Comparing sexual quality of life after different tubal ligation methods
Sexuality After Tubal Sterilization by Conventional Abdominal Laparoscopy or Vaginal Natural Orifice Transluminal Endoscopy (vNOTES) : a Randomised Controlled Trial
This study is trying to see if women’s sexual quality of life is similar six months after having tubal ligation using either a traditional surgery or a newer, less invasive method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University Hospital, Clermont-Ferrand Academic / other |
| Locations | 2 sites (Clermont-Ferrand and 1 other locations) |
| Trial ID | NCT05910385 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the quality of sexual life in women six months after undergoing tubal ligation, using either abdominal laparoscopy or vNOTES (vaginal Natural Orifice Transluminal Endoscopic Surgery). Participants will complete the FSFI-19 questionnaire to assess their sexual quality of life before and after the procedure. The study is based on a non-inferiority hypothesis, meaning it seeks to determine if the two methods yield similar outcomes in terms of sexual satisfaction. The trial will include adult women who are sexually active and eligible for tubal ligation.
Who should consider this trial
Good fit: Ideal candidates for this study are sexually active adult women eligible for tubal ligation procedures.
Not a fit: Patients who are currently pregnant, breastfeeding, or have certain medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the best surgical approach for preserving sexual quality of life after tubal ligation.
How similar studies have performed: While similar studies have explored surgical methods, this specific comparison of vNOTES and laparoscopy in relation to sexual quality of life is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult woman, eligible for tubal ligation by total salpingectomy or tubal section coagulation, sexually active at the time of inclusion * Able to give informed consent to participate in research * Affiliated to a social security system. Exclusion Criteria: * Current pregnancy or breastfeeding * Indications of another concomitant surgical procedure (other than procedure on the appendix) * History of upper genital infection * Proven or suspected rectovaginal endometriosis on clinical examination * History of rectal surgery * Virgin patient * Any concomitant pathology deemed incompatible with the study. * Uncured COVID or SARS-COv2 positivity dated less than 3 days prior to surgery. * Protected adult patient, under guardianship or curatorship * Patients not affiliated to the social security system * Patients who do not speak French * Patients under legal protection * Refusal to participate.
Where this trial is running
Clermont-Ferrand and 1 other locations
- CHU de Clermont-Ferrand — Clermont-Ferrand, France (Recruiting)
- CH d'Issoire — Issoire, France (Recruiting)
Study contacts
- Principal investigator: Sandra Curinier — University Hospital, Clermont-Ferrand
- Study coordinator: Lise LACLAUTRE
- Email: promo_interne_drci@chu-clermontferrand.fr
- Phone: +33473754963
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.