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NCT Number: NCT01651819

Urological Physical Therapy in HTLV-1 With Urinary Symptoms

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.

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Key information

Conditions

Tropical Spastic Paraparesis Central Nervous System Diseases Central Nervous System Infections Deltaretrovirus Infections Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications HTLV-1 HTLV-I Infections Infections Male Urogenital Diseases Myelitis Nervous System Diseases Neuroinflammatory Diseases Neurologic Manifestations Paraparesis, Tropical Spastic Pathological Conditions, Signs and Symptoms RNA Virus Infections Retroviridae Infections Signs and Symptoms Spinal Cord Diseases Urinary Bladder Diseases Urinary Bladder, Neurogenic Urogenital Diseases Urologic Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitário Prof. Edgard Santos

Salvador, Estado de Bahia, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Urological physical therapy

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.

Other names: Electrotherapy;, Behavior therapy;, Manual therapy;, Kinesiotherapy.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Hospital Universitário Professor Edgard Santos

Other

Registry information

Official study title

Effects of Physiotherapy in the Treatment of Neurogenic Bladder in Patients Infected With Human T-Lymphotropic Virus 1

Acronym: UROHTLV

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Jul 27, 2012
Registry last updated
Oct 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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