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

Detrusor Overactivity Clinical Trial

Official title:

Prevalence of Urodynamic Stress Incontinence and/or Detrusor Overactivity in Women With Cystocele and the Changes of Continence Function After Cystocele Repair

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04978714
• Other study ID #: 202105056RINC
• Status: Completed
• Start date: November 1, 2010
• Est. completion date: October 31, 2020

Study information

• Verified date: July 2021
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 483
• Est. completion date: October 31, 2020
• Est. primary completion date: October 31, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Cystocele
• Detrusor Overactivity
• Urinary Bladder, Overactive
• Urinary Incontinence, Stress
• Urodynamic Stress Incontinence

Intervention

Procedure:
• Cystocele repair
Fascial repair for endopelvic fascia and anterior colporrhaphy

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

References & 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)/Internation — View 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. — View 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. — View 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. — View 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. Review. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Detrusor overactivity	the occurrence of involuntary detrusor contractions during filling cytometry	November 2010 and October 2020