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BO and DO in Women With Cystocele Before and After Cystocele Repair

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04981054
Collaborator
(none)
483
Enrollment
1
Location
120
Actual Duration (Months)
4
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 bladder oversensitivity and detrusor overactivity in women with ≥ stage II cystocele and the changes of storage function after cystocele repair.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Cystocele repair

Detailed Description

Bladder oversensitivity and detrusor overactivity are two important diagnosis of urodynamic study regarding storage function of bladder. 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. Bladder oversensitivity was diagnosed if the volume of strong desire was less than 300mL. 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 Bladder Oversensitivity and Detrusor Overactivity in Women With Cystocele and the Changes of Storage 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
cystocele with repairment

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

Procedure: Cystocele repair
Repair of endopelvic fascia and anterior colporrhaphy

Outcome Measures

Primary Outcome Measures

  1. Bladder oversensitivity [November 2010 and October 2020]

    the volume of strong desire was less than 300mL

  2. 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:
No
Inclusion Criteria:

  • Women with ≥ stage II cystocele

  • Received cystocele repair

  • Complete urodynamic study before and after surgery

Exclusion Criteria:

  • Recurrent cystocele after repairment

  • Incomplete data

  • Chronic infection

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:
NCT04981054
Other Study ID Numbers:
  • 202105071RINC
First Posted:
Jul 28, 2021
Last Update Posted:
Jul 28, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by National Taiwan University Hospital
Bladder oversensitivity
Detrusor Overactivity
Cystocele
Additional relevant MeSH terms:
Cystocele
Urinary Bladder, Overactive

Study Results

No Results Posted as of Jul 28, 2021