Effects of Visceral Manipulation in Women With Urinary Incontinence

Urinary Incontinence Clinical Trial

Official title:

Effects of Visceral Manipulation Associated With Pelvic Floor Muscles Training in Women With Urinary Incontinence: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03945578
• Other study ID #: Visceral Manipulation
• Status: Completed
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: July 5, 2020

Study information

• Verified date: January 2021
• Source: University of the State of Santa Catarina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: July 5, 2020
• Est. primary completion date: May 10, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Enuresis
• Urinary Incontinence

Intervention

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).
• 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.
• Manual Sham Therapy - MST
The manual sham therapy protocol was perfomed by gentle techniques applied to the thoracic spine, scapular waist and cervical spine

Locations

Country	Name	City	State
Brazil	Center for Health and Sport Sciences of the State University of Santa Catarina	Florianópolis	Santa Catarina

Sponsors (1)

Lead Sponsor	Collaborator
University of the State of Santa Catarina

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Pre intervention, week 3 and 1 week post intervention
Secondary	Change from baseline in vaginal resting pressure	this outcome will be measured by digital perineometer - Peritron 9300®	Pre intervention and 1 week post intervention
Secondary	Change from baseline in maximum voluntary contraction of the pelvic floor muscles	this outcome will be measured by digital perineometer - Peritron 9300®	Pre intervention and 1 week post intervention