Effect of Tibial Transcutaneous Electrostimulation in Women with Urgency Urinary Incontinence

NCT05590481 | Completed

• 1 other identifier: TIBIALTENS
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

Brief Summary

Urge urinary incontinence (UUI) is associated with nocturia, a common cause of sleep disorders, also related to levels of anxiety and depression. Studies demonstrate improvement in the clinical parameters of women with UUI after treatment with transcutaneous tibial nerve stimulation (TTNS). However, there are few data available on the association of urinary symptoms in women with UUI with sedentary behavior (SB), physical activity level (PAL) and sleep quality (SQ). Our study has the objective of evaluating the impact of TTNS on urinary symptoms, anxiety level, life quality(LQ), sleep parameters, PAL and SB in women with UUI.

Conditions

Urinary Incontinence, Urge

Keywords

urinary incontinence; Sleep; nocturia; sedentary behavior; anxiety; quality of life

Outcome Measures

Primary Outcomes (1)

• Nocturia

  People with an overactive bladder can experience nocturia, which means they need to get up frequently at night to go to the bathroom. Nocturia will be evaluated through the voiding diary that the volunteers will be instructed to complete. The more times the volunteer gets up at night to urinate, the more severe the condition.

  Baseline/ change after the 6th week of treatment /change 30 days after the 6th week of treatment(follow up).

Secondary Outcomes (12)

• sleep quality

  Baseline/ change after the 6th week of treatment /change 30 days after the 6th week of treatment(follow up).

• physical activity level

  Baseline/ change after the 6th week of treatment /change 30 days after the 6th week of treatment(follow up).

• sedentary behavior

  Baseline/ change after the 6th week of treatment /change 30 days after the 6th week of treatment(follow up).

• anxiety level

  Baseline/ change after the 6th week of treatment /change 30 days after the 6th week of treatment(follow up).

• Sleep parameters - Total time of sleep

  Baseline/ change after the 6th week of treatment /change 30 days after the 6th week of treatment(follow up).

Study Arms (2)

EG (experimental group): TIBIAL TRANSCUTANEOUS ELECTROSTIMULATION + Behavioral Therapy

EXPERIMENTAL

EG (experimental group): submitted to a behavioral therapy protocol, which involves bladder training, pelvic floor muscle training and modification of liquid intake. The orientation will be based on the initial evaluation of the patient, in which the responsible researcher will give verbal orientations and deliver booklets on the pathology, behavioral therapy and sleep hygiene. In addition, patients will be submitted to biphasic current and surface electrodes during 12 treatment sessions, twice a week, on non-consecutive days, with a DUALPEX 961s electrical stimulation device (Quark, Brazil).

Device: TIBIAL TRANSCUTANEOUS ELECTROSTIMULATION; Behavioral: behavioral therapy protocol

GS (Sham-sham group): Behavioral therapy

SHAM COMPARATOR

GS (Sham-sham group): submitted to a behavioral therapy protocol, which involves bladder training, pelvic floor muscle training and modification of liquid intake. The orientation will be based on the initial evaluation of the patient, in which the responsible researcher will give verbal orientations and deliver booklets on the pathology, behavioral therapy and sleep hygiene. Twelve sessions will be held, twice a week, on non-consecutive days. The electrodes of the DUALPEX 961 equipment will be positioned one immediately posterior to the lateral malleolus of the ankle and the other approximately 30 cm above it, where there is no stimulus for the tibial nerve.

Behavioral: behavioral therapy protocol

Interventions

TIBIAL TRANSCUTANEOUS ELECTROSTIMULATION DEVICE

The electrodes will be surface (silicone rubber and carbonate), brand Quark®, with dimensions of 5 cm by 3 cm, coupled with conductive gel and fixed to the volunteer's skin with micropore tape. For the placement of the electrodes, the volunteer will be positioned in the horizontal supine position on the stretcher, with the knee in semiflexion and the head supported on a pillow. The electrodes will be positioned one immediately posterior to the medial malleolus of the ankle and the other approximately 10 cm above it, both fixed with micropore tape, on both legs of the patient. To ensure that the electrodes stimulate the tibial nerve, a transcutaneous electrical nerve stimulation (TENS) current with a frequency of 1 Hz will first be applied, with a gradual increase in intensity, to verify a rhythmic movement of flexion of the hallux. The following parameters will be used for TTNS: frequency 10Hz (Hertz), pulse duration 200 μs (microseconds), for 30 minutes.

EG (experimental group): TIBIAL TRANSCUTANEOUS ELECTROSTIMULATION + Behavioral Therapy

behavioral therapy protocol BEHAVIORAL

submitted to a behavioral therapy protocol, which involves bladder training, pelvic floor muscle training and modification of liquid intake. The orientation will be based on the initial evaluation of the patient, in which the responsible researcher will give verbal orientations and deliver booklets on the pathology, behavioral therapy and sleep hygiene.

EG (experimental group): TIBIAL TRANSCUTANEOUS ELECTROSTIMULATION + Behavioral Therapy; GS (Sham-sham group): Behavioral therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female sex;
• Age from 18 years old;
• Diagnosis of urgency urinary incontinence or mixed urinary incontinence
• Score greater than or equal to 8 on the Hyperactive Bladder - Validated 8 Question Awareness Tool (OAB-V8)

You may not qualify if:

• Active urinary infection in the last four weeks;
• Alcoholism, smoking or drug addiction;
• Lesions and alteration of skin sensitivity in the place where electrotherapy will be applied;
• Drug and/or physiotherapeutic treatment for urgency urinary incontinence;
• Use of sleep-inducing medication,
• Any neurological disease (multiple sclerosis, Alzheimer's disease, stroke and Parkinson's disease);
• Use of anticholinergic drugs, calcium antagonists, b-antagonists and dopamine antagonists;
• Presence of pelvic organ prolapse (POP), measured by a score greater than III by the POP-Q system;
• Any comprehension difficulty or cognitive deficit that makes it impossible to carry out the research;
• Gestational or puerperal period.

Sponsors & Collaborators

• Instituto Materno Infantil Prof. Fernando Figueira: lead
• Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.: collaborator

Study Sites (1)

Instituto de medicina integral fernando figueira

Recife, Pernambuco, 50070-902, Brazil

Location

MeSH Terms

Conditions

Urinary Incontinence, Urge; Urinary Incontinence; Nocturia; Sedentary Behavior; Anxiety Disorders

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Mental Disorders

Study Officials

• Leila Katz, PHD

  Instituto Materno Infantil Prof. Fernando Figueira

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Phd Leila Katz

Study Record Dates

• First Submitted: August 29, 2022
• First Posted: October 21, 2022
• Study Start: January 23, 2023
• Primary Completion: October 30, 2023
• Study Completion: December 30, 2023
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

BR (1)