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

NCT06637475 | Active Not Recruiting

• 1 other identifier: ZKORKUT
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Vaginal Laxity

Keywords

vaginal laxity, pelvic floor, electrical stimulation

Outcome Measures

Primary Outcomes (1)

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

  Change from basline at 8 weeks

Secondary Outcomes (5)

• 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

Study Arms (2)

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).

Device: Electric stimulation

control group

NO INTERVENTION

Interventions

Electric stimulation DEVICE

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.

electric stimulation group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may not qualify if:

• 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

Sponsors & Collaborators

• Selcuk University: lead

Study Sites (1)

Selcuk University

Konya, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Electric Stimulation

Intervention Hierarchy (Ancestors)

Physical Stimulation; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof.

Model Details: 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).

Study Record Dates

• First Submitted: October 9, 2024
• First Posted: October 15, 2024
• Study Start: July 15, 2024
• Primary Completion: February 15, 2025
• Study Completion: March 15, 2025
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)