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The effects of Behavioral Therapy associated with Electrotherapy of the Tibial, Parasacral and Medial Plantar Nerves on sleep quality in women with Urgency to Urinate: a randomized controlled clinical trial

The impacts of Behavioral Therapy associated with Transcutaneous Electrostimulation of the Tibial, Parasacral and Medial Plantar Nerves on sleep quality in women with Urgent Urinary Incontinence: a randomized controlled clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-83jyh6g
Enrollment
Unknown
Registered
2024-10-05
Start date
2024-01-03
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Bladder Overactive. Urge Urinary Incontinence

Interventions

The effect of behavioral therapy associated with transcutaneous electrostimulation of the tibial nerve (control group), behavioral therapy associated with transcutaneous electrostimulation of the medi
F04.754.137
E02.331.800

Sponsors

Faculdade de Educação Física e Fisiotrapia
Lead Sponsor
Universidade Federal de Uberlândia
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Women over 18 years of age; women with complaints of urinary urgency; who may have UUI (Urgency Urinary Incontinence); MUI (Mixed Urinary Incontinence – urgency + stress); OBS (Overactive Bladder Syndrome); who obtain a score = 8 on the Overactive Bladder – Validated 8 – Overactive Bladder Assessment Instrument (OAB-V8) questionnaire

Exclusion criteria

Exclusion criteria: Not knowing how to read and not being able to answer the questionnaires; having a urinary tract infection; not having undergone previous pelvic surgery with the exception of a Cesarean section; not having undergone previous pelvic radiotherapy; having a neurological disease; not undergoing pharmacological and physiotherapeutic treatment for OBS (Overactive Bladder Syndrome); having only SUI (Stress Urinary Incontinence) without UM (Urinary Urgency); having a diagnosis of obstructive sleep apnea and not accepting to participate in the research and/or not signing the TCLE (Free and Informed Consent Form)

Design outcomes

Primary

MeasureTime frame
The primary outcome will be to measure urinary urgency assessed by the Overactive Bladder – Validated 8 – Question Awareness Tool (OAB-V8).—

Secondary

MeasureTime frame
And the secondary outcomes will be to investigate the quality of sleep using the PSQI questionnaire (Pittsburgh Sleep Quality Index), the amount of sleep using the sleep diary, daytime sleepiness assessed by the Epworth Sleepiness Scale and quality of life and urinary habits (urinary frequency, episodes of urinary loss, episodes of urinary urgency) using the King's Health Questionnaire (KHQ) and the 24-hour Voiding Diary (DM-24h), respectively.—

Countries

Brazil

Contacts

Public ContactAna Paula Bernardes

Universidade Federal de Uberlândia

anapaulamrb@ufu.br+55 (34) 32349902

Outcome results

None listed

Source: REBEC (via WHO ICTRP)