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NCT Number: NCT07666035

Female Sexual Function After Surgery for Benign Perianal Diseases

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.

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Key information

Age range

18 year–70 year

Sex eligibility

Female

Study type

Observational

About this study

Female sexual function is a multidimensional concept influenced by physical, psychological, and social factors. Benign perianal diseases are common surgical conditions that may adversely affect sexual function through chronic pain, bleeding, discharge, prolapse, discomfort, embarrassment, and reduced quality of life.

Previous studies have demonstrated impaired sexual function among patients with anorectal disorders. Furthermore, improvement in male sexual function following surgical treatment of benign anorectal diseases has been reported. However, prospective data regarding female sexual function after surgical treatment of benign perianal diseases remain scarce.

This single-center prospective observational cohort study will be conducted at Gazi University Faculty of Medicine. Sexually active women aged 18 to 70 years undergoing surgery for chronic anal fissure, hemorrhoidal disease, or cryptoglandular anal fistula will be enrolled.

Participants will complete the Female Sexual Function Index (FSFI), Cleveland Clinic Incontinence Score (CCIS/Wexner), and Visual Analog Scale (VAS) questionnaires before surgery and at postoperative 3 and 6 months.

The primary outcome will be the change in total FSFI score from baseline to postoperative 6 months. Secondary outcomes will include changes in FSFI at 3 months, changes in CCIS and VAS scores, and subgroup analyses according to disease type and symptom severity.

The investigators hypothesize that successful surgical treatment of benign perianal diseases will result in significant improvement in female sexual function and that this improvement will correlate with reductions in pain and disease-related symptoms.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Surgical Treatment for Benign Perianal Diseases

Procedure

Standard surgical treatment for chronic anal fissure, hemorrhoidal disease, or cryptoglandular anal fistula according to routine clinical indications. No experimental intervention will be administered.

Primary outcomes

  1. Change in Total Female Sexual Function Index Score From Baseline to 6 Months

    Time frame: Baseline and postoperative 6 months

    Change in total Female Sexual Function Index (FSFI) score between the preoperative baseline assessment and postoperative 6-month follow-up. The FSFI total score ranges from 2 to 36, with higher scores indicating better female sexual function.

Secondary outcomes

  1. Change in Total Female Sexual Function Index Score From Baseline to 3 Months

    Time frame: Baseline and postoperative 3 months

    Change in total Female Sexual Function Index (FSFI) score between the preoperative baseline assessment and postoperative 3-month follow-up. The FSFI total score ranges from 2 to 36, with higher scores indicating better female sexual function.

  2. Change in Cleveland Clinic Incontinence Score From Baseline to 6 Months

    Time frame: Baseline and postoperative 6 months

    Change in Cleveland Clinic Incontinence Score/Wexner score between baseline and postoperative 6 months. The score ranges from 0 to 20, with higher scores indicating more severe fecal incontinence.

  3. Change in Visual Analog Scale Pain Score From Baseline to 6 Months

    Time frame: Baseline and postoperative 6 months

    Change in anal pain assessed using a 0-10 Visual Analog Scale between baseline and postoperative 6 months. Higher scores indicate more severe pain.

  4. Disease-specific Change in Total FSFI Score

    Time frame: Baseline, postoperative 3 months, and postoperative 6 months

    Comparison of change in total Female Sexual Function Index (FSFI) score among disease subgroups, including chronic anal fissure, hemorrhoidal disease, and cryptoglandular anal fistula. The FSFI total score ranges from 2 to 36, with higher scores indicating better female sexual function.

Study contacts

Contact information is provided by the study sponsor or research team.

Mesut Yavaş, MD, Assistant of Professor

CONTACT

[email protected]

+905019127287

Sponsors and collaborators

Lead sponsor

Gazi University

Other

Registry information

Official study title

Prospective Evaluation of Female Sexual Function Following Surgical Treatment of Benign Perianal Diseases: A Single-Center Observational Cohort Study

Acronym: PERISEX

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 24, 2026
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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