✅ A comparative study of two methods of pelvic floor muscle training and pelvic floor biofeedback on sexual function and sexual satisfaction in women with urinary incontinence referred to Health and Medical Centers affiliated to Shahrekord University of Medical Sciences

To compare the effects of pelvic floor muscle training and biofeedback on sexual function and satisfaction in women with urinary incontinence attending healthcare centers affiliated with Shahrekord University of Medical Sciences.

Randomized, three-arm parallel group trial in six health centers. Participants selected by simple random sampling. Block randomization with concealed allocation. Duration: 8 weeks. Outcome assessors blinded.

Trial conducted in six health centers. Participants randomly recruited and allocated by concealed block randomization. Intervention lasted 8 weeks. Outcome assessors blinded. Participants and providers not blinded. Adherence monitored by weekly calls and exercise logs.

Inclusion: Married women aged 20-51, sexually active, literate, no neurological or chronic diseases affecting sexual function, not using drugs affecting sexual function. Exclusion: Withdrawal, vaginal infection or bleeding, use of urinary incontinence medication, severe emotional stress, menopausal symptoms, recent surgery.

Group 1 (Control): Home pelvic floor muscle training (PFMT) without biofeedback, 4 days/week for 8 weeks. Group 2: Weekly supervised biofeedback therapy using EMG vaginal probe for 8 weeks. Group 3: Combination of home PFMT and weekly biofeedback for 8 weeks.

Mean sexual function and satisfaction scores compared among three groups (home PFMT, biofeedback, combined), measured before and immediately after intervention.

In this study, the unit of randomization was the individual participant. After confirming eligibility based on inclusion and exclusion criteria and determining the type of urinary incontinence using the Bradley questionnaire, participants were randomly allocated to one of three intervention groups: (1) pelvic floor muscle training, (2) pelvic floor biofeedback, or (3) combined pelvic floor muscle training with biofeedback. The method of randomization was permuted block randomization, with a fixed block size of six. A total of eleven blocks were generated to cover the planned sample size. The random sequence was generated in advance by a statistician who was not involved in participant recruitment, using the Random Allocation Software. The random sequence assigned two participants to each group in each block, ensuring balanced group sizes throughout recruitment. Allocation concealment was maintained by keeping the randomization sequence confidential and inaccessible to the researcher responsible for enrollment, who only assigned participants to groups according to the pre-prepared list at the time of inclusion.

In this study, the participants and the data analyst were blinded to the group allocation. Participants were unaware of which intervention group they were assigned to, in order to minimize performance and response bias. The data analyst, who performed the statistical analysis, was also blinded to the group codes to prevent analysis bias. The principal investigator, care providers, and outcome assessors were not blinded due to the nature of the interventions, which required direct supervision and implementation by the research team.

The anonymized individual participant data (including baseline characteristics, outcomes, and adverse events), as well as the final version of the study protocol, statistical analysis plan, and informed consent form, will be shared. Data will be made available to researchers who submit a methodologically sound proposal, for purposes of achieving the aims outlined in the approved proposal. Requests for data access should be sent to the corresponding author at [ziba758@gmail.com. Data will be shared after publication of the main results and will remain available for up to 3 years following publication. Access will be granted through secure data transfer upon approval of the request.

Anonymized individual participant data and associated documents will be available starting from the date of publication of the main results and continuing for 3 years thereafter.

The anonymized individual participant data and supporting documents will be available to qualified researchers affiliated with academic institutions or research organizations who submit a methodologically sound proposal. Requests from researchers working in other sectors (e.g., industry) will also be considered if their proposals align with the study objectives and ethical standards.

Access to the deidentified individual participant data (IPD) and supporting documents will be granted only for research purposes that are consistent with the aims of the original study and comply with ethical and legal standards. Proposals must include a clear and methodologically sound analysis plan. All requests will be reviewed by the principal investigator and a data access committee to ensure scientific merit, feasibility, and adherence to data protection and confidentiality policies. Data will be shared through a secure data transfer mechanism after approval.

The anonymized individual participant data and supporting documents can be requested by contacting the corresponding author via email at [ziba758@gmail.com]. Requests should include a detailed research proposal and intended use of the data. Additional communication can be made via phone at +98 38 32240556. Upon approval, data will be shared through a secure transfer system. For postal correspondence, please contact:

Applicants interested in accessing the anonymized individual participant data and supporting documents must submit a formal request via email to the corresponding author at ziba758@gmail.com]. The request should include a detailed research proposal outlining the objectives, methodology, and planned analyses. Upon receiving the request, the research team will review the proposal for scientific merit, feasibility, and ethical compliance. This review process typically takes up to 4 weeks. If the request is approved, the applicant will be asked to sign a data use agreement to ensure confidentiality and proper use of the data.

All data sharing will comply with ethical guidelines and privacy regulations to ensure participant confidentiality. Any requests for additional information or clarifications can be directed to the corresponding author via the provided contact details