Lower Urinary Tract Symptoms (LUTS), Multiple Sclerosis (MS), Neurogenic Bladder Disorder, Urinary Incontinence (UI), Urinary Urgency
Conditions
Brief summary
The goal of this clinical trial is to learn if essential oil aromatherapy works to improve urinary symptoms in adults with multiple sclerosis. It will also learn about the safety of essential oil use in this population. The main questions it aims to answer are: * Does essential oil aromatherapy reduce urinary urgency, frequency, and incontinence episodes in participants with multiple sclerosis? * What medical problems do participants have when using essential oil aromatherapy? Researchers will compare essential oil aromatherapy to a placebo (a look-alike neutral oil with no therapeutic properties) to see if essential oil aromatherapy works to improve urinary symptoms in multiple sclerosis patients. Participants will: * Use essential oil aromatherapy or a placebo oil every day for 6 weeks * Complete a urinary symptom scales to record the frequency, urgency, and any leakage episodes each day * Fill out quality of life questionnaires at the beginning and end of the study
Interventions
OTHEREssential Oil Blend (Lavender, Rosemary)
This intervention consists of a standardized topical blend of Lavender (Lavandula angustifolia) at 3% and Rosemary (Rosmarinus officinalis) at 2%, diluted in apricot kernel oil as a carrier. The blend was formulated to target neurogenic lower urinary tract symptoms in patients with multiple sclerosis, based on the antispasmodic properties of Lavender and the neuromodulatory and anti-inflammatory properties of Rosemary. The essential oils used are batch-controlled for chemical purity and concentration. The blend is applied topically via gentle circular massage on the lower abdomen, for a total duration of 6 consecutive weeks. This specific combination, route of administration, and target population distinguish this intervention from other aromatherapy studies that have used single oils, inhalation methods, or non-neurological populations.
OTHERNeutral Carrier Oil (Apricot Kernel Oil)
This intervention consists of pure Apricot Kernel oil, used as an inert placebo comparator. The placebo oil contains no active essential oils or therapeutic compounds. It is identical to the experimental intervention in terms of appearance, color, viscosity, volume, packaging, and method of application, ensuring effective masking of participants and outcome assessors. The placebo oil is applied topically via gentle circular massage on the lower abdomen, for a total duration of 6 consecutive weeks, mirroring exactly the administration protocol of the experimental arm.
Sponsors
University of Oran 1
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Confirmed diagnosis of Multiple Sclerosis (any form) * Documented lower urinary tract symptoms defined by an Overactive Bladder Symptom Score (OABSS) ≥ 3 at screening * Age between 18 and 65 years * Willing and able to provide written informed consent * Capable of performing daily topical self-application of the study oil, or having a caregiver available to assist throughout the study period
Exclusion criteria
* Active urinary tract infection confirmed by urine culture at screening * Pre-existing urological condition unrelated to Multiple Sclerosis (e.g., bladder cancer, benign prostatic hyperplasia, or interstitial cystitis) * Known allergy or hypersensitivity to essential oils, apricot kernel oil, lavender, or rosemary * Active skin lesions, wounds, or dermatological conditions on the lower abdomen at the intended site of application * Pregnancy, breastfeeding, or planning to become pregnant during the study period * Significant cognitive impairment preventing understanding of study procedures or completion of questionnaires * Current use of an indwelling urinary catheter or practice of intermittent self-catheterization
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overactive Bladder Symptom Score (OABSS) | Baseline, and Week 6 | Overactive Bladder Symptom Score (OABSS) (Overactive Bladder Symptom Score) Scale range: minimum 0 - maximum 15. Higher scores indicate a worse outcome (greater severity of overactive bladder symptoms). \[Time Frame: Baseline and Week 6\] |
| Qualiveen questionnaire | Baseline and Week 6 | Qualiveen - Urinary Disorder-Specific Quality of Life Questionnaire (Qualiveen, Domain 1: "Bother with Limitations") Scale range: minimum 0 - maximum 4 per item (9 items, total domain score = sum of items ÷ 9). Higher scores indicate a worse outcome (greater bother related to urinary problems). \[Time Frame: Baseline and Week 6\] |
Countries
Algeria
Contacts
CONTACTZitouni-Nourine Saida Hanane
Outcome results
None listed