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Treatment of Advanced Vaginal Prolapse: Prospective, Randomized Study

Up Hold x Splentis in the treatment of advanced Pelvic Organ Prolapse: Prospective and Randomized Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-52bw3b
Enrollment
Unknown
Registered
2019-11-12
Start date
2019-12-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic organ prolapse

Interventions

Eighty patients with advanced advanced organ prolapse for surgical treatment will be randomized using two separate commercial screens (UP HOLD x SPLENTIS), , making a total of 40 patients in each grou
Procedure/surgery
C12.777.829.707
C13.351.500.852.833
C23.300.842.624

Sponsors

Hospital Maternidade Escola Vila Nova Cachoeirinha
Lead Sponsor
Hospital Maternidade Escola Vila Nova Cachoeirinha
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Adult women, over 45 years old,constituted offspring, with stage III or IV advanced pelvic organ prolapse, treated at a single referral center, at Hospital Municipal e Martenidade Escola - Dr Mário de Moraes Altenfelder Silva - Vila Nova Cachoeirinha.

Exclusion criteria

Exclusion criteria: Vaginal, cervical or uterine cancer; Genital system or urinary tract infection; During pregnancy; Sensitivity or known allergy to polypropylene; Hypertrophic uterine cervix; Pelvic Radiotherapy

Design outcomes

Primary

MeasureTime frame
Expected Outcome 1 Surgical success for correction of pelvic organ prolapse at an advanced stage after 1 year of surgery, verified through POP-Q measurements during postoperative gynecological examination. total vaginal length (C < or = CVT / 3), Ba and Bp points less than -1 and no reoperation for vaginal prolapse.;Expected Outcome 2 Subjective success with improvement in quality of life and absence of symptoms of prolapse vaginal after surgery, verified through the application of questionnaires such as PGI-I, and answers 1 and 2 were considered as success.—

Secondary

MeasureTime frame
Expected Outcome 1 Adequate tolerability of postoperative pain with the two techniques used for prolapse correction, verified by the application of the Visual Analog Pain Scale (VAS) at 7, 14 and 30 days postoperatively, being considered adequate control responses 0 (no pain). or 1 and 2 (mild pain).—

Countries

Brazil

Contacts

Public ContactRaphael Moreira

Hospital Maternidade Escola Vila Nova Cachoeirinha

raphaeljm@hotmail.com+5511987056107

Outcome results

None listed

Source: REBEC (via WHO ICTRP)