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An Acupuncture Study for Prostate Cancer Survivors With Urinary Issues

Nocturia in Prostate Cancer Survivors - Acupuncture Pilot Study (NOCTURNAL)

Status
Active, not recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05540392
Enrollment
60
Registered
2022-09-14
Start date
2022-09-09
Completion date
2026-09-30
Last updated
2025-10-10

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

Conditions

Prostate Cancer, Survivorship

Keywords

Acupuncture, Urinary issue, Nocturia, 22-270

Brief summary

The purpose of this study is to test whether acupuncture can improve nocturia in prostate cancer survivors. This is the first time acupuncture is being studied for nocturia in prostate cancer survivors. Researchers will see if acupuncture is a practical treatment option for prostate cancer survivors with nocturia. The study will also look at the effect acupuncture has on nocturia and other symptoms prostate cancer survivors experience such as insomnia, hot flashes, anxiety, depression, tiredness (fatigue), sexual dysfunction, and cognitive (mental) difficulties.

Interventions

OTHERWaitlist Control

The waitlist control group will not receive any acupuncture treatments during the 14-week waiting period. Patients in waitlist control group will have the option to receive up to 10 acupuncture treatments after a 14-week waiting period.

OTHERQuestionnaires

Patients will complete Patient Reported Outcomes (PRO)

PROCEDUREAcupuncture

10 treatments of acupuncture over the course of 10 weeks

Sponsors

Memorial Sloan Kettering Cancer Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age 18 or older * Prior PC diagnosis * No evidence of Prostate Cancer * Clinically meaningful nocturia, defined as ≥2 nocturia episodes every night for the past month

Exclusion criteria

* \<1 month since completion of PC treatment (surgery, chemotherapy, radiation, ADT) * Score of ≥5 on the STOP-Bang questionnaire indicative of high risk of moderate-to severe obstructive sleep apnea * Other untreated primary sleep disorder (e.g. delayed/advanced sleep phase syndrome) * Untreated primary psychiatric disorder (e.g. bipolar disorder, schizophrenia, substance abuse, dementia) * Initiation of new medications for urinary symptoms in the past 4 weeks * Altered dosing of medications for urinary symptoms in the past 4 weeks * Plan to initiate/change medications or other treatments (e.g. surgery, behavioral intervention, complementary therapies) for urinary symptoms during the study * Implanted electronically charged medical device * Unable to provide consent for himself * Unwilling to adhere to all study-related procedures

Design outcomes

Primary

MeasureTime frameDescription
success1 yearIf a participant completes at least 8 out of 10 acupuncture sessions. Feasibility will be evaluated based on the respective definitions of success for the acupuncture.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026