Clinical trial NCT04733885: 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
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Organ Prolapse
Keywords: pelvic organ prolapse
electrical stimulation
Lead sponsor: KTO Karatay University
Sponsor class: OTHER
Collaborators: name: Ankara Yildirim Beyazıt University
name: Necmettin Erbakan University
First posted: 2021-02-02
Enrollment: 26
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The prolapse stage will be measured with Simplified POP-Q
timeFrame: Change from baseline prolapse stage at 4 weeks and 8 weeks
Secondary outcomes:
measure: Pelvic floor muscle strength will be measured measured with PFX Perineometer device(Cardio Design Pty Ltd, Australia)
timeFrame: Change from baseline Pelvic floor muscle strength at 4 weeks and 8 weeks
measure: The pelvic organ prolapse symptoms will be assessed by Pelvic Organ Prolapse Symptom Score(POP-SS).
timeFrame: Change from baseline the pelvic organ prolapse symptoms at 4 weeks and 8 weeks
measure: The pelvic organ prolapse symptoms severity will be assessed by the Pelvic Floor Distress Inventory (PFDI-20) .
timeFrame: Change from baseline the pelvic organ prolapse symptoms severity at 4 weeks and 8 weeks
measure: Patients' quality of life will be assessed using the Prolapse Quality of Life Scale (P-QOL).
timeFrame: Change from baseline quality of life at 4 weeks and 8 weeks
measure: Patients' sexual function will be assessed by the Pelvic Organ Prolapse/Incontinence Sexual Function Questionnaire-12 (PISQ-12)
timeFrame: Change from baseline sexual function at 4 weeks and 8 weeks
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Selcuk University
Study officials:
References: