DU and BOO in Women With and Without Symptoms of VD

NCT04981080 | Completed

• 1 other identifier: 202105082RINA
• Study Type: observational
• Target: 1,886
• Locations: 1 country
• Sites: 1

Brief Summary

Women with symptoms of voiding dysfunction may be associated with detrusor underactivity or bladder outlet obstruction. However, the prevalence of detrusor underactivity and bladder outlet obstruction remained obscure. Thus, the aim of this study was to elucidate the prevalence of detrusor underactivity and bladder outlet obstruction in women with and without symptoms of voiding dysfunction.

Conditions

Detrusor Underactivity; Bladder Outlet Obstruction

Keywords

detrusor underactivity; bladder outlet obstruction; voiding dysfunction

Outcome Measures

Primary Outcomes (2)

• Detrusor underactivity

  The detrusor pressure when maximal flow rate was less than 20 cmH2O, the maximal flow rate was less than 15 mL/s, and the bladder voiding efficiency was less than 90 %

  February 2005 and December 2020

• Bladder outlet obstruction

  The detrusor pressure when maximal flow rate was not less than 40 cmH2O, and the maximal flow rate was less than 12 mL/s

  February 2005 and December 2020

Study Arms (2)

Symptom of voiding dysfunction

Women with lower urinary tract symptoms including voiding symptoms but without cystocele who visited the urogynecological department of a medical center for urodynamic evaluation were reviewed

Diagnostic Test: Urodynamic study

No symptom of voiding dysfunction

Women with lower urinary tract symptoms but without cystocele or voiding symptoms who visited the urogynecological department of a medical center for urodynamic evaluation were reviewed

Diagnostic Test: Urodynamic study

Interventions

Urodynamic study DIAGNOSTIC_TEST

The urodynamic assessment, including noninstrumented uroflowmetry, filling cystometry with 35°C distilled water at a rate of 60 mL/sec, a pressure flow study, and urethral pressure profilometry, was performed with the patient in a sitting position according to the recommendations by the International Continence Society.

No symptom of voiding dysfunction; Symptom of voiding dysfunction

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

women with lower urinary tract symptoms but without cystocele who visited the urogynecological department of a medical center for urodynamic evaluation

You may qualify if:

• Women with lower urinary tract symptoms
• Complete urodynamic study

You may not qualify if:

• Advanced cystocele
• After surgery for cystocele repair
• Chronic infection
• Incomplete data

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Related Publications (7)

• 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: 19941278 RESULT

• Choi YS, Kim JC, Lee KS, Seo JT, Kim HJ, Yoo TK, Lee JB, Choo MS, Lee JG, Lee JY. Analysis of female voiding dysfunction: a prospective, multi-center study. Int Urol Nephrol. 2013 Aug;45(4):989-94. doi: 10.1007/s11255-013-0475-2. Epub 2013 May 31.

  PMID: 23722818 RESULT

• Retraction: Current Concepts in Voiding Dysfunction and Dysfunctional Voiding: A Review from a Urogynaecologist's Perspective. J Midlife Health. 2018 Jan-Mar;9(1):50. doi: 10.4103/0976-7800.227258.

  PMID: 29628732 RESULT

• Robinson D, Staskin D, Laterza RM, Koelbl H. Defining female voiding dysfunction: ICI-RS 2011. Neurourol Urodyn. 2012 Mar;31(3):313-6. doi: 10.1002/nau.22213. Epub 2012 Mar 13.

  PMID: 22415792 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

• Lukacz ES, DuHamel E, Menefee SA, Luber KM. Elevated postvoid residual in women with pelvic floor disorders: prevalence and associated risk factors. Int Urogynecol J Pelvic Floor Dysfunct. 2007 Apr;18(4):397-400. doi: 10.1007/s00192-006-0164-0. Epub 2006 Jun 28.

  PMID: 16804634 RESULT

• Milleman M, Langenstroer P, Guralnick ML. Post-void residual urine volume in women with overactive bladder symptoms. J Urol. 2004 Nov;172(5 Pt 1):1911-4. doi: 10.1097/01.ju.0000140502.34334.75.

  PMID: 15540753 RESULT

MeSH Terms

Conditions

Urinary Bladder, Underactive; Urinary Bladder Neck Obstruction

Condition Hierarchy (Ancestors)

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

Study Officials

• Ho-Hsiung Lin, PhD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 20, 2021
• First Posted: July 28, 2021
• Study Start: February 1, 2005
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: July 28, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)