Clinical trial NCT04978714: USI and/or DO in Women With Cystocele Before and After Cystocele Repair
Official title: Prevalence of Urodynamic Stress Incontinence and/or Detrusor Overactivity in Women With Cystocele and the Changes of Continence Function After Cystocele Repair
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urodynamic Stress Incontinence
Detrusor Overactivity
Keywords: Urodynamic stress incontinence
Detrusor Overactivity
Cystocele
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2021-07-27
Enrollment: 483
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: women with ≥ stage II cystocele who visited the urogynecological department of a medical center for cystocele repair

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Urodynamic stress incontinence
timeFrame: November 2010 and October 2020
measure: Detrusor overactivity
timeFrame: November 2010 and October 2020
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Ho-Hsiung Lin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.