Effect of topical black seed oil on urinary incontinence in elderly women

Determining the effect of topical use of black seed oil on urinary incontinence in elderly women

A randomized, parallel-controlled group clinical trial on 80 patients in 2021

First, convenience sampling method will be performed to select eligible elderly women with urinary incontinence, including stress, urge and mixed types, from mild to moderate urinary incontinence referred to the gynecology clinic of Imam Khomeini Hospital, Touba Clinic and health centers of Sari. After obtaining informed written consent from patients and obtaining approval from their medical practitioners, random assignment of samples to intervention and control groups will be performed. In the intervention group, 15 drops of black seed oil will be applied from the umbilicus to the pubic area for 6 weeks, twice a day (morning and night). In the control group, Firooz Body Oil for Baby will be applied in the same manner. The random allocation and the administration of black seed oil and placebo oil to the samples will be performed by the secretary. Researchers and patients will be unaware of their own assignment to one of the two intervention or control groups.

Inclusion criteria: 1- Normal cognitive status (obtaining a score of ≥7 based on cognitive assessment tools) 2- History of mild to moderate urinary incontinence (obtaining a score of 1 to 12) Exclusion criteria 1- No history of taking medication for urinary incontinence during the two weeks before the intervention 2- Absence of active urinary tract infection

In the intervention group, 15 drops of black seed oil will be applied from the umbilicus to the pubic area for 6 weeks, twice a day (morning and night). In the control group, Firooz Body Oil for Baby will be applied in the same manner.

Urinary incontinence

• Permuted block randomization is designed to randomly assign participants to two intervention groups and the control group in equal numbers in each group using appropriate software. In this method, each block with a certain number is assigned to each group. Six possible combinations of group assignment (AABB, ABAB, BAAB, BABA, BBAA, ABBA) exist in quadruple blocks. Each time, the computer program randomly selects one of the scenarios and sets the order. For example, if the AABB mode is selected for the first time, the first and second persons will be in group A and the third and fourth persons will be in group B. Finally, the assignment of research units is determined in order for 80 samples. Thus, 80 opaque envelopes are prepared, which are numbered from 1 to 80. Based on computer results, the letter A or letter B is written inside each envelope. No one knows which group in the envelope belongs to. The secretary of the clinic opens the envelopes for the elderly in the order in which they visit, to place the people in their own designated group. Group A will be the intervention group and will receive the necessary interventions according to the protocol. The intervention in the control group is routine (using placebo). The evaluator is also unaware of the group assignment. .

The random allocation and the administration of black seed oil and placebo oil to the samples will be performed by the secretary. Researchers and patients will be unaware of their own assignment to one of the two intervention or control groups. The lid of Firooz Baby Oil container (Oil for placebo) is impregnated with black seed oil. Both containers of oil (placebo and black seed) are similar.