin[@]ntuh.gov.tw
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Urodynamic finding with low bladder compliance

Exclusion Criteria:

• Nil.

Related Conditions & MeSH terms

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

Intervention

Drug:
• medical 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.

Locations

Country	Name	City	State
Taiwan	Department of Obstetrics and Gynecology, National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	1996/1/1~2021/12/31