NCT04978714

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
483

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2020

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 20, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 27, 2021

Completed
Last Updated

July 27, 2021

Status Verified

July 1, 2021

Enrollment Period

10 years

First QC Date

July 20, 2021

Last Update Submit

July 20, 2021

Conditions

Urodynamic Stress IncontinenceDetrusor Overactivity

Keywords

Urodynamic stress incontinenceDetrusor OveractivityCystocele

Outcome Measures

Primary Outcomes (2)

  • Urodynamic stress incontinence

    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

    November 2010 and October 2020

  • Detrusor overactivity

    the occurrence of involuntary detrusor contractions during filling cytometry

    November 2010 and October 2020

Study Arms (1)

Women with cystocele

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

Procedure: Cystocele repair

Interventions

Cystocele repairPROCEDURE

Fascial repair for endopelvic fascia and anterior colporrhaphy

Women with cystocele

Eligibility Criteria

Age20 Years - 85 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Incomplete data
  • Chronic infection
  • Recurrent surgery for cystocele

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Related Publications (6)

  • 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.

    PMID: 19941278RESULT

  • 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.

    PMID: 26337427RESULT

  • 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.

    PMID: 29692690RESULT

  • 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.

    PMID: 28754926RESULT

  • Hsiao SM, Chang TC, Wu PC, Lin HH. Predictors of an improvement in the severity of concomitant urodynamic stress incontinence after transvaginal mesh surgery for pelvic organ prolapse. J Formos Med Assoc. 2020 May;119(5):917-924. doi: 10.1016/j.jfma.2019.12.016. Epub 2020 Mar 5.

    PMID: 32146026RESULT

  • 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.

    PMID: 26573101RESULT

MeSH Terms

Conditions

Urinary Bladder, OveractiveCystocele

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPelvic Organ ProlapseProlapsePathological Conditions, Anatomical

Study Officials

  • Ho-Hsiung Lin, PhD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2021

First Posted

July 27, 2021

Study Start

November 1, 2010

Primary Completion

October 31, 2020

Study Completion

October 31, 2020

Last Updated

July 27, 2021

Record last verified: 2021-07

Locations

TW(1)