The Relationship Between Lumbar Disc Herniation and Urinary Incontinence

NCT06120517 | Unknown

• 1 other identifier: FztSelverSevalSogan
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research; To evaluate the relationship between low back pain and pelvic floor muscle strength, urinary incontinence, constipation and sexual dysfunction in female individuals with lumbar disc herniation. No study on this has been found in the literature. Hypotheses of the study; Ho: ''There is no difference in terms of the relationship between low back pain and Pelvic Floor Muscle Strength, Urinary Incontinence, Constipation and Sexual Dysfunction in Female Individuals with Lumbar Disc Herniation.'' H1: ''There is a difference in terms of the relationship between low back pain and Pelvic Floor Muscle Strength, Urinary Incontinence, Constipation and Sexual Dysfunction in Female Individuals with Lumbar Disc Herniation.''

Conditions

Lumbar Disc Herniation

Outcome Measures

Primary Outcomes (5)

• Oswestry Low Back Pain Disability Questionnaire

  Oswestry Low Back Pain Disability Questionnaire: This test is designed to obtain information about how much your back (or leg) complaint affects your daily life. It includes sections such as pain intensity, personal care (washing, dressing, etc.), lifting loads, walking, sitting, standing, sleep, sexual life (if applicable), social life, and travel. There are 6 sub-items in each section. The numbers next to the marked sub-items are added up. If there is more than 1 checked option in the same question, the highest value is taken. The maximum score is 50. The total score is calculated as = {\[total score\] /\[(number of marked questions)x5\]}x100. The validation of the Turkish version of the Oswestry Disability Index for patients with low back pain was made in our country in 2004 by Yakut, Düger, Öksüz, Yörükan, Üreten, Turan, Kardeşliği, Kiraz, Krd, Kayhan Yakut, Güler

  1 weeks

• Pelvic Floor Muscle Strength Measurement

  It is the measurement of the electrical activity occurring during pelvic floor muscle contraction and relaxation using superficial electrodes and reflecting it on the screen with appropriate equipment. The active electrode can be applied to the perineal area at 2 and 7 o'clock, 3 and 9 o'clock, or 5 and 11 o'clock. The reference electrode is usually attached to the adductor muscle group or medial to the tuber ischii. If dual channels are to be used, electrodes are placed on the abdomen. When evaluating pelvic floor muscle activity, segments such as basal rest, tonic activity - slow twitch muscles, phasic activity - fast twitch muscles, endurance are evaluated. In sEmg analysis, values such as work average, rest average, release average, onset average, peak and minimum are recorded.

  1 weeks

• King Health Survey

  It is a tool recommended by the European Clinical Practice Guidelines. It is a frequently used questionnaire to evaluate the quality of life of patients with incontinence, consisting of 32 items and two parts. It includes 7 subheadings consisting of multiple items in addition to two single-item questions such as general health status and impact on quality of life. These include: role limitations, physical limitations, social limitations, limitations in personal relationships, emotional problems, incontinence-related sleep and energy disorders, and severity measurements for incontinence. The second part is the 11-item Symptom Severity Scale, which evaluates the presence and severity of urinary symptoms. The score of the Symptom Severity Scale varies between 0 (best) and 30 (worst). For other survey areas, scores range from 0 (best) to 100 (worst). The Turkish reliability and validity of the survey was tested in 2015.

  1 weeks

• Constipation Severity Scale

  There are 16 questions in total within the scope of the scale. It includes Large Intestinal Laziness, Fecal Obstruction and Pain subdimension. The score in the Large Intestinal Laziness dimension is between 0 and 29, the score in the Fecal Obstruction dimension is between 0 and 28, and the score in the Pain dimension is between 0 and 16. In this context, the lowest score that can be obtained is 0, while the highest score is 73. High scores from the scale indicate that the symptoms are at a serious level. The reliability and validity study of this scale was conducted in our country by Kaya and Turan in 2011.

  1 weeks

• Sexual Quality of Life Scale - Female

  This scale is a six-point Likert type and consists of 18 items. Each item is expected to be answered considering your sexual life in the last four weeks. In evaluating the scale, an item is scored between 1 and 6 (1 = Completely agree, 2 = Largely agree, 3 = Partially agree, 4 = Partially disagree, 5 = Largely disagree, 6 = Strongly disagree). The score range that can be obtained from the scale varies between 18-108. In this point system, the total score received from the scale is converted to 100. To convert the total scale score to 100; It is stated that the formula (raw score taken from the scale -18)x100/90 should be used. For example, the scale score of an individual whose total raw score from the scale is 63 is converted to 100; (63- 18)x100/90=50. A high score from the scale indicates that the quality of sexual life is good. The validity and reliability study of the Turkish version of this scale was conducted in our country by Tuğut and Gölbaşı in 2010.

  1 weeks

Interventions

emg- biofeedback COMBINATION_PRODUCT

EMG activity shows the electrical activity measured during striated muscle contraction. The electrical activity of the muscle is in microvolts (1 volt = 1,000,000μV). Biofeedback units usually produce audio or visual feedback depending on the amount of electrical activity. Recording the bio-electrical activity of the muscle is a practical indicator of its contractility.

Eligibility Criteria

• Age: 18 Years - 55 Years
• Gender Eligibility Details: Since urinary incontinence problem is more common in women, our research was planned to be conducted on female gender.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Female individuals between the ages of 18-55 diagnosed with lumbar disc herniation will be included in our study.

You may qualify if:

• Diagnosed with Protruded and Extruded Lumbar Disc Herniation, Those who are between the ages of 18-55, BMI below 30 kg/m2

You may not qualify if:

• Trauma, Tumoral Causes - Cancer, Signs of neurological disease, Diabetus Mellitus, Hypertension etc. systemic disorder, Operated Disc Herniation, pregnancy, Those diagnosed with sequestered disc herniation

Sponsors & Collaborators

• Sanko University: lead

Study Sites (1)

Sanko University

Gaziantep, Şehitkamil, 27500, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Selver Seval Soğan

CONTACT

+905525864646; selver.sogan@sankotip.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: November 2, 2023
• First Posted: November 7, 2023
• Study Start: June 1, 2023
• Primary Completion: April 1, 2024
• Study Completion: June 1, 2024
• Last Updated: November 7, 2023

Record last verified: 2023-11

Locations

TU (1)