Assessment of Sexual Function in Male Patients Undergoing Hydrocelectomy and Their Partners

NCT07069985 | Completed

• 2 other identifiers: University of Health Sci ATRHSecondary ID: 756
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to assess changes in sexual function in men undergoing hydrocelectomy and their partners. Male patients who underwent hydrocelectomy in our clinic between 2020 and 2024 were included in the study This study was designed as a prospective cohort. Sexually active male patients between the ages of 18 and 75 who underwent hydrocelectomy and had no history of previous scrotal surgery were included. Patients with postoperative complications such as large scrotal hematomas, mental or physical disabilities, or moderate to severe erectile dysfunction before surgery were excluded. Written informed consent was obtained from both the patients and their partners. Demographic and clinical data including age, comorbidities, previous surgeries, and the presence of penile abnormalities were recorded. Penile length was measured in a temperature-controlled room (23-25°C) under similar conditions for all patients. Measurements were taken in the flaccid state, from the base to the tip along the dorsal side, using a ruler marked in millimeters by the same physician. The size of the hydrocele was also recorded: the largest vertical diameter (top to bottom) was defined as the vertical size, and the largest horizontal diameter (side to side) as the transverse size. Sexual function was assessed through face-to-face interviews, with attention to social distancing. Questionnaires were administered before surgery and again one month after the operation. Male patients completed the International Index of Erectile Function (IIEF), which includes 15 items and a total possible score of 75, covering five domains: erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction. Female partners were evaluated using the Female Sexual Function Index (FSFI), consisting of 19 items and six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain, with a maximum score of 36. A post hoc power analysis was performed using G\*Power 3.1.9.7. Based on an effect size of 0.5 and a significance level of 0.05, a sample size of 44 was calculated to provide 90% power. Statistical analysis was conducted using IBM SPSS version 20. Normality was checked using the Shapiro-Wilk test and P-P plots. Normally distributed data were presented as mean ± standard deviation, while non-normally distributed data were expressed as median (minimum-maximum). Categorical variables were shown as numbers and percentages. The Pearson Chi-square test was used for comparing categorical variables. The paired samples t-test was used to compare pre- and postoperative scores of the sexual function questionnaires. A p-value of less than 0.05 was considered statistically significant.

Conditions

Hydrocelectomy; Erectile Dysfunction; Sexual Dysfunction Male; Sexual Dysfunction Female

Keywords

erectile dysfunction; hydrocelectomy; sexual dysfunction

Outcome Measures

Primary Outcomes (2)

• Changes in International Index of Erectile Function (IIEF) questionnaire

  The questionnaires were administered preoperatively and at 1 month postoperatively. For male patients, the nationally validated International Index of Erectile Function (IIEF) questionnaire consisting of 15 questions with a maximum total score of 75 was administered. This questionnaire includes 5 subgroups: erectile function, orgasmic function, sexual desire, sexual satisfaction and overall satisfaction.

  1 month after hydrocelectomy

• Changes in Female Sexual Function Index (FSFI)

  The questionnaires were administered preoperatively and at 1 month postoperatively. Female partners were assessed using the Female Sexual Function Index (FSFI), which consists of 19 questions and has a maximum total score of 36. This questionnaire includes 6 subgroups: sexual desire, sexual arousal, lubrication, orgasm, satisfaction and pain. Increases in total IIEF and its subdomain scores, as well as in total FSFI and the subdomains of desire, arousal, lubrication, orgasm, and satisfaction, indicate improvement; an increase in the FSFI pain score reflects reduced pain.

  1 month after hydrocelectomy

Study Arms (1)

Group 1: male patients who underwent hydrocelectomy, group 2: partners of the male patients

Group 1: Heterosexual male patients who underwent hydrocelectomy in our clinic between 2020 and 2024. Sexually active patients between the ages of 18-75 years who underwent hydrocelectomy and who had no previous history of scrotal surgery were included. Patients with postoperative complications (large scrotal hematoma), those with mental or physical disabilities, and those with preoperative moderate to severe erectile dysfunction were excluded. Group 2: Female partners of the male patients who underwent hydrocelectomy.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male patients who underwent hydrocelectomy in our clinic between 2020-2024 and their partners

You may qualify if:

• Sexually active patients between the ages of 18-75 years who underwent hydrocelectomy and who had no previous history of scrotal surgery were included.

You may not qualify if:

• Patients with postoperative complications (large scrotal hematoma), those with mental or physical disabilities, and those with preoperative moderate to severe erectile dysfunction were excluded.

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

University of Medical Sciences, Department of Urology Clinic of Ankara Training and Research Hospital

Ankara, 06340, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Erectile Dysfunction; Sexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Officials

• Omer G Doluoglu, Professor

  UHS, Department of Urology Clinic of Ankara Training and Research Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2025
• First Posted: July 17, 2025
• Study Start: February 1, 2020
• Primary Completion: September 1, 2024
• Study Completion: October 1, 2024
• Last Updated: July 17, 2025

Record last verified: 2025-05

Locations

TU (1)