Randomized comparison of oophorectomy or not in conjunction with radical cystectomy in women

ISRCTN ISRCTN18217210
DOI https://doi.org/10.1186/ISRCTN18217210
Secondary identifying numbers 1/2017
Submission date
18/04/2017
Registration date
24/05/2017
Last edited
24/01/2025
Recruitment status
Recruiting
Overall study status
Ongoing
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
Bladder cancer is where a tumour develops in the bladder lining. Patients who have high-risk early bladder cancer, invasive bladder cancer or locally advanced bladder cancer may have to have their bladder removed (radical cystectomy). In women, sometimes the ovaries may also need to be removed (oophorectomy). There are at present no studies on whether oophorectomy should be performed with radical cystectomy as treatment for muscle-invasive bladder cancer in women. Information is also lacking regarding the effects on hormone levels and sexual function. This study aims to assess the hormone levels and sexual function of women undergoing radical cystectomy with or without oophorectomy for bladder cancer.

Who can participate?
Women aged 18-85 undergoing radical cystectomy for bladder cancer

What does the study involve?
Participants are randomly allocated to undergo radical cystectomy with either no oophorectomy, removal of one ovary or removal of both ovaries. Sexual function and blood hormone levels are assessed at the start of the study and 12 and 52 weeks after the operation.

What are the possible benefits and risks of participating?
Participants allocated to no oophorectomy may benefit from better hormonal, sexual and general function after surgery. There are no risks in participating in this study.

Where is the study run from?
Skåne University Hospital (Sweden)

When is the study starting and how long is it expected to run for?
April 2017 to December 2027

Who is funding the study?
Hillevi Fries Foundation (Sweden)

Who is the main contact?
Prof Fredrik Liedberg

Contact information

Prof Fredrik Liedberg
Principal Investigator

Dept. of Urology
Skåne University Hospital
Jan Waldenströmsgata 5
Malmö
SE-205 02
Sweden

ORCiD logoORCID ID 0000-0001-8193-0370
Phone +46 40331000
Email fredrik.liedberg@med.lu.se

Study information

Study designProspective randomised study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet No participant information sheet available
Scientific titleImpact of oophorectomy at cystectomy for urinary bladder cancer on female hormonal status and sexual function: Randomized study on Oophorectomy at Cystectomy (ROC study)
Study acronymROC
Study objectivesPreservation of ovarian tissue increases sexual function and improves hormonal status after radical cystectomy.
Ethics approval(s)The Regional Ethical Review Board in Lund, 14/02/2017, ref: 2016/1036 and 2017/2
Health condition(s) or problem(s) studiedBladder cancer treated with radical cystectomy
InterventionPatients undergoing radical cystectomy will be randomized using closed envelopes to undergo either:
1. No oophorectomy
2. Excision of one ovary
3. Excision of both ovaries

Oophorectomy will be performed by standard surgical methods, including ligation of parametrium with Ligasure when preserving the one or two ovaries. Follow-up will be 12 months postoperatively according to the protocol, however clinical follow-up will be according to clinical routines.
Intervention typeProcedure/Surgery
Primary outcome measure1. Sexual function, measured using Female Sexual Function Index (FSFI) score at baseline, 12 and 52 weeks postoperatively
2. Hormonal status, measured using plasma levels of total testosterone, dihydrotestosterone, SHBG, anti-müllerian-hormone, androstenedione, dehydroepiandrosterone sulphate, progesterone, oestradiol (sensitive method for postmenopausal women), LH and FSH, at baseline, 12 and 52 weeks postoperatively
Secondary outcome measuresNo secondary outcome measures
Overall study start date09/04/2017
Completion date31/12/2027

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit85 Years
SexFemale
Target number of participants360 female patients
Key inclusion criteria1. Women undergoing radical cystectomy
2. Aged 18-85 years
Key exclusion criteria1. Clinical suspicion of tumour involvement of either ovaries
2. Previous radiation of the pelvis
3. Previous cystectomy
4. Previous oophorectomy
Date of first enrolment18/04/2017
Date of final enrolment31/12/2026

Locations

Countries of recruitment

  • Sweden

Study participating centre

Skåne University Hospital
Department of Urology
Malmö
SE-205 02
Sweden

Sponsor information

Lund University
University/education

Dept. of Translational Medicine
Malmö
205 02
Sweden

ROR logo "ROR" https://ror.org/012a77v79

Funders

Funder type

Charity

Hillevi Fries Foundation

No information available

Results and Publications

Intention to publish date31/12/2027
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot expected to be made available
Publication and dissemination planThe study will be published in a urologic journal after closure.
IPD sharing planThe datasets generated during and/or analysed during the current study are not expected to be made available due to integrity reasons for the participating patients.

Editorial Notes

24/01/2025: The following changes were made to the study record:
1. The recruitment end date was changed from 31/12/2025 to 31/12/2026.
2. The overall study end date was changed from 31/12/2026 to 31/12/2027.
05/12/2023: The study contacts were updated.
07/11/2023: The contact confirmed the record is up to date.
03/03/2021: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/12/2021 to 31/12/2025.
2. The overall end date was changed from 31/12/2022 to 31/12/2026.
3. The intention to publish date was changed from 31/12/2021 to 31/12/2027.
4. The plain English summary was updated to reflect these changes.
12/07/2019: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/12/2020 to 31/12/2021.
2. The overall trial end date was changed from 31/12/2020 to 12/31/2022.