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出境医 / 临床实验 / Effects of Visceral Manipulation in Women With Urinary Incontinence

Effects of Visceral Manipulation in Women With Urinary Incontinence

Study Description
Brief Summary:
The objective of the study is to compare the effects of visceral manual therapy associated with pelvic floor muscle training on urinary incontinence symptoms, vaginal resting pressure and maximum voluntary contraction of the pelvic floor muscles in women. This is a randomized controlled trial with double blinding. Participants will be randomized into two groups: control and experimental. Both groups will undergo a pelvic floor muscle training program twice weekly for 5 consecutive weeks. Participants in the intervention group will also receive, once a week, a visceral manual therapy protocol and control group participants will receive a manual sham therapy protocol.

Condition or disease Intervention/treatment Phase
Urinary Incontinence Other: Pelvic Floor muscle training - PFMT Other: Visceral Manual Therapy - VMT Other: Manual Sham Therapy - MST Not Applicable

Detailed Description:
This study is a double-blind randomized controlled trial with two groups. Participants will be evaluated by a trained blinded investigator and assigned randomly to the experimental and control groups. Both groups will undergo a pelvic floor muscle training program twice weekly for 5 consecutive weeks. Participants in the intervention group will also receive, once a week, a visceral manual therapy protocol and control group participants will receive a sham manual therapy protocol. Participants who agree to participate in the survey will sign a Free and Informed Consent Form and will be informed of the possibility of withdrawing from the survey at any stage, without penalty. The collection of the evaluation and intervention will be carried out in a salon Clinic School of Physiotherapy in the Center of Health and Sports Sciences (CEFID) of the State University of Santa Catarina (UDESC) in the city of Florianópolis - SC. All personal identification data of the participants will be preserved according to resolution of the national health council, taking into account the possibility of scientific dissemination of the results obtained. The risks of these procedures will be medium, since the participant may present muscle pain after the intervention protocol. To minimize these risks will be available, if necessary, attendance at the Clinic School of Physiotherapy. The sample will be selected in a non-probabilistic way for convenience. The participants will Female volunteers , aged from 18 years with urinary incontinence.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Visceral Manipulation Associated With Pelvic Floor Muscles Training in Women With Urinary Incontinence: a Randomized Controlled Trial
Actual Study Start Date : July 1, 2019
Actual Primary Completion Date : May 10, 2020
Actual Study Completion Date : July 5, 2020
Arms and Interventions
Arm Intervention/treatment
Active Comparator: Control Group

This group performed a supervised Pelvic Floor Muscle Training (PFMT) protocol associated with a manual sham therapy (MST) sessions.

The PFMT protocol consisted of 20 sessions of 45-60 minutes each, twice a week, totalizing a five weeks treatment.

The MST protocol was performed once a week, during five weeks lasting approximately 15 minutes.

 Other: Pelvic Floor muscle training - PFMT
Pelvic Floor muscle training is an active exercise-based treatment designed to strengthen the pelvic floor muscles. The PFMT protocol was divided into four phases. Proprioceptive (2 weeks): where the woman has gained adequate perception of PFM and control of fast and slow contractions; Simple (1 week): performed with the objective of promoting control of fast and slow contractions associated with small functional exercises; Elaborated (1 week): where the exercise evolved into functional exercises of greater amplitude; and Power (1 week): where the control of the pelvic floor was promoted during efforts. In all sessions, contractions were performed for slow and for fast fibers (the list of exercises and a detailed description of them is in Appendix 1).

Other: Manual Sham Therapy - MST
The manual sham therapy protocol was perfomed by gentle techniques applied to the thoracic spine, scapular waist and cervical spine
Experimental: Experimental Group

The experimental group performed the same PFMT protocol as the CG, but associated with a Visceral Manual Therapy (VMT) protocol.

The VMT sessions were held once a week, for five weeks. Each session lasted approximately 20 minutes.

