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NCT Number: NCT06637475

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Vaginal Laxity

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Selcuk University

Konya, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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Treatment and study plan

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.

Primary outcomes

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

    Time frame: Change from basline at 8 weeks

Secondary outcomes

  1. Pelvic floor symptoms Pelvic Floor Distress Inventory-20 (PTDE-20)

    Time frame: Change from basline at 8 weeks

  2. Sexual function Female Sexual Function Index (FSFI)

    Time frame: Change from baseline at 8 weeks

  3. Pelvic floor muscle morphometry (levator ani thickness)

    Time frame: Change from baseline at 8 weeks

  4. Pelvic floor muscle strength and endurance

    Time frame: Change from baseline at 8 weeks

  5. Vaginal wall and mucosa thickness

    Time frame: Change from basline at 8 weeks

Sponsors and collaborators

Lead sponsor

Selcuk University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 15, 2024
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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