HydrocelectomyNCT07069985
Assessment of Sexual Function in Male Patients Undergoing Hydrocelectomy and Their Partners
An observational study of Hydrocelectomy and Erectile Dysfunction, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hydrocelectomy, Erectile Dysfunction, Sexual Dysfunction Male
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2020to 1 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Adult, Older adult
Study population: Male patients who underwent hydrocelectomy in our clinic between 2020-2024 and their partners
Who may be able to join
- Sexually active patients between the ages of 18-75 years who underwent hydrocelectomy and who had no previous history of scrotal surgery were included.
Who cannot join
- Patients with postoperative complications (large scrotal hematoma), those with mental or physical disabilities, and those with preoperative moderate to severe erectile dysfunction were excluded.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Medical Sciences, Department of Urology Clinic of Ankara Training and Research Hospital
Ankara, 06340
About this study
Official title: Assessment of Sexual Function in Male Patients Undergoing Hydrocelectomy and Their Partners: A Prospective Study Based on IIEF an FSFI Scores
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.
Read more
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.
Read the detailed description
We hypothesized that men who underwent hydrocelectomy and their partners would have improved sexual function in the postoperative period compared to the preoperative period. In our study, we aimed to compare preoperative and postoperative sexual dysfunction in 80 male patients who underwent hydrocelectomy and their partners using nationally validated sexual function assessment questionnaires.
Male patients who underwent hydrocelectomy in our clinic between 2020 and 2024 were included in the study. The study was designed as a prospective cohort. 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. Written informed consent was obtained from all patients and their partners. Patients' age, comorbidities, previous operations and presence of penile anomalies were reported. Penile length was measured under similar environmental conditions (air-conditioned room and temperatures ranging from 23 to 25°C). The penis was measured from the base to the distal tip in the flaccid state by the same physician along the penile dorsum with a millimeter-marked ruler. The largest diameter between the top and bottom of the hydrocele sac was measured and reported as vertical hydrocele size, and the largest diameter between lateral and medial was measured and reported as transverse hydrocele size by the same physician.
Assessment of sexual function All patients and their partners were interviewed face-to-face, social distancing rules were observed and sexual function assessment questionnaires were administered. 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 (8). 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 (9).
Statistical Analysis Post Hoc Power analysis was performed. (G*Power 3.1.9.7 software, Heinrich-Heine-Universität Düsseldorf, Düsseldorf, Germany). When the effect size was taken as 0.5 and the study power was calculated as 90%, the number of patients required for the study was calculated as 44 with a margin of error of 0.05.
While evaluating the data obtained in the study, IBM SPSS (Statistical Package for the Social Sciences) program version 20 was used for statistical analysis (SPSS, Chicago, IL). Shapiro-Wilk and P-P plot analysis were used to test the conformity of continuous data to normal distribution. Data conforming to normal distribution were reported as mean ± standard deviation (SD) and data not conforming to normal distribution were reported as median (minimum-maximum). Categorical data were given as number and percentage (%) and Pearson Chi-square test was used to compare categorical data between groups. Paired samples t-test was used to compare preoperative and postoperative sexual function assessment questionnaires and subgroups. All statistical tests were two-tailed and p<0.05 was considered statistically significant.
- Keywords
- erectile dysfunction, hydrocelectomy, sexual dysfunction
- Medical subject headings
- Erectile Dysfunction, Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 month after hydrocelectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study start1 Feb 2020
- Primary completion1 Sep 2024
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HydrocelectomyStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Omer G Doluoglu, Professor, Study director, UHS, Department of Urology Clinic of Ankara Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07069985
- Sponsor's protocol ID
- University of Health Sci ATRH
- Other IDs
- Secondary ID: 756
- Status last verified
- May 2025
- First submitted
- 11 Jun 2025
- Last updated
- 17 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Sexual Function in Male Patients Undergoing Hydrocelectomy and Their Partners: A Prospective Study Based on IIEF an FSFI Scores
- ClinicalTrials.gov ID
- NCT07069985
- Acronym / sponsor ID
- University of Health Sci ATRH
- Keywords
- erectile dysfunction, hydrocelectomy, sexual dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 17 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
We hypothesized that men who underwent hydrocelectomy and their partners would have improved sexual function in the postoperative period compared to the preoperative period. In our study, we aimed to compare preoperative and postoperative sexual dysfunction in 80 male patients who underwent hydrocelectomy and their partners using nationally validated sexual function assessment questionnaires.
Male patients who underwent hydrocelectomy in our clinic between 2020 and 2024 were included in the study. The study was designed as a prospective cohort. 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. Written informed consent was obtained from all patients and their partners. Patients' age, comorbidities, previous operations and presence of penile anomalies were reported. Penile length was measured under similar environmental conditions (air-conditioned room and temperatures ranging from 23 to 25°C). The penis was measured from the base to the distal tip in the flaccid state by the same physician along the penile dorsum with a millimeter-marked ruler. The largest diameter between the top and bottom of the hydrocele sac was measured and reported as vertical hydrocele size, and the largest diameter between lateral and medial was measured and reported as transverse hydrocele size by the same physician.
Assessment of sexual function All patients and their partners were interviewed face-to-face, social distancing rules were observed and sexual function assessment questionnaires were administered. 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 (8). 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 (9).
Statistical Analysis Post Hoc Power analysis was performed. (G*Power 3.1.9.7 software, Heinrich-Heine-Universität Düsseldorf, Düsseldorf, Germany). When the effect size was taken as 0.5 and the study power was calculated as 90%, the number of patients required for the study was calculated as 44 with a margin of error of 0.05.
While evaluating the data obtained in the study, IBM SPSS (Statistical Package for the Social Sciences) program version 20 was used for statistical analysis (SPSS, Chicago, IL). Shapiro-Wilk and P-P plot analysis were used to test the conformity of continuous data to normal distribution. Data conforming to normal distribution were reported as mean ± standard deviation (SD) and data not conforming to normal distribution were reported as median (minimum-maximum). Categorical data were given as number and percentage (%) and Pearson Chi-square test was used to compare categorical data between groups. Paired samples t-test was used to compare preoperative and postoperative sexual function assessment questionnaires and subgroups. All statistical tests were two-tailed and p<0.05 was considered statistically significant.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Male patients who underwent hydrocelectomy in our clinic between 2020-2024 and their partners
Key inclusion criteria (1 listed)
- Sexually active patients between the ages of 18-75 years who underwent hydrocelectomy and who had no previous history of scrotal surgery were included.
Key exclusion criteria (1 listed)
- Patients with postoperative complications (large scrotal hematoma), those with mental or physical disabilities, and those with preoperative moderate to severe erectile dysfunction were excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes in International Index of Erectile Function (IIEF) questionnaire
Time frame: 1 month after hydrocelectomy
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.
Changes in Female Sexual Function Index (FSFI)
Time frame: 1 month after hydrocelectomy
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Omer G Doluoglu, Professor study director
UHS, Department of Urology Clinic of Ankara Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hydrocelectomy and Erectile Dysfunction, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in International Index of Erectile Function (IIEF) questionnaire (time frame: 1 month after hydrocelectomy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2025.