Vaginal Laxity
Conditions
Keywords
vaginal laxity, pelvic floor, electrical stimulation
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.
Interventions
DEVICEElectric 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.
Sponsors
Selcuk University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
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).
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 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 \-
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vaginal Symptoms International Consultation on Incontinence Questionnaire - Vaginal Symptoms (ICIQ-VS) | Change from basline at 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Turkey (Türkiye)
Outcome results
None listed