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Clinical Trials in Turkey / NCT07094698
Active, not recruiting Not applicable

Sacral Stimulation in Women With Low Back Pain: Effects on Pelvic Functions and Daily Life

NCT07094698 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2025-03-01
Last updated
2025-07-30

Condition(s) studied

Pelvic Floor DysfunctionLow Back Pain

Investigational drug(s) / intervention(s)

sacral stimulation

sacral stimulation: A low-frequency (2-10 Hz) current with a pulse duration of 200 μs will be applied for 30 minutes, 5 days a week, under the supervision of a physiotherapist for 6 weeks.

Study summary

Pelvic floor dysfunction is a term used to describe a variety of disorders involving moderate to severe impairment of the pelvic floor muscles. The pelvic floor is a layer of muscle designed to support the abdominal organs and maintain urethral, anal, and vaginal continence. It includes the pubococcygeus, puborectalis, and iliococcygeus muscles. Pelvic floor muscle dysfunction, which causes significant morbidity particularly in women, is associated with stress urinary incontinence, anal and fecal incontinence, pelvic organ prolapse, and sexual dysfunction, all of which can negatively affect quality of life in women. Moreover, various comorbid conditions such as back and neck pain, asthma, cardiovascular diseases, and psychiatric disorders are also associated with pelvic floor dysfunction.

In patients diagnosed with lumbar disc herniation, changes in pelvic floor muscle strength have been observed. These changes may be accompanied by urinary and sexual problems. Individuals with low back pain are at twice the risk of urinary incontinence compared to those without back pain, and strengthening of the pelvic floor muscles has been shown to reduce back pain.

This study aims to understand the characteristics of transcutaneous sacral nerve stimulation, examine the neurophysiological basis of this treatment method, and evaluate its potential for future innovative approaches.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: Having complaints of urinary incontinence Having complaints of low back pain Diagnosed with constipation according to Rome IV criteria Women with pelvic floor dysfunction Being under 65 years of age Having normal mood and memory functions Being able to speak Turkish Being literate Voluntarily agreeing to participate in the study Exclusion Criteria: Neuromuscular diseases (such as Multiple Sclerosis, Parkinson's disease, Myasthenia Gravis, etc.) Malignant tumors Diabetes and other serious medical conditions Pelvic radiation, rectal surgery, spinal surgery Hysterectomy Pelvic inflammation Urinary tract infection Vaginitis Pacemaker implantation Pregnancy Cognitive impairment

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Medipol Acıbadem Regional Hospital Istanbul Turkey (Türkiye)

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07094698 on ClinicalTrials.gov ↗ ← All trials in Turkey