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

Selcuk University1 site in 1 country36 target enrollmentJuly 15, 2024

ConditionsVaginal Laxity

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Vaginal Laxity
Sponsor: Selcuk University
Enrollment: 36
Locations: 1
Primary Endpoint: Vaginal Symptoms International Consultation on Incontinence Questionnaire - Vaginal Symptoms (ICIQ-VS)
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

July 15, 2024

End Date

March 15, 2025

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Selcuk University

Responsible Party

Principal Investigator

Zehra KORKUT

Asst. Prof.

Selcuk University

Eligibility Criteria

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

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)(Change from basline at 8 weeks)
Sexual function Female Sexual Function Index (FSFI)(Change from baseline at 8 weeks)
Pelvic floor muscle morphometry (levator ani thickness)(Change from baseline at 8 weeks)
Pelvic floor muscle strength and endurance(Change from baseline at 8 weeks)
Vaginal wall and mucosa thickness(Change from basline at 8 weeks)