Biopsychosocial and Conventional Approach in Bladder Pain Syndrome

Hacettepe University

Status: Unknown

Conditions: Interstitial Cystitis; Bladder Pain Syndrome

Treatments: Device: Transcutaneous electrical nerve stimulation; Other: Relaxation exercises; Other: Pain Neuroscience Education; Other: Pelvic floor stretching exercises; Other: Cognition target exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT05155384

KA- 21109

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

biopsychosocial model-based treatment

Experimental group

Description:

Biopsychosocial model-based management will be applied including pain neuroscience education, functional exercises, and relaxation training.

Treatment:

Other: Relaxation exercises

Other: Cognition target exercise

Other: Pain Neuroscience Education

Conventional physiotherapy

Active Comparator group

Description:

Conventional physiotherapy will be applied including standard exercises and electrical stimulation.

Treatment:

Device: Transcutaneous electrical nerve stimulation

Other: Pelvic floor stretching exercises