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The Effects of Adding Pelvic Floor Muscle Exercises to Behavioral Therapy Associated with Transcutaneous Parasacral Nerve Electrical Stimulation on Sleep Quality in Women Who Are Awakened by Their Bladder to Urinate: A Randomized Controlled Clinical Trial

The effects of adding Pelvic Floor Muscle Training to Behavioral Therapy associated with Transcutaneous Parasacral Nerve Electrostimulation on Sleep Quality in women with Nocturia: a randomized, controlled clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-2rzx848
Enrollment
Unknown
Registered
2025-01-02
Start date
2025-02-03
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

Pelvic Floor

Interventions

This is a randomized, controlled, two-arm, double-blind clinical study. Experimental group: 41 women will receive pelvic floor muscle training treatment with behavioral therapy associated with transcu
E02.760.169.063.500.387.875

Sponsors

Faculdade de Educação Física e Fisiotrapia
Lead Sponsor
Faculdade de Educação Física e Fisiotrapia
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 nocturia (being woken up by the bladder at least once a night, every night for the last 30 days); having Overactive Bladder Syndrome (OBS) who obtain a score = 8 on the Overactive Bladder – Validated 8 (OAB-V8) questionnaire - an instrument for assessing overactive bladder and scoring very or very high on question 6 in the same questionnaire and who have a high risk of sleep apnea; the research participant must have had sexual intercourse for the pelvic muscle assessment to be carried out

Exclusion criteria

Exclusion criteria: Not knowing how to read and not being able to answer the questionnaires; having a urinary tract infection in the last two weeks; smoking; having undergone previous pelvic surgery with the exception of a cesarean section; having undergone previous pelvic radiotherapy; having a neurological disease; not undergoing pharmacological and physiotherapeutic treatment for Overactive Bladder Syndrome (OBS); having only Stress Urinary Incontinence (SUI); pelvic floor muscle strength 0 and 1 on the modified Oxford scale; being pregnant and up to 3 months postpartum; using medications that may affect nocturnal urination (antimuscarinics, diuretics); uncontrolled type 2 diabetes and heart disease; uncontrolled high blood pressure; low risk of sleep apnea; night and shift workers; not accepting to participate in the research and/or not signing the free and informed consent form (FICF)

Design outcomes

Primary

MeasureTime frame
It is expected to reduce the number of awakenings to go to the bathroom (nocturia), which will be measured by the Overactive Bladder – Validated 8 – Question Awareness Tool (OAB-V8) and also by sleep and voiding diaries.—

Secondary

MeasureTime frame
To assess sleep quality using the PSQI questionnaire (Pittsburgh Sleep Quality Index), sleep quantity using the sleep diary, daytime sleepiness assessed using the Epworth Sleepiness Scale and urinary habits (daytime and nighttime urinary frequency, urinary loss episodes) using the 24-hour Voiding Diary, and strength, endurance, coordination using the Modified Oxford Scale and pelvic floor muscle pressure using manometry measured pre and post intervention.—

Countries

Brazil

Contacts

Public ContactAna Paula;Wanessa Bernardes ;Oliveira

Universidade Federal de Uberlândia;Universidade Federal de Uberlândia

anapaulamrb@ufu.br;wanessa.oliveira@ufu.br+55 (34) 32349902 ;+55 (34) 32349902

Outcome results

None listed

Source: REBEC (via WHO ICTRP)