Pelvic Organ ProlapseNCT04733885
Electrical Stimulation in Women With Pelvic Organ Prolapse
A study testing Experimental in people with Pelvic Organ Prolapse, run by KTO Karatay University at 1 site in Turkey (Türkiye).
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) Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- Experimental
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Feb 2021to 1 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being in the age range of 18-65 ,
- Having stage1-2 symptomatic prolapse according to the POP-Q system,
- Being a volunteer and literate
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effects of Electrical Stimulation in Women With Pelvic Organ
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)
Read the 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.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- Experimental, Control
- Keywords
- pelvic organ prolapse, electrical stimulation
- Medical subject headings
- Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExperimentalDevice
Also called Electrical Stimulation
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.
ControlDevice
Also called Sham Electrical Stimulation
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
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.
Measured: 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).
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.
Measured: 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) .
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.
Measured: 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).
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.
Measured: 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)
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).
Measured: Change from baseline sexual function at 4 weeks and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2021
- Study start15 Feb 2021
- Primary completion20 Sep 2021
- Study completion1 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- KTO Karatay University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04733885
- Sponsor's protocol ID
- KaratayZK
- Status last verified
- Jan 2021
- First submitted
- 24 Jan 2021
- Last updated
- 24 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Electrical Stimulation in Women With Pelvic Organ
- ClinicalTrials.gov ID
- NCT04733885
- Acronym / sponsor ID
- KaratayZK
- Conditions
- Pelvic Organ Prolapse
- Keywords
- pelvic organ prolapse, electrical stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- KTO Karatay UniversityUniversity, hospital or other
- Collaborators
- Ankara Yildirim Beyazıt University, Necmettin Erbakan University
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- 20 Sep 2021 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 2 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electrical Stimulation group | Experimental | Device: ExperimentalES 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 Electric Stimulation group | Sham comparator | Device: ControlSham 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Being in the age range of 18-65 ,
- Having stage1-2 symptomatic prolapse according to the POP-Q system,
- Being a volunteer and literate
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExperimentalAlso: Electrical StimulationCurrent 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. | Device | Electrical Stimulation group |
| ControlAlso: Sham Electrical StimulationThe 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. | Device | Sham Electric Stimulation group |
Primary outcome
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
5 secondary outcomes
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental in people with Pelvic Organ Prolapse, run by KTO Karatay University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The prolapse stage will be measured with Simplified POP-Q (time frame: Change from baseline prolapse stage at 4 weeks and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2024.