Evaluating the effectiveness of electromagnetic stimulation on female sexual disorders: a double-blind randomized controlled clinical trial

Evaluating the effectiveness of electromagnetic stimulation on the treatment of sexual disorders

Randomised, superiority, parallel group trial with blinded outcome assessment. Randomisation was centralised and computerised with concealed randomisation sequence carried out at an external site.

Investigation of women with pelvic floor disorders who were referred to the women's clinic of Firouzgar Hospital.

Inclusion criteria: • Women with pelvic floor disorders with at least one delivery • Women with an age range of 20 to 45 years • Women with a minimum level of primary education (6 years of education) • and informed consent to participate in the study. Exclusion criteria include: • Suffering from urinary incontinence or fecal incontinence • Women with a history of surgery due to urinary incontinence or fecal incontinence or pelvic floor surgery Pelvic prolapse grade 3 or 4 based on (ICS classification) • Taking drugs, eg diuretics, alpha-adrenergic antagonists or other drugs prescribed for bladder dysfunction • Simultaneous use of internal medical devices with electrical or magnetic components, e.g. pacemakers • Metal prosthesis of the pelvis or lower limb • Previous history of 2 or more abortions. • Taking medications that may affect sexual performance • Patients with neurological disorders such as MS and Parkinson's.

The intervention group included women with pelvic floor disorders who were treated with EM for 6 months (three days per week) will be placed. The control group will include women who will receive a sham treatment with the same method as the intervention group (patients will be placed on a chair with the same intervention protocol but will receive stimulation).

Pelvic floor disorders and sexual disorders

The randomization process will be done in a simple way by the epidemiologist using Random Allocation Software 2.0. Patients will be allocated to two groups (intervention and control) with equal proportions. In this software, after entering the total sample size, a list of numbers of people who are placed in the intervention and control groups is provided to the researcher. Based on the list, the researcher will assign the patients to two groups.

Patients will be blinded to the type of regimen received. Also, the outcome evaluators will be blinded to the type of treatment method. Finally, the data will be analyzed without specifying the treatment groups and only based on group 1 and group 2.

All demographic data and primary and secondary outcome information after de-identification of shareable subjects

The access period starts 6 months after the results are published.

Data and other documentation will be available to researchers working in academic and scientific institutions.

After publishing the results in the form of an article, the data will be available for researchers to design the study by providing a logical reason to the correspondence author with the condition of maintaining ethical principles. Also, the data will be available if requested by the ethics committee of the university to evaluate the accuracy of the results.

To receive the required documents and data, applicants can contact Dr. Zahra Feridouni, Assistant Gynecology and Obstetrics Specialist, Iran University of Medical Sciences, Address: Tehran Province, Tehran, Valiasr Square, Karim Khan Zand Street, Firouzgar Medical, Educational and Therapeutic Center and email: zahraferidouni @gmail.com

Applicants must follow the protocols and procedures according to Iran University of Medical Sciences rules to access the desired files