An interventional study of Patient Education and Aerobic Exercise Training in Bladder Pain Syndrome, Painful Bladder Syndrome and Painful Bladder Syndrome (PBS), sponsored by Hacettepe University. Recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by Hacettepe University · Not applicable, Interventional, and Treatment
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
236 studies on the registry are indexed under Cystitis, Interstitial; 35 are open to participants now.
This study's planned enrollment of 36 is below the median of 51 across 158 interventional studies indexed under Cystitis, Interstitial.
Browse Cystitis, Interstitial studies →Hacettepe University is the lead sponsor of 1,007 studies on the registry; 214 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this group will receive patient education together with an 8-week multimodal physiotherapy program including aerobic exercise training and connective tissue massage. The interventions will be delivered according to the planned protocol. Each session will last approximately 70 to 75 minutes.
Behavioral: Patient Education · Behavioral: Aerobic Exercise Training · Other: Connective Tissue Massage
Participants in this group will receive patient education alone. During the study period, participants will be followed at regular two-week intervals. During these follow-ups, symptom status will be checked and brief reminders about lifestyle and symptom management recommendations provided during patient education will be given.
Behavioral: Patient Education
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.
Participants in the intervention group will receive an 8-week aerobic exercise training program in addition to patient education.
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.
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
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
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
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
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
Change in Central Sensitization-Related Symptoms
Central sensitization-related symptoms will be assessed using the Central Sensitization Inventory. The scale includes 25 items related to symptoms such as pain, fatigue, sleep disturbance, cognitive complaints, and emotional symptoms. Total scores range from 0 to 100, with higher scores indicating greater central sensitization-related symptom burden.
Time frame: Baseline and 8 weeks
Change in Anxiety and Depression Symptoms
Anxiety and depression symptoms will be assessed using the Hospital Anxiety and Depression Scale. The scale consists of 14 items and includes two 7-item subscales evaluating anxiety and depression. Scores for each subscale range from 0 to 21, with higher scores indicating greater anxiety or depression symptom severity.
Time frame: Baseline and 8 weeks
Change in Functional Exercise Capacity
Functional exercise capacity will be assessed using the 6-Minute Walk Test. Participants will be asked to walk as far as possible without running for 6 minutes in a suitable corridor. The total distance walked will be recorded in meters.
Time frame: Baseline and 8 weeks
Change in Health-Related Quality of Life
Health-related quality of life will be assessed using the 12-Item Short Form Health Survey. The questionnaire yields Physical Component Summary and Mental Component Summary scores. Each score ranges from 0 to 100, with higher scores indicating better physical or mental health-related quality of life.
Time frame: Baseline and 8 weeks
Subjective Perception of Change in Bladder-Related Pain Symptoms
Participants' perceived change in bladder-related pain symptoms compared with the beginning of treatment will be assessed using a 7-point subjective perception of change scale. Scores range from 1 to 7, where 1 indicates markedly worse, 4 indicates no change, and 7 indicates markedly improved. Higher scores indicate greater perceived improvement.
Time frame: At 8 weeks
Adherence to Exercise and Intervention
Adherence to the intervention will be assessed based on attendance at clinical sessions and continuation of out-of-clinic aerobic exercises. Attendance at clinical sessions will be recorded after each session. Adherence to out-of-clinic aerobic exercises will be monitored using exercise diaries kept by participants and the physiotherapist, and adherence will be calculated as a percentage.
Time frame: During the 8-week intervention period
Adherence to Lifestyle Recommendations
Adherence to lifestyle recommendations will be assessed using a Numeric Rating Scale. Participants will be asked to rate their overall adherence to the lifestyle recommendations on a scale from 0 to 10, where 0 indicates no adherence and 10 indicates complete adherence.
Time frame: At 8 weeks
Plan to share: Undecided — The decision regarding individual participant data sharing has not yet been finalized.
No publications or documents are linked to this record.
Started Apr 2026 (actual). Primary completion is estimated for Apr 2029, 36 months after the start.
Of 35 non-industry interventional studies with no phase under Cystitis, Interstitial, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 34. This study's planned 36 months is above that.
Counting every sponsor, half of 39 studies reached it within 23 months; a quarter within 16 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
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