Clinical trial NCT01651819: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tropical Spastic Paraparesis
HTLV-1
Keywords: HTLV-1
neurogenic bladder
physical therapy
Tropical Spastic Paraparesis
Lead sponsor: Hospital Universitário Professor Edgard Santos
Sponsor class: OTHER
First posted: 2012-07-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Reduction in urinary symptoms
timeFrame: 6 months
Secondary outcomes:
measure: Improve in quality of life
timeFrame: 6 months
Other outcomes:
Locations:
city: Salvador
country: Brazil
facility: Hospital Universitário Prof. Edgard Santos
state: Bahia
Study officials:
affiliation: Federal University of Bahia
name: Rosana Andrade, Master
role: PRINCIPAL_INVESTIGATOR
References: