The Effect of the Distance Between Mesh and the Urethra on Sexuality in Patients Who Underwent Transobturator Tape.

January 9, 2024 updated by: fatih sahin, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Urinary incontinence, commonly observed among women aged 30 to 60, encompasses Stress Urinary Incontinence (SUI), responsible for the majority of cases. This condition significantly affects the quality of life, influencing physical, emotional, and sexual aspects. Severe cases impact libido and cause vaginal dryness, affecting not just sexual function but also relationships, leading to an overall decline in quality of life. Hence, examining sexual functions in those affected by SUI holds significance.

The study aimed to evaluate the impact of mesh-urethra distance on sexual functions using perineal ultrasound in continent patients post-transobturator tape (TOT) surgery for isolated SUI.

Patients achieving continence post-surgery were categorized based on the distance from the posterior of the urethra at the bladder neck to the nearest proximal edge of the tape: < 5 mm and > 5 mm.

Questionnaires, including the Female Sexual Function Index (FSFI) and The Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI SF), were administered preoperatively and at the 6-month postoperative follow-up.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Urinary incontinence, often seen in women aged 30 to 60, involves Stress Urinary Incontinence (SUI) in most cases. It significantly affects life, impacting physical, emotional, and sexual well-being. Severe cases can lower sex drive and cause vaginal dryness, affecting not just the individual's sex life but also relationships, leading to a lower quality of life overall. That's why looking at how SUI affects sexual aspects is crucial.

The study aimed to see how the distance between the mesh and urethra after transobturator tape (TOT) surgery might affect sexual function in patients who no longer experienced incontinence. Patients were divided based on this distance, and surveys like the Female Sexual Function Index (FSFI) and The Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI SF) were used before and six months after surgery.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34320
        • Prof.Dr.Cemil Taşcıoğlu Hospital
      • Istanbul, Turkey, 34320
        • Cemil Taşcıoğlu City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Between January 2020 and January 2022, a total of 82 continent patients ages 18 to 45 who underwent MUS surgery due to isolated SUI were included in the study

Description

Inclusion Criteria:

-Continent patients ages 18 to 45 who underwent mid-urethral sling (MUS) surgery due to isolated SUI were included in the study

Exclusion Criteria:

  • Patients who experienced surgical failure in incontinence surgery,
  • who had undergone previous vaginal surgeries, who had a history of hysterectomy,
  • who underwent additional surgeries during the same session,
  • who had pelvic organ prolapse, who had received radiation therapy,
  • who had a diagnosis of malignancy,
  • who were menopausal, who received external hormone treatment,
  • who were sexually inactive, whose partners had erectile dysfunction,
  • who did not attend postoperative follow-up appointments,
  • who became postoperatively pregnant,
  • who had undergone non-synthetic mesh (autologous fascia) surgery for SUI were excluded from the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
the urethra at the bladder neck to the nearest proximal edge of the tape: < 5 mm
Patients who achieved continence after surgery were split into two subgroups based on the distance from the posterior of the urethra at the bladder neck to the nearest proximal edge of the tape: < 5 mm and >5 mm. The position of the sling along the urethra was measured as a percentage of urethral length and referred to as the sling percentile. This measurement was calculated as follows: the proximal urethral length (distance from the sling's proximal point to the bladder neck) divided by the total urethral length (distance from the bladder neck to the external urethral meatus) on the sagittal plane, where the bladder neck and the external urethral meatus represent 0% and 100% of urethral length, respectively. Additionally, perineal ultrasound was used to evaluate various parameters including bladder descent, pubo-urethral distance, urethral thickness, detrusor thickness, cystocele descent, rectal descent, and uterine descent.
Procedure: transobturator tape
transobturator tape :The surgeon makes a small incision in the vagina and small incisions in the right and left groin. The surgical process is similar to the retropubic approach, but the mesh passes through the groin muscles rather than the abdominal wall. transperineal ultrasound: patients who underwent TOT and were evaluated with transperineal ultrasonography, women with incontinence 6 months after the surgery showed discrepancies in the movement of the urethra with the sling compared to continent women, along with asymmetry between the mesh arms, bladder neck descent, and varied sling positions.
the urethra at the bladder neck to the nearest proximal edge of the tape: > 5 mm
Patients who achieved continence after surgery were split into two subgroups based on the distance from the posterior of the urethra at the bladder neck to the nearest proximal edge of the tape: < 5 mm and >5 mm. The position of the sling along the urethra was measured as a percentage of urethral length and referred to as the sling percentile. This measurement was calculated as follows: the proximal urethral length (distance from the sling's proximal point to the bladder neck) divided by the total urethral length (distance from the bladder neck to the external urethral meatus) on the sagittal plane, where the bladder neck and the external urethral meatus represent 0% and 100% of urethral length, respectively. Additionally, perineal ultrasound was used to evaluate various parameters including bladder descent, pubo-urethral distance, urethral thickness, detrusor thickness, cystocele descent, rectal descent, and uterine descent.
Procedure: transobturator tape
transobturator tape :The surgeon makes a small incision in the vagina and small incisions in the right and left groin. The surgical process is similar to the retropubic approach, but the mesh passes through the groin muscles rather than the abdominal wall. transperineal ultrasound: patients who underwent TOT and were evaluated with transperineal ultrasonography, women with incontinence 6 months after the surgery showed discrepancies in the movement of the urethra with the sling compared to continent women, along with asymmetry between the mesh arms, bladder neck descent, and varied sling positions.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
To evaluate the significance of postoperative FSFI scores on sexual functions in patients with continent status who underwent TOT surgery due to isolated SUI.
Time Frame: 6 months
The primary outcome measure involves assessing the impact of postoperative FSFI (Female Sexual Function Index) scores specifically on the sexual functions of patients who have maintained continence status and underwent TOT (Transobturator Tape) surgery attributable to isolated Stress Urinary Incontinence (SUI)
6 months
To assess the significance of sexual functions using The ICIQ-UI SF score in patients with continence status who underwent TOT surgery due to isolated SUI.
Time Frame: 6 months
evaluating the relevance of sexual functions utilizing The ICIQ-UI SF (International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form) score among patients maintaining continence status following Transobturator Tape (TOT) surgery due to isolated Stress Urinary Incontinence (SUI)
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 27, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 9, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 18, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 18, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 9, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • e27

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Urinary Incontinence

Clinical Trials on transobturator tape

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings