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Investigation after vaginal cystocele repair with double-layered fascia plication and hysterectomy for prolapse

Investigation after vaginal cystocele repair with double-layered fascia plication and hysterectomy for prolapse

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00021807
Enrollment
67
Registered
2020-06-30
Start date
2020-05-04
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

N81.1 R39.1

Interventions

Group 1: Patients included in the study are invited to a one-time visit to the DBBZ. There, a personal survey is carried out on current complaints and the condition regarding quality of life after the

Sponsors

Deutsches Beckenbodenzentrum, Klinik für Urogynäkologie, St. Hedwig-Krankenhaus
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: -Double-layered vaginal cystocele repair and vaginal hysterectomy for prolapse in the period 01/2018 to 12 months before examination -patients of the DBBZ over the age of 18 -ability to informed consent -Willing and able to join follow-up visit and complete a questionnaire

Exclusion criteria

Exclusion criteria: -Previous pelvic floor repair -concomitant surgery such as posterior vaginal wall repair, perineal body reconstruction, incontinence procedures (not excluded are simultaneous interventions such as biopsy samples, cyst extirpation, adnectomy, adhesiolysis)

Design outcomes

Primary

MeasureTime frame
Cure rate is defined anatomically, primary endpoint is the number of women with anatomical success 1-2 years after surgery. Anatomical success is evaluated using the ICS-POPQ system for objective assessment. A success can be assumed if the anterior vaginal wall and the vaginal apex (point Aa, Ba and C in the ICS-POPQ system) are more than 1 cm proximal of the hymen (stage 0 and I according to POPQ).

Secondary

MeasureTime frame
Percentage of women with improvement in bladder emptying (postvoidal residual) 1-2 years after surgery compared to before surgery. In case of sonographic postvoidal residual it is measured by single-use catheter. Development of quality of life 1-2 years after surgery (postoperative satisfaction based on the Likert scale).

Countries

Germany

Contacts

Public ContactFlora Graefe

Deutsches Beckenbodenzentrum, Klinik für Urogynäkologie, St. Hedwig-Krankenhaus

f.graefe@alexianer.de030 2311 2106

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026