Pelvic Organ Prolapse Clinical Trial
Official title:
A Prospective, Observational Trial of Transvaginal Uterine Suspension With the New Minimally Invasive Uterine Suspension
Transvaginal or transabdominal surgeries are current choices of uterus-preserving surgeries for pelvic organ prolapse. Laparoscopic lateral uterine suspension, a modified surgical approach of uterine suspension from bilateral abdominal wall fascia, performed with expected safety and simplicity of surgery besides advantages including small wound incision and fast recovery in laparoscopic surgeries. This trial aim to discuss the therapeutic efficacy, long term safety, and adverse events of laparoscopic lateral uterine suspension and compare with the conventional transvaginal sacrospinous ligament fixation with native tissue repair.
Status | Recruiting |
Enrollment | 90 |
Est. completion date | December 31, 2029 |
Est. primary completion date | December 31, 2029 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 21 Years and older |
Eligibility | Inclusion Criteria: - older than 21 years old. - uterine prolapse stage 2 at least, defined by C point distal to -1cm by POP-Q system. - patients willing to receive a uterine-preserving surgery for pelvic organ prolapse, and is suitable for anesthesia after evaluation. - patients who had or had not received conservative treatments for pelvic organ prolapse. - patients able and willing to finish the questionnaire evaluation. Exclusion Criteria: - patient who had received a previous hysterectomy, or is planning on concomitant hysterectomy in the surgery for pelvic organ prolapse. - patient who had received a previous surgery for pelvic organ prolapse. - patient with history of adverse events following a synthetic mesh. - patients with chronic or acute pelvic pain. - patients who had received abdominal or pelvic irradiation. - patients who cannot receive either surgery due to comorbidity. - patients pregnant or with future plan of pregnancy. - patients with vaginal length less than 5cm. |
Country | Name | City | State |
---|---|---|---|
Taiwan | National Cheng Kung University Hospital | Tainan |
Lead Sponsor | Collaborator |
---|---|
National Cheng-Kung University Hospital |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Safety outcome | Surgery-related complications and mesh-related long term complications. | 5 years | |
Primary | Recurrence | Composite outcome of subjective and objective recurrence of uterine prolapse. | 5 years | |
Secondary | Anatomical outcome | Comparison of total vaginal length (TVL), Ba, Bp points defined by POP-Q system. | 5 years | |
Secondary | Functional outcome | Comparison of urination and defecation functions by Pelvic floor disability index-20 (PFDI-20). | 5 years | |
Secondary | Sexual function outcome | Comparison of sexual function by Female Sexual Function Index (FSFI). | 5 years | |
Secondary | Urodynamic outcome | Comparison of post residual urine amount, uroflowmetry, and 1-hour pad test. | 6 months |
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