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Completed

NCT Number: NCT04733885

Electrical Stimulation in Women With Pelvic Organ Prolapse

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)

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Key information

Conditions

Pelvic Organ Prolapse Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Prolapse

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Selcuk University

Konya, 42090, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Electrical Stimulation

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.

Other names: Sham Electrical Stimulation

Primary outcomes

  1. The prolapse stage will be measured with Simplified POP-Q

    Time frame: Change from baseline prolapse stage at 4 weeks and 8 weeks

    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 outcomes

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

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

    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.

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

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

    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.

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

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

    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.

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

    Time frame: Change from baseline quality of life at 4 weeks and 8 weeks

    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.

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

    Time frame: Change from baseline sexual function at 4 weeks and 8 weeks

    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).

Sponsors and collaborators

Lead sponsor

KTO Karatay University

Other

Collaborators

  • Ankara Yildirim Beyazıt University
  • Necmettin Erbakan University

Registry information

Official study title

Evaluation of the Effects of Electrical Stimulation in Women With Pelvic Organ

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Feb 2, 2021
Registry last updated
Jan 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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