Electrical Stimulation in Women With Pelvic Organ Prolapse

Pelvic Organ Prolapse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04733885
• Other study ID #: KaratayZK
• Status: Completed
• Phase: N/A
• Start date: February 15, 2021
• Est. completion date: February 1, 2022

Study information

• Verified date: January 2021
• Source: KTO Karatay University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: February 1, 2022
• Est. primary completion date: September 20, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Intervention

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.
• 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.

Locations

Country	Name	City	State
Turkey	Selcuk University	Konya

Sponsors (3)

Lead Sponsor	Collaborator
KTO Karatay University	Ankara Yildirim Beyazit University, Necmettin Erbakan University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Change from baseline Pelvic floor muscle strength at 4 weeks and 8 weeks
Secondary	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.	Change from baseline the pelvic organ prolapse symptoms at 4 weeks and 8 weeks
Secondary	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.	Change from baseline the pelvic organ prolapse symptoms severity at 4 weeks and 8 weeks
Secondary	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.	Change from baseline quality of life at 4 weeks and 8 weeks
Secondary	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).	Change from baseline sexual function at 4 weeks and 8 weeks