Effects of Visceral Manipulation in Women With Urinary Incontinence

NCT03945578 | Completed

• 1 other identifier: Visceral Manipulation
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change from baseline in vaginal resting pressure

  Pre intervention and 1 week post intervention

• Change from baseline in maximum voluntary contraction of the pelvic floor muscles

  Pre intervention and 1 week post intervention

Study Arms (2)

Control Group

ACTIVE COMPARATOR

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; Other: Manual Sham Therapy - MST

Experimental Group

EXPERIMENTAL

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; Other: Visceral Manual Therapy - VMT

Interventions

Pelvic Floor muscle training - PFMT OTHER

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).

Control Group; Experimental Group

Visceral Manual Therapy - VMT OTHER

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.

Experimental Group

Manual Sham Therapy - MST OTHER

The manual sham therapy protocol was perfomed by gentle techniques applied to the thoracic spine, scapular waist and cervical spine

Control Group

Eligibility Criteria

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

Sponsors & Collaborators

• University of the State of Santa Catarina: lead

Study Sites (1)

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

Florianópolis, Santa Catarina, 88080350, Brazil

Location

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: May 3, 2019
• First Posted: May 10, 2019
• Study Start: July 1, 2019
• Primary Completion: May 10, 2020
• Study Completion: July 5, 2020
• Last Updated: January 26, 2021

Record last verified: 2021-01

Locations

BR (1)