Physiotherapeutic Interventions Applied to the Bladder Pain Syndrome

NCT03755375 | Completed

• 1 other identifier: 61595016.0.0000.0068
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Related to urological and gynecological systems, patients with Bladdeer Pain Syndrome (BPS) often present pain, pressure and chronic discomfort in suprapubic and perineal area associated with low urinary tract symptoms. This condition can generates a negative impact in cognitive, social, behavioral and sexual quality of life. As Bladder Pain Syndrome originates from different causes and includes the genitourinary, gastrointestinal, musculoskeletal and neuropsychological systems, a multidisciplinary approach is needed with doctors,physiotherapists, psychologists and others. Physiotherapeutic interventions are recommended as a conservative treatment for patients with BPS. The physiotherapeutic interventions include the use of Biofeedback to relax the pelvic floor muscles and manual therapy (myofascial trigger points release) to decrease muscle tension. Transcutaneous electrostimulation (TENS) is used to decrease the pain and postural exercises to improve the pelvic mobility. In this study, our hypothesis was that women with BPS presented musculoskeletal dysfunction, and we tested a different physiotherapy approach that was not being used. The reason for that understanding was the presence of refractory urinary and pain symptoms notwithstanding the physiotherapy conventional treatment, such as manual therapy and biofeedback. To test our hypothesis, we decided to add either TENS or postural exercises to the conventional treatment. The objective of this study was to verify the effects of biofeedback (BF) and manual therapy (MT) associated with transcutaneous electrical nerve stimulation (TENS) or postural exercises (PE) in the treatment of bladder pain syndrome (BPS) in women regarding pain and urinary symptoms.

Conditions

Interstitial Cystitis; Painful Bladder Syndrome; Bladder Pain Syndrome

Keywords

Bladder pain syndrome; Physical therapy; Postural balance; Manual therapy; Biofeedback

Outcome Measures

Primary Outcomes (2)

• Pain symptoms

  Change from Baseline in pain sympotms on the Visual Analog Scale after treatment

  up to 3 months

• Urinary symptoms

  Change from Baseline in urinary symptoms on the O'Leary- Sant Urinary symptoms and problems score after treatment

  up to 3 months

Secondary Outcomes (1)

• Sexual activity

  up to 3 months

Study Arms (3)

E-stim Group

ACTIVE COMPARATOR

TENS group was treated with biofeedback, manual therapy, andtranscutaneous electrostimulation (TENS), a peripheral neuromodulation to promote analgesia in pain areas, using two transcutaneous self-adhesive electrodes Axelgaard 5 cm x 5 cm with 2 cm of distance between them. The parameters used were frequency = 100 Hz, pulse width = 50-100 µs, and current intensity according to the patient's sensitivity.

Device: TENS; Device: Biofeedback; Behavioral: Manual therapy

Postural Group

ACTIVE COMPARATOR

Postural group was treated with biofeedback, manual therapy, and postural exercises , which promoted pelvic mobility and functional training associated with respiratory exercises increasing the diaphragmatic excursion.Postural exercises consisted of 10 repetitions of breathing exercises in the lay-down position, 10 repetitions of hip anteversion and retroversion in the sitting position, and 10 repetitions of hip anteversion, retroversion, and lateral movement in the stand-up position.

Behavioral: Postural exercises; Device: Biofeedback; Behavioral: Manual therapy

Conventional Group

ACTIVE COMPARATOR

Conventional group was treated with biofeedback for pelvic floor relaxation and manual therapy to release the tension in the suprapubic, pelvic, and intravaginal areas. The manual therapy consisted of a myofascial trigger point release maneuver using digital pressure and muscle fiber stretching in pain areas. Biofeedback consisted of pelvic floor muscle coordination and relaxation exercises using intravaginal probes. The training program was initiated with 10 fast contractions with 5 seconds of relaxation between them followed by 10 sustained contractions of 5 seconds with 10 seconds of relaxation between them. Finally, one minute of pelvic floor relaxation was performed.

Device: Biofeedback; Behavioral: Manual therapy

Interventions

TENS DEVICE

transcutaneous electrostimulation to improve the pain.

E-stim Group

Postural exercises BEHAVIORAL

breathing exercises in the lay-down position, hip anteversion and retroversion in the sitting position, and anteversion, retroversion, and lateral movement in the stand-up position

Postural Group

Biofeedback DEVICE

pelvic floor muscle coordination and relaxation exercises using intravaginal probes

Conventional Group; E-stim Group; Postural Group

Manual therapy BEHAVIORAL

myofascial trigger point release maneuver using digital pressure and muscle fiber stretching in pain areas

Conventional Group; E-stim Group; Postural Group

Eligibility Criteria

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

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Universidade de São Paulo

São Paulo, 05403-000, Brazil

Location

MeSH Terms

Conditions

Cystitis, Interstitial

Interventions

Transcutaneous Electric Nerve Stimulation; Biofeedback, Psychology; Musculoskeletal Manipulations

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)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia; Mind-Body Therapies; Complementary Therapies; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Study Officials

• Clarice Tanaka, PhD

  University of Sao Paulo

  STUDY DIRECTOR

• Homero Bruschini, PhD

  University of Sao Paulo

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: After the assessment, participants were blinded randomized by a mask researcher using random.org and allocated into three groups of treatment (TENS, Postural and Conventional) held over 10 sessions once a week.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: Randomized control trial. All patients will be randomized by the computer (www.random.org) in 3 groups of treatment. Then, they were assessed by specialized physiotherapists through a medical history data; application of validated questionnaires of pain, urinary symptoms, sexual function and quality of life; pelvic floor muscles physical and surface electromyographic assessment. Patients were randomized to 3 different treatment groups, and treatment consisted by 10 sessions, once a week. TENS group was treated using Biofeedback , manual therapy and transcutaneous electrostimulation. Postural group was treated using Biofeedback , manual therapy and postural exercises. Conventional group was treated using Biofeedback and manual therapy. All participants were evaluated post treatment and at 3 months of follow-up using the same procedures of the initial assessment.

Study Record Dates

• First Submitted: October 11, 2018
• First Posted: November 28, 2018
• Study Start: February 5, 2018
• Primary Completion: December 19, 2019
• Study Completion: December 19, 2019
• Last Updated: May 16, 2023

Record last verified: 2023-05

Locations

BR (1)