Aerobic Exercise and Connective Tissue Massage in Painful Bladder Syndrome

NCT07839689 — Not applicable, Recruiting, 36 participants, Hacettepe University

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Effects of Aerobic Exercise Training and Connective Tissue Massage in Individuals With Bladder Pain Syndrome

RegistryNCT07839689
StatusRecruiting
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: single, treatment
Enrollment36 (Estimated)
SponsorHacettepe University (Other)
ConditionsBladder Pain Syndrome, Painful Bladder Syndrome, Painful Bladder Syndrome (PBS), Interstitial Cystitis and Bladder Pain Syndrome, Interstitial Cystitis/Painful Bladder Syndrome
InterventionsPatient Education, Aerobic Exercise Training, Connective Tissue Massage (Behavioral, other)
Datesstart 2026-04-30, primary completion 2029-04-30 (estimated), completion 2029-04-30 (estimated), first posted 2026-09-24, last updated 2026-09-24
Locations1 site in Turkey (Türkiye)

Related Papers Related Patents Related Grants Related Experts
All trials for Bladder Pain Syndrome All trials for Painful Bladder Syndrome All trials of Patient Education All trials of Aerobic Exercise Training

-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. 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

Expand all sections  ·  Collapse all

+Arms and interventions

ArmTypeInterventionsDescription
Patient Education + Multimodal PhysiotherapyExperimentalBehavioral: 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 EducationActive comparatorBehavioral: 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.
  • 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): 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.

+Outcome measures

Primary outcomes

  • Change in Bladder-Related Pain Severity [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.

Secondary outcomes

  • Change in Bladder Pain Syndrome-Related Symptom Severity [Baseline and 8 weeks]: 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 [Baseline and 8 weeks]: 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 [Baseline and 8 weeks]: 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 [Baseline and 8 weeks]: 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.
  • Change in Central Sensitization-Related Symptoms [Baseline and 8 weeks]: 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.
  • Change in Anxiety and Depression Symptoms [Baseline and 8 weeks]: 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.
  • Change in Functional Exercise Capacity [Baseline and 8 weeks]: 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.
  • Change in Health-Related Quality of Life [Baseline and 8 weeks]: 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.
  • Subjective Perception of Change in Bladder-Related Pain Symptoms [At 8 weeks]: 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.
  • Adherence to Exercise and Intervention [During the 8-week intervention period]: 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.
  • Adherence to Lifestyle Recommendations [At 8 weeks]: 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.

+Eligibility

Sex: Female, ages: 18 Years to any

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

+Locations (1)

FacilityCityCountryStatus
Hacettepe University Faculty of Physical Therapy and RehabilitationAnkara, AnkaraTurkey (Türkiye)Recruiting