 Other: Pelvic Floor muscle training - PFMT
Pelvic Floor muscle training is an active exercise-based treatment designed to strengthen the pelvic floor muscles. The PFMT protocol was divided into four phases. Proprioceptive (2 weeks): where the woman has gained adequate perception of PFM and control of fast and slow contractions; Simple (1 week): performed with the objective of promoting control of fast and slow contractions associated with small functional exercises; Elaborated (1 week): where the exercise evolved into functional exercises of greater amplitude; and Power (1 week): where the control of the pelvic floor was promoted during efforts. In all sessions, contractions were performed for slow and for fast fibers (the list of exercises and a detailed description of them is in Appendix 1).

Other: Visceral Manual Therapy - VMT
Visceral manual therapy:is a manual treatment intended to the release of visceral fascias. The VMT protocol was based on the work proposed by Vanderheyden-Busquet (2014). To act on the abdominal and pelvic visceral fasciae, the VMT was performed through slow and deep mobilizations, respecting the participant's tissue resistance and painful response, in different regions of the abdômen.
Outcome Measures
Primary Outcome Measures :
  1. Change from baseline in symptoms of urinary incontinence and its impact on quality of life [ Time Frame: Pre intervention, week 3 and 1 week post intervention ]
    This outcome will be measured through the International Consultation on Incontinence Questionnaire - Short Form. This is a self-administered questionnaire designed to assess the frequency, severity, and impact of urinary incontinence on the quality of life of patients of both sexes. It consists of four items. The first three assess the frequency, severity, and impact of urinary incontinence on quality of life. From the sum of these three items the total score is obtained, which can vary between 0 and 21 points. The higher the score, greater the severity of the symptoms of urinary incontinence. The overall score can be divided into four severity categories: mild (1-5 points), moderate (6-12 points), severe (13-18 points), very severe (19-21 points). The fourth item does not enter the total score but serves to determine the type of urinary incontinence (stress, urgency or mixed).


Secondary Outcome Measures :
  1. Change from baseline in vaginal resting pressure [ Time Frame: Pre intervention and 1 week post intervention ]
    this outcome will be measured by digital perineometer - Peritron 9300®

  2. Change from baseline in maximum voluntary contraction of the pelvic floor muscles [ Time Frame: Pre intervention and 1 week post intervention ]
    this outcome will be measured by digital perineometer - Peritron 9300®


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: having a pre-established complaint or diagnosis of UI symptoms (assessed using the International Consultation on Incontinence Questionnaire - Short Form - ICIQ-UI-SF), age ≥ 18 years, have not undergone drug treatment for UI for at least 6 months; and have not previously performed surgical procedure for UI or PFMT in the 6 months before the research.

Exclusion Criteria: diagnosis or signs and symptoms of neurological diseases (self-report), BMI ≥35, gestational period, ongoing gynecological disease, initiate drug treatment for UI during the research, not reaching 80% attendance at intervention sessions, pelvic organs prolapse with a degree greater than II, absence of pelvic floor muscle contraction during assessment, known aortic aneurysm, acute inflammatory phase of gastrointestinal or genitourinary tract diseases, any other contraindication to performed VMT, or any other condition that would limit the execution of VMT.

