Vaginal LaxityNCT06637475
Investigation of the Effects of External Electrical Stimulation in Women With Vaginal Laxity
A study testing Electric stimulation in people with Vaginal Laxity, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to investigate the effects of external electrical stimulation on clinical symptoms such as vaginal symptoms, pelvic floor symptoms, sexual function, pelvic floor muscle morphometry (levator ani thickness) and functions (strength, endurance), vaginal wall thickness and perception of healing in… Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Vaginal Laxity
- What is being tested?
- Electric stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jul 2024to 15 Mar 2025
- 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 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
None listed.
Who cannot join
- Sensory loss Presence of infection Having a pacemaker Metal implant presence Malignancy story Having serious cardiovascular problems Presence of severe pelvic organ prolapse (above stage 2) Having undergone surgery for POP/incontinence (within the last 1 year) Pregnancy presence Having enough laxity to require surgery Having a neurological disorder Receiving estrogen therapy
- -
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study was to investigate the effects of external electrical stimulation on clinical symptoms such as vaginal symptoms, pelvic floor symptoms, sexual function, pelvic floor muscle morphometry (levator ani thickness) and functions (strength, endurance), vaginal wall thickness and perception of healing in women with vaginal laxity.
- Conditions
- Vaginal Laxity
- Being tested
- Electric stimulation
- Keywords
- vaginal laxity, pelvic floor, electrical stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electric stimulationDevice
Patients with baseline assessments will be followed up for 8 weeks within a planned treatment program. Treatment protocol for the ES group:
external ES wearable apparatus will be applied three days a week for 30 minutes with symmetrical biphasic current at a frequency of 50 Hertz (Hz), with stimulation and rest periods of 5 s contraction and 5 s rest, with a current intensity ranging from 0-100 mA while the patients are in the supine position. The device will be attached to the patients in such a way that it wraps around the upper thigh, the electrodes will be attached to the anterior and posterior of the right and left thigh, the right-left pelvic side and the right-left gluteal region. The current intensity in each session will be determined as the maximum current intensity that will not cause pain and discomfort in individuals.
| Study group | Role | What they receive |
|---|---|---|
| electric stimulation group | Experimental | Individuals who meet the inclusion criteria and who have signed the consent form will be randomly divided into 2 groups (treatment and control groups). Randomization will be done by a researcher who is not involved in the study using computer-assisted randomization blocks. The treatment group patients will receive 3 sessions of external stimulation per week for 8 weeks, while the control group will not receive any intervention (consisting of patients waiting on the treatment list). Receives: Device: Electric stimulation |
| control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaginal Symptoms International Consultation on Incontinence Questionnaire - Vaginal Symptoms (ICIQ-VS)
Measured: Change from basline at 8 weeks
Secondary outcomes (5)
Pelvic floor symptoms Pelvic Floor Distress Inventory-20 (PTDE-20)
Measured: Change from basline at 8 weeks
Sexual function Female Sexual Function Index (FSFI)
Measured: Change from baseline at 8 weeks
Pelvic floor muscle morphometry (levator ani thickness)
Measured: Change from baseline at 8 weeks
Pelvic floor muscle strength and endurance
Measured: Change from baseline at 8 weeks
Vaginal wall and mucosa thickness
Measured: Change from basline at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start15 Jul 2024
- Primary completion15 Feb 2025 (estimated)
- Study completion15 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal LaxityStudies of the same condition, open and under way.
