Urological Physical Therapy in HTLV-1 With Urinary Symptoms (UROHTLV)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
ROSANA CRISTINA PEREIRA DE ANDRADE, Hospital Universitário Professor Edgard Santos
ClinicalTrials.gov Identifier:
NCT01651819
First received: July 25, 2012
Last updated: July 26, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention
Tropical Spastic Paraparesis
HTLV-1
Procedure: Urological physical therapy

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Urological Physical Therapy Treatment in HTLV-1 Overactive Bladder Patients

Resource links provided by NLM:


Further study details as provided by Hospital Universitário Professor Edgard Santos:

Primary Outcome Measures:
  • Reduction in urinary symptoms [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    reduce or cure the complaints of urinary symptoms measured by daily and nocturnal frequency, presence of incontinence, urgency, dysuria.


Secondary Outcome Measures:
  • Improve in quality of life [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    improving the quality of life measured by SF-36 scale that is applied before and after therapy


Enrollment: 20
Study Start Date: March 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Procedure: 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.
Other Names:
  • Electrotherapy;
  • Behavior therapy;
  • Manual therapy;
  • Kinesiotherapy.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01651819

Locations
Brazil
Hospital Universitário Prof. Edgard Santos
Salvador, Bahia, Brazil
Sponsors and Collaborators
Hospital Universitário Professor Edgard Santos
Investigators
Principal Investigator: Rosana Andrade, Master Federal University of Bahia
  More Information

No publications provided

Responsible Party: ROSANA CRISTINA PEREIRA DE ANDRADE, master, Hospital Universitário Professor Edgard Santos
ClinicalTrials.gov Identifier: NCT01651819     History of Changes
Other Study ID Numbers: ROAND2012
Study First Received: July 25, 2012
Last Updated: July 26, 2012
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Hospital Universitário Professor Edgard Santos:
HTLV-1
neurogenic bladder
physical therapy
Tropical Spastic Paraparesis

Additional relevant MeSH terms:
Paraparesis
Paraparesis, Spastic
Paraparesis, Tropical Spastic
Paresis
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Myelitis
Central Nervous System Viral Diseases
Virus Diseases
HTLV-I Infections
Deltaretrovirus Infections
Retroviridae Infections
RNA Virus Infections
Central Nervous System Infections
Central Nervous System Diseases
Spinal Cord Diseases

ClinicalTrials.gov processed this record on September 22, 2014