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

NCT ID: NCT04978714

Last Updated: 2021-07-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

483 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-11-01

Study Completion Date

2020-10-31

Brief Summary

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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

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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.

Conditions

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Urodynamic Stress Incontinence Detrusor Overactivity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Women with cystocele

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

Cystocele repair

Intervention Type PROCEDURE

Fascial repair for endopelvic fascia and anterior colporrhaphy

Interventions

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Cystocele repair

Fascial repair for endopelvic fascia and anterior colporrhaphy

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ho-Hsiung Lin, PhD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

References

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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.

Reference Type RESULT
PMID: 19941278 (View on PubMed)

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.

Reference Type RESULT
PMID: 26337427 (View on PubMed)

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.

Reference Type RESULT
PMID: 29692690 (View on PubMed)

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.

Reference Type RESULT
PMID: 28754926 (View on PubMed)

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.

Reference Type RESULT
PMID: 32146026 (View on PubMed)

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.

Reference Type RESULT
PMID: 26573101 (View on PubMed)

Other Identifiers

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202105056RINC

Identifier Type: -

Identifier Source: org_study_id

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