About this trial
The goal of this clinical trial is to learn if aerobic exercise training and connective tissue massage, in addition to patient education, can help treat women with bladder pain syndrome. The main questions it aims to answer are:
Does aerobic exercise training and connective tissue massage reduce bladder-related pain severity?
Does this intervention improve urinary symptoms, pain sensitivity, central sensitization-related symptoms, psychological symptoms, and quality of life?
Researchers will compare patient education plus aerobic exercise training and connective tissue massage with patient education alone to see if the combined physiotherapy program is more effective.
Participants will:
Receive patient education about bladder pain syndrome
Be randomly assigned to one of two groups
Receive either patient education alone or patient education together with aerobic exercise training and connective tissue massage for 8 weeks
Complete assessments at the beginning of the study and after 8 weeks
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female individuals aged 18 years or older
Diagnosis of bladder pain syndrome
Bladder-related pain, discomfort, and/or burning symptoms lasting for at least 6 months
Bladder-related symptom severity, including pain, discomfort, and/or burning, of at least 3 cm on the Visual Analog Scale during the last week
Disqualifiers
Presence of acute urinary tract or urogynecological infection
Pregnancy and/or breastfeeding
Diagnosis of pelvic, urological, and/or gynecological malignancy or history of pelvic radiotherapy
Pelvic or abdominal surgery within the last 6 months
Trial design
Parallel
Treatments tested in this trial
Patient Education
BehavioralParticipants will receive patient education about bladder pain syndrome, symptom management, lifestyle recommendations, and strategies to support self-management. This intervention will be provided to both study groups.
Aerobic Exercise Training
BehavioralParticipants in the intervention group will receive an 8-week aerobic exercise training program in addition to patient education.
Connective Tissue Massage
Other interventionParticipants in the intervention group will receive connective tissue massage in addition to patient education and aerobic exercise training. The intervention will be delivered by a physiotherapist according to the study protocol as part of the 8-week multimodal physiotherapy program.
Treatment groups
Trial outcomes
Primary outcomes
Change in Bladder-Related Pain Severity
Bladder-related pain severity will be assessed using a 10-cm Visual Analog Scale. Participants will be asked to mark the point that best represents the most severe bladder-related pain or pain-like discomfort, such as burning, pressure, or discomfort, experienced during the last three days. Scores range from 0 to 10, with higher scores indicating greater pain severity.
Secondary outcomes
Change in Bladder Pain Syndrome-Related Symptom Severity
Bladder pain syndrome-related symptom severity will be assessed using the Interstitial Cystitis Symptom Index. The index consists of 4 items assessing urinary urgency, urinary frequency, nocturia, and bladder pain or burning. Total scores range from 0 to 20, with higher scores indicating greater bladder pain syndrome-related symptom severity.
Change in Bladder Pain Syndrome-Related Problem Severity
Bladder pain syndrome-related problem severity will be assessed using the Interstitial Cystitis Problem Index. The index consists of 4 items assessing the extent to which urinary frequency, nocturia, urinary urgency, and bladder pain or burning are experienced as problems. Total scores range from 0 to 16, with higher scores indicating greater bladder pain syndrome-related problem severity.
Change in Pressure Pain Threshold
Pressure pain threshold will be assessed using a digital pressure algometer over the suprapubic region, peroneal region, and ulnar surface of the forearm. The value at which the participant first perceives the applied pressure as painful will be recorded. Three measurements will be taken from each site.
Change in Conditioned Pain Modulation
Conditioned pain modulation will be assessed using pressure pain threshold measurement over the upper trapezius muscle as the test stimulus and a cuff pressure test applied to the contralateral upper extremity as the conditioning stimulus. Pressure pain threshold will be measured before and immediately after the conditioning stimulus.
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