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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
History of Changes

July 25, 2012
July 26, 2012
March 2012
July 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01651819 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Urological Physical Therapy in HTLV-1 With Urinary Symptoms
Urological Physical Therapy Treatment in HTLV-1 Overactive Bladder Patients

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.

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.
Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Tropical Spastic Paraparesis
  • HTLV-1
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.
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.
Intervention: Procedure: Urological physical therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
20
December 2014
July 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01651819
ROAND2012
No
ROSANA CRISTINA PEREIRA DE ANDRADE, Hospital Universitário Professor Edgard Santos
Hospital Universitário Professor Edgard Santos
Not Provided
Principal Investigator: Rosana Andrade, Master Federal University of Bahia
Hospital Universitário Professor Edgard Santos
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP