Bladder Pain SyndromeNCT07839689
Aerobic Exercise and Connective Tissue Massage in Painful Bladder Syndrome
A study testing Patient Education, Aerobic Exercise Training and Connective Tissue Massage in people with Bladder Pain Syndrome and Painful Bladder Syndrome, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Bladder Pain Syndrome, Painful Bladder Syndrome, Painful Bladder Syndrome (PBS)
- What is being tested?
- Patient Education, Aerobic Exercise Training and Connective Tissue Massage
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Apr 2026to 30 Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Receiving stable medical treatment
- Being medically suitable for moderate-intensity aerobic exercise according to the Physical Activity Readiness Questionnaire
- Volunteering to participate in the study and signing the informed consent form
- For individuals aged 65 years or older, a Mini-Mental State Examination score of 24 or higher
Who cannot join
- 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
- Presence of congenital urinary system anomalies
- History of neurological disease or diagnosis of neurogenic bladder
- Open wound or active skin infection in the area where manual therapy will be applied
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Hacettepe University Faculty of Physical Therapy and Rehabilitation
Ankara, Ankara
Serap Ozgul, Prof. Dr., +90 312 305 25 25 ext. 173, serapky@yahoo.com
Hilal Yazici Ilhan, Research Assistant, hilalyazici@hacettepe.edu.tr
About this study
Official title: Effects of Aerobic Exercise Training and Connective Tissue Massage in Individuals With Bladder Pain Syndrome
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?
Read more
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
- Conditions
- Bladder Pain Syndrome, Painful Bladder Syndrome, Painful Bladder Syndrome (PBS), Interstitial Cystitis and Bladder Pain Syndrome, Interstitial Cystitis/Painful Bladder Syndrome
- Being tested
- Patient Education, Aerobic Exercise Training, Connective Tissue Massage
- Keywords
- aerobic exercises, Connective Tissue Massage, Bladder Pain Syndrome, Interstitial Cystitis, Physiotherapy
- Medical subject headings
- Cystitis, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient EducationBehavioural
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 TrainingBehavioural
Participants in the intervention group will receive an 8-week aerobic exercise training program in addition to patient education.
Connective Tissue MassageOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Patient Education + Multimodal Physiotherapy | Experimental | 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. Receives: Behavioral: Patient Education; Behavioral: Aerobic Exercise Training; Other: Connective Tissue Massage |
| Patient Education | Active comparator | 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. Receives: Behavioral: Patient Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 8 weeks
Secondary outcomes (11)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2026
- Study start30 Apr 2026
- Primary completion30 Apr 2029 (estimated)
- Study completion30 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder Pain SyndromeStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SERAP ÖZGÜL, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07839689
- Sponsor's protocol ID
- FTREK26/34
- Status last verified
- Sep 2026
- First submitted
- 11 Sep 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The decision regarding individual participant data sharing has not yet been finalized.
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Aerobic Exercise Training and Connective Tissue Massage in Individuals With Bladder Pain Syndrome
- ClinicalTrials.gov ID
- NCT07839689
- Acronym / sponsor ID
- FTREK26/34
- Conditions
- Bladder Pain Syndrome, Painful Bladder Syndrome, Painful Bladder Syndrome (PBS), Interstitial Cystitis and Bladder Pain Syndrome, Interstitial Cystitis/Painful Bladder Syndrome
- Keywords
- aerobic exercises, Connective Tissue Massage, Bladder Pain Syndrome, Interstitial Cystitis, Physiotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 30 Apr 2026 (actual)
- Primary completion
- 30 Apr 2029 (estimated)
- Study completion
- 30 Apr 2029 (estimated)
- First posted
- 24 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient Education + Multimodal Physiotherapy | Experimental | Behavioral: Patient Education, Behavioral: Aerobic Exercise Training, Other: Connective Tissue MassageParticipants 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. |
| Patient Education | Active comparator | Behavioral: Patient EducationParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
- Receiving stable medical treatment
Key exclusion criteria (7 listed)
- 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
- Presence of congenital urinary system anomalies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient EducationParticipants 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. | Behavioural | Patient Education, Patient Education + Multimodal Physiotherapy |
| Aerobic Exercise TrainingParticipants in the intervention group will receive an 8-week aerobic exercise training program in addition to patient education. | Behavioural | Patient Education + Multimodal Physiotherapy |
| Connective Tissue MassageParticipants 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. | Other | Patient Education + Multimodal Physiotherapy |
Primary outcome
Change in Bladder-Related Pain Severity
Time frame: Baseline and 8 weeks
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.
11 secondary outcomes
Change in Bladder Pain Syndrome-Related Symptom Severity
Time frame: Baseline and 8 weeks
Change in Bladder Pain Syndrome-Related Problem Severity
Time frame: Baseline and 8 weeks
Change in Pressure Pain Threshold
Time frame: Baseline and 8 weeks
Change in Conditioned Pain Modulation
Time frame: Baseline and 8 weeks
Change in Central Sensitization-Related Symptoms
Time frame: Baseline and 8 weeks
Change in Anxiety and Depression Symptoms
Time frame: Baseline and 8 weeks
Change in Functional Exercise Capacity
Time frame: Baseline and 8 weeks
Change in Health-Related Quality of Life
Time frame: Baseline and 8 weeks
Subjective Perception of Change in Bladder-Related Pain Symptoms
Time frame: At 8 weeks
Adherence to Exercise and Intervention
Time frame: During the 8-week intervention period
Adherence to Lifestyle Recommendations
Time frame: At 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: Undecided. The decision regarding individual participant data sharing has not yet been finalized.
Related trials for Bladder Pain Syndrome
Enrolling by invitationObservational study
Migraine Medication Effects on Urinary Symptoms
Overactive Bladder, Bladder Pain Syndrome
Recruiting
EPPIC: Easing Pelvic Pain Interventions Clinical Research Program
Urologic Chronic Pelvic Pain Syndrome (UCPPS), Interstitial Cystitis
Recruiting
Investigation of PEMF Therapy for Female Patients With IC/BPS
Interstitial Cystitis, Chronic Interstitial Cystitis
RecruitingPhase 2/3
Amniotic Membrane Therapy for Interstitial Cystitis/Painful Bladder Syndrome
Interstitial Cystitis, Painful Bladder Syndrome
Not yet recruitingPhase 1
Mirogabalin Plus EBMP for IC/BPS
Bladder Pain Syndrome, Educational Behavioral Intervention
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hacettepe University Faculty of Physical Therapy and Rehabilitation
Ankara, Turkey (Türkiye)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Education, Aerobic Exercise Training and Connective Tissue Massage in people with Bladder Pain Syndrome and Painful Bladder Syndrome, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Bladder-Related Pain Severity (time frame: Baseline and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.