Contacts and Locations

Locations
Layout table for location information
Brazil
Center for Health and Sport Sciences of the State University of Santa Catarina
Florianópolis, Santa Catarina, Brazil, 88080350
Sponsors and Collaborators
University of the State of Santa Catarina
Tracking Information
First Submitted Date  ICMJE May 3, 2019
First Posted Date  ICMJE May 10, 2019
Last Update Posted Date January 26, 2021
Actual Study Start Date  ICMJE July 1, 2019
Actual Primary Completion Date May 10, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 23, 2021) 		Change from baseline in symptoms of urinary incontinence and its impact on quality of life [ Time Frame: Pre intervention, week 3 and 1 week post intervention ]
This outcome will be measured through the International Consultation on Incontinence Questionnaire - Short Form. This is a self-administered questionnaire designed to assess the frequency, severity, and impact of urinary incontinence on the quality of life of patients of both sexes. It consists of four items. The first three assess the frequency, severity, and impact of urinary incontinence on quality of life. From the sum of these three items the total score is obtained, which can vary between 0 and 21 points. The higher the score, greater the severity of the symptoms of urinary incontinence. The overall score can be divided into four severity categories: mild (1-5 points), moderate (6-12 points), severe (13-18 points), very severe (19-21 points). The fourth item does not enter the total score but serves to determine the type of urinary incontinence (stress, urgency or mixed).
Original Primary Outcome Measures  ICMJE
 (submitted: May 8, 2019) 		Change from baseline in symptoms of urinary incontinence and its impact on quality of life [ Time Frame: Pre intervention and 1 week post intervention ]
This outcome will be measured through the International Consultation on Incontinence Questionnaire - Short Form. This is a self-administered questionnaire designed to assess the frequency, severity, and impact of urinary incontinence on the quality of life of patients of both sexes. It consists of four items. The first three assess the frequency, severity, and impact of urinary incontinence on quality of life. From the sum of these three items the total score is obtained, which can vary between 0 and 21 points. The higher the score, greater the severity of the symptoms of urinary incontinence. The overall score can be divided into four severity categories: mild (1-5 points), moderate (6-12 points), severe (13-18 points), very severe (19-21 points). The fourth item does not enter the total score but serves to determine the type of urinary incontinence (stress, urgency or mixed).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 23, 2021)
  • Change from baseline in vaginal resting pressure [ Time Frame: Pre intervention and 1 week post intervention ]
    this outcome will be measured by digital perineometer - Peritron 9300®
  • Change from baseline in maximum voluntary contraction of the pelvic floor muscles [ Time Frame: Pre intervention and 1 week post intervention ]
    this outcome will be measured by digital perineometer - Peritron 9300®
Original Secondary Outcome Measures  ICMJE
 (submitted: May 8, 2019)
  • Change from baseline in Thickness of the anterior wall of the bladder [ Time Frame: Pre intervention and 1 week post intervention ]
    this outcome will be measured through abdominal ultrasound - Nanomax; Sonosite, Bothell, WA, EUA, - transductor of 3-5 mhz
  • Change from baseline in resting tonus of the perineum muscles. [ Time Frame: Pre intervention and 1 week post intervention ]
    this outcome will be measured by digital perineometer - Peritron 9300®
  • Change from baseline in the capacity of contraction of the perineum muscles. [ Time Frame: Pre intervention and 1 week post intervention ]
    this outcome will be measured by digital perineometer - Peritron 9300®
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Visceral Manipulation in Women With Urinary Incontinence
Official Title  ICMJE Effects of Visceral Manipulation Associated With Pelvic Floor Muscles Training in Women With Urinary Incontinence: a Randomized Controlled Trial
Brief Summary The objective of the study is to compare the effects of visceral manual therapy associated with pelvic floor muscle training on urinary incontinence symptoms, vaginal resting pressure and maximum voluntary contraction of the pelvic floor muscles in women. This is a randomized controlled trial with double blinding. Participants will be randomized into two groups: control and experimental. Both groups will undergo a pelvic floor muscle training program twice weekly for 5 consecutive weeks. Participants in the intervention group will also receive, once a week, a visceral manual therapy protocol and control group participants will receive a manual sham therapy protocol.
Detailed Description This study is a double-blind randomized controlled trial with two groups. Participants will be evaluated by a trained blinded investigator and assigned randomly to the experimental and control groups. Both groups will undergo a pelvic floor muscle training program twice weekly for 5 consecutive weeks. Participants in the intervention group will also receive, once a week, a visceral manual therapy protocol and control group participants will receive a sham manual therapy protocol. Participants who agree to participate in the survey will sign a Free and Informed Consent Form and will be informed of the possibility of withdrawing from the survey at any stage, without penalty. The collection of the evaluation and intervention will be carried out in a salon Clinic School of Physiotherapy in the Center of Health and Sports Sciences (CEFID) of the State University of Santa Catarina (UDESC) in the city of Florianópolis - SC. All personal identification data of the participants will be preserved according to resolution of the national health council, taking into account the possibility of scientific dissemination of the results obtained. The risks of these procedures will be medium, since the participant may present muscle pain after the intervention protocol. To minimize these risks will be available, if necessary, attendance at the Clinic School of Physiotherapy. The sample will be selected in a non-probabilistic way for convenience. The participants will Female volunteers , aged from 18 years with urinary incontinence.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Urinary Incontinence
Intervention  ICMJE
  • Other: Pelvic Floor muscle training - PFMT
    Pelvic Floor muscle training is an active exercise-based treatment designed to strengthen the pelvic floor muscles. The PFMT protocol was divided into four phases. Proprioceptive (2 weeks): where the woman has gained adequate perception of PFM and control of fast and slow contractions; Simple (1 week): performed with the objective of promoting control of fast and slow contractions associated with small functional exercises; Elaborated (1 week): where the exercise evolved into functional exercises of greater amplitude; and Power (1 week): where the control of the pelvic floor was promoted during efforts. In all sessions, contractions were performed for slow and for fast fibers (the list of exercises and a detailed description of them is in Appendix 1).
  • Other: Visceral Manual Therapy - VMT
    Visceral manual therapy:is a manual treatment intended to the release of visceral fascias. The VMT protocol was based on the work proposed by Vanderheyden-Busquet (2014). To act on the abdominal and pelvic visceral fasciae, the VMT was performed through slow and deep mobilizations, respecting the participant's tissue resistance and painful response, in different regions of the abdômen.
  • Other: Manual Sham Therapy - MST
    The manual sham therapy protocol was perfomed by gentle techniques applied to the thoracic spine, scapular waist and cervical spine
Study Arms  ICMJE
  • Active Comparator: Control Group

