Effects of Epi-no Device on Pelvic Floor Dysfunctions

Status Completed

Clinical Trial Summary

Perineal injury is the most common maternal obstetric complication associated with vaginal delivery. Perineal traumas are associated with maternal morbidity, including pain, urinary and fecal incontinence, genital prolapses, dyspareunia, physical and psychological impairment. EPI-NO is a device with the objective of preparing and training the pelvic floor for normal childbirth, this training allows smooth and slow movement along the perineal structures in the prenatal period, by causing a rapid traumatic laceration during childbirth. The objective of this study is to verify the effect of 10 pelvic stretching rows with Epi-No in preventing urinary incontinence and dyspareunia 6 months after delivery. The study group will consist of primiparous, over 18 years of age, between 30 and 32 weeks of gestation, will be evaluated before the intervention and 6 months after delivery. The control group will be evaluated only once, in the sixth month after delivery. The evaluation will consist of: anamnesis, physical examination (vaginal examination and palpation), perineometry, International Urinary Incontinence Questionnaire (ICIQ-UISF), Visual Analogue Scale for dyspareunia; Questionnaire for assessing dyspareunia Female Sexual Function Index (FSFI). Pregnant women referred for intervention will perform 10 sessions (twice a week for 5 weeks) of perineal preparation with the Epi-No device. It is expected at the end of the study to prove the effectiveness of the effect of 10 pelvic lengthening graft with Epi-No in relation to the degrees of laceration and episiotomy and, consequently, reduction of urinary incontinence and dyspareunia.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04955418
Study type	Interventional
Source	Universidade Estadual de Londrina
Contact
Status	Completed
Phase	N/A
Start date	October 1, 2017
Completion date	January 1, 2021

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05534412` - A Practice-Based Intervention To Improve Care for a Diverse Population Of Women With Urinary Incontinence	N/A
Recruiting	`NCT05515198` - Improving Care for Women With Urinary Incontinence (EMPOWER)	N/A
Completed	`NCT04071301` - Collection of Real-life Measurement Data for TENA SmartCare Change Indicator in Subjects With Urinary Incontinence	N/A
Completed	`NCT03623880` - Enhancing Behavioral Treatment for Women With Pelvic Floor Disorders	N/A
Recruiting	`NCT05880862` - Comparative Effectiveness of Initial OAB Treatment Options Among Older Women at High Risk of Falls	Early Phase 1
Recruiting	`NCT04159467` - Effect of Pelvic Floor Muscle Training on Urinary Incontinence Reports in Obese Women Undergoing a Low Calorie Diet	N/A
Completed	`NCT05485922` - Performance of a Single-use Intermittent Micro-hole Zone Catheter	N/A
Completed	`NCT06268782` - The Effectiveness of an Online Exercise Program on Well-being of Postpartum Women	N/A
Not yet recruiting	`NCT03027986` - Evaluation of a Postural Rehabilitation Program Based on Sensory-motor Control in Men With Urinary Incontinence After Prostatectomy	N/A
Recruiting	`NCT02490917` - ACT™ Balloons Versus Artificial Urinary Sphincter (AMS800™) for the Treatment of Female Stress Urinary Incontinence	N/A
Enrolling by invitation	`NCT02530372` - Feasibility of the UriCap-F for Urine Collection in Hospitalized Women	N/A
Enrolling by invitation	`NCT02529371` - Pre-Marketing Feasibility Evaluation of the UriCap-RM - Urine Collection in Hospitalized Male Patients	N/A
Completed	`NCT02338726` - Pelvic Floor Symptoms and Quality of Life in Elderly Women - a Population-based Pilot Study	N/A
Completed	`NCT02549729` - Effect of the Pelvic Floor Training in Postmenopausal Women With or Without Hormonal Therapy	N/A
Completed	`NCT02600676` - Transcutaneous Electric Nerve Stimulation (TENS) in Children With Enuresis	N/A
Completed	`NCT02239796` - Feasibility Controlled Trial of Tibial Nerve Stimulation for Stroke Related Urinary Incontinence	N/A
Completed	`NCT02368262` - Prevalence of Incontinence and Risk Factors in Children With Cerebral Palsy	N/A
Completed	`NCT01942681` - Female Patients With Signs of uRgE and Stress Urinary Incontinence Study of Propiverine Hydrochloride	N/A
Recruiting	`NCT01804153` - Stem Cells Tratment for the Local Feminine Stress Urinary Incontinence Treatment (HULPURO)	Phase 1/Phase 2
Completed	`NCT01520948` - Behavioral Therapy to Treat Urinary Symptoms in Parkinson Disease	Phase 3