4 eye-opening clinical trials about sex

By Naveed Saleh, MD, MS | Medically reviewed by Kristen Fuller, MD
Published January 12, 2023

Key Takeaways

  • In four clinical trials, researchers are examining the impact of a variety of conditions on sexual health.

  • These studies focus on sexual dysfunction after surgery and the use of psychotherapy to treat such pathologies.

  • Hopefully, the trials will yield evidence-based, actionable results that clinicians can put to use with their patients.

Medical researchers are doing significant work in the area of sexual health, investigating this vitally important component of patients’ lives and well-being.

Here are four trials of note listed on the ClinicalTrials.gov database that involve a variety of conditions that may impair an individual’s sexual health.

Evaluating QOL after rectal cancer surgery

In a multicenter, prospective trial, Canadian researchers aim to examine the effects of low anterior resection syndrome (LARS), sexual and urinary dysfunction (SUD), emotional distress, financial distress, and patient activation on quality of life (QOL) in patients receiving restorative prostatectomy.[]

LARS refers to long-term bowel dysfunction, which presents as increased stool frequency, incontinence, and difficult defecation.

LARS, SUD, and other types of functional impairments negatively affect QOL and frequently result in emotional distress.

On ClinicalTrials.gov, the investigators wrote, “The main contributions of this study are 1) provision of reference baseline North American values for important rectal cancer PROMs [patient required outcome measures] for clinical and research use, 2) an understanding of the evolution of functional outcomes and QOL post-treatment to counsel patients peri-operatively and throughout survivorship, and 3) to provide the basis for future tailored programs to support rectal cancer survivors.”

Reproductive and sexual health of colorectal cancer patients

In this prospective trial, Memorial Sloan Kettering researchers aim to assess how colorectal cancer treatments, including radiation therapy and chemotherapy, impact reproductive and sexual health in patients with early-onset colorectal cancer.[]

"This information will help researchers know more about how cancer treatments affect reproductive and sexual health, including the ability to have children (fertility)."

Memorial Sloan Kettering Cancer Center investigators

Endpoints include hormone biomarker analysis, QOL questionnaires, and semen analysis (for men). Female participants aged < 40 years will be measured for changes in estradiol, anti-Müllerian hormone, and follicle-stimulating hormone (FSH), while men aged < 40 years will be tested for changes in testosterone, FSH, steroid hormone binding globulin, and inhibin B.

Online programs for female sexual dysfunction

Nearly one-third of the world’s female population experiences female sexual dysfunction (FSD), with biopsychosocial consequences.

Although cognitive behavioral therapy (CBT) and mindfulness-based therapy are both effective evidence-based treatments, in-person treatment can be expensive. Also, individuals living in remote or rural areas may lack access to such services.

To help address these challenges, University of British Columbia (UBC) researchers are planning a randomized controlled trial to assess the efficacy and patient satisfaction of two online interventions for FSD.[]

Women will be randomly assigned to an online CBT program, online mindfulness-based program, or wait-list control group. Treatment will last between 8–12 weeks, with women meeting in video chats with a navigator who will provide personal support.

Comparing mindfulness with CBT

Treatment for prostate cancer can adversely impact sexual function, which predicts poorly for intimacy and QOL. It’s estimated that up to 90% of men who receive such treatment experience sexual dysfunction.

In the randomized INTROSPPECT clinical trial, UBC researchers analyzed the effects of mindfulness-based therapy compared with those of CBT in couples in which the men received therapy for prostate cancer.[] Both of these psychotherapies are evidence-based.

Couples were randomized to 4 weeks of either treatment or no treatment. When planning the trial, investigators hypothesized that outcomes could determine the impact of intimacy on overall QOL, as well as factors that moderated improvement, such as personality and treatment adherence.

The team hoped to glean insights into who benefited most in each treatment arm. Interviews were conducted, and participants in the control group could crossover to the experimental group.

The results of this pilot study were published in Sexual Medicine.[] The authors wrote that the outcomes “provide preliminary support in favor of treatment feasibility and add to mounting support in favor of adopting a mindfulness-based couples therapy to address intimacy concerns, this time in PC [prostate cancer] survivors and their partners.”

"There is a strong theoretical rationale for moving toward acceptance of what is, as opposed to the existent approach of encouraging couples to work toward pre-PC treatment levels of sexual function, a stance that is often futile and discouraging."

Bossio, et al., in Sexual Medicine

What this means for you

Whether you treat patients with sexual dysfunction or merely express an interest in the topic, a variety of trials are in the works to assess it in association with various conditions. Common themes include sexual dysfunction after surgery and the use of psychotherapy to treat such pathology. These trials include patients from across the gamut of the world’s population. It’s hoped that the trials will yield actionable, evidence-based results.

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