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Completed

NCT Number: NCT07538895

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

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.

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Key information

Conditions

Menopausal Complaints

Age range

45 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Beni-Suef University

Banī Suwayf, Beni Suweif Governorate, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transcutaneous Tibial Nerve Stimulation Technique

Device

(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).

Primary outcomes

  1. Volume of post- void residue of urine in bladder

    Time frame: 5 months

    Estimation 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).

Sponsors and collaborators

Lead sponsor

Beni-Suef University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 20, 2026
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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