Urological Physical Therapy in HTLV-1 With Urinary Symptoms

NCT ID: NCT01651819

Last Updated: 2018-10-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-01
• Study Completion Date: 2015-07-30

Brief Summary

Urological physical therapy is described to improve urinary symptoms in patients with myelopathy or neurological dysfunction and to increase the quality of life. Although it was never tested on HTLV-1 associated overactive bladder syndrome, an disabling disease that is common seen in HAM/TSP patients but can also appear as an isolated form. Our hypothesis is that urological physical therapy can improve urinary symptoms like incontinence, urgency and nocturia in HTLV-1 infected population with those complains.

Detailed Description

The T-lymphotropic virus type 1 (HTLV-1) is an human retrovirus that was proved to be the main agent of the acute T cell lymphoma/leukemia (ATLL) and a progressive neurological disease called HTLV-1 associated myelopathy/ tropical spastic paraparesis (HAM/TSP).

The HTLV-1 was first isolated in 1980 and it is endemic in Japan, Caribbean, Africa and South America. It is estimated that about 20 million people is infected worldwide. In Brazil it is present in all states with variable prevalences. The factors associated with HTLV-1 transmission in Brazil are related to the social and demographic condition, characterized by rural exodus and increase of urban population in the coast areas.

Several studies based in Brazil reported that the epicenter of HTLV-1 infection is on Bahia, Maranhão and Pernambuco with the highest prevalence of 1,8% in Salvador, Bahia capital.

The urinary incontinence is a bladder-sphincter disturbance often found in HTLV-1 patients. In this infection the most common pathology finding is overactive bladder syndrome due detrusor overactivity and sphincter-detrusor dyssynergia and the symptoms are urgency, nocturia and incontinence.

This disabling disease is associated with psychosocial issues like loss of self confidence, social isolation and reduced quality of life.

The physical therapy treatment have the objective of promote social adequacy and reestablish the bladder function. It is based on resources like: bladder reeducation, biofeedback, kinesiotherapy of the pelvic wall, utilization of vaginal cones and electrostimulation.

Those can be associated or not with anticholinergic drugs and bladder catheterization.

The need of urologic and gynecologic physical therapy follow up in patients with HTLV-1 and neurogenic bladder is important to reduce disability, preserve pelvic muscles and renal function.

Conditions

Tropical Spastic Paraparesis; HTLV-1

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Urological physical therapy

Urologic physical therapy is going to be apply in 20 patients with HTLV-1 infection and overactive bladder symptoms like urgency, incontinence and nocturia. There will be 20 sessions with one hour duration and a interval of 3 or 4 days between the sections.

Group Type: EXPERIMENTAL

Urological physical therapy

Intervention Type: PROCEDURE

Individual patient attending with one hour duration beginning with Behavior therapy and education, teaching urinary maneuvers, water adequate intake. Second part is manual therapy an Kinesiotherapy with specific exercises, followed by patient repetition. Last part is constituted by electrotherapy for specific muscle stimulation and biofeedback.

Interventions

Urological physical therapy

Individual patient attending with one hour duration beginning with Behavior therapy and education, teaching urinary maneuvers, water adequate intake. Second part is manual therapy an Kinesiotherapy with specific exercises, followed by patient repetition. Last part is constituted by electrotherapy for specific muscle stimulation and biofeedback.

Intervention Type: PROCEDURE

Other Intervention Names

Electrotherapy; Behavior therapy; Manual therapy; Kinesiotherapy.

Eligibility Criteria

Inclusion Criteria

• Patients with HTLV-1 with more than 18 years and neurogenic bladder defined by urodynamic study.

Exclusion Criteria

• Diabetes Mellitus,
• Stroke,
• Multiple Sclerosis,
• Parkinson disease,
• use of pacemaker,
• urinary infection.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Universitário Professor Edgard Santos

OTHER

Sponsor Role: lead

Responsible Party

ROSANA CRISTINA PEREIRA DE ANDRADE

coordenadora do Ambulatório de Fisioterapia Nas Disfunções perineias

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rosana Andrade, Master

Role: PRINCIPAL_INVESTIGATOR

Federal University of Bahia

Locations

Hospital Universitário Prof. Edgard Santos

Salvador, Estado de Bahia, Brazil

Countries

Brazil

Other Identifiers

ROAND2012

Identifier Type: -

Identifier Source: org_study_id