Urinary Continence of Female POPRC and OIN

• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05325216
• Collaborator: Peking University Third Hospital (Other)
• Enrollment: 58
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 72
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Urinary Bladder Neoplasms; Woman; Sexual Dysfunction, Physiological; Treatment Outcome; Urinary Incontinence	Procedure: POPRC+OIN; Procedure: SRC+OIN	N/A

Detailed Description

Radical cystectomy is the gold standard for muscle-invasive bladder. Orthotopic ileal neobladder, as one of the urinary diversion methods, is preferred whenever possible to achieve a better postoperative quality of life.

For standard radical cystectomy (SRC) in females, the uterus, fallopian tubes, ovaries, anterior vaginal wall, and regional lymph nodes undergo en bloc resection with the bladder and urethra . With regard to the wide range of resection, continence disorder and sexual dysfunction are very common after surgery. Pelvic-organ sparing radical cystectomy involves the preservation of the female vagina, uterus, neurovascular bundles, and any enhancement of the aforementioned techniques . Previous studies demonstrated that POPRC might not affect long-term survival and instead improve continence outcomes. However, most of the available studies are retrospective with limited cases in a single center. The current study primarily aims to urinary continence rate and long-term oncological outcomes of POPRC+OIN versus SRC+OIN in a prospective randomized controlled trial.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 58 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Urinary Continence of Female Pelvic Organ-preserving Radical Cystectomy and Orthotopic Ileal Neobladder: A Randomized Controlled Study
• Anticipated Study Start Date: Apr 1, 2022
• Anticipated Primary Completion Date: Apr 1, 2028
• Anticipated Study Completion Date: Apr 1, 2028

Arms and Interventions

Arm	Intervention/Treatment
Experimental: POPRC group pelvic-organ preserving radical cystectomy with orthotopic ileal neobladder	Procedure: POPRC+OIN; Pelvic-organ preserving radical cystectomy with orthotopic ileal neobladder
Active Comparator: SRC group standard radical cystectomy with orthotopic ileal neobladder	Procedure: SRC+OIN; Standard radical cystectomy with orthotopic ileal neobladder

Outcome Measures

Primary Outcome Measures

1. day-time and night-time continence rate [6 months]

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

Secondary Outcome Measures

1. postoperative sexual function [6 months]

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

2. perioperative complications rate [1 months]

   perioperative complications rate within 1 month

3. overall survival [5 years]

   5-year overall survival rate

4. recurrence-free survival [5 years]

   5-year overall recurrence-free survival rate

5. operative time [24 hours]

   operative time (mins)

6. estimated blood loss [24 hours]

   estimated blood loss (ml)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 55 Years to 75 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Female patients aged between 55-75.

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

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

4. ECOG score between 0-2;

5. Normal renal function;

6. Patients those who volunteer to participate in this study and sign the informed consents.

7. Patients those who are able to cooperate in the study.

Exclusion Criteria:

1. Absence of tumour in bladder neck or urethra;

2. Patients thsoe who are diagnosed distant metastasis before surgery.

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

4. Patients those who are diagnosed with other malignancies.;

5. Patients those who had received pelvic radiotherapy or major pelvic operation.

6. Pregnancy status;

7. Any other conditions that the researcher considers to be excluded from this study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sun Yat-Sen Memorial Hospital	Guangzhou	Guangdong	China

Sponsors and Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Peking University Third Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• ClinicalTrials.gov Identifier: NCT05325216
• Other Study ID Numbers: 2021-KY-074
• First Posted: Apr 13, 2022
• Last Update Posted: Apr 13, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: Bladder cancer, Female, Pelvic organ preserving-radical cystectomy, Radical cystectomy, Orthotopic ileal neobladder
• Additional relevant MeSH terms: Urinary Bladder Neoplasms; Urinary Incontinence; Sexual Dysfunction, Physiological

Study Results

No Results Posted as of Apr 13, 2022