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

NCT07538895 | Completed

• 1 other identifier: FMBSUREC/07092025/Awad
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Menopausal Complaints

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Volume of post- void residue of urine in bladder

  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).

  5 months

Study Arms (2)

Placebo Group

NO INTERVENTION

routine pelvic floor strengthening exercises at home as well as advice

Intervention group

EXPERIMENTAL

participants attended 12-week physiotherapy sessions composed of transcutaneous tibial nerve stimulation with pelvic floor, behavioral bladder exercises and advice.

Device: Transcutaneous Tibial Nerve Stimulation Technique

Interventions

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).

Intervention group

Eligibility Criteria

• Age: 45 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

Beni-Suef University

Banī Suwayf, Beni Suweif Governorate, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor of physical therapy for woman's health, Physical Therapy Department for Woman and Child Health, Faculty of Physical Therapy, Beni-Suef University, Beni-Suef , Egypt

Model Details: 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.

Study Record Dates

• First Submitted: April 13, 2026
• First Posted: April 20, 2026
• Study Start: October 1, 2025
• Primary Completion: March 30, 2026
• Study Completion: April 1, 2026
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)