Training and Counseling Program for Overactive Bladder Treatment

NCT ID: NCT03544554

Last Updated: 2018-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-01
• Study Completion Date: 2017-03-01

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.

Detailed Description

The population of this study included all women who received treatment in the Urogynecology Outpatient Clinic of the Gynecology and Obstetrics Department in İstanbul Faculty of Medicine at İstanbul University between January 2015 and October 2016. Permission was obtained for the study from the Ethics Committee of İstanbul University Cerrahpaşa Faculty of Medicine and İstanbul University İstanbul Faculty of Medicine. The study sample included 100 women diagnosed with OAB syndrome. Of them, 50 were selected for the intervention group and 50 were selected for the control group.

Detailed information was given to the women beginning pharmacological treatment who met the inclusion criteria, and their consent was obtained using an Informed Voluntary Consent Form. During the pharmacological treatment, anticholinergic drugs, which contained active ingredients such as tolterodine 4 mg/day, trospium cl 60 mg/day, fesoterodine 4-8 mg/day, and solifenacin 5 or 10 mg/day were prescribed. The women in each group were instructed to take the prescribed anticholinergic drugs regularly, informed about the side effects of these drugs, and advised on the situations when they should seek immediate treatment before their next scheduled appointment. The women with OAB were divided into groups using random allocation (by drawing lots). To set an equal distribution of patients into the intervention and control groups, the group of the first patient was determined by lot, and the next patient was allocated to the other group.

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 45-minute presentation based on Pender's Health Promotion Model. Within the scope of the counseling and training program, the patients were given information about the female reproductive system, anatomy and physiology of the urinary system, OAB definition, OAB symptoms, and HLSBs (adequate fluid intake, diet, prevention methods for urinary tract infections, weight control, regular bowel movements, smoking cessation, treatment of chronic diseases, and regular medication). The patients were informed about the importance of concentration, learning about pelvic floor muscle contraction and exercises and performing them regularly, as well as designing bladder training programs and sticking to them to manage urgency and urinary incontinence. They were also given "A Manual for Training on Healthy Lifestyle Behaviors among Women with Overactive Bladder". Figure 1 shows the HLSB development based on Pender's Health Promotion Model in OAB treatment.

The intervention group was requested to follow a weekly-scheduled bladder training program, keep records on the Urinary Diary form for six weeks, and bring this form at the end of each week. The researcher called each patient 8-10 times: every week during the first six weeks and once a month afterwards to encourage implementation of the practices for three months starting from the first interview. During the phone calls, the patients were asked about their drug use, average daily fluid intake, and any concerns as well as state of performing pelvic floor muscle contraction and exercises, sticking to the scheduled bladder training hours, and weight loss. The data obtained through these calls were recorded on the Practice Registration Form. The control group, on the other hand, was called once a month and instructed to continue taking their drugs, which was also recorded on the form.

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 (4-day), 24-hour Standard Pad Test, Overactive Bladder Questionnaire (OAB V8), King's Health Questionnaire (KHQ), Healthy Lifestyle Behavior Scale II (HLSB II), and Brief Symptom Inventory (BSI). In addition, an Inspection Form was administered in the third month.

Conditions

Overactive Bladder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention group and control group

This research is planned with semi experimental design

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

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

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

The control group was not provided with training

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Biruni University

OTHER

Sponsor Role: lead

Responsible Party

Gulsen Cayir

Assistant professor, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: DERIVED

PMID: 33870822 (View on PubMed)

Other Identifiers

0925-0586

Identifier Type: -

Identifier Source: org_study_id