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

Sponsor

National Taiwan University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04978714

Collaborator

(none)

483

Enrollment

Location

120

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Urodynamic Stress Incontinence Detrusor Overactivity	Procedure: 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 Design

Study Type:

Observational

Actual Enrollment :

483 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Prevalence of Urodynamic Stress Incontinence and/or Detrusor Overactivity in Women With Cystocele and the Changes of Continence Function After Cystocele Repair

Actual Study Start Date :

Nov 1, 2010

Actual Primary Completion Date :

Oct 31, 2020

Actual Study Completion Date :

Oct 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Women with cystocele All women with ≥ stage II cystocele who visited the urogynecological department of a medical center for cystocele repair	Procedure: Cystocele repair Fascial repair for endopelvic fascia and anterior colporrhaphy

Arm

Intervention/Treatment

Women with cystocele

All women with ≥ stage II cystocele who visited the urogynecological department of a medical center for cystocele repair

Procedure: Cystocele repair

Fascial repair for endopelvic fascia and anterior colporrhaphy

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 85 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

Incomplete data
Chronic infection
Recurrent surgery for cystocele

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Taiwan University Hospital	Taipei		Taiwan	100

Sponsors and Collaborators

National Taiwan University Hospital

Investigators

Principal Investigator: Ho-Hsiung Lin, PhD, National Taiwan University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

National Taiwan University Hospital

ClinicalTrials.gov Identifier:

NCT04978714

Other Study ID Numbers:

202105056RINC

First Posted:

Jul 27, 2021

Last Update Posted:

Jul 27, 2021

Last Verified:

Jul 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by National Taiwan University Hospital

Urodynamic stress incontinence

Detrusor Overactivity

Cystocele

Additional relevant MeSH terms:

Urinary Incontinence, Stress

Urinary Bladder, Overactive

Cystocele

Study Results

No Results Posted as of Jul 27, 2021