Investigation of Effects of Electrical Stimulation in Women With Vaginal Laxity

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-10

Study Completion Date

2025-06-30

Brief Summary

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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.

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Detailed Description

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Current treatment options in the management of AAM are graded into 4 steps by various clinical guidelines. The first step consists of behavioral treatment methods such as lifestyle modification and bladder training and physiotherapy and rehabilitation approaches. Physiotherapy and rehabilitation approaches include various techniques such as pelvic floor muscle training, electrical stimulation (ES), manual therapy and kinesio taping. Transcutaneous electrical nerve stimulation (TENS) is a non-invasive therapeutic method commonly preferred for acute and chronic pain management.

The purpose of TENS in the management of AAM is one of the external ES methods used to inhibit presynaptic afferent neurons carrying impulses from the bladder by stimulating peripheral segmental dermatome nerves. Thus, TENS can affect neural pathways that modulate afferent/efferent impulses in the spinal and supraspinal areas. The portable TENS device is a two-channel output device with self-adhesive electrodes and adjustable treatment frequency and duration. The device is used in AAM by selecting 200 millisecond pulse width and 10 hz frequency parameters. With this frequency, related neural pathways can be modulated and detrusor overactivity can be controlled.

Neuromuscular ES (Innovo ®) (Atlantic Therapeutics, Galway, Ireland), which can be used as external ES in the treatment of AAM, is a new neuromuscular ES device developed to retrain the pelvic floor muscles and inhibit the detrusor muscle through electrodes placed in a garment in the treatment of incontinence. In the literature, this device is also known as a type of external ES application (new generation external ES) applied over the pelvis/hip and can be easily worn and used by the patient. This device is attached to a 2-piece wrapped garment that holds the four electrodes in place in the pelvis/hip with hydrogel adhesive. Program 2 was designed in this device for the presence of urge/pinch type incontinence. This program includes 10 Hz frequency, 250 ms pulse width, 0.5 seconds acceleration and deceleration times, 5 seconds contraction time and 0 seconds parameters. With this program, the nerve controlling the pelvic floor muscle mechanism is stimulated and detrusor overactivity can be controlled.

While tibial nerve stimulation has been mostly used in patients with AAM, it has recently been observed that external ES applications have started to be applied alone or in combination with other treatments. When the literature is reviewed, it is seen that there are a limited number of external ES applications in patients with AAM, but there is no study comparing these applications. Therefore, the aim of this study was to compare the effects of different external ES applications on bladder functions, AAM symptoms, quality of life and patients' perception of recovery in women with AAM. In this sense, it is thought that our study will contribute to the literature and will have original value.

Conditions

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Overactive Bladder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Individuals who meet the inclusion criteria and sign the consent form will be randomly divided into 3 groups (Control, Neuromuscular ES, TENS). Randomization will be performed by a researcher who is not involved in the study using computer-assisted randomization blocks.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Control

Patients in this group will receive only lifestyle recommendations (fluid consumption, diet, weight gain, constipation and bladder irritations) to maintain urinary control.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Treatment

Intervention Type DEVICE

Nöromusculer and Transcutaneus Electrical Neuron stimulations

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.

Group Type EXPERIMENTAL

Treatment

Intervention Type DEVICE

Nöromusculer and Transcutaneus Electrical Neuron stimulations

Interventions

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Treatment

Nöromusculer and Transcutaneus Electrical Neuron stimulations

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

To be between the ages of 18-65 Being diagnosed with AAM Volunteer 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) Pregnancy presence Lumbosacral peripheral nerve lesion

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No