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

NCT ID: NCT07094698

Last Updated: 2025-07-30

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2026-07-01

Brief 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.

Detailed Description

Pelvic floor dysfunction is a term used to describe various 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 is collectively referred to as the levator ani and includes the pubococcygeus, puborectalis, and iliococcygeus muscles. Pelvic floor muscle dysfunction, which causes significant morbidity especially in women, is associated with stress urinary incontinence, anal and fecal incontinence, pelvic organ prolapse, and sexual dysfunction. These conditions negatively affect women's quality of life. Additionally, several comorbidities 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 developing urinary incontinence compared to those without low back pain. It has been shown that strengthening the pelvic floor muscles can help reduce low back pain.

This study is planned to be conducted at Istanbul Medipol Acıbadem Regional Hospital between May 1, 2025, and December 1, 2025. All participants will be provided with detailed information about the study, and written informed consent will be obtained from those who agree to participate voluntarily.

All individuals included in the study will complete a demographic information form, which includes age, gender, height, weight, medication use, family history, and smoking status.

The study population will consist of 40 voluntary female participants between the ages of 18 and 65 who have complaints of urinary incontinence. All participants will be placed in a single group and will receive a low-frequency (2-10 Hz), 200 μs pulse duration current for 30 minutes a day, 5 days a week for 6 weeks under the supervision of a physiotherapist.

Data collection tools in this study include:

The Sociodemographic Information Form, The Oswestry Low Back Pain Disability Questionnaire to assess low back pain levels, The King's Health Questionnaire (KHQ) to evaluate urinary incontinence, The Constipation Severity Instrument (CSI) to assess constipation, The Sexual Quality of Life Questionnaire - Female (SQoL-F) to evaluate sexual dysfunction.

Necessary permissions have been obtained from the original authors for the use of all questionnaires with established validity and reliability.

Conditions

Pelvic Floor Dysfunction; Low Back Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

sacral stimulation

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Uskudar University

OTHER

Sponsor Role: lead

Responsible Party

Dr. Öğr. Üyesi Muhammed Fatih Kavak

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

muhammed fatih kavak, dr

Role: STUDY_DIRECTOR

Uskudar University

Locations

Medipol Acıbadem Regional Hospital

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

61351342/020-1199

Identifier Type: -

Identifier Source: org_study_id