Pathophysiologic Study to Understand and Possibly Treat Nocturia

Nocturia Clinical Trial

Official title:

Pathophysiologic Study to Understand and Possibly Treat Nocturia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05298384
• Other study ID #: 21-00542
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2024
• Est. completion date: November 2024

Study information

• Verified date: November 2023
• Source: NYU Langone Health
• Contact: John Maesaka, MD
• Phone: 516-663-2169
• Email: John.Maesaka[@]nyulangone.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will mainly look at how well compression stockings decrease body weight between morning and night and the number of nocturia events, by preventing blood from pooling in your legs. Also, this research study is being done to collect the thoughts/reactions/opinions on how nocturia affects the life of one who suffers from nocturia.

Description:

This study intends to investigate the different causes nocturia. Patients with nocturia will be assigned to wearing knee high then thigh high compression stockings to assess the effect on weight gain during the day and the number of nocturia events. Renin and aldosterone levels will also be assessed. Furthermore, fluorescein dye will be used to to demonstrate vascular leakage of the fluorescent dye.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: November 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 110 Years

Eligibility

Inclusion Criteria:

• Age above or equal to 18 years at the time of signing informed consent

• Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures

• Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study prior to initiation of any protocol-mandated procedures.

Exclusion Criteria:

• Suspected or proven peripheral arterial disease, including history of peripheral arterial bypass grafting

• Any sensory impairment such as severe peripheral neuropathy as evidenced by patient reported intermittent claudication and/or signs of ischemia such as "blue toes".

• Allergy to stocking textile material.

• Leg edema or pulmonary edema from congestive heart failure.

• Local skin or soft-tissue condition, including recent skin graft, gangrene, oozing dermatitis and severe cellulitis.

• Extreme deformity of the leg, or unusual leg shape or size that would prevent correct fit.

• Treatment with any diuretics such as furosemide or hydrochlorothiazide.

Related Conditions & MeSH terms

• Nocturia

Intervention

Other:
• Compression stockings
Graduated compression stockings (GCS) are used to treat chronic venous diseases and edema. They help to improve blood flow and prevent blood pooling in the legs. The use of GCS will be in accordance with this indication. The greatest pressure is exerted at the ankle with gradually decreasing pressures up the length of the stockings. GCS are designed for use out of bed and are manufactured using strict medical and technical specifications.

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the level of nocturia	To measure the reduction of nocturia by the absolute change in body weight between morning and night and nocturia events at baseline and after compression stocking use.	Baseline, Day 11-20 visit, Day 21-30 visit
Primary	Change in the quality of life for people with nocturia	To measure the effect of nocturia on Quality of Life by the percent change in QOL score when comparing baseline and 20 days of treatment with compression stockings.	Baseline visit, Day 20 visit