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Effect Of Transcutaneous Tibial Nerve Stimulation Technique Combined With Exercise on High Post-Void Residual Urine Volume in Post-Menopausal Women

Effect Of Transcutaneous Tibial Nerve Stimulation Technique Combined With Exercise on High Post-Void Residual Urine Volume in Post-Menopausal Women: A Randomized Clinical Trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07538895
Enrollment
60
Registered
2026-04-20
Start date
2025-10-01
Completion date
2026-04-01
Last updated
2026-04-20

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

Conditions

Menopausal Complaints

Keywords

Menopause- post-void residual- exercise- Tibial nerve stimulation

Brief summary

Objective of the study is to explore effect of combining transcutaneous tibial nerve stimulation with exercise on high post-void residual urine volume in post-menopausal women. The main question to be answered by this study: Does transcutaneous tibial nerve stimulation technique combined with exercise have effect on high post-void residual urine in post-menopausal women? Researchers will compare 2 groups of 60 post-menopausal women. Group A participants will attend 12-week physiotherapy sessions composed of transcutaneous tibial nerve stimulation with exercise program and advice. While, control participants will take the same advice and routine care as group A participants.

Interventions

DEVICETranscutaneous Tibial Nerve Stimulation Technique

(TTNS) via using surface electrodes and biphasic current ; a cathode electrode was placed posterior to the medial malleolus while, the anode electrode was placed ten centimeters above it (Gymna Neuromuscular Electrical Stimulation device).

Sponsors

Beni-Suef University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Intervention model description

A 6 months comparative randomized clinical trial composing of 2 groups of 60 post-menopausal women. Group A participants attended 12-week physiotherapy sessions composed of transcutaneous tibial nerve stimulation with pelvic floor, behavioral bladder exercises and advice. Whereas, control participants were included in group B, who took the same advice as group A as well as performed routine pelvic floor strengthening exercises at home.

Eligibility

Sex/Gender
FEMALE
Age
45 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* a total of 60 women will be recruited from Out- Patient Gynecology Clinic of Beni- Suef University Hospital, Beni-Suef, Egypt. Their ages will be ranged from 45-65 years and their body mass index (BMI) will not exceed 30 kg/m2.

Exclusion criteria

* Women will be excluded from the study, if they were diagnosed with a history of irradiation and/or hormonal therapy in the last six months; the presence of neurological diseases (multiple sclerosis, Alzheimer's disease, stroke and Parkinson's disease); the use of anticholinergic drugs, calcium antagonists, b-antagonists, and dopamine antagonists; the presence of pelvic organ prolapse (POP), as measured by a score greater than III by the POP-Q system, predominantly neurogenic or predominantly mixed urinary incontinence populations, chronic physical or mental illness, or failed to complete an informed consent form.

Design outcomes

Primary

MeasureTime frameDescription
Volume of post- void residue of urine in bladder5 monthsEstimation of the amount of post void residual urine in millilitres was conducted by using a transabdominal ultrasound scanner (Toshiba Xario100, 8-12 MHz linear transducer).

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 21, 2026