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Clinical Trials/NCT02701010
NCT02701010
Completed
Not Applicable

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

Saglik Bilimleri Universitesi Gulhane Tip Fakultesi1 site in 1 country60 target enrollmentNovember 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Urinary Bladder, Overactive
Sponsor
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
Enrollment
60
Locations
1
Primary Endpoint
Urogenital Distress Inventory (UDI-6)
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2012
End Date
May 2013
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
Responsible Party
Principal Investigator
Principal Investigator

Sercan YILMAZ

Medical Doctor

Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

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

  • Urinary Incontinence-Specific Quality of Life Instrument (I-QOL)(baseline to 6 or 8 weeks)

Study Sites (1)

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