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

N/AActive Not RecruitingNCT06637475

Selcuk University36 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Vaginal Laxity

Interventions

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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 \-

Locations (1)

Selcuk University

Konya, Turkey (Türkiye)

Outcomes

Primary Outcomes

Vaginal Symptoms International Consultation on Incontinence Questionnaire - Vaginal Symptoms (ICIQ-VS)

Time frame: Change from basline at 8 weeks

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

Data from ClinicalTrials.gov

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