the Indications and Clinical Efficacy of Pelvic Organ Prolapse Surgery

The Clinical Efficacy of Pelvic Organ Prolapse Surgery

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02599311

Enrollment

1000

Registered

2015-11-06

Start date

2015-08-31

Completion date

2020-10-31

Last updated

2017-05-23

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

Conditions

Pelvic Organ Prolapse

Keywords

pelvic organ prolapse

Brief summary

One thousand patients with stage\>2 POP are recruited. The patients are all received surgeries,such as transvaginal synthetic mesh surgery, the sacral fixation, tissue repair surgery and colpocleisis. The patients with POP who have not undergone surgery are excluded. Postoperatively, the investigators investigate the indications and clinical efficacy of pelvic organ prolapse surgery.

Detailed description

Postoperatively, the investigators analyze the patients' subjective and objective recurrent rates. The investigators compare the quality of life by filling out the preoperative and postoperative scoring questionnaires (PISQ 12, PFDI-20, PFIQ-7).The electrical physiological changes will be focused on. The investigators also use Overactive Bladder Symptom Score(OABss) to assess the lower urinary tract symptoms.

Interventions

DEVICEtransvaginal synthetic mesh

transvaginal synthetic mesh

DRUGTolterodine

Tolterodine tartrate can improve patients' LUTS.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

30 Years to 80 Years

Healthy volunteers

Yes

Inclusion criteria

* The patients with stage\>2 POP are recruited.The patients are all received surgeries, which include transvaginal synthetic mesh surgery, the sacral fixation, tissue repair surgery and colpocleisis.

Exclusion criteria

* The patients with POP who have not undergone surgery are excluded.

Design outcomes

Primary

Measure	Time frame	Description
the objective recurrent rate	one year after surgery	The objective recurrence means postoperative stage≥2 (POP-Q) in any compartment.

Secondary

Measure	Time frame	Description
the rate of the lower urinary tract symptoms	one year after surgery	We focus on lower urinary tract symptoms (LUTS), including frequent micturition, urgent urination, cough (or sneezing) leakage, dysuria, and urinary incontinence.
the quality of life questionnaires	one year after surgery	The QOL questionnaires include PFDI-20 and PFIQ-7.

Countries

China

Contacts

Primary ContactXiuli Sun, professor

zzucaotingting@163.com861088324354

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026