Investigation of the Effects of External Electrical Stimulation in Women With Vaginal Laxity
NCT ID: NCT06637475
Last Updated: 2024-10-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
NA
36 participants
INTERVENTIONAL
2024-07-15
2025-03-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Investigation of the Effect of Manual Therapy and Pelvic Floor Exercises on Pelvic Floor Muscles
NCT06494917
Pelvic Floor Muscle Exercises Effect After Stoma Closure
NCT04824287
Effect of Vaginal Radiofrequency Therapy on Vaginal Laxity : Pilot Trial
NCT04227392
The Effects of Postisometric Relaxation Technique in Female Patients With Dyssynergic Defecation
NCT06215924
Effects of Exercise Training on Pelvic Floor Symptoms and Function in Adults With Constipation
NCT04661202
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
electric stimulation group
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).
Electric stimulation
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.
control group
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Electric stimulation
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Exclusion Criteria
\-
18 Years
60 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Selcuk University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Zehra KORKUT
Asst. Prof.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Selcuk University
Konya, , Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ZKORKUT
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.