Detrusor Underactivity and Bladder Outlet Obstruction in Women With Cystocele

NCT04184128 | Completed

• 1 other identifier: 201907008RINC
• Study Type: observational
• Target: 623
• Locations: 1 country
• Sites: 1

Brief Summary

Women with cystocele may be associated with detrusor underactivity (DU) or bladder outlet obstruction (BOO). However, the impact of cystocele repair on the rates of DU and BOO remained obscure. Thus, the aim of this study was to elucidate the prevalence of DU and BOO in each age group and elucidate the impact of cystocele repair on the rates of DU and BOO.

Conditions

Cystocele

Keywords

Bladder outlet obstruction; Detrusor underactivity; Cystocele

Outcome Measures

Primary Outcomes (1)

• DU or BOO

  The DU was defined when the PdetQmax was less than 20 cmH2O, the Qmax was less than 15 mL/s, and the bladder voiding efficiency (BVE) was less than 90 % \[1\]. The BOO was defined when the PdetQmax was not less than 40 cmH2O, and the Qmax was less than 12 mL/s \[1\]. BVE = voided volume / (voided volume+ PVR) x 100%.

  Between November 2010 and September 2018

Study Arms (3)

Detrusor underactivity

The DU was defined when the PdetQmax was less than 20 cmH2O, the Qmax was less than 15 mL/s, and the bladder voiding efficiency (BVE) was less than 90 %. BVE = voided volume / (voided volume+ PVR) x 100%.

Diagnostic Test: Urodynamic study

Bladder outlet obstruction

The BOO was defined when the PdetQmax was not less than 40 cmH2O, and the Qmax was less than 12 mL/s.

Diagnostic Test: Urodynamic study

Non-DU/BOO group

Those women without DU or BOO were allocated to the non-DU/BOO group.

Diagnostic Test: Urodynamic study

Interventions

Urodynamic study DIAGNOSTIC_TEST

The urodynamic assessment included uroflowmetry, filling cystometry with 35°C distilled water at a rate of 60 mL/sec, a pressure flow study, and a stress urethral pressure profile with patient in sitting position \[14\]. A 20-minute pad test for each woman was also performed \[15, 16\]. Multichannel urodynamic equipment (Life-Tech, Houston, TX, USA) with computer analysis and Urovision (Urolab Janus System V, Houston) was used. All terminology conformed to the standards recommended by the ICS \[3\]. All procedures were performed by an experienced technician, and the data were interpreted by a single observer to avoid interobserver variability.

Also known as: Pad test

Bladder outlet obstruction; Detrusor underactivity; Non-DU/BOO group

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All medical records of women with ≥ POP-Q stage II cystocele who visited the urogynecological department of a medical center for urodynamic evaluation were reviewed.

You may qualify if:

• ≥ POP-Q stage II cystocele
• Female

You may not qualify if:

• Those women who have no complete data of maximum flow rate (Qmax), voided volume, post void residual volume (PVR) and detrusor pressure at maximum flow rate (PdetQmax) were excluded from this study.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

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. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Int Urogynecol J. 2010 Jan;21(1):5-26. doi: 10.1007/s00192-009-0976-9. Epub 2009 Nov 25.

  PMID: 19937315 RESULT

• 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: 26337427 RESULT

• Frigerio M, Manodoro S, Cola A, Palmieri S, Spelzini F, Milani R. Detrusor underactivity in pelvic organ prolapse. Int Urogynecol J. 2018 Aug;29(8):1111-1116. doi: 10.1007/s00192-017-3532-z. Epub 2017 Dec 21.

  PMID: 29270721 RESULT

• 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: 28754926 RESULT

• 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: 26573101 RESULT

• Salinas Casado J, Adot Zurbano JM, Dambros M, Virseda Chamorro M, Ramirez Fernandez JC, Moreno Sierra J, Marcos Diaz J, Silmi Moyano A. [Factors for voiding dysfunction and cystocele]. Arch Esp Urol. 2005 May;58(4):316-23. doi: 10.4321/s0004-06142005000400006. Spanish.

  PMID: 15989095 RESULT

MeSH Terms

Conditions

Cystocele; Urinary Bladder Neck Obstruction; Urinary Bladder, Underactive

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pelvic Organ Prolapse; Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Urethral Obstruction; Urethral Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms

Study Officials

• Ho-Hsiung Lin, PhD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2019
• First Posted: December 3, 2019
• Study Start: November 1, 2010
• Primary Completion: September 30, 2018
• Study Completion: September 30, 2018
• Last Updated: December 9, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)