Training and Counseling Program for Overactive Bladder Treatment

NCT03544554 | Completed

• 1 other identifier: 0925-0586
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study concluded that HLSB training reduced OAB symptoms among women, improved the quality of their lives, changed their HLSBs, and positively affected their mental states. Thus, a holistic approach to the treatment of women with OAB increased the success of the treatment.

Conditions

Overactive Bladder

Keywords

Overactive bladder; healthy lifestyle behaviors; quality of life

Outcome Measures

Primary Outcomes (4)

• Change from baseline Overactive Bladder Questionnaire (OAB-V8) scores at 12 weeks

  12 weeks a between implementation of pre-post test

  Intervention and control group cases were assessed at baseline and week 12. The OAB-v8 is a patient-reported outcome questionnaire which have six point rating system (0-40 scores).

• Change from baseline King's Health Questionnaire (KHQ) scores at 12 weeks

  12 weeks a between implementation of pre-post test.

  Intervention and control group cases were assessed at baseline and week 12. KHQ is a patient self-administered self-report . The responses in KHQ have four point rating system. The eight subscales scored between 0 (best) and 100 (worst).

• Change from baseline Brief Symptom Inventory (BSI) scores at 12 weeks

  12 weeks a between implementation of pre-post test

  Intervention and control group cases were assessed at baseline and week 12. The Brief Symptom Inventory (BSI) is a brief form of the Symptom Checklist, The responses in BSI have five point rating system(0-212 scores).

• Change from baseline Healthy Life Style Behavior Scale II (HLSB II) scores at 12 weeks

  12 weeks a between implementation of pre-post test

  Intervention and control group cases were assessed at baseline and week 12. HLSB II is used to measure the degree of engagement in a health-promoting lifestyle along 6 dimensions. The responses in HLPS II have four point rating system(52-208 scores).

Study Arms (1)

Intervention group and control group

EXPERIMENTAL

This research is planned with semi experimental design

Behavioral: a counseling and training program that consisted of a 45-minute presentation based on Pender's Health Promotion Model. Within the scope of the counseling and training program

Interventions

a counseling and training program that consisted of a 45-minute presentation based on Pender's Health Promotion Model. Within the scope of the counseling and training program BEHAVIORAL

The intervention group was provided with a counseling and training program that consisted of a 45-minute presentation based on Pender's Health Promotion Model.

Also known as: The control group was not provided with training

Intervention group and control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 years or older
• Being literate
• Diagnosed with OAB
• Beginning to receive pharmacological treatment for OAB
• Volunteering to participate in the study

You may not qualify if:

• Presence of a perceptual or psychiatric disorder which prevents communicating
• Presence of a neurological disorder
• Presence of neurological neuropathy caused by Diabetes Mellitus
• Second or higher stage pelvic organ prolapse
• Having an anti-incontinence surgery
• Being pregnant

Sponsors & Collaborators

• Biruni University: lead

Related Publications (1)

• Cayir G, Kizilkaya Beji N. The effect of a counseling and training program on the treatment of women with overactive bladder. Psychol Health Med. 2022 Sep;27(8):1726-1738. doi: 10.1080/13548506.2021.1916962. Epub 2021 Apr 19.

  PMID: 33870822 DERIVED

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Investigator
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor, PhD

Model Details: The study sample included 100women (50 for the intervention and 50 for the control group) diagnosed with OAB syndrome. The control group was not provided with training. In addition to the pharmacological treatment, the intervention group was provided with a counseling and training program that consisted of a 45minute presentation based on Pender's Health Promotion Model. They were also given "A Manual for Training on HealthyLifestyleBehaviors among women with OAB". The intervention group was requested to follow a weekly-scheduled bladder training program, keep records on the Urinary Diary form for six weeks. In the first interview and in the third month, the women in the intervention and control groups were administered the Introductory Information Form, Urinary Diary (4day), 24hour Standard Pad Test, OAB-V8, King'sHealthQuestionnaire, Healthy LifestyleBehaviorScaleII, and BriefSymptomInventory. In addition, an Inspection Form was administered in the third month.

Study Record Dates

• First Submitted: April 13, 2018
• First Posted: June 4, 2018
• Study Start: January 1, 2015
• Primary Completion: October 30, 2016
• Study Completion: March 1, 2017
• Last Updated: June 4, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share