NCT07599189

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

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
6mo left

Started Sep 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 4, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 20, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

May 20, 2026

Status Verified

May 1, 2026

Enrollment Period

3 months

First QC Date

May 4, 2026

Last Update Submit

May 16, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Overactive Bladder Symptom Score (OABSS)

    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). \[Time Frame: Baseline and Week 6\]

    Baseline, and Week 6

  • Qualiveen questionnaire

    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). \[Time Frame: Baseline and Week 6\]

    Baseline and Week 6

Study Arms (2)

Essential Oil Aromatherapy Group

EXPERIMENTAL
Other: Essential Oil Blend (Lavender, Rosemary)

Placebo Oil Group

PLACEBO COMPARATOR
Other: Neutral Carrier Oil (Apricot Kernel Oil)

Interventions

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.

Essential Oil Aromatherapy Group

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.

Placebo Oil Group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Aboubakr abdelmadjid

Oran, Oran Province, 31000, Algeria

Location

Zitouni-Nourine Saida Hanane

Oran, Algeria

Location

MeSH Terms

Conditions

Multiple SclerosisUrinary Bladder, NeurogenicUrinary IncontinenceLower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesNeurologic ManifestationsUrinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsUrination DisordersUrological Manifestations

Central Study Contacts

Zitouni-Nourine Saida Hanane

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 4, 2026

First Posted

May 20, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

March 1, 2027

Last Updated

May 20, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations