Behavioural Therapy Program for Female Overactive Bladder

March 4, 2016 updated by: Sercan YILMAZ, Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Kecioren
      • Ankara, Kecioren, Turkey, 06010
        • Gülhane Military Medical Academy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1
Structured training and leaflet
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.
Active Comparator: Group 2
Structured training
Behavioral: 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.
Active Comparator: Group 3
Leaflet
Behavioral: Leaflet
The patients who were given "only educational leaflet" were included in this group.
Sham Comparator: Group 4
Control group
Behavioral: Control Group
Patients who were given unstructured explanations about continence care by a healthcare worker were included in control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline to 6 or 8 weeks
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
baseline to 6 or 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline to 6 or 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

March 2, 2016

First Submitted That Met QC Criteria

March 4, 2016

First Posted (Estimate)

March 7, 2016

Study Record Updates

Last Update Posted (Estimate)

March 7, 2016

Last Update Submitted That Met QC Criteria

March 4, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • -1491-160-12/1648.4-5263

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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