Electrical Stimulation in Women With Pelvic Organ Prolapse

KTO Karatay University

Status: Completed

Conditions: Pelvic Organ Prolapse

Treatments: Device: Experimental; Device: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT04733885

KaratayZK

Details and patient eligibility

About

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)

Full 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.

Enrollment: 26 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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26 participants in 2 patient groups

Electrical Stimulation group

Experimental group

Description:

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.

Treatment:

Device: Experimental

Sham Electric Stimulation group

Sham Comparator group

Description:

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.

Treatment:

Device: Control