Electrical Stimulation in Women With Pelvic Organ Prolapse

• ClinicalTrials.gov Identifier: NCT04733885
• Recruitment Status: Not yet recruiting
• First Posted: February 2, 2021
• Last Update Posted: February 2, 2021
• Sponsor: KTO Karatay University
• Collaborators: Ankara Yildirim Beyazıt University; Necmettin Erbakan University
• Information provided by (Responsible Party): KTO Karatay University

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)

Condition or disease	Intervention/treatment	Phase
Pelvic Organ Prolapse	Device: Experimental; Device: Control	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Evaluation of the Effects of Electrical Stimulation in Women With Pelvic Organ
• Estimated Study Start Date: February 2021
• Estimated Primary Completion Date: June 2021
• Estimated Study Completion Date: February 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Device: 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.; Other Name: Electrical Stimulation
Sham Comparator: 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.	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.; Other Name: Sham Electrical Stimulation

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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).

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: ZEHRA KORKUT; +905076147080; zehra.korkut@karatay.edu.tr

Contact: SEYDA TOPRAK CELENAY, Assoc.Prof.; +90 312 906 1000; sydtoprak@hotmail.com

Sponsors and Collaborators

KTO Karatay University

Ankara Yildirim Beyazıt University

Necmettin Erbakan University

More Information

• Responsible Party: KTO Karatay University
• ClinicalTrials.gov Identifier: NCT04733885
• Other Study ID Numbers: KaratayZK
• First Posted: February 2, 2021
• Last Update Posted: February 2, 2021
• Last Verified: January 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by KTO Karatay University:

pelvic organ prolapse; electrical stimulation

Additional relevant MeSH terms:

Prolapse; Pelvic Organ Prolapse; Pathological Conditions, Anatomical