Urological Physical Therapy in HTLV-1 With Urinary Symptoms

Tropical Spastic Paraparesis Clinical Trial

— UROHTLV  

Official title:

Effects of Physiotherapy in the Treatment of Neurogenic Bladder in Patients Infected With Human T-Lymphotropic Virus 1

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01651819
• Other study ID #: ROAND2012
• Status: Completed
• Phase: N/A
• Start date: March 1, 2012
• Est. completion date: July 30, 2015

Study information

• Verified date: October 2018
• Source: Hospital Universitário Professor Edgard Santos
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 30, 2015
• Est. primary completion date: December 30, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• HTLV-1
• Muscle Spasticity
• Paraparesis
• Paraparesis, Spastic
• Tropical Spastic Paraparesis
• Urinary Bladder, Neurogenic

Intervention

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.

Locations

Country	Name	City	State
Brazil	Hospital Universitário Prof. Edgard Santos	Salvador	Bahia

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitário Professor Edgard Santos

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in urinary symptoms	reduce or cure the complaints of urinary symptoms measured by daily and nocturnal frequency, presence of incontinence, urgency, dysuria.	6 months
Secondary	Improve in quality of life	improving the quality of life measured by King' Health scale that is applied before and after therapy	6 months