Menopausal ComplaintsNCT07538895
Effect Of Transcutaneous Tibial Nerve Stimulation Technique Combined With Exercise on High Post-Void Residual Urine Volume in Post-Menopausal Women
A study testing Transcutaneous Tibial Nerve Stimulation Technique in people with Menopausal Complaints, run by Beni-Suef University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 to 65 years, women only
- Conditions the study is for
- Menopausal Complaints
- What is being tested?
- Transcutaneous Tibial Nerve Stimulation Technique
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2025to 1 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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
- Being tested
- Transcutaneous Tibial Nerve Stimulation Technique
- Keywords
- Menopause- post-void residual- exercise- Tibial nerve stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Tibial Nerve Stimulation TechniqueDevice
(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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Transcutaneous Tibial Nerve Stimulation Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start1 Oct 2025
- Primary completion30 Mar 2026
- Study completion1 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menopausal ComplaintsStudies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Awad, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07538895
- Sponsor's protocol ID
- FMBSUREC/07092025/Awad
- Status last verified
- Apr 2026
- First submitted
- 13 Apr 2026
- Last updated
- 20 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07538895
- Acronym / sponsor ID
- FMBSUREC/07092025/Awad
- Conditions
- Menopausal Complaints
- Keywords
- Menopause- post-void residual- exercise- Tibial nerve stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 30 Mar 2026 (actual)
- Study completion
- 1 Apr 2026 (actual)
- First posted
- 20 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Placebo Group | No intervention | –routine pelvic floor strengthening exercises at home as well as advice |
| Intervention group | Experimental | Device: Transcutaneous Tibial Nerve Stimulation Techniqueparticipants attended 12-week physiotherapy sessions composed of transcutaneous tibial nerve stimulation with pelvic floor, behavioral bladder exercises and advice. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Device | Intervention group |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Tibial Nerve Stimulation Technique in people with Menopausal Complaints, run by Beni-Suef University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volume of post- void residue of urine in bladder (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.