Investigation of Effects of Electrical Stimulation in Women With Vaginal Laxity

NCT06935240 | Recruiting

• 1 other identifier: 2025/190
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Overactive Bladder

Outcome Measures

Primary Outcomes (1)

• Symptom severity Overactive Bladder-V8 Questionnaire (OAB-V8)

  6 weeks

Secondary Outcomes (1)

• bladder diary results

  6 weeks

Study Arms (3)

Control

NO INTERVENTION

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

Nöromusculer Es

EXPERIMENTAL

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.

Device: Treatment

Tens

EXPERIMENTAL

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.

Device: Treatment

Interventions

Treatment DEVICE

Nöromusculer and Transcutaneus Electrical Neuron stimulations

Nöromusculer Es; Tens

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To be between the ages of 18-65 Being diagnosed with AAM Volunteer Becoming literate

You may not qualify if:

• 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

Sponsors & Collaborators

• Selcuk University: lead
• Ankara Yildirim Beyazıt University: collaborator
• Necmettin Erbakan University: collaborator

Study Sites (1)

Selcuk University

Konya, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: April 11, 2025
• First Posted: April 20, 2025
• Study Start: March 10, 2025
• Primary Completion: May 30, 2025
• Study Completion: June 30, 2025
• Last Updated: April 20, 2025

Record last verified: 2025-04

Locations

TU (1)