Female Sexual Function After Surgery for Benign Perianal Diseases
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Surgical Treatment for Benign Perianal Diseases.
- Who it may be relevant to
- Registry conditions: Chronic Anal Fissure, Hemorrhoidal Disease, Cryptoglandular Anal Fistula. Basic parameters: 18 years — 70 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Prospective Evaluation of Female Sexual Function Following Surgical Treatment of Benign Perianal Diseases: A Single-Center Observational Cohort Study
Overview
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.
Detailed description
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.
Interventions
- Procedure Surgical Treatment for Benign Perianal Diseases
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 outcome measures
- Change in Total Female Sexual Function Index Score From Baseline to 6 Months [Time frame: Baseline and postoperative 6 months]
Secondary outcome measures (4)
- Change in Total Female Sexual Function Index Score From Baseline to 3 Months [Time frame: Baseline and postoperative 3 months]
- Change in Cleveland Clinic Incontinence Score From Baseline to 6 Months [Time frame: Baseline and postoperative 6 months]
- Change in Visual Analog Scale Pain Score From Baseline to 6 Months [Time frame: Baseline and postoperative 6 months]
- Disease-specific Change in Total FSFI Score [Time frame: Baseline, postoperative 3 months, and postoperative 6 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- 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
- 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
Identifiers
NCT: NCT07666035 · GU-PERISEX-2026