Behavioural Therapy Program for Female Overactive Bladder

NCT02701010 | Completed DMC

• 1 other identifier: -1491-160-12/1648.4-5263
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Researchers aimed to identify the effectiveness of three methods of patient education for behavioral therapy (BT), including verbal instructions combined with a leaflet on a structured training program of BT, only verbal instructions on a structured training and only a leaflet on a structured BT training. Therefore, a randomized controlled trial was designed to compare effectiveness of those methods of patient education in BT based on the two validated patient- reported outcome measures (PROMs) for women with overactive bladder. Idiopathic overactive bladder (iOAB) symptoms in female patients are perceived as normal, which does not threaten life and not require to be treated immediately. It is necessary to raise the awareness of iOAB on women. The education and consultancy role of continence nurses is important in the treatment and care of urinary incontinence (UI) associated with iOAB. In the study, it was seen that the training to be provided to patients is helpful regardless of the teaching method used. Also it was found that the method of verbal instructions in the form of a structured training plus giving a leaflet to patient is the most effective method of BT for female iOAB.

Conditions

Urinary Bladder, Overactive

Keywords

behavioral therapy; overactive bladder; urinary incontinence

Outcome Measures

Primary Outcomes (2)

• Urogenital Distress Inventory (UDI-6)

  improvement in bladder functions at 6-8 weeks of the intervention compared to baseline

  baseline to 6 or 8 weeks

• Incontinence Impact Questionnaire (IIQ-7)

  improvement in bladder functions at 6-8 weeks of the intervention compared to baseline

  baseline to 6 or 8 weeks

Secondary Outcomes (1)

• Urinary Incontinence-Specific Quality of Life Instrument (I-QOL)

  baseline to 6 or 8 weeks

Study Arms (4)

Group 1

ACTIVE COMPARATOR

Structured training and leaflet

Behavioral: Structured training and leaflet

Group 2

ACTIVE COMPARATOR

Structured training

Behavioral: Structured training

Group 3

ACTIVE COMPARATOR

Leaflet

Behavioral: Leaflet

Group 4

SHAM COMPARATOR

Control group

Behavioral: Control Group

Interventions

Structured training and leaflet BEHAVIORAL

The patients who were given both "explanatory verbal instructions of the educational leaflet on the structured behavioural therapy for iOAB" by continence nurse and the educational leaflet were included in this group.

Group 1

Structured training BEHAVIORAL

The patients who were given only "explanatory verbal instructions of the educational leaflet on the structured behavioural therapy" by continence nurse were included in this group.

Group 2

Leaflet BEHAVIORAL

The patients who were given "only educational leaflet" were included in this group.

Group 3

Control Group BEHAVIORAL

Patients who were given unstructured explanations about continence care by a healthcare worker were included in control group.

Group 4

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Saglik Bilimleri Universitesi Gulhane Tip Fakultesi: lead

Study Sites (1)

Gulhane Military Medical Academy

Ankara, Kecioren, 06010, Turkey (Türkiye)

Location

Related Publications (22)

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  PMID: 19941278 BACKGROUND

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• Abrams P. CL, Khoury S, Wein A, ed Incontinence 4th Edition. 21 ed. Paris: Health Publication; 2009. 4th International Consultation on Incontinence.

  BACKGROUND

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  PMID: 17083117 BACKGROUND

• Uebersax JS, Wyman JF, Shumaker SA, McClish DK, Fantl JA. Short forms to assess life quality and symptom distress for urinary incontinence in women: the Incontinence Impact Questionnaire and the Urogenital Distress Inventory. Continence Program for Women Research Group. Neurourol Urodyn. 1995;14(2):131-9. doi: 10.1002/nau.1930140206.

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• Available from: https://www.sealedenvelope.com/simple-randomiser/v1/lists, available date: 01.11.2012

  BACKGROUND

• Subak LL, Goode PS, Brubaker L, Kusek JW, Schembri M, Lukacz ES, Kraus SR, Chai TC, Norton P, Tennstedt SL; Urinary Incontinence Treatment Network. Urinary incontinence management costs are reduced following Burch or sling surgery for stress incontinence. Am J Obstet Gynecol. 2014 Aug;211(2):171.e1-7. doi: 10.1016/j.ajog.2014.03.012. Epub 2014 Mar 11.

