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

NCT ID: NCT01387893

Last Updated: 2015-10-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2009-11-30

Brief Summary

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.

Detailed 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.

Conditions

Benign Prostatic Hyperplasia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Immediate & Delayed Instruction

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.

Group Type: EXPERIMENTAL

the Digital Repetitive Infrapubic Pressure maneuver

Intervention Type: BEHAVIORAL

The Digital Repetitive Infrapubic Pressure maneuver is performed by exerting moderate inwards pressure with the index and middle fingers, spread slightly apart, palm-side up, pushing into the fold of skin at the base of the penis, where it comes forward beneath the pubic bones, one fingertip on each side of the penis' suspensory ligament. By repeatedly pushing inwards and slightly upwards, at a rate of about once per second, to a distance of about two centimeters, at times of significant urinary hesitancy it is often possible either to initiate spontaneous flow, or to pass a small quantity of urine with each push, such that after a minute or two one can empty the bladder to a satisfactory degree. While a few men find it useful when voiding in a standing position, for the majority, the maneuver requires a forward-leaning seated posture for optimal results.

Interventions

the Digital Repetitive Infrapubic Pressure maneuver

The Digital Repetitive Infrapubic Pressure maneuver is performed by exerting moderate inwards pressure with the index and middle fingers, spread slightly apart, palm-side up, pushing into the fold of skin at the base of the penis, where it comes forward beneath the pubic bones, one fingertip on each side of the penis' suspensory ligament. By repeatedly pushing inwards and slightly upwards, at a rate of about once per second, to a distance of about two centimeters, at times of significant urinary hesitancy it is often possible either to initiate spontaneous flow, or to pass a small quantity of urine with each push, such that after a minute or two one can empty the bladder to a satisfactory degree. While a few men find it useful when voiding in a standing position, for the majority, the maneuver requires a forward-leaning seated posture for optimal results.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Kaiser Permanente

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Perrin L French, MD

Role: PRINCIPAL_INVESTIGATOR

Kaiser Permanente Santa Clara

Locations

Kaiser Permanente

Santa Clara, California, United States

Countries

United States

Other Identifiers

02-0115-9922

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CN-07PFren-01-H

Identifier Type: -

Identifier Source: org_study_id