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

Not Applicable

Completed

• Conditions: Benign Prostatic Hyperplasia
• Interventions: Behavioral: the Digital Repetitive Infrapubic Pressure maneuver

• Registration Number: NCT01387893
• Lead Sponsor: Kaiser Permanente

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.

Study Timeline

• Study Start: 2008-05
• Primary Completion: 2009-03
• Study Completion: 2009-11
• Study First Submitted: 2011-06-29
• Study First Submitted QC: 2011-07-01
• Study First Posted: 2011-07-06
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-01
• Last Update Posted: 2015-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Immediate & Delayed Instruction	the Digital Repetitive Infrapubic Pressure maneuver	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.

Primary Outcome Measures

Name	Time	Method
Change in the International Prostate Symptom Score (IPSS)	The initial time frame was to average four weeks. There was a subsequent follow up time frame averaging nine months	The primary efficacy analyses compared the change over time in the IPSS scores between the immediate and the delayed intervention groups, and the changes over time between pre- and post-intervention scores for all patients completing the study.

Secondary Outcome Measures

Name	Time	Method
Continued use of technique following intervention	Nine months after intial 4 week intervention	Secondary efficacy analysis: The number of patients (percentage of patients completing the study) who were still employing the technique on follow-up nine months later.

Trial Locations

Locations (1)

Kaiser Permanente; 🇺🇸 Santa Clara, California, United States