Clinical Trial: Urological Physical Therapy in HTLV-1 With Urinary Symptoms

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

Official Title: TREATMENT OF NEUROGENIC BLADDER IN PATIENTS INFECTED WITH HUMAN T-LYMPHOTROPIC VIRUS 1

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 Summary:

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 cathete
Sponsor: Hospital Universitário Professor Edgard Santos

Current Primary Outcome: Reduction in urinary symptoms [ Time Frame: 6 months ]

reduce or cure the complaints of urinary symptoms measured by daily and nocturnal frequency, presence of incontinence, urgency, dysuria.


Original Primary Outcome: Same as current

Current Secondary Outcome: Improve in quality of life [ Time Frame: 6 months ]

improving the quality of life measured by King' Health scale that is applied before and after therapy


Original Secondary Outcome: Improve in quality of life [ Time Frame: 6 months ]

improving the quality of life measured by SF-36 scale that is applied before and after therapy


Information By: Hospital Universitário Professor Edgard Santos

Dates:
Date Received: July 25, 2012
Date Started: March 2012
Date Completion: July 2017
Last Updated: February 17, 2016
Last Verified: February 2016