Investigating the effect of adding cinnamon to toltrodine in the treatment of urinary incontinence in women

Investigating the effect of adding cinnamon to toltrodine in the treatment of urinary incontinence in women

The present study is a double‑blind, randomized clinical trial with parallel groups (using block randomization), conducted on a total of 80 patients.

This study is a double‑blind randomized clinical trial conducted on patients with urgency urinary incontinence who present to the outpatient clinic of Reza Ashtiani Hospital in Arak. Patients are assigned to two groups (A and B) using block randomization (blocks of four) through the Sealed Envelope software. The medications are prepared in identical, coded capsules by an independent individual, and both the patients and the outcome assessors are blinded to group allocation. Finally, the two groups are compared in terms of outcomes.

Inclusion criteria: All women diagnosed with urge urinary disorder; provision of informed consent to participate in the study. Exclusion criteria: Presence of significant underlying conditions, including systemic diseases (hepatic disorders, renal disorders, diabetes), autoimmune diseases such as multiple sclerosis, neurological disorders, and pelvic floor disorders such as cystocele and rectocele; history of allergy to cinnamon or its derivatives.

Intervention group: Participants in the intervention group will receive a 1‑gram cinnamon capsule (Dr. Abidi Pharmaceutical Co.) once daily for 6 weeks. Placebo group: Participants in the placebo group will receive a starch‑filled placebo capsule once daily for 6 weeks.

Daily urinary frequency, Number of daily urgency urinary incontinence episodes, Number of daily urinary urgency episodes, Number of nocturia episodes per night

The participants will be assigned to two intervention and placebo groups based on the randomization sequence that will be generated in advance. This sequence is unpredictable and its arrangement is completely random. Block randomization method with 4 blocks will be used to allocate the samples. In this way, using the site www.sealedenvelope.com, blocks of 4 letters A and B are randomly generated based on the sample size. The order of placement of letters A and B in each block from the first block to the last block is considered as a randomization sequence. The production of these blocks and their random sequence is completely done by this site and the researcher does not know how they are sequenced.

In this study, a capsule resembling the cinnamon capsule, made of starch and serving as a placebo, will be prepared and administered to the placebo group; therefore, the participants will not be aware of their group allocation. The medications will be prescribed by the attending physician, who is the principal supervisor. The designated assistant will collect the patients’ outcomes based on their medical record number or their name and surname and will provide them to the attending physician, who will then code the data. Therefore, the data collector, who is the resident responsible for the project, will remain blinded to the group assignments.

After conducting this study and analytical studies on it, only a part of the data such as information about the main outcome and patient demographic information will be published to the researchers who do the necessary correspondence with the person in charge of this study.

Access will be from 2026/01/21 to 2029/01/21 for 3 years.

University researchers

Academic researchers or university professors or students who intend to use the data of this study, after obtaining permission from the relevant people mentioned, can use the information of this study in the field of metallurgical studies or other relevant review studies. In addition, if requested, they can use the information of this study for the prerequisites of their future studies and the existence of questions and ambiguities. Using the information of this study is subject to mentioning the names and logos of the responsible persons in this study.

Academic researchers and university faculty members, after initiating contact via message or email with the relevant supervisor, may request permission to access and use the data from Dr. Maryam Shekarpour. Dr. Maryam Shekarpour: Phone: +98‑918‑363‑4212 Email: Maryam_shokrpour@yahoo.com Address: Sina Rezaei Ashtiani Hospital, Basij Square, Sardasht, Arak, Iran

Letter writing should be done with professors and universities.