Clinical trial NCT05155384: Biopsychosocial and Conventional Approach in Bladder Pain Syndrome
Official title: Comparison of Biopsychosocial and Conventional Approach in the Treatment of Bladder Pain Syndrome/Interstitial Cystitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Interstitial Cystitis
Bladder Pain Syndrome
Keywords: chronic pain
pain neuroscience education
Bladder Pain Syndrome
Interstitial Cystitis
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2021-12-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: severity of symptoms
timeFrame: change in severity of symptoms from baseline up to end of 6th week
Secondary outcomes:
measure: severity of pain
timeFrame: change in severity of pain from baseline up to end of 6th week
measure: Pain cognitions
timeFrame: change in pain cognitions from baseline up to end of 6th week
measure: urinary symptoms
timeFrame: change in urinary symptoms from baseline up to end of 6th week
measure: severity of disability
timeFrame: change in severity of disability from baseline up to end of 6th week
measure: psychological distress
timeFrame: change in psychological distress from baseline up to end of 6th week
measure: quality of life of the patients
timeFrame: change in quality of life from baseline up to end of 6th week
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University, Faculty of Physical Therapy and Rehabilitation
city: Ankara
country: Turkey
facility: Hacettepe University, Faculty of Physical Therapy and Rehabilitation
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
affiliation: Hacettepe University
name: Ceren Gürşen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.