Female Sexual Function After Surgery for Benign Perianal Diseases (NCT07666035) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Female Sexual Function After Surgery for Benign Perianal Diseases
120 participantsStarted 2026-08
Plain-language summary
Benign perianal diseases such as chronic anal fissure, hemorrhoidal disease, and cryptoglandular anal fistula may negatively affect female sexual function through pain, bleeding, discharge, discomfort, and impairment in quality of life. Although improvement in male sexual function after surgery for benign anorectal disorders has been reported, data regarding female sexual function remain limited.
This prospective observational cohort study aims to evaluate changes in Female Sexual Function Index (FSFI) scores following surgical treatment of benign perianal diseases. Female patients undergoing surgery for chronic anal fissure, hemorrhoidal disease, or cryptoglandular anal fistula will be assessed preoperatively and at postoperative 3 and 6 months using the FSFI, Cleveland Clinic Incontinence Score (CCIS/Wexner), and Visual Analog Scale (VAS).
The primary objective is to determine whether female sexual function improves following surgical treatment. Secondary objectives include evaluating the relationship between symptom improvement, continence status, pain reduction, and changes in female sexual function.
Who can participate
Age range
18 Years – 70 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Female patients aged 18-70 years
* Sexually active during the previous 4 weeks
* Diagnosed with chronic anal fissure, hemorrhoidal disease, or cryptoglandular anal fistula
* Scheduled for surgical treatment according to routine clinical indications
* Able to understand and complete study questionnaires
* Willing to provide written informed consent
Exclusion Criteria:
* Inflammatory bowel disease (Crohn's disease or ulcerative colitis)
* Pregnancy
* Postpartum period within the previous 12 months
* Pelvic organ prolapse
* Previous treatment for female sexual dysfunction
* Current antidepressant medication use
* Active psychiatric disorder
* Gynecological malignancy
* Previous pelvic radiotherapy
* Inability or unwillingness to complete study questionnaires
* Refusal to provide informed consent
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Total Female Sexual Function Index Score From Baseline to 6 Months