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Effects of Visceral Manipulation in Women With Urinary Incontinence

Primary Purpose

Urinary Incontinence

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Pelvic Floor muscle training - PFMT
Visceral Manual Therapy - VMT
Manual Sham Therapy - MST
Sponsored by
University of the State of Santa Catarina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Incontinence

Eligibility Criteria

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

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.

Sites / Locations

  • Center for Health and Sport Sciences of the State University of Santa Catarina

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control Group

Experimental Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change from baseline in symptoms of urinary incontinence and its impact on quality of life
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

Change from baseline in vaginal resting pressure
this outcome will be measured by digital perineometer - Peritron 9300®
Change from baseline in maximum voluntary contraction of the pelvic floor muscles
this outcome will be measured by digital perineometer - Peritron 9300®

Full Information

First Posted
May 3, 2019
Last Updated
January 23, 2021
Sponsor
University of the State of Santa Catarina
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1. Study Identification

Unique Protocol Identification Number
NCT03945578
Brief Title
Effects of Visceral Manipulation in Women With Urinary Incontinence
Official Title
Effects of Visceral Manipulation Associated With Pelvic Floor Muscles Training in Women With Urinary Incontinence: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
May 10, 2020 (Actual)
Study Completion Date
July 5, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of the State of Santa Catarina

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Pelvic Floor muscle training - PFMT
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Visceral Manual Therapy - VMT
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Manual Sham Therapy - MST
Intervention Description
The manual sham therapy protocol was perfomed by gentle techniques applied to the thoracic spine, scapular waist and cervical spine
Primary Outcome Measure Information:
Title
Change from baseline in symptoms of urinary incontinence and its impact on quality of life
Description
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).
Time Frame
Pre intervention, week 3 and 1 week post intervention
Secondary Outcome Measure Information:
Title
Change from baseline in vaginal resting pressure
Description
this outcome will be measured by digital perineometer - Peritron 9300®
Time Frame
Pre intervention and 1 week post intervention
Title
Change from baseline in maximum voluntary contraction of the pelvic floor muscles
Description
this outcome will be measured by digital perineometer - Peritron 9300®
Time Frame
Pre intervention and 1 week post intervention

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Center for Health and Sport Sciences of the State University of Santa Catarina
City
Florianópolis
State/Province
Santa Catarina
ZIP/Postal Code
88080350
Country
Brazil

12. IPD Sharing Statement

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Effects of Visceral Manipulation in Women With Urinary Incontinence

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