Prevalence of Detrusor Underactivity and Bladder Outlet Obstruction in Female Without Cystocele

NCT04184752 | Completed

• 1 other identifier: 201907011RINC
• Study Type: observational
• Target: 602
• Locations: 1 country
• Sites: 1

Brief Summary

Women with symptoms of voiding dysfunction may be associated with detrusor underactivity (DU) or bladder outlet obstruction (BOO). The treatment strategies are different between DU and BOO. In general, urodynamic/videourodynamic studies are important for differential diagnosis. However, urodynamic/videourodynamic studies are invasive. The investigators are interested in whether there were specific symptoms or measurements that can be used for initial differential diagnosis between DU and BOO. Thus, the aim of this study was to elucidate the prevalence of DU and BOO in each age group and elucidate the clinical and urodynamic differences between the DU, BOO and non-DU/BOO groups.

Conditions

Voiding Disorders

Keywords

Bladder outlet obstruction; Detrusor underactivity; Voiding dysfunction

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Detrusor underactivity or Bladder outlet obstruction

  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 %. The BOO was defined when the PdetQmax was not less than 40 cmH2O, and the Qmax was less than 12 mL/s. BVE = voided volume / (voided volume+ PVR) x 100%.

  Between April 1996 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 women with symptoms of voiding dysfunction and without cystocele who visited the urogynecological department of a medical center for urodynamic evaluation were reviewed.

You may qualify if:

• Women with symptoms of voiding dysfunction.

You may not qualify if:

• Cystocele
• 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 (7)

• 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

• 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

• Karmakar D, Sharma JB. Current concepts in voiding dysfunction and dysfunctional voiding: A review from a urogynaecologist's perspective. J Midlife Health. 2014 Jul;5(3):104-10. doi: 10.4103/0976-7800.141185.

  PMID: 25316994 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 Neck Obstruction; Urinary Bladder, Underactive

Condition Hierarchy (Ancestors)

Urethral Obstruction; Urethral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, 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 4, 2019
• Study Start: April 1, 1996
• Primary Completion: September 30, 2018
• Study Completion: September 30, 2018
• Last Updated: December 9, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)