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Physiotherapeutic Interventions Applied to the Bladder Pain Syndrome

Primary Purpose

Interstitial Cystitis, Painful Bladder Syndrome, Bladder Pain Syndrome

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
TENS
Postural exercises
Biofeedback
Manual therapy
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Interstitial Cystitis focused on measuring Bladder pain syndrome, Physical therapy, Postural balance, Manual therapy, Biofeedback

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Participants are eligible for this multicenter RCT if they meet the following:

    1. Participant has signed and dated the appropriate Informed Consent document.
    2. Agreed to participate in study procedures.
    3. Participant reports a response of at least 1 on the pain, pressure or discomfort scale.

Participant reports an unpleasant sensation of pain, pressure or discomfort, perceived to be related to the bladder and/or pelvic region, associated with lower urinary tract symptoms for the majority of the time during the last 6 months.

Exclusion Criteria:

  • Individuals will not be eligible for enrollment in the multicenter RCT if they meet any of the criteria listed below:

    1. Oncology patients
    2. Previous pelvic radiotherapy treatment
    3. Systemic or neurological diseases that can compromise the pelvic structures or organs
    4. Patients with cognitive deficiency

Sites / Locations

  • Universidade de São Paulo

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

E-stim Group

Postural Group

Conventional Group

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Pain symptoms
Change from Baseline in pain sympotms on the Visual Analog Scale after treatment
Urinary symptoms
Change from Baseline in urinary symptoms on the O'Leary- Sant Urinary symptoms and problems score after treatment

Secondary Outcome Measures

Sexual activity
Change from Baseline in Female sexual function index score after treatment

Full Information

First Posted
October 11, 2018
Last Updated
May 11, 2023
Sponsor
University of Sao Paulo General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03755375
Brief Title
Physiotherapeutic Interventions Applied to the Bladder Pain Syndrome
Official Title
The Effects of Physiotherapeutic Interventions Applied to the Bladder Pain Syndrome: A Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
February 5, 2018 (Actual)
Primary Completion Date
December 19, 2019 (Actual)
Study Completion Date
December 19, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
In the initial assessment, two specialized and trained physiotherapists applied a demographic questionnaire to identify the characteristics of the sample and validated questionnaires of perineal and suprapubic pain (Visual Analog Scale of Pain [VAS])(21) to quantify the pain; urinary symptoms and problems (O'Leary-Sant - The Interstitial Cystitis Symptom and Problem Index) (22) to evaluate the presence of urgency, frequency, nocturia and to quantify how much these symptoms represent a problem to the patients, and the Female Sexual Function Index (FSFI) (23) to evaluate the impact on sexual life. Then, a physical assessment by the inspection and palpation of pelvic and perineal areas was made to identify myofascial trigger points. 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. All participants needed to attend the whole treatment to be included with a maximum delay of 2 weeks to start treatment. 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. TENS group was treated with biofeedback, manual therapy, and transcutaneous 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. 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. The biofeedback and TENS device used was a Myotrac Infiniti T9800 (Thought Technology Ltda., Montreal, Canada, ISO 13485:2016ISO 13485:2016), a 2-channel system of surface electromyography and electrostimulation using the Biograph Infiniti platform. For biofeedback training, we used intravaginal electrodes St-Cloud/Femelex 6.9 cm. All participants were evaluated post treatment and at 3 months of follow-up using the same procedures of the initial assessment. All participants were instructed to perform home training daily 3 times/day during treatment and completed an exercise diary to demonstrate adherence to treatment. TENS and Conventional groups were instructed to perform pelvic floor relaxation exercises, and Postural group was instructed to perform pelvic floor relaxation exercises plus postural exercises.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Interstitial Cystitis, Painful Bladder Syndrome, Bladder Pain Syndrome
Keywords
Bladder pain syndrome, Physical therapy, Postural balance, Manual therapy, Biofeedback

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Participant
Masking Description
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.
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
E-stim Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Postural Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Conventional Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
TENS
Intervention Description
transcutaneous electrostimulation to improve the pain.
Intervention Type
Behavioral
Intervention Name(s)
Postural exercises
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Biofeedback
Intervention Description
pelvic floor muscle coordination and relaxation exercises using intravaginal probes
Intervention Type
Behavioral
Intervention Name(s)
Manual therapy
Intervention Description
myofascial trigger point release maneuver using digital pressure and muscle fiber stretching in pain areas
Primary Outcome Measure Information:
Title
Pain symptoms
Description
Change from Baseline in pain sympotms on the Visual Analog Scale after treatment
Time Frame
up to 3 months
Title
Urinary symptoms
Description
Change from Baseline in urinary symptoms on the O'Leary- Sant Urinary symptoms and problems score after treatment
Time Frame
up to 3 months
Secondary Outcome Measure Information:
Title
Sexual activity
Description
Change from Baseline in Female sexual function index score after treatment
Time Frame
up to 3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: women with a diagnosis of BPS according to NIH clinical criteria ≥ 18 years old, who presented symptoms of perineal and suprapubic pain, using painkillers, anticholinergics, antidepressants, and anticonvulsants for at least 6 months, and exhibited absence of urinary infection for at least 3 months for the initial assessment. Exclusion criteria: women with positive uroculture, under actual or previous oncologic treatment, with systemic or neurological diseases that could compromise pelvic structures, with cognitive deficiency that compromised the understanding of the provided instructions and those who refused to participate in the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clarice Tanaka, PhD
Organizational Affiliation
University of Sao Paulo
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Homero Bruschini, PhD
Organizational Affiliation
University of Sao Paulo
Official's Role
Study Chair
Facility Information:
Facility Name
Universidade de São Paulo
City
Sao Paulo
ZIP/Postal Code
05403-000
Country
Brazil

12. IPD Sharing Statement

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Physiotherapeutic Interventions Applied to the Bladder Pain Syndrome

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