Biopsychosocial and Conventional Approach in Bladder Pain Syndrome

Not Applicable

• Conditions: Interstitial Cystitis; Bladder Pain Syndrome
• Interventions: Other: Pain Neuroscience Education; Other: Pelvic floor stretching exercises; Device: Transcutaneous electrical nerve stimulation; Other: Relaxation exercises; Other: Cognition target exercise

• Registration Number: NCT05155384
• Lead Sponsor: Hacettepe University

Brief Summary

The aim of the present study is to compare the effects of biopsychosocial and conventional approach on symptom severity, pain parameters (pain intensity and pain cognitions), disability, psychological distress and quality of life in patients who are suffering from bladder pain syndrome/interstitial cystitis. The study is designed as a randomized clinical trial including two parallel arms.

Individuals who meet the inclusion criteria and agree to participate will be randomly assigned into one of the two research arms: biopsychosocial approach group or conventional approach group. A biopsychosocial approach, which is a holistic approach that includes pain neuroscience education, relaxation training and cognitive exercises, will be applied to the patients in the first research arm for the treatment of chronic pain symptoms. For the patients in the second research arm, a conventional approach including pelvic floor stretching exercises and Transcutaneous Electrical Nerve Stimulation (TENS) will be applied for the treatment of chronic pain complaints. Treatments will be lasted for a total of six weeks, with two sessions per week. Participants will be evaluated at the baseline (before treatments) and at the end of the 6th week (after treatments). In the evaluations, information about the demographic and physical characteristics, medical and surgical background, medications and lifestyle characteristics (water, tea, coffee, alcohol, cigarette consumption, the presence constipation and physical activity level) of the individuals will be recorded. For primary or secondary outcome measures, Interstitial Cystitis Symptom and Problem Index, Visual Analog Scale, Pain Catastrophizing Scale, Pain Self-Efficacy Questionnaire, 3-day voiding diary, Pain Disability Index, Hospital Anxiety and Depression Scale, and Short Form-36 will be used. The present study is planned to be carried out with a total of 60 individuals, 30 for each study group based on a sample size analysis.

After reaching required sample for the present study, in patients with bladder pain syndrome/interstitial cystitis, the effects of biopsychosocial and conventional approach on symptom and problem severity, pain parameters, disability, psychological status and quality of life will be analyzed using (2\*2) two-way ANOVA.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2021-11-12
• Status Verified: 2021-12
• Study First Submitted: 2021-12-10
• Study First Submitted QC: 2021-12-10
• Study First Posted: 2021-12-13
• Last Update Submitted: 2021-12-13
• Last Update Posted: 2022-01-03
• Primary Completion: 2022-10-15
• Study Completion: 2022-10-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Diagnosed with Bladder Pain Syndrome/Interstitial Cystitis
• with chronic symptoms (more than 6 months)
• Bladder pain severity in the last week should be at least 3/10 according to the Visual Analogue Scale (VAS)
• Stable medication schedule
• Individuals over the age of 18 (individuals over 65 years of age with a Mini Mental Test score ≥ 24) voluntarily to participate in the study will be included.

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Exclusion Criteria

• Acute disease state (with ongoing urinary tract infection, active vaginitis, active Herpes infection)
• Stones in the bladder, ureter, or urethra in the last 3 months
• Having an ulcer appearance on cystoscopy
• For women: during pregnancy and/or breastfeeding
• Previous history of urological and/or pelvic malignancy
• Congenital anomaly of the upper and/or lower urinary tract
• who have started a new drug treatment in the last 3 months, or undergoing implantation operation of neuromodulation devices
• Diagnosed with opioid dependence
• Neurogenic bladder dysfunction or concomitant neurologic conditions
• Not cooperating with assessment and/or treatment, and illiterate individuals

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional physiotherapy	Transcutaneous electrical nerve stimulation	Conventional physiotherapy will be applied including standard exercises and electrical stimulation.
biopsychosocial model-based treatment	Relaxation exercises	Biopsychosocial model-based management will be applied including pain neuroscience education, functional exercises, and relaxation training.
biopsychosocial model-based treatment	Cognition target exercise	Biopsychosocial model-based management will be applied including pain neuroscience education, functional exercises, and relaxation training.
biopsychosocial model-based treatment	Pain Neuroscience Education	Biopsychosocial model-based management will be applied including pain neuroscience education, functional exercises, and relaxation training.
Conventional physiotherapy	Pelvic floor stretching exercises	Conventional physiotherapy will be applied including standard exercises and electrical stimulation.

Primary Outcome Measures

Name	Time	Method
severity of symptoms	change in severity of symptoms from baseline up to end of 6th week	The Interstitial Cystitis Symptom and Problem Index will be used to assess the severity of symptoms. This scale consists of two separate parts as symptom and problem index, both of which are four questions. Participants will be asked to fill in both parts.

Secondary Outcome Measures

Name	Time	Method
urinary symptoms	change in urinary symptoms from baseline up to end of 6th week	A 3-day voiding diary will be used to evaluate Urinary Symptoms. On this chart, they are asked to record the time they urinate, the amount of urine, the presence of urinary incontinence, the amount and type of fluid consumed.
severity of pain	change in severity of pain from baseline up to end of 6th week	Pain severity will be evaluated with the Visual Analogue Scale (VAS). Considering the last week, the patients will be asked to mark the severity of pain on a 10-centimeter (cm) straight line, with the starting end as "no pain" and the ending end as "unbearable pain". It will be calculated in cm by measuring the starting tip and the part marked by the patient.
Pain cognitions	change in pain cognitions from baseline up to end of 6th week	Pain Catastrophizing Scale and Pain Self-Efficacy Questionnaire will be used to assess individuals' cognitions about pain (catastrophizing and self-efficacy).
severity of disability	change in severity of disability from baseline up to end of 6th week	The Pain Disability Index will be used to question the impact of individuals' daily life due to their pain and the resulting disability.
psychological distress	change in psychological distress from baseline up to end of 6th week	The Hospital Anxiety and Depression Scale will be used to evaluate the psychological distress of individuals. The questionnaire has two sub-dimensions, depression and anxiety.
quality of life of the patients	change in quality of life from baseline up to end of 6th week	Quality of Life will be assessed using the SF-36 scale. Short Form-36 will be used for evaluations. This questionnaire consists of eight different sub-parameters (physical function, physical role difficulty, general health status, pain status, energy/fatigue, social function, emotional role difficulty, and emotional well-being).

Trial Locations

Locations (2)

Hacettepe University, Faculty of Physical Therapy and Rehabilitation; 🇹🇷 Ankara, Turkey

Hacettepe University; 🇹🇷 Ankara, Turkey