Investigation of Effects of Electrical Stimulation in Women With Vaginal Laxity

Sponsor
Selcuk University
Study ID
NCT06935240
Status
Recruiting
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Conditions

  • Overactive Bladder

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Treatment — DEVICE
    Nöromusculer and Transcutaneus Electrical Neuron stimulations

Study Details

The purpose of this study is to compare the effects of different externally applied electrical stimulation methods on overactive bladder (OAB) symptoms, quality of life, and patients' perception of improvement.

Key Dates

First listed
Apr 20, 2025
Start date
Mar 10, 2025
Status verified
Apr 2025
Primary completion
May 30, 2025
Completion
Jun 30, 2025

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: Control
    Patients in this group will receive only lifestyle recommendations (fluid consumption, diet, weight gain, constipation and bladder irritations) to maintain urinary control.
  • Experimental: Nöromusculer Es
    The neuromuscular ES wearable device INNOVO® (Atlantic Therapeutics, Galway, Ireland) will be used three days a week in the supine hook position with urge mode (program 2: 10 Hz frequency, 250 ms pulse width, 0.5 seconds acceleration and deceleration times, 5 seconds contraction time and 0 seconds parameters) along with lifestyle recommendations. The device will be glued around the hip/pelvis of the patients so that the electrodes will coincide with the anterior and posterior of the right and left hip, the right-left pelvic side and the right-left gluteal region. The application will take 30 minutes.
  • Experimental: Tens
    A current with a pulse width of 200 milliseconds and a frequency of 10 Hz will be applied three days a week in the prone position with a parasacral TENS device (Intelect, economy) along with lifestyle recommendations. Electrodes will be placed bilaterally and parasacrally. The application will last 30 minutes.

Primary Outcome Measure

Symptom severity Overactive Bladder-V8 Questionnaire (OAB-V8) [ Time Frame: 6 weeks ]

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