CClinicalTrials.gg
CompletedNCT04981054Updated Jul 28, 2021

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

An observational study in Bladder Oversensitivity and Detrusor, Overactive, sponsored by National Taiwan University Hospital. Completed at 1 site in Taiwan. Open to female participants aged 20 Years to 85 Years. Per ClinicalTrials.gov, last updated 2021-07-28.

Sponsored by National Taiwan University Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
483
Ages
20 Years to 85 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Bladder Oversensitivity
  • Detrusor, Overactive

Keywords

  • Bladder oversensitivity
  • Detrusor Overactivity
  • Cystocele
03

In context

Cystocele

62 studies on the registry are indexed under Cystocele; 4 are open to participants now.

This study's enrollment of 483 is above the median of 300 across 19 observational studies indexed under Cystocele.

Browse Cystocele studies →

Lead sponsor

National Taiwan University Hospital is the lead sponsor of 2,563 studies on the registry; 569 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 85 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Recurrent cystocele after repairment
  • Incomplete data
  • Chronic infection
05

Study design

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

Groups and cohorts

  • cystocele with repairment

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

    Procedure: Cystocele repair

Interventions

  • ProcedureCystocele repair

    Repair of endopelvic fascia and anterior colporrhaphy

06

What researchers measure

Primary outcomes

  1. Bladder oversensitivity

    the volume of strong desire was less than 300mL

    Time frame: November 2010 and October 2020

  2. Detrusor overactivity

    the occurrence of involuntary detrusor contractions during filling cytometry

    Time frame: November 2010 and October 2020

07

Study locations

1 site
  • National Taiwan University Hospital
    Taipei, 100, Taiwan
08

References and documents

Publications

  • Haylen BT, de Ridder D, Freeman RM, Swift SE, Berghmans B, Lee J, Monga A, Petri E, Rizk DE, Sand PK, Schaer GN; International Urogynecological Association; International Continence Society. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Neurourol Urodyn. 2010;29(1):4-20. doi: 10.1002/nau.20798. PubMed 19941278 ↗
  • Lamblin G, Delorme E, Cosson M, Rubod C. Cystocele and functional anatomy of the pelvic floor: review and update of the various theories. Int Urogynecol J. 2016 Sep;27(9):1297-305. doi: 10.1007/s00192-015-2832-4. Epub 2015 Sep 4. PubMed 26337427 ↗
  • Leron E, Weintraub AY, Mastrolia SA, Schwarzman P. Overactive Bladder Syndrome: Evaluation and Management. Curr Urol. 2018 Mar;11(3):117-125. doi: 10.1159/000447205. Epub 2018 Feb 20. PubMed 29692690 ↗
  • Hsiao SM, Lin HH, Kuo HC. Videourodynamic Studies of Women with Voiding Dysfunction. Sci Rep. 2017 Jul 28;7(1):6845. doi: 10.1038/s41598-017-07163-2. PubMed 28754926 ↗
  • Huang WC, Yang SH, Yang JM. Clinical Importance and Surgical Outcomes of Green Type III Cystocele in Women With Anterior Vaginal Prolapse. J Ultrasound Med. 2015 Dec;34(12):2279-85. doi: 10.7863/ultra.14.11066. Epub 2015 Nov 16. PubMed 26573101 ↗

Individual participant data

Plan to share: No — Individual participant data is available under reasonable request

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 28, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04981054
Lead sponsor
National Taiwan University Hospital
Responsible party
Sponsor
First posted
Jul 28, 2021
Start date
Nov 1, 2010
Primary completion
Oct 31, 2020
Completion
Oct 31, 2020
Last update
Jul 28, 2021

Study contacts

Ho-Hsiung Lin, PhD
principal investigator · National Taiwan University Hospital

Oversight

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

Not currently enrolling

This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion