Aerobic Exercise and Connective Tissue Massage in Painful Bladder Syndrome

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorHacettepe University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Patient Education

    Behavioral

    Participants 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

    Behavioral

    Participants in the intervention group will receive an 8-week aerobic exercise training program in addition to patient education.

  • Connective Tissue Massage

    Other intervention

    Participants 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

36 Participants
are divided into 2 treatment groups
Group A: Patient Education + Multimodal PhysiotherapyExperimental treatment 3 interventions
Group B: Patient EducationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline and 8 weeks

Secondary outcomes

1

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.

Time frame
Baseline and 8 weeks
2

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.

Time frame
Baseline and 8 weeks
3

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.

Time frame
Baseline and 8 weeks
4

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.

Time frame
Baseline and 8 weeks

Other outcomes

Sponsors and contacts

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