Aerobic Exercise and Connective Tissue Massage in Painful Bladder Syndrome

NCT07839689 | Recruiting

• 1 other identifier: FTREK26/34
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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

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

Outcome Measures

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.

  Baseline and 8 weeks

Secondary Outcomes (11)

• Change in Bladder Pain Syndrome-Related Symptom Severity

  Baseline and 8 weeks

• Change in Bladder Pain Syndrome-Related Problem Severity

  Baseline and 8 weeks

• Change in Pressure Pain Threshold

  Baseline and 8 weeks

• Change in Conditioned Pain Modulation

  Baseline and 8 weeks

• Change in Central Sensitization-Related Symptoms

  Baseline and 8 weeks

Study Arms (2)

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.

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.

Behavioral: Patient Education

Interventions

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.

Patient Education; Patient Education + Multimodal Physiotherapy

Aerobic Exercise Training BEHAVIORAL

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

Patient Education + Multimodal Physiotherapy

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.

Patient Education + Multimodal Physiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University Faculty of Physical Therapy and Rehabilitation

Ankara, Ankara, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Cystitis, Interstitial

Interventions

Patient Education as Topic

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessments will be performed by an assessor who is blinded to group allocation. Due to the nature of the physiotherapy interventions, participants and the care provider delivering the intervention cannot be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: September 11, 2026
• First Posted: September 24, 2026
• Study Start: April 30, 2026
• Primary Completion (Estimated): April 30, 2029
• Study Completion (Estimated): April 30, 2029
• Last Updated: September 24, 2026

Record last verified: 2026-09

Locations

TU (1)