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Long Term Follow Up Of Transvaginal Cystocele Repair Using Four Armed Collagen Coated Polyester Mesh

23. juli 2026 opdateret af: Ibrahim Abdelghany, Ain Shams University

Long Term Follow Up Of Transvaginal Cystocele Repair Using Four Armed Collagen Coated Polyester Mesh; Retrospective Cohort Study With Prospective Long-term Follow-up

This study aims to assess safety and efficacy of transvaginal repair of cystocele using four armed collagen coated polyester mesh beyond 5 years postoperatively.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Cystocele, also known as anterior vaginal wall prolapse, is a common condition in females, particularly those with or without uterine prolapse.

Traditionally, cystocele repair has been performed using native tissue suturing techniques. This method involves reinforcing the weakened vaginal wall by plicating and tightening the patient's tissues without introducing any foreign material. While suture repair is associated with fewer foreign body complications, long-term studies have reported notable recurrence rates, leading some surgeons to seek alternative methods.

Mesh insertion involves placing a synthetic material underneath the bladder to reinforce the vaginal wall and improve long-term anatomical outcomes. Although mesh repairs initially showed promising results in reducing recurrence, concerns have arisen regarding complications such as mesh erosion, chronic pelvic pain, and dyspareunia.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

20

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Egypten
    • Cairo Governorate
      • Cairo, Cairo Governorate, Egypten, 11591

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

This retrospective cohort study with prospective long-term follow-up will be conducted on 20 patients at Ain Shams University Hospital.

Beskrivelse

Inclusion Criteria:

• Data of patients who underwent transvaginal cystocele repair using four-armed collagen coated polyester mesh

Exclusion Criteria:

  • Patients with insufficient postoperative follow-up data.
  • Patients with incomplete or missing medical records.
  • Patients undergone radiation, laser therapy, or chemotherapy in the pelvic area postoperatively.
  • Patients newly discovered uncontrolled diabetes mellitus.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Study group
Patients who undergo transvaginal cystocele repair using four-armed collagen coated polyester mesh
Procedure: transvaginal cystocele repair
Patients who undergo transvaginal cystocele repair using four-armed collagen coated polyester mesh.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Long-term anatomical success rate
Tidsramme: 5 years of follow-up postoperatively
Long-term anatomical success rate is defined as the absence of anterior vaginal wall prolapse or the presence of only Stage 0-I cystocele according to Pelvic Organ Prolapse Quantification (POP-Q) classification after 5 years of follow-up postoperatively.
5 years of follow-up postoperatively

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Functional improvement
Tidsramme: 5 years of follow-up postoperatively
Sustained improvement in urinary symptoms will be recorded.
5 years of follow-up postoperatively
Sexual function
Tidsramme: 5 years of follow-up postoperatively

The Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) is a validated, condition-specific questionnaire will be used to evaluate sexual function in women with pelvic floor disorders.

It is a shortened form of the original 31-item PISQ, specifically designed for sexually active women experiencing pelvic organ prolapse (POP) and urinary incontinence (UI).

The questionnaire consists of 12 self-administered questions that assess the impact of pelvic floor health over the past six months. It spans three primary domains:

Behavioral-Emotive Domain (Questions 1-4): Focuses on desire, excitement, frequency, and overall sexual satisfaction.

Physical Domain (Questions 5-9): Evaluates physical symptoms during sex, such as pain, urine leakage, and restrictions due to fear or vaginal bulging.

Partner-Related Domain (Questions 10-12): Addresses the partner's erectile or ejaculatory function as it impacts sexual activity
5 years of follow-up postoperatively
Long-term complications
Tidsramme: 5 years of follow-up postoperatively
Long-term complications including groin pain, urinary retention, vaginal shortening, infection, mesh erosion or need for mesh removal will be recorded.
5 years of follow-up postoperatively
Assesment of quality of life
Tidsramme: 5 years of follow-up postoperatively

The Incontinence Impact Questionnaire - Short Form (IIQ-7) will be used to evaluate the quality of life.

It is a condensed version of the original 30-item questionnaire, designed to evaluate life impact over the past month across physical, emotional, and social life areas.

The IIQ-7 consists of 7 self-administered items divided into four clinical domains:

Physical Activity (Items 1 & 2): Measures impact on household chores and physical recreation like walking or swimming.

Travel (Items 3 & 4): Evaluates restrictions on entertainment outings and traveling by car or bus more than 30 minutes from home.

Social Relationships (Item 5): Assesses participation in social activities outside the home.

Emotional Health (Items 6 & 7): Tracks the burden on mental wellbeing, specifically feelings of nervousness, depression, or frustration
5 years of follow-up postoperatively

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Ain Shams University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

29. juni 2026

Primær færdiggørelse (Anslået)

30. december 2026

Studieafslutning (Anslået)

30. december 2026

Datoer for studieregistrering

Først indsendt

23. juli 2026

Først indsendt, der opfyldte QC-kriterier

23. juli 2026

Først opslået (Faktiske)

28. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

28. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • FMASU MS 473/2026

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

IPD-delingstidsramme

After the end of study for one year.

IPD-delingsadgangskriterier

The data will be available upon a reasonable request from the corresponding author.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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