    This group performed a supervised Pelvic Floor Muscle Training (PFMT) protocol associated with a manual sham therapy (MST) sessions.

    The PFMT protocol consisted of 20 sessions of 45-60 minutes each, twice a week, totalizing a five weeks treatment.

    The MST protocol was performed once a week, during five weeks lasting approximately 15 minutes.

    Interventions:
    • Other: Pelvic Floor muscle training - PFMT
    • Other: Manual Sham Therapy - MST
  • Experimental: Experimental Group

    The experimental group performed the same PFMT protocol as the CG, but associated with a Visceral Manual Therapy (VMT) protocol.

    The VMT sessions were held once a week, for five weeks. Each session lasted approximately 20 minutes.

    Interventions:
    • Other: Pelvic Floor muscle training - PFMT
    • Other: Visceral Manual Therapy - VMT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 23, 2021) 		52
Original Estimated Enrollment  ICMJE
 (submitted: May 8, 2019) 		46
Actual Study Completion Date  ICMJE July 5, 2020
Actual Primary Completion Date May 10, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria: having a pre-established complaint or diagnosis of UI symptoms (assessed using the International Consultation on Incontinence Questionnaire - Short Form - ICIQ-UI-SF), age ≥ 18 years, have not undergone drug treatment for UI for at least 6 months; and have not previously performed surgical procedure for UI or PFMT in the 6 months before the research.

Exclusion Criteria: diagnosis or signs and symptoms of neurological diseases (self-report), BMI ≥35, gestational period, ongoing gynecological disease, initiate drug treatment for UI during the research, not reaching 80% attendance at intervention sessions, pelvic organs prolapse with a degree greater than II, absence of pelvic floor muscle contraction during assessment, known aortic aneurysm, acute inflammatory phase of gastrointestinal or genitourinary tract diseases, any other contraindication to performed VMT, or any other condition that would limit the execution of VMT.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03945578
Other Study ID Numbers  ICMJE Visceral Manipulation
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gilmar Moraes Santos, PT, University of the State of Santa Catarina
Study Sponsor  ICMJE University of the State of Santa Catarina
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of the State of Santa Catarina
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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