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

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.

Study Overview

• Status: Completed
• Conditions: Menopausal Complaints
• Intervention / Treatment: Device: Transcutaneous Tibial Nerve Stimulation Technique

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Beni Suweif Governorate
    • Banī Suwayf, Beni Suweif Governorate, Egypt
      • Beni-Suef University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Placebo Group; routine pelvic floor strengthening exercises at home as well as advice
Experimental: Intervention group; 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; (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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Beni-Suef University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2025
• Primary Completion (Actual): March 30, 2026
• Study Completion (Actual): April 1, 2026

Study Registration Dates

• First Submitted: April 13, 2026
• First Submitted That Met QC Criteria: April 13, 2026
• First Posted (Actual): April 20, 2026

Study Record Updates

• Last Update Posted (Actual): April 20, 2026
• Last Update Submitted That Met QC Criteria: April 13, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Menopause- post-void residual- exercise- Tibial nerve stimulation
• Other Study ID Numbers: FMBSUREC/07092025/Awad

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No