Biopsychosocial and Conventional Approach in Bladder Pain Syndrome

Interstitial Cystitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05155384
• Other study ID #: KA- 21109
• Status: Recruiting
• Phase: N/A
• Start date: November 12, 2021
• Est. completion date: October 15, 2022

Study information

• Verified date: December 2021
• Source: Hacettepe University
• Contact: Ceren Gursen, PhD
• Phone: +905380644120
• Email: cerengursen[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 15, 2022
• Est. primary completion date: October 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bladder Pain Syndrome
• Cystitis
• Cystitis, Interstitial
• Interstitial Cystitis
• Somatoform Disorders
• Syndrome

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Turkey	Hacettepe University	Ankara
Turkey	Hacettepe University, Faculty of Physical Therapy and Rehabilitation	Ankara
Turkey	Hacettepe University, Faculty of Physical Therapy and Rehabilitation	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

References & Publications (8)

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. — View Citation

Nicholas MK. The pain self-efficacy questionnaire: Taking pain into account. Eur J Pain. 2007 Feb;11(2):153-63. Epub 2006 Jan 30. — View Citation

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. — View Citation

Pollard CA. Preliminary validity study of the pain disability index. Percept Mot Skills. 1984 Dec;59(3):974. — View Citation

Süren M, Okan I, Gökbakan 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. — View Citation

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. Review. — View Citation

Ware JE Jr. SF-36 health survey update. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3130-9. Review. — View Citation

Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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