Electrical Stimulation in Women With Pelvic Organ Prolapse

NCT ID: NCT04733885

Last Updated: 2024-01-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-15
• Study Completion Date: 2022-02-01

Brief Summary

The aim of this study is to search the effects of electrical stimulation on clinical symptoms such as pelvic floor muscle strength, stage of POP, symptoms of pelvic floor, quality of life and sexual function in women with pelvic organ prolapse (POP)

Detailed Description

This study is planned as a prospective, sham radomized controlled study. Individuals who volunteered to participate in the study, complying with the inclusion criteria and signed the consent paper will be randomly allocated into ES and Sham ES groups.

The study includes women aged 18-65 diagnosed with staged 1-2 POP by the physician.All patients were evaluated by the same doctor who performed the POP-Q measurement, who was blinded to the baseline results. The treatment of patients will be given by the same therapist. Measurements will be made 3 times at baseline (before treatment), interim period (4th week) and after treatment.

Conditions

Pelvic Organ Prolapse

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Electrical Stimulation group

ES and lifestyle advice have been applied ES application will be done 3 days a week for 8 weeks, 20 minutes. An informative brochure with lifestyle advice will be provided for both groups.

Group Type: EXPERIMENTAL

Experimental

Intervention Type: DEVICE

Current application will be made in the frequency range of 20-50 Hz. The Chattanooga (Intelect Neo) device with interfering current will be used for treatment, vacuum electrodes will be made in the form of 4 pole application. Two electrodes to the outside of the inguinal ligament, the other two electrodes will be placed on the upper inner part of the thigh.ES applications will be performed in the supine position with head and knee pillow supported.

Sham Electric Stimulation group

Sham ES and lifestyle advice have been applied Sham ES application will be done 3 days a week for 8 weeks, 20 minutes. An informative brochure with lifestyle advice will be provided for both groups.

Group Type: SHAM_COMPARATOR

Control

Intervention Type: DEVICE

The Chattanooga (Intelect Neo) device with interfering current will be used for treatment, vacuum electrodes will be made in the form of 4 pole application. Two electrodes to the outside of the inguinal ligament, the other two electrodes will be placed on the upper inner part of the thigh. The same device used in ES application to the sham group will be attached to the patients, however, active ES will not be issued from the device and only vacuum will turn on. ES applications will be performed in the supine position with head and knee pillow supported.

Interventions

Experimental

Current application will be made in the frequency range of 20-50 Hz. The Chattanooga (Intelect Neo) device with interfering current will be used for treatment, vacuum electrodes will be made in the form of 4 pole application. Two electrodes to the outside of the inguinal ligament, the other two electrodes will be placed on the upper inner part of the thigh.ES applications will be performed in the supine position with head and knee pillow supported.

Intervention Type: DEVICE

Control

The Chattanooga (Intelect Neo) device with interfering current will be used for treatment, vacuum electrodes will be made in the form of 4 pole application. Two electrodes to the outside of the inguinal ligament, the other two electrodes will be placed on the upper inner part of the thigh. The same device used in ES application to the sham group will be attached to the patients, however, active ES will not be issued from the device and only vacuum will turn on. ES applications will be performed in the supine position with head and knee pillow supported.

Intervention Type: DEVICE

Other Intervention Names

Electrical Stimulation; Sham Electrical Stimulation

Eligibility Criteria

Inclusion Criteria

• Being in the age range of 18-65 ,
• Having stage1-2 symptomatic prolapse according to the POP-Q system,
• Being a volunteer and literate

Exclusion Criteria

• Being pregnant,
• being stage 3-4 prolapse, Those whose evaluation parameters are missing and who do not regularly participate,
• Inadequate understanding and cooperation in treatment and evaluation parameters,
• Have malignant disease, urinary infection,
• accompanying neurological disease, diabetes mellitus and cardiopathy with complications,
• have electronic and metal implant, loss of sensation, sacral peripheral nerve lesion
• Patients with at least one of the kidney failure requiring hemodialysis

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ankara Yildirim Beyazıt University

OTHER

Sponsor Role: collaborator

Necmettin Erbakan University

OTHER

Sponsor Role: collaborator

KTO Karatay University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Selcuk University

Konya, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

KaratayZK

Identifier Type: -

Identifier Source: org_study_id