Electrical Stimulation in Women With Pelvic Organ Prolapse

NCT04733885 | Completed

• 1 other identifier: KaratayZK
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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)

Conditions

Pelvic Organ Prolapse

Keywords

pelvic organ prolapse; electrical stimulation

Outcome Measures

Primary Outcomes (1)

• The prolapse stage will be measured with Simplified POP-Q

  The measurements are taken when the Valsalva maneuver is performed while the patient is in the dorsal lithotomy position. According to the reference point of the hymen, It is measured at a total of 4 points: cervix, posterior fornix, anterior and posterior vaginal wall. The stage of prolapse is graded. Stage 0: There is no prolapse. Stage 1: The most distal part of the prolapse is more than 1 cm above the prolapse. Stage 2: The most distal part of the prolapse, between 1 cm above and 1 cm below the prolapse Stage 3: The most distal part of the prolapse protrudes more than 1 cm below the prolapse. Stage 4: Complete eversion of the lower genital tract

  Change from baseline prolapse stage at 4 weeks and 8 weeks

Secondary Outcomes (5)

• Pelvic floor muscle strength will be measured measured with PFX Perineometer device(Cardio Design Pty Ltd, Australia)

  Change from baseline Pelvic floor muscle strength at 4 weeks and 8 weeks

• The pelvic organ prolapse symptoms will be assessed by Pelvic Organ Prolapse Symptom Score(POP-SS).

  Change from baseline the pelvic organ prolapse symptoms at 4 weeks and 8 weeks

• The pelvic organ prolapse symptoms severity will be assessed by the Pelvic Floor Distress Inventory (PFDI-20) .

  Change from baseline the pelvic organ prolapse symptoms severity at 4 weeks and 8 weeks

• Patients' quality of life will be assessed using the Prolapse Quality of Life Scale (P-QOL).

  Change from baseline quality of life at 4 weeks and 8 weeks

• Patients' sexual function will be assessed by the Pelvic Organ Prolapse/Incontinence Sexual Function Questionnaire-12 (PISQ-12)

  Change from baseline sexual function at 4 weeks and 8 weeks

Study Arms (2)

Electrical Stimulation group

EXPERIMENTAL

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.

Device: Experimental

Sham Electric Stimulation group

SHAM COMPARATOR

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.

Device: Control

Interventions

Experimental 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.

Also known as: Electrical Stimulation

Electrical Stimulation group

Control 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.

Also known as: Sham Electrical Stimulation

Sham Electric Stimulation group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• KTO Karatay University: lead
• Ankara Yildirim Beyazıt University: collaborator
• Necmettin Erbakan University: collaborator

Study Sites (1)

Selcuk University

Konya, 42090, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse

Interventions

Electric Stimulation

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Stimulation; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2021
• First Posted: February 2, 2021
• Study Start: February 15, 2021
• Primary Completion: September 20, 2021
• Study Completion: February 1, 2022
• Last Updated: January 24, 2024

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)