- More trials run by Selcuk 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
- Individuals who meet the inclusion criteria and who have signed the consent form will be randomly divided into 2 groups (treatment and control groups). Randomization will be done by a researcher who is not involved in the study using computer-assisted randomization blocks. The treatment group patients will receive 3 sessions of external stimulation per week for 8 weeks, while the control group will not receive any intervention (consisting of patients waiting on the treatment list).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zehra KORKUT, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06637475
- Sponsor's protocol ID
- ZKORKUT
- Status last verified
- Oct 2024
- First submitted
- 9 Oct 2024
- Last updated
- 15 Oct 2024
- 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 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of External Electrical Stimulation in Women With Vaginal Laxity
- ClinicalTrials.gov ID
- NCT06637475
- Acronym / sponsor ID
- ZKORKUT
- Conditions
- Vaginal Laxity
- Keywords
- vaginal laxity, pelvic floor, electrical stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 15 Jul 2024 (actual)
- Primary completion
- 15 Feb 2025 (estimated)
- Study completion
- 15 Mar 2025 (estimated)
- First posted
- 15 Oct 2024 (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.
The aim of this study was to investigate the effects of external electrical stimulation on clinical symptoms such as vaginal symptoms, pelvic floor symptoms, sexual function, pelvic floor muscle morphometry (levator ani thickness) and functions (strength, endurance), vaginal wall thickness and perception of healing in women with vaginal laxity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Individuals who meet the inclusion criteria and who have signed the consent form will be randomly divided into 2 groups (treatment and control groups). Randomization will be done by a researcher who is not involved in the study using computer-assisted randomization blocks. The treatment group patients will receive 3 sessions of external stimulation per week for 8 weeks, while the control group will not receive any intervention (consisting of patients waiting on the treatment list).
| Arm | Type | Receives |
|---|---|---|
| electric stimulation group | Experimental | Device: Electric stimulationIndividuals who meet the inclusion criteria and who have signed the consent form will be randomly divided into 2 groups (treatment and control groups). Randomization will be done by a researcher who is not involved in the study using computer-assisted randomization blocks. The treatment group patients will receive 3 sessions of external stimulation per week for 8 weeks, while the control group will not receive any intervention (consisting of patients waiting on the treatment list). |
| control group | No intervention | – |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- Sensory loss Presence of infection Having a pacemaker Metal implant presence Malignancy story Having serious cardiovascular problems Presence of severe pelvic organ prolapse (above stage 2) Having undergone surgery for POP/incontinence (within the last 1 year) Pregnancy presence Having enough laxity to require surgery Having a neurological disorder Receiving estrogen therapy
- -
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 |
|---|---|---|
| Electric stimulationPatients with baseline assessments will be followed up for 8 weeks within a planned treatment program. Treatment protocol for the ES group: external ES wearable apparatus will be applied three days a week for 30 minutes with symmetrical biphasic current at a frequency of 50 Hertz (Hz), with stimulation and rest periods of 5 s contraction and 5 s rest, with a current intensity ranging from 0-100 mA while the patients are in the supine position. The device will be attached to the patients in such a way that it wraps around the upper thigh, the electrodes will be attached to the anterior and posterior of the right and left thigh, the right-left pelvic side and the right-left gluteal region. The current intensity in each session will be determined as the maximum current intensity that will not cause pain and discomfort in individuals. | Device | electric stimulation group |
Primary outcome
Vaginal Symptoms International Consultation on Incontinence Questionnaire - Vaginal Symptoms (ICIQ-VS)
Time frame: Change from basline at 8 weeks
5 secondary outcomes
Pelvic floor symptoms Pelvic Floor Distress Inventory-20 (PTDE-20)
Time frame: Change from basline at 8 weeks
Sexual function Female Sexual Function Index (FSFI)
Time frame: Change from baseline at 8 weeks
Pelvic floor muscle morphometry (levator ani thickness)
Time frame: Change from baseline at 8 weeks
Pelvic floor muscle strength and endurance
Time frame: Change from baseline at 8 weeks
Vaginal wall and mucosa thickness
Time frame: Change from basline at 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- 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 Electric stimulation in people with Vaginal Laxity, run by Selcuk University at 1 site in Turkey (Türkiye).
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 0 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 15 Oct 2024. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
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?
Vaginal Symptoms International Consultation on Incontinence Questionnaire - Vaginal Symptoms (ICIQ-VS) (time frame: Change from basline at 8 weeks). 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 15 Oct 2024.