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

Impact of oophorectomy at cystectomy for urinary bladder cancer on female hormonal status and sexual function: Randomized study on Oophorectomy at Cystectomy (ROC study)

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN18217210

Enrollment

360

Registered

2017-05-24

Start date

2017-04-18

Completion date

Unknown

Last updated

2026-03-23

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

Conditions

Bladder cancer treated with radical cystectomy Cancer Malignant neoplasm of bladder

Interventions

Patients 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 perfor

Eligibility

Sex/Gender

Female

Age

18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Women undergoing radical cystectomy 2. Aged 18-85 years

Exclusion criteria

Exclusion criteria: 1. Clinical suspicion of tumour involvement of either ovaries 2. Previous radiation of the pelvis 3. Previous cystectomy 4. Previous oophorectomy

Design outcomes

Primary

Measure	Time frame
1. 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	—

Measure

Time frame

1. 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

Measure	Time frame
No secondary outcome measures	—

Countries

Sweden

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 27, 2026