Clinical trial NCT06935240: Investigation of Effects of Electrical Stimulation in Women With Vaginal Laxity
Official title: Investigation of Effects of External Electrical Stimulation in Women With Vaginal Laxity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Overactive Bladder
Lead sponsor: Selcuk University
Sponsor class: OTHER
Collaborators: name: Ankara Yildirim Beyazıt University
name: Necmettin Erbakan University
First posted: 2025-04-20
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Symptom severity Overactive Bladder-V8 Questionnaire (OAB-V8)
timeFrame: 6 weeks
Secondary outcomes:
measure: bladder diary results
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Selcuk University
Study officials:
References: