USI and/or DO in Women With Cystocele Before and After Cystocele Repair

Completed

• Conditions: Urodynamic Stress Incontinence; Detrusor Overactivity
• Interventions: Procedure: Cystocele repair

• Registration Number: NCT04978714
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

The changes of lower urinary tract function after cystocele repair are important for perioperative consultation and management. Thus, the aim of this retrospective study was to evaluate the prevalence of urodynamic stress incontinence and/or detrusor overactivity in women with ≥ stage II cystocele and the changes of incontinence function after cystocele repair.

Detailed Description

Between November 2010 and October 2020, all women with ≥ stage II cystocele who visited the urogynecological department of a medical center for cystocele repair were reviewed. Those women who had complete data of preoperative and postoperative 3-month follow-up urodynamic data were excluded from this study. Urodynamic stress incontinence was diagnosed by the finding of involuntary leakage during filling cystometry or stress urethral pressure profile, associated with increased intra-abdominal pressure, in the absence of a detrusor contraction. Detrusor overactivity was defined as the occurrence of involuntary detrusor contractions during filling cytometry.

STATA software was used for statistical analysis. Chi2 test, univariate and multivariable logistic regression tests were used for statistical analysis as appropriate. A p \< 0.05 was considered as statistically significant.

Study Timeline

• Study Start: 2010-11-01
• Primary Completion: 2020-10-31
• Study Completion: 2020-10-31
• Status Verified: 2021-07
• Study First Submitted: 2021-07-20
• Study First Submitted QC: 2021-07-20
• Last Update Submitted: 2021-07-20
• Study First Posted: 2021-07-27
• Last Update Posted: 2021-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 483

Inclusion Criteria

• Women with ≥ stage II cystocele
• Received cystocele repair
• Complete urodynamic study before and after surgery

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Exclusion Criteria

• Incomplete data
• Chronic infection
• Recurrent surgery for cystocele

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Women with cystocele	Cystocele repair	All women with ≥ stage II cystocele who visited the urogynecological department of a medical center for cystocele repair

Primary Outcome Measures

Name	Time	Method
Urodynamic stress incontinence	November 2010 and October 2020	the finding of involuntary leakage during filling cystometry or stress urethral pressure profile, associated with increased intra-abdominal pressure, in the absence of a detrusor contraction
Detrusor overactivity	November 2010 and October 2020	the occurrence of involuntary detrusor contractions during filling cytometry

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan