Urological Physical Therapy in HTLV-1 With Urinary Symptoms (UROHTLV)
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|ClinicalTrials.gov Identifier: NCT01651819|
Recruitment Status : Unknown
Verified February 2016 by ROSANA CRISTINA PEREIRA DE ANDRADE, Hospital Universitário Professor Edgard Santos.
Recruitment status was: Enrolling by invitation
First Posted : July 27, 2012
Last Update Posted : February 19, 2016
|Condition or disease||Intervention/treatment||Phase|
|Tropical Spastic Paraparesis HTLV-1||Procedure: Urological physical therapy||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||TREATMENT OF NEUROGENIC BLADDER IN PATIENTS INFECTED WITH HUMAN T-LYMPHOTROPIC VIRUS 1|
|Study Start Date :||March 2012|
|Actual Primary Completion Date :||December 2014|
|Estimated Study Completion Date :||July 2017|
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.
- Reduction in urinary symptoms [ Time Frame: 6 months ]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 ]improving the quality of life measured by King' Health scale that is applied before and after therapy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01651819
|Hospital Universitário Prof. Edgard Santos|
|Salvador, Bahia, Brazil|
|Principal Investigator:||Rosana Andrade, Master||Federal University of Bahia|