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En ny laparoskopisk apikal promontofiksasjonsteknikk med samtidig perineal rekonstruksjon for pasienter med symptomatisk bekkenorganprolaps

19. september 2026 oppdatert av: Riga East Clinical University Hospital

Pelvic organ prolapse in women is a common gynecological condition worldwide, with prevalence reported by different authors ranging from 15% to 50%. Up to 20% of women require surgical intervention during their lifetime due to genital prolapse or urinary incontinence. Surgical correction of prolapse provides an immediate effect by restoring the anatomical and physiological position of the pelvic organs, while also improving women's daily quality of life. Approximately 80-90% of women report satisfaction with the outcomes of prolapse surgery. However, there is still no global consensus regarding the optimal technique for performing colposacropexy. Multiple surgical approaches are currently in use, which prevents a definitive evaluation of the best method for surgical management of this condition. The classical laparoscopic sacrocolpopexy technique, while effective, does not eliminate the risk of mesh-related complications, particularly when synthetic implants are placed along the full length of the anterior and posterior vaginal walls.

Therefore, there is a strong rationale for developing a novel, simplified surgical approach for prolapse correction, derived from the original laparoscopic apical promontofixation, with simultaneous correction of cystocele and rectocele. This could potentially improve surgical outcomes for patients with pelvic organ prolapse while reducing the risk of complications associated with synthetic mesh implantation.

Studieoversikt

Detaljert beskrivelse

This is a prospective randomized study conducted at Riga East University Hospital (Latvia) and Pauls Stradins Clinical University Hospital (Latvia). Two groups of female patients will be compared. In the first group, patients will undergo laparoscopic reconstructive pelvic organ prolapse surgery using a polypropylene implant according to the 'classical' technique, involving fixation to the levator ani muscle and promontofixation. In the second group, patients will undergo a novel laparoscopic reconstructive pelvic organ prolapse procedure using a polypropylene implant based on a 'modified' technique, consisting of laparoscopic apical promontofixation combined with vaginal and perineal tissue repair using native tissues.

Group1 (Classical technique): Half of the patients will undergo laparoscopic sacrocolpopexy using a polypropylene mesh implant fixed to the cervix and along the entire anterior vaginal wall up to the bladder neck, with additional fixation along the posterior vaginal wall and to the levator ani muscles, ensuring physiological tension by securing the implant proximally to the sacral promontory, precisely to the anterior longitudinal vertebral ligament. Separate intracorporeal nonabsorbable sutures will be placed 1.5-2.0 cm apart.

Group2 (Modified technique): Half of the patients will undergo laparoscopic apical promontofixation combined with simultaneous vaginal and perineal reconstruction using native tissues. The procedure includes placement of a polypropylene implant with distal fixation to the bilateral uterosacral ligaments (according to the MacCall technique) and to the cervix, as well as along the anterior vaginal wall up to the bladder neck, maintaining physiological tension, with proximal fixation to the sacral promontory, precisely to the anterior longitudinal vertebral ligament. A simultaneous colpoperineolevatoroplasty will also be performed. During the laparoscopic stage, separate intracorporeal nonabsorbable sutures will be placed 1.5-2.0 cm apart. During the vaginal stage, posterior colporrhaphy with simultaneous levatoroplasty for rectocele repair will be performed in patients with posterior vaginal wall prolapse or perineal defects.

The following parameters will be analyzed: frequency and severity of intraoperative and postoperative complications (early and late), duration of surgery, length of hospital stay, recurrence rate, sexual activity, quality of life before and after surgery, as well as anatomical and functional outcomes. Anatomical results will be evaluated according to the Pelvic Organ Prolapse Quantification System classification. Functional outcomes will be assessed using standardized questionnaires, including Pelvic Floor Distress Inventory-20, Female Sexual Function Index, and International Consultation on Incontinence Questionnaire, in addition to urodynamic testing. Anatomical and functional results, quality of life, and sexual activity will be analyzed over a 6-month postoperative follow-up period.

Based on the study results, the novel laparoscopic apical promontofixation technique with simultaneous perineal repair using native tissues will be introduced into clinical practice in hospitals providing gynecological care. Furthermore, a new unified clinical protocol will be developed to facilitate practical application, including a simplified diagnostic algorithm based on 4-6 key symptoms, enabling family physicians and outpatient gynecologists to identify women with pelvic organ prolapse and refer them for specialist evaluation and appropriate treatment planning.

Additionally, a new objective method for assessing the degree of prolapse will be developed, allowing specialists to more accurately measure anterior, posterior, and central vaginal wall defects. This method will involve specific markings on a gynecological plastic speculum, enabling more precise evaluation of vaginal wall defects during routine gynecological examination. The new method will also be compared with other internationally recognized approaches for surgical management of pelvic organ prolapse.

Studietype

Intervensjonell

Registrering (Faktiske)

60

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

      • Riga, Latvia
        • Riga East Clinical University Hospital. Pauls Stradins Clinical University Hospital.