  PMID: 24631433 BACKGROUND

• Lucas MG, Bosch RJ, Burkhard FC, Cruz F, Madden TB, Nambiar AK, Neisius A, de Ridder DJ, Tubaro A, Turner WH, Pickard RS; European Association of Urology. EAU guidelines on assessment and nonsurgical management of urinary incontinence. Eur Urol. 2012 Dec;62(6):1130-42. doi: 10.1016/j.eururo.2012.08.047. Epub 2012 Aug 31.

  PMID: 22985745 BACKGROUND

• Botlero R, Urquhart DM, Davis SR, Bell RJ. Prevalence and incidence of urinary incontinence in women: review of the literature and investigation of methodological issues. Int J Urol. 2008 Mar;15(3):230-4. doi: 10.1111/j.1442-2042.2007.01976.x.

  PMID: 18304218 BACKGROUND

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  PMID: 23764126 BACKGROUND

• Tsai YC, Liu CH. Urinary incontinence among Taiwanese women: an outpatient study of prevalence, comorbidity, risk factors, and quality of life. Int Urol Nephrol. 2009 Dec;41(4):795-803. doi: 10.1007/s11255-009-9523-3. Epub 2009 Feb 6.

  PMID: 19199071 BACKGROUND

• Hsieh CH, Su TH, Chang ST, Lin SH, Lee MC, Lee MY. Prevalence of and attitude toward urinary incontinence in postmenopausal women. Int J Gynaecol Obstet. 2008 Feb;100(2):171-4. doi: 10.1016/j.ijgo.2007.08.013. Epub 2007 Oct 31.

  PMID: 17977542 BACKGROUND

• Hunskaar S. A systematic review of overweight and obesity as risk factors and targets for clinical intervention for urinary incontinence in women. Neurourol Urodyn. 2008;27(8):749-57. doi: 10.1002/nau.20635.

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• Hagglund D, Walker-Engstrom ML, Larsson G, Leppert J. Reasons why women with long-term urinary incontinence do not seek professional help: a cross-sectional population-based cohort study. Int Urogynecol J Pelvic Floor Dysfunct. 2003 Nov;14(5):296-304; discussion 304. doi: 10.1007/s00192-003-1077-9. Epub 2003 Aug 29.

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• O'Donnell M, Lose G, Sykes D, Voss S, Hunskaar S. Help-seeking behaviour and associated factors among women with urinary incontinence in France, Germany, Spain and the United Kingdom. Eur Urol. 2005 Mar;47(3):385-92; discussion 392. doi: 10.1016/j.eururo.2004.09.014. Epub 2004 Nov 21.

  PMID: 15716205 BACKGROUND

• Subak LL, Quesenberry CP, Posner SF, Cattolica E, Soghikian K. The effect of behavioral therapy on urinary incontinence: a randomized controlled trial. Obstet Gynecol. 2002 Jul;100(1):72-8. doi: 10.1016/s0029-7844(02)01993-2.

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• Kök G, Şenel N, Akyüz A. Nurses' roles in identifying urinary incontinence and its effects on social life. Int J Urol Nurs 2008;2:119-124.

  BACKGROUND

• Altaweel W, Alharbi M. Urinary incontinence: prevalence, risk factors, and impact on health related quality of life in Saudi women. Neurourol Urodyn. 2012 Jun;31(5):642-5. doi: 10.1002/nau.22201. Epub 2012 Mar 13.

  PMID: 22415626 BACKGROUND

• Funada S, Yoshioka T, Luo Y, Sato A, Akamatsu S, Watanabe N. Bladder training for treating overactive bladder in adults. Cochrane Database Syst Rev. 2023 Oct 9;10(10):CD013571. doi: 10.1002/14651858.CD013571.pub2.

  PMID: 37811598 DERIVED

MeSH Terms

Conditions

Urinary Bladder, Overactive; Urinary Incontinence

Interventions

Control Groups

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; Urination Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: March 2, 2016
• First Posted: March 7, 2016
• Study Start: November 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: May 1, 2013
• Last Updated: March 7, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will share

Locations

TU (1)