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Behavioural Therapy Program for Female Overactive Bladder

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02701010
Enrollment
60
Registered
2016-03-07
Start date
2012-11-30
Completion date
2013-05-31
Last updated
2016-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Bladder, Overactive

Keywords

behavioral therapy, overactive bladder, urinary incontinence

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.

Detailed 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.

Interventions

BEHAVIORALStructured 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.

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.

BEHAVIORALLeaflet

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

BEHAVIORALControl Group

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

Sponsors

Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

.

Design outcomes

Primary

MeasureTime frameDescription
Urogenital Distress Inventory (UDI-6)baseline to 6 or 8 weeksimprovement in bladder functions at 6-8 weeks of the intervention compared to baseline
Incontinence Impact Questionnaire (IIQ-7)baseline to 6 or 8 weeksimprovement in bladder functions at 6-8 weeks of the intervention compared to baseline

Secondary

MeasureTime frameDescription
Urinary Incontinence-Specific Quality of Life Instrument (I-QOL)baseline to 6 or 8 weekspositive changes in quality of life at 6-8 weeks of the intervention compared to baseline

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026