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Completed

NCT Number: NCT02701010

Behavioural Therapy Program for Female Overactive Bladder

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Leaflet

Behavioral

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

Control Group

Behavioral

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

Primary outcomes

  1. Urogenital Distress Inventory (UDI-6)

    Time frame: baseline to 6 or 8 weeks

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

  2. Incontinence Impact Questionnaire (IIQ-7)

    Time frame: baseline to 6 or 8 weeks

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

Secondary outcomes

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

    Time frame: baseline to 6 or 8 weeks

    positive changes in quality of life at 6-8 weeks of the intervention compared to baseline

Sponsors and collaborators

Lead sponsor

Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Mar 7, 2016
Registry last updated
Mar 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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