Behavioural Therapy Program for Female Overactive Bladder

Urinary Bladder, Overactive Clinical Trial

Official title:

Comparative Effectiveness of Three Different Teaching Methods in Behavioural Therapy Program for Female Overactive Bladder: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02701010
• Other study ID #: -1491-160-12/1648.4-5263
• Status: Completed
• Phase: N/A
• First received: March 2, 2016
• Last updated: March 4, 2016
• Start date: November 2012
• Est. completion date: May 2013

Study information

• Verified date: March 2016
• Source: Gulhane Military Medical Academy
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Description:

Behavioural therapy (BT) is the first-line treatment for urinary incontinence including idiopathic overactive bladder (iOAB) syndrome. It requires education of the actively participated patient as well as time and effort from the clinician. However, the most effective method for patient education in BT remains unclear. Researchers designed a randomized controlled trial to compare effectiveness of 3 different methods of patient education in BT for women with overactive bladder.

The sample of the study consisted of 60 iOAB female patients who applied to urogynecology clinic between November 2012 and April 2013. These patients were equally randomized into 4 groups of teaching models for BT. Group I included the patients educated by a continence nurse's verbal instructions in the form of a structured training including bladder training, bladder control strategies, pelvic floor muscle training and lifestyle changes and a leaflet containing information stated in structured training, group II included the patients taught by a continence nurse as the only verbal structured training, group III included the patients who were given only the leaflet and group IV was the control group consisted of female iOAB patients who were given an unstructured training by a healthcare worker with no specific experience in continence care.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Eligible participants were all ambulatory adults aged 18 or over with predominant iOAB syndrome with or without stress urinary incontinence (the number of urgency and urgency incontinence episodes exceeded the number of stress incontinence episodes and other accidents in bladder diary), who were candidates for behavioural therapy as a first-line treatment after initial clinical assessment, including history, physical examination, symptom questionnaires, 3-day bladder diary, repeated uroflowmetry and postvoid residual measurements for all patients and urodynamics for some patients with a suspicion of presence of the exclusion criteria.

Exclusion criteria were pregnancy, suspected neurogenic disease, stress predominant mixed urinary incontinence, continuous urinary leakage, previous anti-incontinence surgery, voiding dysfunction (PVR> 100 ml), genitourinary malignancies, current or previous behavioural therapy programs, previous or current use of antimuscarinic agents, symptomatic pelvic organ prolapse, severe co-morbidities such as congestive heart failure, chronic renal failure, impaired cognitive functions.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Urinary Bladder, Overactive

Intervention

Behavioral:
• Structured training and leaflet
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.
• Structured training
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.
• Leaflet
The patients who were given "only educational leaflet" were included in this group.
• Control Group
Patients who were given unstructured explanations about continence care by a healthcare worker were included in control group.

Locations

Country	Name	City	State
Turkey	Gulhane Military Medical Academy	Ankara	Kecioren

Sponsors (1)

Lead Sponsor	Collaborator
Gulhane Military Medical Academy

Country where clinical trial is conducted

Turkey, 

References & Publications (21)

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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. — View Citation

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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. Review. — View Citation

Cam C, Sakalli M, Ay P, Cam M, Karateke A. Validation of the short forms of the incontinence impact questionnaire (IIQ-7) and the urogenital distress inventory (UDI-6) in a Turkish population. Neurourol Urodyn. 2007;26(1):129-33. — View Citation

Elbiss HM, Osman N, Hammad FT. Social impact and healthcare-seeking behavior among women with urinary incontinence in the United Arab Emirates. Int J Gynaecol Obstet. 2013 Aug;122(2):136-9. doi: 10.1016/j.ijgo.2013.03.023. Epub 2013 Jun 10. — View Citation

Gormley EA, Lightner DJ, Faraday M, Vasavada SP; American Urological Association; Society of Urodynamics, Female Pelvic Medicine. Diagnosis and treatment of overactive bladder (non-neurogenic) in adults: AUA/SUFU guideline amendment. J Urol. 2015 May;193(5):1572-80. doi: 10.1016/j.juro.2015.01.087. Epub 2015 Jan 23. Review. — View Citation

Hägglund D, Walker-Engström 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. Epub 2003 Aug 29. — View Citation

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. Review. — View Citation

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. Epub 2007 Oct 31. — View Citation

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. Review. — View Citation

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

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. Erratum in: Eur Urol. 2013 Jul;64(1):e20. — View Citation

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. Epub 2004 Nov 21. — View Citation

Ozerdogan N, Beji NK, Yalçin O. Urinary incontinence: its prevalence, risk factors and effects on the quality of life of women living in a region of Turkey. Gynecol Obstet Invest. 2004;58(3):145-50. Epub 2004 Jun 29. — View Citation

Patrick DL, Martin ML, Bushnell DM, Yalcin I, Wagner TH, Buesching DP. Quality of life of women with urinary incontinence: further development of the incontinence quality of life instrument (I-QOL). Urology. 1999 Jan;53(1):71-6. Erratum in: Urology 1999 May;53(5):1072. — View Citation

Sacco E, Tienforti D, D'Addessi A, Pinto F, Racioppi M, Totaro A, D'Agostino D, Marangi F, Bassi P. Social, economic, and health utility considerations in the treatment of overactive bladder. Open Access J Urol. 2010 Feb 11;2:11-24. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	Urinary Incontinence-Specific Quality of Life Instrument (I-QOL)	positive changes in quality of life at 6-8 weeks of the intervention compared to baseline	baseline to 6 or 8 weeks	No