Urological Physical Therapy in HTLV-1 With Urinary Symptoms (UROHTLV)
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||TREATMENT OF NEUROGENIC BLADDER IN PATIENTS INFECTED WITH HUMAN T-LYMPHOTROPIC VIRUS 1|
- 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.
- Improve in quality of life [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]improving the quality of life measured by King' Health scale that is applied before and after therapy
|Study Start Date:||March 2012|
|Estimated Study Completion Date:||July 2015|
|Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01651819
|Hospital Universitário Prof. Edgard Santos|
|Salvador, Bahia, Brazil|
|Principal Investigator:||Rosana Andrade, Master||Federal University of Bahia|