Urological Physical Therapy in HTLV-1 With Urinary Symptoms

Brief Title

Urological Physical Therapy in HTLV-1 With Urinary Symptoms

Official Title

Effects of Physiotherapy in the 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 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.
    


Study Type

Interventional


Primary Outcome

Reduction in urinary symptoms

Secondary Outcome

 Improve in quality of life

Condition

Tropical Spastic Paraparesis

Intervention

Urological physical therapy

Study Arms / Comparison Groups

 Urological physical therapy
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

20

Start Date

March 1, 2012

Completion Date

July 30, 2015

Primary Completion Date

December 30, 2014

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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Rosana Andrade, Master, , 

Location Countries

Brazil

Location Countries

Brazil

Administrative Informations


NCT ID

NCT01651819

Organization ID

ROAND2012


Responsible Party

Principal Investigator

Study Sponsor

Hospital Universitário Professor Edgard Santos


Study Sponsor

Rosana Andrade, Master, Principal Investigator, Federal University of Bahia


Verification Date

October 2018