Clinical trial NCT02259712: Effectiveness of Hypopressive Exercises Versus Pelvic-perineal Physiotherapy
Official title: Effectiveness of Hypopressive Exercises Versus Pelvic- Perineal Physiotherapy in Women With Pelvic Floor Dysfunction: Randomised, Single-blinded, Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Floor Disorders
Urinary Incontinence
Fecal Incontinence
Pelvic Pain
Keywords: Women
Pelvic floor disorders
Urinary incontinence
Fecal incontinence
Physical Therapy Modalities
Lead sponsor: University of Alcala
Sponsor class: OTHER
First posted: 2014-10-08
Enrollment: 78
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Introduction: Hypopressive Exercises are included within a method of physiotherapy which was created with the purpose of strengthening the deep muscles of the abdomen without damaging ligamentous and muscular structures of the perineum, also strengthening the muscles of pelvic floor reflexively. Although this technique has been included as treatment and a prevention method of pelvic floor dysfunction, there are few studies supporting its benefits. The investigators hypothesis is that the combination of both physiotherapy treatments will provided the best results for women who suffer pelvic floor dysfunctions.

Objective: To determine whether Hypopressive Exercises are an option to include in the physiotherapy treatment of women suffer at least one pelvic floor dysfunction and whether the results reported are comparable to those provided by pelvic-perineal physiotherapy.

Subjects and methods: A randomized clinical trial, the examiner being blinded unaware of the intervention group to which subjects were assigned. Participants will be randomly assigned to three groups:

1. An experimental group, where the participants will be treated by Hypopressive exercises and hygienic and behavioral measures;
2. Another experimental group where pelvic-perineal physiotherapy will join with Hypopressive exercises and hygienic and behavioral advises;
3. And a third group where will be done pelvic-perineal physiotherapy and hygienic and behavioral measures.

Pre- intervention, immediate post-intervention, 3, 6 and 12 months assessments will be made. The selection criteria will be: adult women who present signs and symptoms that indicate a pelvic floor dysfunction or have a medical diagnosis to confirm it. All participants must understand and sign freely Informed Consent.

Sample size: Accepting an alpha risk of 0.05 and a beta risk of 0.2 in a bilateral contrast, 26 subjects were required in each group to detect a difference equal to or greater than 3 microvolts (Total of 78 subjects). It assumes a standard deviation of 4.8 microvolts and the rate of loss to follow up esteem 20% (Magalhães-Resende et al. 2012).

Data Analysis: A descriptive analysis of all variables was performed. It establish for all cases a confidence level of 95% (p \<0.05). The effectiveness was assessed by comparing the experienced change of the three goups in outcome variables between physicaltherapy examinations.


Eligibility criteria: Inclusion Criteria:

* Women who experience signs and symptoms evidencing pelvic floor dysfunction.
* Women with a medical diagnosis of pelvic floor dysfunction.
* Women with signs and or symptoms of urinary incontinence, anal incontinence, overactive bladder syndrome and prolapse in grade I-II.
* All participants must understand and sign freely Informed Consent.

Exclusion Criteria:

* Women minors.
* Pregnant women.
* Women who have had a vaginal delivery or cesarean in the past six months.
* Women with pelvic floor dysfunction which is serious and the first indication is surgical (prolapses grades III-IV).
* Women who have been treated for perineal physiotherapy in the past 12 months.
* Participants submit any pathology that may affect treatment (neurological, gynecological or urological), or recurrent urinary tract infection or hematuria.
* Women with cognitive limitations in understanding the information, respond to questionnaires, consent and / or participate in the study.

Primary outcomes:
measure: The change of signs, symptoms and impact of pelvic floor dysfunction between reviews
timeFrame: Pre-treatment, post-treatment, 3, 6 and 12 months assessments were required.
measure: The change of signs, symptoms and impact of pelvic floor dysfunction between reviews
timeFrame: Pre-treatment, post-treatment, 3, 6 and 12 months assessments were required.
Secondary outcomes:
measure: The change of pelvic floor muscles strenght
timeFrame: Pre-treatment, post-treatment, 3, 6 and 12 months assessments were required.
measure: The change of pelvic floor muscles pressure force
timeFrame: Pre-treatment, post-treatment, 3, 6 and 12 months assessments were required.
Other outcomes:
Locations:
city: Alcalá de Henares
country: Spain
facility: Teacher care and research in physiotherapy Unit. Department of Physiotherapy. University of Alcala.
state: Madrid
Study officials:
affiliation: University of Alcala
name: Beatriz N Navarro, PhD student
role: PRINCIPAL_INVESTIGATOR
References: