Urinary Continence of Female POPRC and OIN

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age55-75
SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University

About this trial

To compare the urinary continence rate and long-term oncological outcomes of pelvic-organ preserving radical cystectomy (POPRC) with orthotopic ileal neobladder (OIN) versus standard radical cystectomy(SRC) with OIN.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female patients aged between 55-75.

Patients those who are diagnosed with organ-confined urothelial carcinoma(<pT3)

Patients those who are capable for radical cystectomy with orthotopic ileal neobladder.

ECOG score between 0-2;

Disqualifiers

Absence of tumour in bladder neck or urethra;

Patients thsoe who are diagnosed distant metastasis before surgery.

Previous history of malignancy of pelvic organs or surgical resection of pelvic organs;

Patients those who are diagnosed with other malignancies.;

Trial design

Design model

Parallel

Treatments tested in this trial

  • POPRC+OIN

    Procedure/Surgery

    Pelvic-organ preserving radical cystectomy with orthotopic ileal neobladder

  • SRC+OIN

    Procedure/Surgery

    Standard radical cystectomy with orthotopic ileal neobladder

Treatment groups

58 Participants
are divided into 2 treatment groups
Group A: POPRC groupExperimental treatment 1 intervention
Group B: SRC groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

day-time and night-time continence rate

We will use pad-test to evaluate the urinary continence for patients

Time frame
6 months

Secondary outcomes

1

postoperative sexual function

International index of erectile function-5 (IIEF-5)

Time frame
6 months
2

perioperative complications rate

perioperative complications rate within 1 month

Time frame
1 months
3

overall survival

5-year overall survival rate

Time frame
5 years
4

recurrence-free survival

5-year overall recurrence-free survival rate

Time frame
5 years

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: