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Electrical Stimulation in Women With Pelvic Organ Prolapse

Primary Purpose

Pelvic Organ Prolapse

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Experimental
Control
Sponsored by
KTO Karatay University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pelvic Organ Prolapse focused on measuring pelvic organ prolapse, electrical stimulation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    Electrical Stimulation group

    Sham Electric Stimulation group

    Arm 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.

    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.

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Pelvic floor muscle strength will be measured measured with PFX Perineometer device(Cardio Design Pty Ltd, Australia)
    Indicators of this measuring device range from 0-12 kilo Pascal (kPa). During the measurement, The patient whose perineometer sensor is placed in her vagina, will be asked to relax and then to tighten the sensor strongly. The difference between the first and last value in the perineometer is the contraction strength. This evaluation will be repeated three times and averaged and recorded.
    The pelvic organ prolapse symptoms will be assessed by Pelvic Organ Prolapse Symptom Score(POP-SS).
    Pelvic Organ Prolapse Symptom Score (POP-SS) consists of 7 questions whose answers are scored between 0 and 5. The total score ranges from 0 to 28. The higher the score, the higher the severity of POP symptoms.
    The pelvic organ prolapse symptoms severity will be assessed by the Pelvic Floor Distress Inventory (PFDI-20) .
    The PFDI comprises three subscales: the Pelvic Organ Prolapse Distress Inventory-6, the ColoRectal-Anal Distress Inventory-8 and the Urinary Distress Inventory-6. The scores range from 0 to l00 for the all subscales. Higher scores signifying severe symptom.
    Patients' quality of life will be assessed using the Prolapse Quality of Life Scale (P-QOL).
    The scale consists of 9 fields and 20 questions. The first question is general health perception, the second question is the effect of urogenital prolapse on the quality of life, the 3rd and 4th questions are role limitations, the 5th and 6th questions are physical limitations, the 7th and 8th questions are social limitations, 9-11. questions on interpersonal relationships, 12-14. questions ask emotions, questions 15 and 16 examine sleep / energy influence, and questions 16 and 20 examine severity. The score ranges from 0-100, with a higher score indicating poor quality of life.
    Patients' sexual function will be assessed by the Pelvic Organ Prolapse/Incontinence Sexual Function Questionnaire-12 (PISQ-12)
    This survey, consisting of 12 questions, includes 3 subtitles.This survey, consisting of 12 questions, includes 3 subtitles. 1-4. Questions are emotional, 5-9. questions are physical, 10-12. questions constitute subheadings containing partner dependent areas (range 0-48, with higher scores indicating better sexual functioning).

    Full Information

    First Posted
    January 24, 2021
    Last Updated
    January 30, 2021
    Sponsor
    KTO Karatay University
    Collaborators
    Ankara Yildirim Beyazıt University, Necmettin Erbakan University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04733885
    Brief Title
    Electrical Stimulation in Women With Pelvic Organ Prolapse
    Official Title
    Evaluation of the Effects of Electrical Stimulation in Women With Pelvic Organ
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 2021 (Anticipated)
    Primary Completion Date
    June 2021 (Anticipated)
    Study Completion Date
    February 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    KTO Karatay University
    Collaborators
    Ankara Yildirim Beyazıt University, Necmettin Erbakan University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pelvic Organ Prolapse
    Keywords
    pelvic organ prolapse, electrical stimulation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Electrical Stimulation group
    Arm Type
    Experimental
    Arm 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.
    Arm Title
    Sham Electric Stimulation group
    Arm Type
    Sham Comparator
    Arm 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.
    Intervention Type
    Device
    Intervention Name(s)
    Experimental
    Other Intervention Name(s)
    Electrical Stimulation
    Intervention Description
    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
    Intervention Name(s)
    Control
    Other Intervention Name(s)
    Sham Electrical Stimulation
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    The prolapse stage will be measured with Simplified POP-Q
    Description
    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
    Time Frame
    Change from baseline prolapse stage at 4 weeks and 8 weeks
    Secondary Outcome Measure Information:
    Title
    Pelvic floor muscle strength will be measured measured with PFX Perineometer device(Cardio Design Pty Ltd, Australia)
    Description
    Indicators of this measuring device range from 0-12 kilo Pascal (kPa). During the measurement, The patient whose perineometer sensor is placed in her vagina, will be asked to relax and then to tighten the sensor strongly. The difference between the first and last value in the perineometer is the contraction strength. This evaluation will be repeated three times and averaged and recorded.
    Time Frame
    Change from baseline Pelvic floor muscle strength at 4 weeks and 8 weeks
    Title
    The pelvic organ prolapse symptoms will be assessed by Pelvic Organ Prolapse Symptom Score(POP-SS).
    Description
    Pelvic Organ Prolapse Symptom Score (POP-SS) consists of 7 questions whose answers are scored between 0 and 5. The total score ranges from 0 to 28. The higher the score, the higher the severity of POP symptoms.
    Time Frame
    Change from baseline the pelvic organ prolapse symptoms at 4 weeks and 8 weeks
    Title
    The pelvic organ prolapse symptoms severity will be assessed by the Pelvic Floor Distress Inventory (PFDI-20) .
    Description
    The PFDI comprises three subscales: the Pelvic Organ Prolapse Distress Inventory-6, the ColoRectal-Anal Distress Inventory-8 and the Urinary Distress Inventory-6. The scores range from 0 to l00 for the all subscales. Higher scores signifying severe symptom.
    Time Frame
    Change from baseline the pelvic organ prolapse symptoms severity at 4 weeks and 8 weeks
    Title
    Patients' quality of life will be assessed using the Prolapse Quality of Life Scale (P-QOL).
    Description
    The scale consists of 9 fields and 20 questions. The first question is general health perception, the second question is the effect of urogenital prolapse on the quality of life, the 3rd and 4th questions are role limitations, the 5th and 6th questions are physical limitations, the 7th and 8th questions are social limitations, 9-11. questions on interpersonal relationships, 12-14. questions ask emotions, questions 15 and 16 examine sleep / energy influence, and questions 16 and 20 examine severity. The score ranges from 0-100, with a higher score indicating poor quality of life.
    Time Frame
    Change from baseline quality of life at 4 weeks and 8 weeks
    Title
    Patients' sexual function will be assessed by the Pelvic Organ Prolapse/Incontinence Sexual Function Questionnaire-12 (PISQ-12)
    Description
    This survey, consisting of 12 questions, includes 3 subtitles.This survey, consisting of 12 questions, includes 3 subtitles. 1-4. Questions are emotional, 5-9. questions are physical, 10-12. questions constitute subheadings containing partner dependent areas (range 0-48, with higher scores indicating better sexual functioning).
    Time Frame
    Change from baseline sexual function at 4 weeks and 8 weeks

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    ZEHRA KORKUT
    Phone
    +905076147080
    Email
    zehra.korkut@karatay.edu.tr
    First Name & Middle Initial & Last Name or Official Title & Degree
    SEYDA TOPRAK CELENAY, Assoc.Prof.
    Phone
    +90 312 906 1000
    Email
    sydtoprak@hotmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Electrical Stimulation in Women With Pelvic Organ Prolapse

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