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

Primary Purpose

Tropical Spastic Paraparesis, HTLV-1

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Urological physical therapy
Sponsored by
Hospital Universitário Professor Edgard Santos
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tropical Spastic Paraparesis focused on measuring HTLV-1, neurogenic bladder, physical therapy, Tropical Spastic Paraparesis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Universitário Prof. Edgard Santos

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Urological physical therapy

Arm 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.

Outcomes

Primary Outcome Measures

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

Full Information

First Posted
July 25, 2012
Last Updated
October 3, 2018
Sponsor
Hospital Universitário Professor Edgard Santos
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1. Study Identification

Unique Protocol Identification Number
NCT01651819
Brief Title
Urological Physical Therapy in HTLV-1 With Urinary Symptoms
Acronym
UROHTLV
Official Title
Effects of Physiotherapy in the Treatment of Neurogenic Bladder in Patients Infected With Human T-Lymphotropic Virus 1
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
March 1, 2012 (Actual)
Primary Completion Date
December 30, 2014 (Actual)
Study Completion Date
July 30, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitário Professor Edgard Santos

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tropical Spastic Paraparesis, HTLV-1
Keywords
HTLV-1, neurogenic bladder, physical therapy, Tropical Spastic Paraparesis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Urological physical therapy
Arm Type
Experimental
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Urological physical therapy
Other Intervention Name(s)
Electrotherapy;, Behavior therapy;, Manual therapy;, Kinesiotherapy.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Reduction in urinary symptoms
Description
reduce or cure the complaints of urinary symptoms measured by daily and nocturnal frequency, presence of incontinence, urgency, dysuria.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Improve in quality of life
Description
improving the quality of life measured by King' Health scale that is applied before and after therapy
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rosana Andrade, Master
Organizational Affiliation
Federal University of Bahia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitário Prof. Edgard Santos
City
Salvador
State/Province
Bahia
Country
Brazil

12. IPD Sharing Statement

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Urological Physical Therapy in HTLV-1 With Urinary Symptoms

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