Biopsychosocial and Conventional Approach in Bladder Pain Syndrome

Comparison of Biopsychosocial and Conventional Approach in the Treatment of Bladder Pain Syndrome/Interstitial Cystitis

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ceren Gürşen, PhD; Phone Number: +905380644120; Email: cerengursen@yahoo.com

Study Locations

• Turkey
  • Ankara, Turkey, 06100
    • Recruiting
    • Hacettepe University
    • Contact: Ceren Gürşen, PhD; Phone Number: +905380644120; Email: cerengursen@yahoo.com
  • Ankara, Turkey, 06100
    • Recruiting
    • Hacettepe University, Faculty of Physical Therapy and Rehabilitation
    • Contact: Ceren Gürşen, PhD; Phone Number: +905380644120; Email: cerengursen@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: biopsychosocial model-based treatment; Biopsychosocial model-based management will be applied including pain neuroscience education, functional exercises, and relaxation training.	Other: Pain Neuroscience Education; main topics of pain neuroscience education; neurophysiology of the nervous system, protective mechanism of pain, acute pain formation and chronic pain, factors that increase/reduce pain, central sensitization mechanism, neuroplasticity and treatment strategies in chronic pain.; Other: Relaxation exercises; Relaxation exercises are a training based on deep relaxation techniques and visual imagery. Relaxation exercises will be applied at the end of the training sessions.; Other: Cognition target exercise; Cognition target exercises are a time-based approach that is not symptom-conditioned (not based on fatigue or pain). It includes functional and dynamic exercises.
ACTIVE_COMPARATOR: Conventional physiotherapy; Conventional physiotherapy will be applied including standard exercises and electrical stimulation.	Other: Pelvic floor stretching exercises; Pelvic floor stretching exercises; consists of stretching exercises involving the pelvic floor muscles and surrounding group muscles (such as piriformis, hamstring, adductor group muscles and lumbar extensors).; Device: Transcutaneous electrical nerve stimulation; It will be used with superficial electrodes attached to the suprapubic region of the patients for 20 minutes in each session.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
severity of symptoms	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.	change in severity of symptoms from baseline up to end of 6th week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
severity of pain	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.	change in severity of pain from baseline up to end of 6th week
Pain cognitions	Pain Catastrophizing Scale and Pain Self-Efficacy Questionnaire will be used to assess individuals' cognitions about pain (catastrophizing and self-efficacy).	change in pain cognitions from baseline up to end of 6th week
urinary symptoms	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.	change in urinary symptoms from baseline up to end of 6th week
severity of disability	The Pain Disability Index will be used to question the impact of individuals' daily life due to their pain and the resulting disability.	change in severity of disability from baseline up to end of 6th week
psychological distress	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.	change in psychological distress from baseline up to end of 6th week
quality of life of the patients	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).	change in quality of life from baseline up to end of 6th week

Collaborators and Investigators

• Sponsor: Hacettepe University
• Investigators: Principal Investigator: Ceren Gürşen, PhD, Hacettepe University

Publications and helpful links

General Publications

• Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
• Nicholas MK. The pain self-efficacy questionnaire: Taking pain into account. Eur J Pain. 2007 Feb;11(2):153-63. doi: 10.1016/j.ejpain.2005.12.008. Epub 2006 Jan 30.
• Ware JE Jr. SF-36 health survey update. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3130-9. doi: 10.1097/00007632-200012150-00008. No abstract available.
• O'Leary MP, Sant GR, Fowler FJ Jr, Whitmore KE, Spolarich-Kroll J. The interstitial cystitis symptom index and problem index. Urology. 1997 May;49(5A Suppl):58-63. doi: 10.1016/s0090-4295(99)80333-1.
• Von Korff M, Jensen MP, Karoly P. Assessing global pain severity by self-report in clinical and health services research. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3140-51. doi: 10.1097/00007632-200012150-00009. No abstract available.
• Suren M, Okan I, Gokbakan AM, Kaya Z, Erkorkmaz U, Arici S, Karaman S, Kahveci M. Factors associated with the pain catastrophizing scale and validation in a sample of the Turkish population. Turk J Med Sci. 2014;44(1):104-8. doi: 10.3906/sag-1206-67.
• Pollard CA. Preliminary validity study of the pain disability index. Percept Mot Skills. 1984 Dec;59(3):974. doi: 10.2466/pms.1984.59.3.974. No abstract available.
• Fitzgerald MP, Anderson RU, Potts J, Payne CK, Peters KM, Clemens JQ, Kotarinos R, Fraser L, Cosby A, Fortman C, Neville C, Badillo S, Odabachian L, Sanfield A, O'Dougherty B, Halle-Podell R, Cen L, Chuai S, Landis JR, Mickelberg K, Barrell T, Kusek JW, Nyberg LM; Urological Pelvic Pain Collaborative Research Network. Randomized multicenter feasibility trial of myofascial physical therapy for the treatment of urological chronic pelvic pain syndromes. J Urol. 2013 Jan;189(1 Suppl):S75-85. doi: 10.1016/j.juro.2012.11.018.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 12, 2021
• Primary Completion (ANTICIPATED): October 15, 2022
• Study Completion (ANTICIPATED): October 15, 2022

Study Registration Dates

• First Submitted: December 10, 2021
• First Submitted That Met QC Criteria: December 10, 2021
• First Posted (ACTUAL): December 13, 2021

Study Record Updates

• Last Update Posted (ACTUAL): January 3, 2022
• Last Update Submitted That Met QC Criteria: December 13, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: chronic pain; pain neuroscience education; Interstitial Cystitis; Bladder Pain Syndrome
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Urologic Diseases; Urinary Bladder Diseases; Disease; Syndrome; Cystitis; Somatoform Disorders; Cystitis, Interstitial
• Other Study ID Numbers: KA- 21109

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No