Female Sexual Function After Surgery for Benign Perianal Diseases

NCT07666035 | Not Yet Recruiting

• 1 other identifier: GU-PERISEX-2026
• Study Type: observational
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Chronic Anal Fissure; Cryptoglandular Anal Fistula; Hemorrhoidal Disease

Keywords

Cryptoglandular Anal Fistula; Chronic Anal Fissure; Hemorrhoidal Disease; FSFI; Sexual Functions; Perianal Pain

Outcome Measures

Primary Outcomes (1)

• Change in Total Female Sexual Function Index Score From Baseline to 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.

  Baseline and postoperative 6 months

Secondary Outcomes (4)

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

  Baseline and postoperative 3 months

• Change in Cleveland Clinic Incontinence Score From Baseline to 6 Months

  Baseline and postoperative 6 months

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

  Baseline and postoperative 6 months

• Disease-specific Change in Total FSFI Score

  Baseline, postoperative 3 months, and postoperative 6 months

Study Arms (1)

Women Undergoing Benign Perianal Surgery

Sexually active female patients aged 18 to 70 years undergoing surgical treatment for benign perianal diseases, including chronic anal fissure, hemorrhoidal disease, and cryptoglandular anal fistula. Participants will be prospectively assessed using FSFI, CCIS/Wexner, and VAS scores at baseline and postoperative follow-up.

Procedure: Surgical Treatment for Benign Perianal Diseases

Interventions

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.

Women Undergoing Benign Perianal Surgery

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Sexually active women undergoing surgical treatment for benign perianal diseases at Gazi University Faculty of Medicine.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gazi University: lead

Related Publications (2)

• Buyukkasap C, Bostanci H, Dikmen K, Gobut H, Yavuz A, Altiner S, Bolukbasi B, Atan A. Sexual Function After Surgical Treatment for Benign Anorectal Disorders. Am J Mens Health. 2024 May-Jun;18(3):15579883241252016. doi: 10.1177/15579883241252016.

  PMID: 38712744 RESULT

• Rosen R, Brown C, Heiman J, Leiblum S, Meston C, Shabsigh R, Ferguson D, D'Agostino R Jr. The Female Sexual Function Index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function. J Sex Marital Ther. 2000 Apr-Jun;26(2):191-208. doi: 10.1080/009262300278597.

  PMID: 10782451 RESULT

MeSH Terms

Interventions

Surgical Procedures, Operative

Study Officials

• Mesut Yavaş, MD, Assistant of Professor

  Gazi University Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mesut Yavaş, MD, Assistant of Professor

CONTACT

+905019127287; mesutyavas@gazi.edu.tr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant of Professor of Surgery

Study Record Dates

• First Submitted: June 18, 2026
• First Posted: June 24, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: June 26, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share