A Self-Administered Maneuver to Relieve Symptoms Suggestive of Benign Prostatic Hyperplasia

Kaiser Permanente

Status: Completed

Conditions: Benign Prostatic Hyperplasia

Treatments: Behavioral: the Digital Repetitive Infrapubic Pressure maneuver

Study type: Interventional

Funder types: Other

Identifiers

NCT01387893

CN-07PFren-01-H

02-0115-9922 (Other Grant/Funding Number)

Details and patient eligibility

About

The objective of this study was to evaluate the effectiveness of the Digital Repetitive Infrapubic Pressure maneuver, a self-administered procedure used to provide symptomatic relief in initiating and maintaining urine flow impeded by benign prostatic hyperplasia.

Full description

Eligible patients were alternately assigned to either immediate instruction on the use of the Digital Repetitive Infrapubic Pressure maneuver (immediate intervention group) or to a return appointment to receive instructions in the maneuver four weeks after the initial assessment date (delayed intervention group). Patients were to utilize the procedure on every occasion they had difficulty initiating, maintaining, or completing urine flow between the time of their instruction and their subsequent visit. At the initial assessment visits and the final visit, the patients completed an International Prostate Score Sheet (IPSS). A telephone survey was conducted with all patients an average of nine months following their instruction in the maneuver, to determine the extent to which they were still using it.

Enrollment: 48 patients

Sex: Male

Ages: 45+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• mild to moderate symptoms of difficulty initiating and maintaining the flow of urine
• not currently receiving treatment for the condition
• not taking an alpha-blocker at least one month before randomization
• not taking 5-alpha reductase inhibitor six months or more before randomization.

Exclusion criteria

• non-ambulatory
• taking medications known to affect urination,
• any of the following: a debilitating concomitant illness, a history of prostate or bladder cancer or prostate surgery or radiation treatment to the pelvis, urethral stricture, neurogenic bladder, current urinary tract infection or otherwise potentially compromised urinary tract systems, a creatinine level of over 3.0 mg per deciliter, or a residual urinary volume after voiding of over 350 cubic centimeters.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 1 patient group

Immediate & Delayed Instruction

Experimental group

Description:

Male patients with mild to moderate lower urinary tract symptoms will alternately be assigned to either immediate intervention or delayed intervention groups. Statistical assessments will be performed to establish comparability of baseline characteristics in the two groups.

Treatment:

Behavioral: the Digital Repetitive Infrapubic Pressure maneuver