Ireland
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Investigation of the Effects of External Electrical Stimulation in Women With Vaginal Laxity

NCT06637475 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2024-07-15
Last updated
2024-10-15

Condition(s) studied

Vaginal Laxity

Investigational drug(s) / intervention(s)

Electric stimulation

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.

Study 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 women with vaginal laxity.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
60 Years
Healthy volunteers
No
Inclusion Criteria:Complaining of vaginal laxity To be between 18-60 years old, Being sexually active, Volunteering to participate in the study, Becoming literate - Exclusion Criteria: 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 \-

Primary outcome measure(s)

  • Vaginal Symptoms International Consultation on Incontinence Questionnaire - Vaginal Symptoms (ICIQ-VS) — Change from basline at 8 weeks

Trial sites (1)

FacilityCityRegionStatus
Selcuk University Konya Turkey (Türkiye)
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06637475 on ClinicalTrials.gov ↗ ← All trials in Turkey