Clinical trial NCT05590481: Effect of Tibial Transcutaneous Electrostimulation in Women with Urgency Urinary Incontinence
Official title: Effect of Tibial Transcutaneous Electrostimulation in Women with Urgency Urinary Incontinence Compared to a Sham Group: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence, Urge
Keywords: urinary incontinence
Sleep
nocturia
sedentary behavior
anxiety
quality of life
Lead sponsor: Instituto Materno Infantil Prof. Fernando Figueira
Sponsor class: OTHER
Collaborators: name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
First posted: 2022-10-21
Enrollment: 103
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: A randomized clinical trial, sham-controlled, comparing behavioral therapy and TTNS (intervention) to the use of behavioral therapy alone. It will include women with 18 years or more, diagnosed with UUI or mixed IU attested by the Questionnaire Overactive Bladder Validated 8 (OAB-V8).

Women with active urinary tract infection in the last four weeks, alcoholics, smokers or drug addicts, with lesions and alteration of skin sensitivity in the place where electrotherapy will be applied, in drug and/or physiotherapeutic treatment for UUI or current OAB, using sleep-inducing medication, with any neurological disease, using anticholinergic drugs, calcium antagonists, antagonists and dopamine antagonists, with presence of pelvic organ prolapse, during pregnancy or puerperal or with any difficulty in understanding or cognitive deficit that makes it impossible to carry out the research will be excluded.

Study variables are behavioral therapy, bilateral transcutaneous tibial nerve stimulation, type of UI, PAL, excessive daytime sleepiness, generic and specific LQ, SQ, UI severity, anxiety level, urinary frequency, nocturia and bladder capacity.

Sample size was calculated, adopting a two-tailed test with the following parameters: α = 0.05, β = 0.20 and statistical power of 80% and 102 women will be included.

The study will be carried out in two physiotherapy clinics in Recife, from September 2022 to June 2023, both groups will undergo a behavioral therapy protocol, (bladder training, pelvic floor muscle training and modification of liquid intake). Patients will be submitted to biphasic current and surface electrodes during 12 treatment sessions, twice a week, on non-consecutive days, with a electrical stimulation device (Quark, Brazil). The following parameters will be used for TTNS: frequency 10Hz (dez Hertz), pulse duration 200 μs (microseconds), for 30 minutes. In the experimental group, the electrodes will be positioned on the medial malleolus of both legs), in order to stimulate the tibial nerve path. In the Sham group, the electrodes will be placed on both legs, centered in the middle of the thigh, where there is no stimulus for the tibial or sacral nerve, for 30 minutes.

The project was approved by the Research Ethics Committee of Professor Fernando Figueira Institute of Integral Medicine.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* -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.

Primary outcomes:
measure: Nocturia
timeFrame: Baseline/ change after the 6th week of treatment /change 30 days after the 6th week of treatment(follow up).
Secondary outcomes:
measure: sleep quality
timeFrame: Baseline/ change after the 6th week of treatment /change 30 days after the 6th week of treatment(follow up).
measure: physical activity level
timeFrame: Baseline/ change after the 6th week of treatment /change 30 days after the 6th week of treatment(follow up).
measure: sedentary behavior
timeFrame: Baseline/ change after the 6th week of treatment /change 30 days after the 6th week of treatment(follow up).
measure: anxiety level
timeFrame: Baseline/ change after the 6th week of treatment /change 30 days after the 6th week of treatment(follow up).
measure: Sleep parameters - Total time of sleep
timeFrame: Baseline/ change after the 6th week of treatment /change 30 days after the 6th week of treatment(follow up).
measure: Excessive daytime sleepiness
timeFrame: Baseline/ change after the 6th week of treatment /change 30 days after the 6th week of treatment(follow up).
measure: Severity of urinary incontinence
timeFrame: Baseline/ change after the 6th week of treatment /change 30 days after the 6th week of treatment(follow up).
measure: Life's quality
timeFrame: Baseline/ change after the 6th week of treatment /change 30 days after the 6th week of treatment(follow up).
measure: Sleep parameters - sleep efficiency
timeFrame: Baseline/ change after the 6th week of treatment /change 30 days after the 6th week of treatment(follow up).
measure: Sleep parameters - Total time in bed
timeFrame: Baseline/ change after the 6th week of treatment /change 30 days after the 6th week of treatment(follow up).
measure: Sleep parameters - Nightly awakenings
timeFrame: Baseline/ change after the 6th week of treatment /change 30 days after the 6th week of treatment(follow up).
measure: Sleep parameters - Time awake after falling asleep
timeFrame: Baseline/ change after the 6th week of treatment /change 30 days after the 6th week of treatment(follow up).
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Instituto de medicina integral fernando figueira
state: PE
Study officials:
affiliation: Instituto Materno Infantil Prof. Fernando Figueira
name: Leila Katz, PHD
role: PRINCIPAL_INVESTIGATOR
References: