Early intervention and recovery of sexual function in men and women after treatment of rectal cancer–a randomized placebo-controlled study with tadalafil

Prior treatment

• Concomitant use of anti-androgens or androgens
• Contraindications to the use of tadalafil (PDE5-inhibitor)
• Ongoing drug or alcohol abuse dependence.
• Has a condition or has received medical treatment that, in the judgement of the investigator, precluded successful participation in the study.

Other illness

• Evidence of systemic disease (metastases)
• History or evidence of urogenital malignancy
• History of pelvic radiation
• Serious co-existing mental disorder or medical condition e.g. anaemia, liver or renal failure, cardiovascular disease or diabetes.

Other

• Impaired performance status (Eastern Cooperative Oncology Group (ECOG) performance score above 1.

• Men and women with rectal cancer stage I-III after clinical and radiologic staging, intention to transabdominal resection of rectal cancer.
• Patient reported sexual activity before diagnosis or symptoms of rectal cancer according to FSFI-6 and IIEF-5.
• Age over 18 years
• Fluent in oral and written Swedish language
• Females must not be lactating or pregnant at baseline documented by pregnancy test.
• Given written informed consent