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

30 år til 80 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

Inclusion Criteria:

  1. Female patients with symptomatic isolated or combined forms of pelvic organ prolapse, corresponding to stage II-IV according to the POP-Q classification, including posterior wall prolapse.
  2. Age between 30 and 80 years.
  3. Presence or absence of urinary incontinence symptoms.
  4. Preoperatively verified by urodynamics: occult, mild, or severe stress urinary incontinence, or absence thereof.
  5. Presence or absence of proctogenic constipation.
  6. No prior surgical interventions for pelvic organ prolapse or urinary incontinence.
  7. History of supracervical hysterectomy.

Exclusion Criteria:

  1. Severe extragenital pathology contraindicating surgical treatment.
  2. Malignant pelvic pathology.
  3. Asymptomatic patients.
  4. Patient refusal to undergo subtotal hysterectomy.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Classical technique

Laparoscopic sacrocolpopexy.

Laparoscopic sacrocolpopexy using a polypropylene mesh implant fixed to the cervix and along the entire anterior vaginal wall up to the bladder neck, with additional fixation along the posterior vaginal wall and to the levator ani muscles, ensuring physiological tension by securing the implant proximally to the sacral promontory, precisely to the anterior longitudinal vertebral ligament. Separate intracorporeal nonabsorbable sutures will be placed 1.5-2.0 cm apart. The following parameters will be analyzed: frequency and severity of intraoperative and postoperative complications (early and late), duration of surgery, length of hospital stay, recurrence rate, sexual activity, quality of life before and after surgery, as well as anatomical and functional outcomes. Anatomical results will be evaluated according to the POP-Q classification. Functional outcomes will be assessed using standardized questionnaires, including PFDI-20, FSFI, ICIQ in addition to urodynamic testing.

Sham-komparator: Modified technique

Laparoscopic apical promontofixation combined with simultaneous vaginal and perineal reconstruction using native tissues.

The procedure includes placement of a polypropylene implant with distal fixation to the bilateral uterosacral ligaments (according to the McCall technique) and to the cervix, as well as along the anterior vaginal wall up to the bladder neck, maintaining physiological tension, with proximal fixation to the sacral promontory, precisely to the anterior longitudinal vertebral ligament. A simultaneous colpoperineolevatoroplasty will also be performed. During the laparoscopic stage, separate intracorporeal nonabsorbable sutures will be placed 1.5-2.0 cm apart. During the vaginal stage, posterior colporrhaphy with simultaneous levatoroplasty for rectocele repair will be performed in patients with posterior vaginal wall prolapse or perineal defects. Parameters will be analyzed: frequency of intraoperative and postoperative complications, duration of surgery, length of hospital stay, sexual activity, quality of life before and after surgery, as well as anatomical and functional results.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Anatomical success after pelvic organ prolapse surgery.
Tidsramme: Before and 6 months after surgery.

Anatomical outcome will be assessed using the Pelvic Organ Prolapse Quantification (POP-Q) system. Success is defined as no prolapse beyond the hymen in any vaginal compartment. Unit of Measure: POP-Q stage (0-4).

Before and 6 months after surgery.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Functional outcome - pelvic floor symptoms.
Tidsramme: Before and 6 months after surgery.

Evaluation with standardized questionnaires: Pelvic Floor Distress Inventory (PFDI-20). Unit of Measure: PFDI-20 score (0-300).

Before and 6 months after surgery.
Sexual function.
Tidsramme: Before and 6 months after surgery.

Female Sexual Function Index (FSFI) questionnaire to assess sexual activity and satisfaction. Unit of Measure: FSFI score (2-36).

Before and 6 months after surgery.
Urinary function.
Tidsramme: Before and 6 months after surgery.

International Consultation on Incontinence Questionnaire (ICIQ) and urodynamic testing. Unit of Measure: ICIQ score (0-21); presence/absence of urodynamic abnormalities.

Before and 6 months after surgery.
Postoperative complications.
Tidsramme: Early (within 30 days) and late (up to 6 months) after surgery.

Frequency and severity of intraoperative and postoperative complications (classified according to Clavien-Dindo). Unit of Measure: Number of events and severity grade.

Early (within 30 days) and late (up to 6 months) after surgery.
Operative time.
Tidsramme: 3 hours.

Intraoperative.

3 hours.
Length of hospital stay.
Tidsramme: 7 Days.

From surgery until discharge.

7 Days.

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Quality of life.
Tidsramme: Before and 6 months after surgery.

Assessed using validated patient-reported outcome measures (PFDI-20 global score, condition-specific questionnaires). Unit of Measure: Questionnaire scores.

Before and 6 months after surgery.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

29. august 2024

Primær fullføring (Antatt)

4. oktober 2026

Studiet fullført (Antatt)

31. desember 2027

Datoer for studieregistrering

Først innsendt

20. november 2025

Først innsendt som oppfylte QC-kriteriene

6. desember 2025

Først lagt ut (Faktiske)

9. desember 2025

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

22. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

19. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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